Nonmelanoma Skin Cancer

Actinic keratosis (AK) is the most common cutaneous lesion and is regarded as a precursor to nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC).¹ Field cancerization refers to broad areas of chronically sun-exposed skin that show cumulative sun damage in the form of clinical and subclinical lesions. It is not feasible to treat large areas with multiple overt and subclinical lesions using surgical methods, and photodynamic therapy (PDT) has become a preferred method for treatment of field cancerization.² Topical PDT uses the heme biosynthesis pathway precursors aminolevulinic acid (ALA) or methyl ALA (MAL), which localizes in the treatment area and is metabolized to protoporphyrin IX.³ After an incubation period, activation by a light source results in the formation of cytotoxic oxygen species,⁴ with reports of efficacy over large areas and excellent cosmetic outcomes.²

Laser ablative fractional resurfacing (AFR) also has been investigated as a treatment of AKs; CO₂ laser AFR treatment resulted in a short-term reduction in the number of AK lesions and appeared to reduce the development of new lesions.⁵ However, case reports and small studies have indicated that pretreatment with laser AFR can increase the efficacy of PDT by creating microscopic vertical channels facilitating deeper penetration and uptake of the ALA.⁶ The use of erbium:YAG lasers in combination with PDT has demonstrated notable clinical and aesthetic improvements in treating basal cell carcinomas (BCCs)⁷ and AKs,⁸ with enhanced efficacy in moderate to thick AKs in particular. Hædersdal et al⁶ reported that CO₂ laser AFR facilitated delivery of MAL into porcine skin, with AFR appearing to bypass the stratum corneum and deliver the treatment to the deep dermis.

The combination of CO₂ laser AFR and PDT has shown statistically significant increases in efficacy for treatment of AKs compared to PDT alone (P<.001).⁹ In a small study, Alexiades¹⁰ reported a statistically significant improvement in AKs at 4 and 8 weeks posttreatment for 10 patients receiving CO₂ laser AFR-PDT vs conventional PDT (P<.05). Studies of organ transplant recipients—who are at higher risk for AK and NMSC development—demonstrated favorable results for combined CO₂ laser AFR and PDT vs either laser treatment¹¹ or PDT^9,12 alone, with significant reductions in the number of AKs (P=.002). Results were maintained for 3 to 4 months after treatment. Additional studies have shown that combining CO₂ laser AFR and PDT may reduce the PDT incubation time or number of treatments required to achieve a response over conventional PDT.^13,14

Our proof-of-concept study was designed to assess efficacy of CO₂ laser AFR to enhance an approved drug delivery system in the treatment of AK and NMSC. The objective was to compare effect and durability of AFR-PDT vs standard ALA-PDT in the treatment of AK and NMSCs in a split-sided study of various body locations.

Methods

This randomized, split-sided study compared CO₂ laser AFR-PDT to standard ALA-PDT for the treatment of AK and NMSC conducted at 1 site in Los Gatos, California. Patients who had a skin cancer screening and received a biopsy diagnosis of AK or NMSC were invited to attend an enrollment visit. Key inclusion criteria for enrollment were male or female patients aged 40 to 85 years with notable symmetrically comparable photodamage (at least 1 AK per square centimeter) in 1 or more skin areas—scalp, face, or distal extremities—with presence of clinically identifiable NMSCs proven by biopsy. Key exclusion criteria were patients who were pregnant; patients with epilepsy, seizures, or a photosensitive disorder; those taking photosensitizing medication (eg, doxycycline, hydrochlorothiazide); or immunocompromised patients. The study was approved by an institutional review board (Salus IRB [Austin, Texas]), and each participant underwent a complete and informed consent process.

Laterality for pretreatment with AFR followed by ALA-PDT vs ALA-PDT alone was determined at the time of treatment using a computer-based random number generator; even numbers resulted in pretreatment of the right side, and odd numbers resulted in pretreatment of the left side. Because of the difference in pretreatment methods for the 2 sides, it was not possible to perform the procedure under blinded conditions.

The treatment area was prepared by defatting the entire site with 70% isopropyl alcohol, followed by benzalkonium chloride antibacterial cleansing for the AFR pretreatment side. A 7% lidocaine/7% tetracaine ointment was applied under polyethylene wrap occlusion to the AFR pretreatment side for 20 minutes. Additionally, nerve blocks and field blocks with a mixture of 1.1% lidocaine with epinephrine/0.5% bupivacaine with epinephrine were performed wherever feasible. After 20 minutes, the lidocaine-tetracaine ointment was removed with isopropanol, and AFR treatment commenced immediately with the SmartXide DOT laser (DEKA)(1 pass of 25 W, 1200-microsecond duration at 500-µm spacing, 200-µm spot size, achieving 12% surface area ablation). Hyperkeratotic treated areas were debrided with saline and received a second pass with the laser. Aminolevulinic acid solution 20% (Levulan Kerastick; DUSA Pharmaceuticals, Inc)¹⁵ was applied to both sides of the treatment area and allowed to absorb for a 1-hour incubation period, which was followed by blue-light exposure at a power density of 10 mW/cm² for 16 minutes and 40 seconds using the BLU-U Photodynamic Therapy Illuminator (DUSA Pharmaceuticals, Inc). Areas treated with AFR were then covered with a layer of Aquaphor ointment (Beiersdorf, Inc) and an absorptive hydrogel dressing for48 to 96 hours, with continued application of the ointment until resolution of all crusting. After treatment, patients were instructed to avoid direct sun exposure, wear a hat or visor for the first 2 weeks posttreatment when outdoors, and apply sunscreen with a sun protection factor greater than 30 once skin had healed.

Results

Twenty-four potential participants experiencing AKs and/or NMSCs were screened for the study, with 19 meeting inclusion criteria. All participants were white, non-Hispanic, and had Fitzpatrick skin types I or II. Treated areas for all participants had field cancerization defined as at least 1 AK per square centimeter. All 19 participants enrolled in the study completed the posttreatment evaluations up to 6 months. All AFR-pretreated sites showed superior results in reduction in number, size, or hyperkeratosis of AKs at all follow-up visits, with a complete absence of new AK formation at the 6-month follow-up (Table). Conversely, sites treated with standard PDT only showed some recurrence of AKs at 6 months. Of the 3 participants who had biopsy-confirmed BCCs on the AFR-pretreated side, there were 3 persistent lesions after treatment at the 6-month visit. Two participants experienced persistence of a confirmed SCC in situ that was on the laser-pretreated side only (1 on the forehead and 1 on the hand), whereas 1 participant with an SCC on the leg at baseline had no recurrence at 6 months. A participant who received treatment on the lower lip had persistence of actinic cheilitis on both the AFR- and non–AFR-treated sides of the lip.

Scalp and facial sites healed fully in an average of 7 days, whereas upper extremities—forearm and hands—took approximately 14 days to heal completely. Lower extremity AFR-pretreated sites exhibited substantial weeping, resulting in prolonged healing of approximately 21 days for resolution of all scabbing. Pain during treatment was mild to moderate, as field blocks with local anesthesia and topical anesthetic were used prior to AFR treatment. No novel adverse events were reported in the combined use of laser AFR and PDT; all adverse events noted have been recorded in studies of the separate techniques.^16,17

Comment

In this split-sided study in patients with field cancerization, the use of CO₂ laser AFR before treatment with PDT increased AK lesion clearance compared to ALA-PDT alone. Prior studies of fractional laser–assisted drug delivery on porcine skin using topical MAL showed that laser channels approximately 3-mm apart were able to distribute protoporphyrin through the entire skin.⁶ The ablative nature of AFR theoretically provides deeper and more effusive penetration of the ALA solution than using conventional PDT or erbium:YAG lasers with PDT.^7,8 Helsing et al¹¹ applied CO₂ laser AFR MAL-PDT to AKs in organ transplant recipients and obtained complete responses in 73% of patients compared to a complete response of 31% for AFR alone. The results reported in our study are consistent with Helsing et al,¹¹ showing a complete clinical response for 14 of 19 patients (74%), of whom 4 (21%) had no recurrence of NMSC and 10 (53%) had no recurrence of AK on the AFR-PDT–treated side.

The pretreatment process required for the laser AFR added time to the initial visit compared to conventional PDT, which is balanced by a reduced PDT incubation time (1 hour vs the approved indication of 14–18 hours for face/scalp or 3 hours for upper extremities under occlusion). The use of microneedling as an alternative pretreatment procedure before PDT also has been investigated, with the aim of decreasing the optimum ALA absorption time. The mean reduction in AKs (89.3%) was significantly greater than for PDT alone (69.5%; P<.05) in a small study by Spencer and Freeman.¹⁸ Although microneedling is less time-intensive and labor-intensive than laser AFR, the photocoagulative effect and subsequent microhemorrhages resulting from AFR should result in much deeper penetration of ALA solution than for microneedling.

The limitations of this proof-of-concept study arose from the small sample size of 19 participants and the short follow-up period of 6 months. Furthermore, the unblinded nature of the study could create selection, detection, or reporting bias. Further follow-up appointments would aid in determining the longevity of results, which may encourage future use of this technique, despite the time-consuming preparation. A larger study with follow-up greater than 1 year would be beneficial, particularly for monitoring remission from SCCs and BCCs.

Conclusion

Pretreatment with CO₂ laser AFR before ALA-PDT provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone (Figure). Additionally, the incubation period for ALA absorption can be reduced before PDT, leading to a shorter treatment time overall. The benefits of AFR pretreatment on AK clearance demonstrated in this study warrant further investigation in a larger trial with a longer follow-up period to monitor maintenance of response.

Actinic keratosis (AK) is the most common cutaneous lesion and is regarded as a precursor to nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC).¹ Field cancerization refers to broad areas of chronically sun-exposed skin that show cumulative sun damage in the form of clinical and subclinical lesions. It is not feasible to treat large areas with multiple overt and subclinical lesions using surgical methods, and photodynamic therapy (PDT) has become a preferred method for treatment of field cancerization.² Topical PDT uses the heme biosynthesis pathway precursors aminolevulinic acid (ALA) or methyl ALA (MAL), which localizes in the treatment area and is metabolized to protoporphyrin IX.³ After an incubation period, activation by a light source results in the formation of cytotoxic oxygen species,⁴ with reports of efficacy over large areas and excellent cosmetic outcomes.²

Laser ablative fractional resurfacing (AFR) also has been investigated as a treatment of AKs; CO₂ laser AFR treatment resulted in a short-term reduction in the number of AK lesions and appeared to reduce the development of new lesions.⁵ However, case reports and small studies have indicated that pretreatment with laser AFR can increase the efficacy of PDT by creating microscopic vertical channels facilitating deeper penetration and uptake of the ALA.⁶ The use of erbium:YAG lasers in combination with PDT has demonstrated notable clinical and aesthetic improvements in treating basal cell carcinomas (BCCs)⁷ and AKs,⁸ with enhanced efficacy in moderate to thick AKs in particular. Hædersdal et al⁶ reported that CO₂ laser AFR facilitated delivery of MAL into porcine skin, with AFR appearing to bypass the stratum corneum and deliver the treatment to the deep dermis.

The combination of CO₂ laser AFR and PDT has shown statistically significant increases in efficacy for treatment of AKs compared to PDT alone (P<.001).⁹ In a small study, Alexiades¹⁰ reported a statistically significant improvement in AKs at 4 and 8 weeks posttreatment for 10 patients receiving CO₂ laser AFR-PDT vs conventional PDT (P<.05). Studies of organ transplant recipients—who are at higher risk for AK and NMSC development—demonstrated favorable results for combined CO₂ laser AFR and PDT vs either laser treatment¹¹ or PDT^9,12 alone, with significant reductions in the number of AKs (P=.002). Results were maintained for 3 to 4 months after treatment. Additional studies have shown that combining CO₂ laser AFR and PDT may reduce the PDT incubation time or number of treatments required to achieve a response over conventional PDT.^13,14

Our proof-of-concept study was designed to assess efficacy of CO₂ laser AFR to enhance an approved drug delivery system in the treatment of AK and NMSC. The objective was to compare effect and durability of AFR-PDT vs standard ALA-PDT in the treatment of AK and NMSCs in a split-sided study of various body locations.

Methods

This randomized, split-sided study compared CO₂ laser AFR-PDT to standard ALA-PDT for the treatment of AK and NMSC conducted at 1 site in Los Gatos, California. Patients who had a skin cancer screening and received a biopsy diagnosis of AK or NMSC were invited to attend an enrollment visit. Key inclusion criteria for enrollment were male or female patients aged 40 to 85 years with notable symmetrically comparable photodamage (at least 1 AK per square centimeter) in 1 or more skin areas—scalp, face, or distal extremities—with presence of clinically identifiable NMSCs proven by biopsy. Key exclusion criteria were patients who were pregnant; patients with epilepsy, seizures, or a photosensitive disorder; those taking photosensitizing medication (eg, doxycycline, hydrochlorothiazide); or immunocompromised patients. The study was approved by an institutional review board (Salus IRB [Austin, Texas]), and each participant underwent a complete and informed consent process.

Laterality for pretreatment with AFR followed by ALA-PDT vs ALA-PDT alone was determined at the time of treatment using a computer-based random number generator; even numbers resulted in pretreatment of the right side, and odd numbers resulted in pretreatment of the left side. Because of the difference in pretreatment methods for the 2 sides, it was not possible to perform the procedure under blinded conditions.

The treatment area was prepared by defatting the entire site with 70% isopropyl alcohol, followed by benzalkonium chloride antibacterial cleansing for the AFR pretreatment side. A 7% lidocaine/7% tetracaine ointment was applied under polyethylene wrap occlusion to the AFR pretreatment side for 20 minutes. Additionally, nerve blocks and field blocks with a mixture of 1.1% lidocaine with epinephrine/0.5% bupivacaine with epinephrine were performed wherever feasible. After 20 minutes, the lidocaine-tetracaine ointment was removed with isopropanol, and AFR treatment commenced immediately with the SmartXide DOT laser (DEKA)(1 pass of 25 W, 1200-microsecond duration at 500-µm spacing, 200-µm spot size, achieving 12% surface area ablation). Hyperkeratotic treated areas were debrided with saline and received a second pass with the laser. Aminolevulinic acid solution 20% (Levulan Kerastick; DUSA Pharmaceuticals, Inc)¹⁵ was applied to both sides of the treatment area and allowed to absorb for a 1-hour incubation period, which was followed by blue-light exposure at a power density of 10 mW/cm² for 16 minutes and 40 seconds using the BLU-U Photodynamic Therapy Illuminator (DUSA Pharmaceuticals, Inc). Areas treated with AFR were then covered with a layer of Aquaphor ointment (Beiersdorf, Inc) and an absorptive hydrogel dressing for48 to 96 hours, with continued application of the ointment until resolution of all crusting. After treatment, patients were instructed to avoid direct sun exposure, wear a hat or visor for the first 2 weeks posttreatment when outdoors, and apply sunscreen with a sun protection factor greater than 30 once skin had healed.

Results

Twenty-four potential participants experiencing AKs and/or NMSCs were screened for the study, with 19 meeting inclusion criteria. All participants were white, non-Hispanic, and had Fitzpatrick skin types I or II. Treated areas for all participants had field cancerization defined as at least 1 AK per square centimeter. All 19 participants enrolled in the study completed the posttreatment evaluations up to 6 months. All AFR-pretreated sites showed superior results in reduction in number, size, or hyperkeratosis of AKs at all follow-up visits, with a complete absence of new AK formation at the 6-month follow-up (Table). Conversely, sites treated with standard PDT only showed some recurrence of AKs at 6 months. Of the 3 participants who had biopsy-confirmed BCCs on the AFR-pretreated side, there were 3 persistent lesions after treatment at the 6-month visit. Two participants experienced persistence of a confirmed SCC in situ that was on the laser-pretreated side only (1 on the forehead and 1 on the hand), whereas 1 participant with an SCC on the leg at baseline had no recurrence at 6 months. A participant who received treatment on the lower lip had persistence of actinic cheilitis on both the AFR- and non–AFR-treated sides of the lip.

Scalp and facial sites healed fully in an average of 7 days, whereas upper extremities—forearm and hands—took approximately 14 days to heal completely. Lower extremity AFR-pretreated sites exhibited substantial weeping, resulting in prolonged healing of approximately 21 days for resolution of all scabbing. Pain during treatment was mild to moderate, as field blocks with local anesthesia and topical anesthetic were used prior to AFR treatment. No novel adverse events were reported in the combined use of laser AFR and PDT; all adverse events noted have been recorded in studies of the separate techniques.^16,17

Comment

In this split-sided study in patients with field cancerization, the use of CO₂ laser AFR before treatment with PDT increased AK lesion clearance compared to ALA-PDT alone. Prior studies of fractional laser–assisted drug delivery on porcine skin using topical MAL showed that laser channels approximately 3-mm apart were able to distribute protoporphyrin through the entire skin.⁶ The ablative nature of AFR theoretically provides deeper and more effusive penetration of the ALA solution than using conventional PDT or erbium:YAG lasers with PDT.^7,8 Helsing et al¹¹ applied CO₂ laser AFR MAL-PDT to AKs in organ transplant recipients and obtained complete responses in 73% of patients compared to a complete response of 31% for AFR alone. The results reported in our study are consistent with Helsing et al,¹¹ showing a complete clinical response for 14 of 19 patients (74%), of whom 4 (21%) had no recurrence of NMSC and 10 (53%) had no recurrence of AK on the AFR-PDT–treated side.

The pretreatment process required for the laser AFR added time to the initial visit compared to conventional PDT, which is balanced by a reduced PDT incubation time (1 hour vs the approved indication of 14–18 hours for face/scalp or 3 hours for upper extremities under occlusion). The use of microneedling as an alternative pretreatment procedure before PDT also has been investigated, with the aim of decreasing the optimum ALA absorption time. The mean reduction in AKs (89.3%) was significantly greater than for PDT alone (69.5%; P<.05) in a small study by Spencer and Freeman.¹⁸ Although microneedling is less time-intensive and labor-intensive than laser AFR, the photocoagulative effect and subsequent microhemorrhages resulting from AFR should result in much deeper penetration of ALA solution than for microneedling.

The limitations of this proof-of-concept study arose from the small sample size of 19 participants and the short follow-up period of 6 months. Furthermore, the unblinded nature of the study could create selection, detection, or reporting bias. Further follow-up appointments would aid in determining the longevity of results, which may encourage future use of this technique, despite the time-consuming preparation. A larger study with follow-up greater than 1 year would be beneficial, particularly for monitoring remission from SCCs and BCCs.

Conclusion

Pretreatment with CO₂ laser AFR before ALA-PDT provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone (Figure). Additionally, the incubation period for ALA absorption can be reduced before PDT, leading to a shorter treatment time overall. The benefits of AFR pretreatment on AK clearance demonstrated in this study warrant further investigation in a larger trial with a longer follow-up period to monitor maintenance of response.

Actinic keratosis (AK) is the most common cutaneous lesion and is regarded as a precursor to nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC).¹ Field cancerization refers to broad areas of chronically sun-exposed skin that show cumulative sun damage in the form of clinical and subclinical lesions. It is not feasible to treat large areas with multiple overt and subclinical lesions using surgical methods, and photodynamic therapy (PDT) has become a preferred method for treatment of field cancerization.² Topical PDT uses the heme biosynthesis pathway precursors aminolevulinic acid (ALA) or methyl ALA (MAL), which localizes in the treatment area and is metabolized to protoporphyrin IX.³ After an incubation period, activation by a light source results in the formation of cytotoxic oxygen species,⁴ with reports of efficacy over large areas and excellent cosmetic outcomes.²

Laser ablative fractional resurfacing (AFR) also has been investigated as a treatment of AKs; CO₂ laser AFR treatment resulted in a short-term reduction in the number of AK lesions and appeared to reduce the development of new lesions.⁵ However, case reports and small studies have indicated that pretreatment with laser AFR can increase the efficacy of PDT by creating microscopic vertical channels facilitating deeper penetration and uptake of the ALA.⁶ The use of erbium:YAG lasers in combination with PDT has demonstrated notable clinical and aesthetic improvements in treating basal cell carcinomas (BCCs)⁷ and AKs,⁸ with enhanced efficacy in moderate to thick AKs in particular. Hædersdal et al⁶ reported that CO₂ laser AFR facilitated delivery of MAL into porcine skin, with AFR appearing to bypass the stratum corneum and deliver the treatment to the deep dermis.

The combination of CO₂ laser AFR and PDT has shown statistically significant increases in efficacy for treatment of AKs compared to PDT alone (P<.001).⁹ In a small study, Alexiades¹⁰ reported a statistically significant improvement in AKs at 4 and 8 weeks posttreatment for 10 patients receiving CO₂ laser AFR-PDT vs conventional PDT (P<.05). Studies of organ transplant recipients—who are at higher risk for AK and NMSC development—demonstrated favorable results for combined CO₂ laser AFR and PDT vs either laser treatment¹¹ or PDT^9,12 alone, with significant reductions in the number of AKs (P=.002). Results were maintained for 3 to 4 months after treatment. Additional studies have shown that combining CO₂ laser AFR and PDT may reduce the PDT incubation time or number of treatments required to achieve a response over conventional PDT.^13,14

Our proof-of-concept study was designed to assess efficacy of CO₂ laser AFR to enhance an approved drug delivery system in the treatment of AK and NMSC. The objective was to compare effect and durability of AFR-PDT vs standard ALA-PDT in the treatment of AK and NMSCs in a split-sided study of various body locations.

Methods

This randomized, split-sided study compared CO₂ laser AFR-PDT to standard ALA-PDT for the treatment of AK and NMSC conducted at 1 site in Los Gatos, California. Patients who had a skin cancer screening and received a biopsy diagnosis of AK or NMSC were invited to attend an enrollment visit. Key inclusion criteria for enrollment were male or female patients aged 40 to 85 years with notable symmetrically comparable photodamage (at least 1 AK per square centimeter) in 1 or more skin areas—scalp, face, or distal extremities—with presence of clinically identifiable NMSCs proven by biopsy. Key exclusion criteria were patients who were pregnant; patients with epilepsy, seizures, or a photosensitive disorder; those taking photosensitizing medication (eg, doxycycline, hydrochlorothiazide); or immunocompromised patients. The study was approved by an institutional review board (Salus IRB [Austin, Texas]), and each participant underwent a complete and informed consent process.

Laterality for pretreatment with AFR followed by ALA-PDT vs ALA-PDT alone was determined at the time of treatment using a computer-based random number generator; even numbers resulted in pretreatment of the right side, and odd numbers resulted in pretreatment of the left side. Because of the difference in pretreatment methods for the 2 sides, it was not possible to perform the procedure under blinded conditions.

The treatment area was prepared by defatting the entire site with 70% isopropyl alcohol, followed by benzalkonium chloride antibacterial cleansing for the AFR pretreatment side. A 7% lidocaine/7% tetracaine ointment was applied under polyethylene wrap occlusion to the AFR pretreatment side for 20 minutes. Additionally, nerve blocks and field blocks with a mixture of 1.1% lidocaine with epinephrine/0.5% bupivacaine with epinephrine were performed wherever feasible. After 20 minutes, the lidocaine-tetracaine ointment was removed with isopropanol, and AFR treatment commenced immediately with the SmartXide DOT laser (DEKA)(1 pass of 25 W, 1200-microsecond duration at 500-µm spacing, 200-µm spot size, achieving 12% surface area ablation). Hyperkeratotic treated areas were debrided with saline and received a second pass with the laser. Aminolevulinic acid solution 20% (Levulan Kerastick; DUSA Pharmaceuticals, Inc)¹⁵ was applied to both sides of the treatment area and allowed to absorb for a 1-hour incubation period, which was followed by blue-light exposure at a power density of 10 mW/cm² for 16 minutes and 40 seconds using the BLU-U Photodynamic Therapy Illuminator (DUSA Pharmaceuticals, Inc). Areas treated with AFR were then covered with a layer of Aquaphor ointment (Beiersdorf, Inc) and an absorptive hydrogel dressing for48 to 96 hours, with continued application of the ointment until resolution of all crusting. After treatment, patients were instructed to avoid direct sun exposure, wear a hat or visor for the first 2 weeks posttreatment when outdoors, and apply sunscreen with a sun protection factor greater than 30 once skin had healed.

Results

Twenty-four potential participants experiencing AKs and/or NMSCs were screened for the study, with 19 meeting inclusion criteria. All participants were white, non-Hispanic, and had Fitzpatrick skin types I or II. Treated areas for all participants had field cancerization defined as at least 1 AK per square centimeter. All 19 participants enrolled in the study completed the posttreatment evaluations up to 6 months. All AFR-pretreated sites showed superior results in reduction in number, size, or hyperkeratosis of AKs at all follow-up visits, with a complete absence of new AK formation at the 6-month follow-up (Table). Conversely, sites treated with standard PDT only showed some recurrence of AKs at 6 months. Of the 3 participants who had biopsy-confirmed BCCs on the AFR-pretreated side, there were 3 persistent lesions after treatment at the 6-month visit. Two participants experienced persistence of a confirmed SCC in situ that was on the laser-pretreated side only (1 on the forehead and 1 on the hand), whereas 1 participant with an SCC on the leg at baseline had no recurrence at 6 months. A participant who received treatment on the lower lip had persistence of actinic cheilitis on both the AFR- and non–AFR-treated sides of the lip.

Scalp and facial sites healed fully in an average of 7 days, whereas upper extremities—forearm and hands—took approximately 14 days to heal completely. Lower extremity AFR-pretreated sites exhibited substantial weeping, resulting in prolonged healing of approximately 21 days for resolution of all scabbing. Pain during treatment was mild to moderate, as field blocks with local anesthesia and topical anesthetic were used prior to AFR treatment. No novel adverse events were reported in the combined use of laser AFR and PDT; all adverse events noted have been recorded in studies of the separate techniques.^16,17

Comment

In this split-sided study in patients with field cancerization, the use of CO₂ laser AFR before treatment with PDT increased AK lesion clearance compared to ALA-PDT alone. Prior studies of fractional laser–assisted drug delivery on porcine skin using topical MAL showed that laser channels approximately 3-mm apart were able to distribute protoporphyrin through the entire skin.⁶ The ablative nature of AFR theoretically provides deeper and more effusive penetration of the ALA solution than using conventional PDT or erbium:YAG lasers with PDT.^7,8 Helsing et al¹¹ applied CO₂ laser AFR MAL-PDT to AKs in organ transplant recipients and obtained complete responses in 73% of patients compared to a complete response of 31% for AFR alone. The results reported in our study are consistent with Helsing et al,¹¹ showing a complete clinical response for 14 of 19 patients (74%), of whom 4 (21%) had no recurrence of NMSC and 10 (53%) had no recurrence of AK on the AFR-PDT–treated side.

The pretreatment process required for the laser AFR added time to the initial visit compared to conventional PDT, which is balanced by a reduced PDT incubation time (1 hour vs the approved indication of 14–18 hours for face/scalp or 3 hours for upper extremities under occlusion). The use of microneedling as an alternative pretreatment procedure before PDT also has been investigated, with the aim of decreasing the optimum ALA absorption time. The mean reduction in AKs (89.3%) was significantly greater than for PDT alone (69.5%; P<.05) in a small study by Spencer and Freeman.¹⁸ Although microneedling is less time-intensive and labor-intensive than laser AFR, the photocoagulative effect and subsequent microhemorrhages resulting from AFR should result in much deeper penetration of ALA solution than for microneedling.

The limitations of this proof-of-concept study arose from the small sample size of 19 participants and the short follow-up period of 6 months. Furthermore, the unblinded nature of the study could create selection, detection, or reporting bias. Further follow-up appointments would aid in determining the longevity of results, which may encourage future use of this technique, despite the time-consuming preparation. A larger study with follow-up greater than 1 year would be beneficial, particularly for monitoring remission from SCCs and BCCs.

Conclusion

Pretreatment with CO₂ laser AFR before ALA-PDT provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone (Figure). Additionally, the incubation period for ALA absorption can be reduced before PDT, leading to a shorter treatment time overall. The benefits of AFR pretreatment on AK clearance demonstrated in this study warrant further investigation in a larger trial with a longer follow-up period to monitor maintenance of response.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.