User login
Topical tapinarof heads for phase 3 in atopic dermatitis and psoriasis
GENEVA – Tapinarof cream, a first-in-class topical nonsteroidal anti-inflammatory agent, successfully met its primary and secondary efficacy endpoints in a large international, phase 2, dose-ranging study and is moving on to a phase 3 trial for atopic dermatitis.
Tapinarof is a naturally derived compound whose therapeutic mechanism of action has recently been shown to involve activation of the aryl hydrocarbon receptor, Johnny Peppers, PhD, said at the annual congress of the European Academy of Dermatology and Venereology.
GlaxoSmithKline is also developing tapinarof cream for mild to moderate plaque psoriasis, a disease that hasn’t seen a novel nonsteroidal topical therapy approved in more than 25 years. After a strong showing in a phase 2 study, a phase 3 trial in psoriasis is now scheduled.
Dr. Peppers presented a phase 2, double-blind, vehicle-controlled randomized trial including 247 adolescent and adult patients with mild, moderate, or severe atopic dermatitis. The six study arms were tapinarof cream at 1% or 0.5% or vehicle, self-administered at a frequency of either once or twice daily. Participants had a mean baseline Investigator’s Global Assessment (IGA) score of 3.1 on a 5-point scale, an Eczema Area and Severity Index (EASI) score of 9.8-13.1 in the various study arms, and a 5.1-5.8 score on an 11-point self-rated itch severity score recorded weekly.
“The 1% tapinarof arm showed higher efficacy and had a quicker onset of action than the 0.5% arm or vehicle,” he reported.
Indeed, the 1% tapinarof cream groups separated from controls in terms of the efficacy endpoints as early as week 1, with the maximum treatment effect seen at weeks 8-12, Dr. Peppers added.
The primary endpoint was a composite requiring both an IGA of 0 or 1, meaning clear or almost clear, at 12 weeks, along with a minimum 2-point improvement on the IGA from baseline to week 12. This was achieved in 46% of patients on tapinarof cream 1% applied once daily, 53% of those on tapinarof cream 1% twice a day, and in about 25% of controls on vehicle.
Eighty percent of subjects who achieved the primary endpoint maintained that level of treatment effect 2 weeks post treatment, and 70% still held their treatment response 4 weeks after they stopped using the medication.
There were two secondary endpoints. One was achievement of a 75% improvement from baseline on EASI scores (EASI-75) response. This was seen in 51% of the tapinarof 1% once-daily group, 60% on twice a day therapy, and 26% and 25% of controls. Onset of action was fastest with tapinarof cream 1% once daily.
The other secondary endpoint was at least a 3-point improvement from baseline to week 4 on the 11-point self-rated itch scale. This was achieved by 37% and 33% of patients on tapinarof cream 1% once daily and twice daily, respectively, a success rate twice that seen in controls.
Four percent of patients on tapinarof cream and 7% on vehicle discontinued the trial because of treatment-emergent adverse events. There were no serious treatment-related adverse events. The most frequent adverse events associated with tapinarof were folliculitis and contact dermatitis. The phase 3 trial will incorporate patch testing for contact dermatitis.
“We are very excited about this program. This will be the first topical therapy – if we’re able to achieve treatment success and ultimately regulatory approval – that would be able to treat both psoriasis and atopic dermatitis since topical steroids,” Dr. Peppers said.
The study was funded by GlaxoSmithKline and presented by a company employee.
[email protected]
GENEVA – Tapinarof cream, a first-in-class topical nonsteroidal anti-inflammatory agent, successfully met its primary and secondary efficacy endpoints in a large international, phase 2, dose-ranging study and is moving on to a phase 3 trial for atopic dermatitis.
Tapinarof is a naturally derived compound whose therapeutic mechanism of action has recently been shown to involve activation of the aryl hydrocarbon receptor, Johnny Peppers, PhD, said at the annual congress of the European Academy of Dermatology and Venereology.
GlaxoSmithKline is also developing tapinarof cream for mild to moderate plaque psoriasis, a disease that hasn’t seen a novel nonsteroidal topical therapy approved in more than 25 years. After a strong showing in a phase 2 study, a phase 3 trial in psoriasis is now scheduled.
Dr. Peppers presented a phase 2, double-blind, vehicle-controlled randomized trial including 247 adolescent and adult patients with mild, moderate, or severe atopic dermatitis. The six study arms were tapinarof cream at 1% or 0.5% or vehicle, self-administered at a frequency of either once or twice daily. Participants had a mean baseline Investigator’s Global Assessment (IGA) score of 3.1 on a 5-point scale, an Eczema Area and Severity Index (EASI) score of 9.8-13.1 in the various study arms, and a 5.1-5.8 score on an 11-point self-rated itch severity score recorded weekly.
“The 1% tapinarof arm showed higher efficacy and had a quicker onset of action than the 0.5% arm or vehicle,” he reported.
Indeed, the 1% tapinarof cream groups separated from controls in terms of the efficacy endpoints as early as week 1, with the maximum treatment effect seen at weeks 8-12, Dr. Peppers added.
The primary endpoint was a composite requiring both an IGA of 0 or 1, meaning clear or almost clear, at 12 weeks, along with a minimum 2-point improvement on the IGA from baseline to week 12. This was achieved in 46% of patients on tapinarof cream 1% applied once daily, 53% of those on tapinarof cream 1% twice a day, and in about 25% of controls on vehicle.
Eighty percent of subjects who achieved the primary endpoint maintained that level of treatment effect 2 weeks post treatment, and 70% still held their treatment response 4 weeks after they stopped using the medication.
There were two secondary endpoints. One was achievement of a 75% improvement from baseline on EASI scores (EASI-75) response. This was seen in 51% of the tapinarof 1% once-daily group, 60% on twice a day therapy, and 26% and 25% of controls. Onset of action was fastest with tapinarof cream 1% once daily.
The other secondary endpoint was at least a 3-point improvement from baseline to week 4 on the 11-point self-rated itch scale. This was achieved by 37% and 33% of patients on tapinarof cream 1% once daily and twice daily, respectively, a success rate twice that seen in controls.
Four percent of patients on tapinarof cream and 7% on vehicle discontinued the trial because of treatment-emergent adverse events. There were no serious treatment-related adverse events. The most frequent adverse events associated with tapinarof were folliculitis and contact dermatitis. The phase 3 trial will incorporate patch testing for contact dermatitis.
“We are very excited about this program. This will be the first topical therapy – if we’re able to achieve treatment success and ultimately regulatory approval – that would be able to treat both psoriasis and atopic dermatitis since topical steroids,” Dr. Peppers said.
The study was funded by GlaxoSmithKline and presented by a company employee.
[email protected]
GENEVA – Tapinarof cream, a first-in-class topical nonsteroidal anti-inflammatory agent, successfully met its primary and secondary efficacy endpoints in a large international, phase 2, dose-ranging study and is moving on to a phase 3 trial for atopic dermatitis.
Tapinarof is a naturally derived compound whose therapeutic mechanism of action has recently been shown to involve activation of the aryl hydrocarbon receptor, Johnny Peppers, PhD, said at the annual congress of the European Academy of Dermatology and Venereology.
GlaxoSmithKline is also developing tapinarof cream for mild to moderate plaque psoriasis, a disease that hasn’t seen a novel nonsteroidal topical therapy approved in more than 25 years. After a strong showing in a phase 2 study, a phase 3 trial in psoriasis is now scheduled.
Dr. Peppers presented a phase 2, double-blind, vehicle-controlled randomized trial including 247 adolescent and adult patients with mild, moderate, or severe atopic dermatitis. The six study arms were tapinarof cream at 1% or 0.5% or vehicle, self-administered at a frequency of either once or twice daily. Participants had a mean baseline Investigator’s Global Assessment (IGA) score of 3.1 on a 5-point scale, an Eczema Area and Severity Index (EASI) score of 9.8-13.1 in the various study arms, and a 5.1-5.8 score on an 11-point self-rated itch severity score recorded weekly.
“The 1% tapinarof arm showed higher efficacy and had a quicker onset of action than the 0.5% arm or vehicle,” he reported.
Indeed, the 1% tapinarof cream groups separated from controls in terms of the efficacy endpoints as early as week 1, with the maximum treatment effect seen at weeks 8-12, Dr. Peppers added.
The primary endpoint was a composite requiring both an IGA of 0 or 1, meaning clear or almost clear, at 12 weeks, along with a minimum 2-point improvement on the IGA from baseline to week 12. This was achieved in 46% of patients on tapinarof cream 1% applied once daily, 53% of those on tapinarof cream 1% twice a day, and in about 25% of controls on vehicle.
Eighty percent of subjects who achieved the primary endpoint maintained that level of treatment effect 2 weeks post treatment, and 70% still held their treatment response 4 weeks after they stopped using the medication.
There were two secondary endpoints. One was achievement of a 75% improvement from baseline on EASI scores (EASI-75) response. This was seen in 51% of the tapinarof 1% once-daily group, 60% on twice a day therapy, and 26% and 25% of controls. Onset of action was fastest with tapinarof cream 1% once daily.
The other secondary endpoint was at least a 3-point improvement from baseline to week 4 on the 11-point self-rated itch scale. This was achieved by 37% and 33% of patients on tapinarof cream 1% once daily and twice daily, respectively, a success rate twice that seen in controls.
Four percent of patients on tapinarof cream and 7% on vehicle discontinued the trial because of treatment-emergent adverse events. There were no serious treatment-related adverse events. The most frequent adverse events associated with tapinarof were folliculitis and contact dermatitis. The phase 3 trial will incorporate patch testing for contact dermatitis.
“We are very excited about this program. This will be the first topical therapy – if we’re able to achieve treatment success and ultimately regulatory approval – that would be able to treat both psoriasis and atopic dermatitis since topical steroids,” Dr. Peppers said.
The study was funded by GlaxoSmithKline and presented by a company employee.
[email protected]
AT THE EADV CONGRESS
Key clinical point:
Major finding: Forty-six percent of atopic dermatitis patients on tapinarof cream 1% applied once daily, and 53% of atopic dermatitis patients on tapinarof cream applied twice daily, met the primary study endpoint, rates twice those in vehicle-treated controls.
Data source: A phase 2, double-blind, vehicle-controlled, international 12-week clinical trial in 247 adolescents and adults with moderate to severe atopic dermatitis.
Disclosures: The study was funded by GlaxoSmithKline and presented by a company employee.
Tezacaftor-ivacaftor safe, effective in Phe508del CF
, according to results of a 24-week randomized, placebo-controlled clinical trial.
Patients receiving the tezacaftor-ivacaftor combination experienced a mean increase in their percentage of predicted forced expiratory volume in 1 second of 3.4 percentage points, compared with a mean decrease of 0.6 percentage points in the control group, at the end of the trial (P less than .001). The pulmonary exacerbation rate was 35% lower in the tezacaftor-ivacaftor treatment arm than in the placebo arm (P = .005), data show. These results were recently published in the New England Journal of Medicine (2017 Nov 3. doi: 10.1056/NEJMoa1709846).
Ivacaftor was the first approved modulator of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and tezacaftor is an investigational CFTR corrector. Tezacaftor demonstrated efficacy in a previous phase 2 trial that included patients either homozygous for the Phe508del mutation or heterozygous for the Phe508del and G551D mutations, Dr. Taylor-Cousar and her coauthors said in their report.
The combination of ivacaftor and another CFTR corrector, lumacaftor, is already available to treat cystic fibrosis patients who are homozygous for the Phe508del CFTR mutation. However, not all patients can receive lumacaftor-ivacaftor because of its respiratory side effects, and lumacaftor is associated with “prohibitive drug-drug interactions” due to considerable cytochrome P-450-3A induction, according to the study authors.
“The improved safety profile of combination therapy with tezacaftor-ivacaftor, as compared with currently available therapy, in addition to its effect on multiple efficacy end points, supports its use in a broad range of patients with cystic fibrosis,” wrote Dr. Taylor-Cousar and her colleagues.
The phase 3 trial included 509 cystic fibrosis patients at least 12 years of age who were homozygous for the CFTR Phe508del mutation. The mean percentage of predicted forced expiratory volume in 1 second of the patients was 60.0, at baseline.
All patients were randomized to combination therapy with tezacaftor 100 mg once daily and ivacaftor 150 mg twice daily, or matched placebo. A total of 475 patients completed the 24-week trial. The incidence of serious adverse events was just 12.4% of tezacaftor-ivacaftor–treated patients, compared with 18.2% in the placebo arm, and no serious adverse events led to treatment discontinuation.
“The rate of respiratory adverse events was not higher in the tezacaftor-ivacaftor group than in the placebo group, which shows that the safety profile for tezacaftor-ivacaftor is better than that reported for lumacaftor-ivacaftor,” Dr. Taylor-Cousar and her colleagues wrote.
Treatments that modulate CFTR are promising, according to the authors, because they treat the underlying cause of cystic fibrosis.
Vertex Pharmaceuticals supported the study. Dr. Taylor-Cousar reported personal fees from Vertex Pharmaceuticals outside of the submitted work. Full disclosures for all authors were published on the New England Journal of Medicine website.
, according to results of a 24-week randomized, placebo-controlled clinical trial.
Patients receiving the tezacaftor-ivacaftor combination experienced a mean increase in their percentage of predicted forced expiratory volume in 1 second of 3.4 percentage points, compared with a mean decrease of 0.6 percentage points in the control group, at the end of the trial (P less than .001). The pulmonary exacerbation rate was 35% lower in the tezacaftor-ivacaftor treatment arm than in the placebo arm (P = .005), data show. These results were recently published in the New England Journal of Medicine (2017 Nov 3. doi: 10.1056/NEJMoa1709846).
Ivacaftor was the first approved modulator of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and tezacaftor is an investigational CFTR corrector. Tezacaftor demonstrated efficacy in a previous phase 2 trial that included patients either homozygous for the Phe508del mutation or heterozygous for the Phe508del and G551D mutations, Dr. Taylor-Cousar and her coauthors said in their report.
The combination of ivacaftor and another CFTR corrector, lumacaftor, is already available to treat cystic fibrosis patients who are homozygous for the Phe508del CFTR mutation. However, not all patients can receive lumacaftor-ivacaftor because of its respiratory side effects, and lumacaftor is associated with “prohibitive drug-drug interactions” due to considerable cytochrome P-450-3A induction, according to the study authors.
“The improved safety profile of combination therapy with tezacaftor-ivacaftor, as compared with currently available therapy, in addition to its effect on multiple efficacy end points, supports its use in a broad range of patients with cystic fibrosis,” wrote Dr. Taylor-Cousar and her colleagues.
The phase 3 trial included 509 cystic fibrosis patients at least 12 years of age who were homozygous for the CFTR Phe508del mutation. The mean percentage of predicted forced expiratory volume in 1 second of the patients was 60.0, at baseline.
All patients were randomized to combination therapy with tezacaftor 100 mg once daily and ivacaftor 150 mg twice daily, or matched placebo. A total of 475 patients completed the 24-week trial. The incidence of serious adverse events was just 12.4% of tezacaftor-ivacaftor–treated patients, compared with 18.2% in the placebo arm, and no serious adverse events led to treatment discontinuation.
“The rate of respiratory adverse events was not higher in the tezacaftor-ivacaftor group than in the placebo group, which shows that the safety profile for tezacaftor-ivacaftor is better than that reported for lumacaftor-ivacaftor,” Dr. Taylor-Cousar and her colleagues wrote.
Treatments that modulate CFTR are promising, according to the authors, because they treat the underlying cause of cystic fibrosis.
Vertex Pharmaceuticals supported the study. Dr. Taylor-Cousar reported personal fees from Vertex Pharmaceuticals outside of the submitted work. Full disclosures for all authors were published on the New England Journal of Medicine website.
, according to results of a 24-week randomized, placebo-controlled clinical trial.
Patients receiving the tezacaftor-ivacaftor combination experienced a mean increase in their percentage of predicted forced expiratory volume in 1 second of 3.4 percentage points, compared with a mean decrease of 0.6 percentage points in the control group, at the end of the trial (P less than .001). The pulmonary exacerbation rate was 35% lower in the tezacaftor-ivacaftor treatment arm than in the placebo arm (P = .005), data show. These results were recently published in the New England Journal of Medicine (2017 Nov 3. doi: 10.1056/NEJMoa1709846).
Ivacaftor was the first approved modulator of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and tezacaftor is an investigational CFTR corrector. Tezacaftor demonstrated efficacy in a previous phase 2 trial that included patients either homozygous for the Phe508del mutation or heterozygous for the Phe508del and G551D mutations, Dr. Taylor-Cousar and her coauthors said in their report.
The combination of ivacaftor and another CFTR corrector, lumacaftor, is already available to treat cystic fibrosis patients who are homozygous for the Phe508del CFTR mutation. However, not all patients can receive lumacaftor-ivacaftor because of its respiratory side effects, and lumacaftor is associated with “prohibitive drug-drug interactions” due to considerable cytochrome P-450-3A induction, according to the study authors.
“The improved safety profile of combination therapy with tezacaftor-ivacaftor, as compared with currently available therapy, in addition to its effect on multiple efficacy end points, supports its use in a broad range of patients with cystic fibrosis,” wrote Dr. Taylor-Cousar and her colleagues.
The phase 3 trial included 509 cystic fibrosis patients at least 12 years of age who were homozygous for the CFTR Phe508del mutation. The mean percentage of predicted forced expiratory volume in 1 second of the patients was 60.0, at baseline.
All patients were randomized to combination therapy with tezacaftor 100 mg once daily and ivacaftor 150 mg twice daily, or matched placebo. A total of 475 patients completed the 24-week trial. The incidence of serious adverse events was just 12.4% of tezacaftor-ivacaftor–treated patients, compared with 18.2% in the placebo arm, and no serious adverse events led to treatment discontinuation.
“The rate of respiratory adverse events was not higher in the tezacaftor-ivacaftor group than in the placebo group, which shows that the safety profile for tezacaftor-ivacaftor is better than that reported for lumacaftor-ivacaftor,” Dr. Taylor-Cousar and her colleagues wrote.
Treatments that modulate CFTR are promising, according to the authors, because they treat the underlying cause of cystic fibrosis.
Vertex Pharmaceuticals supported the study. Dr. Taylor-Cousar reported personal fees from Vertex Pharmaceuticals outside of the submitted work. Full disclosures for all authors were published on the New England Journal of Medicine website.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: In patients with cystic fibrosis homozygous for the Phe508del mutation, combined tezacaftor-ivacaftor treatment was effective, with a safety profile comparing favorably to currently available therapies.
Major finding: Patients receiving the tezacaftor-ivacaftor combination experienced a mean increase in their percentage of predicted forced expiratory volume in 1 second of 3.4 percentage points, compared with a decrease of 0.6 percentage points in the control group, at the end of the trial (P less than .001).
Data source: A phase 3, randomized, double-blind, multicenter, placebo-controlled, trial (EVOLVE) including 509 patients at least 12 years of age with cystic fibrosis homozygous for the Phe508del CFTR mutation.
Disclosures: Vertex Pharmaceuticals supported the study. First author Jennifer L. Taylor-Cousar, MD, reported personal fees from Vertex Pharmaceuticals outside of the submitted work. Full disclosures for all authors were published on the New England Journal of Medicine website.
Breast cancer margin guidelines reduced re-excisions, cost
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
AT WSA 2017
Key clinical point: Breast cancer margin guidelines may help reduce re-excisions and lower costs.
Major finding: Operative costs per patient fell by $1,218 after the adoption of the “no ink on tumor” guidelines.
Data source: Retrospective analysis of 237 patients undergoing breast conservation surgery.
Disclosures: The study received no external funding. Dr. Ajkay reported having no financial disclosures.
Pilot study finds a more diverse microbiome in preadolescents with acne, compared with controls
The skin microbiome in preadolescents with acne was more diverse than that of controls, and showed some differences from what is known about the microbiome in adults with acne, in a prospective pilot study.
The results have possible treatment implications, suggesting that preadolescents may require a different treatment approach than adults, although additional, larger studies are needed, according to Carrie C. Coughlin, MD, of the division of dermatology in the departments of medicine and pediatrics at Washington University in St. Louis, and her coauthors (Pediatr Dermatol. 2017 Oct 11. doi: 10.1111/pde.13261).
The study enrolled 13 children aged 7-10 years: 5 with acne (3 randomized to treatment with benzoyl peroxide 5% gel or cream and 2 to treatment with tretinoin 0.025% cream), treated for 7-10 weeks; and 8 controls, matched for sex and age.
At baseline, microbiome samples of facial and retroauricular skin among the controls with no acne showed that Streptococcus “was the genus present in highest relative abundance, followed by Propionibacterium,” the authors wrote. In addition to high levels of Streptococcus, those with acne also “had more Staphylococcus and Propionibacterium than controls at all sites before treatment.”
Among those with acne, average Comprehensive Acne Severity Scale values at baseline were 1.3-1.4, among those with acne, dropping to an average of 1 with treatment, which was not statistically significant at follow-up.
But among those with acne, the diversity of cutaneous bacteria decreased with both treatments, down to levels similar to controls, which was a significant effect (P less than .001). This was a “notable” finding, they wrote, “because benzoyl peroxide and tretinoin are known as comedolytic, but tretinoin is not typically thought of as having antibacterial properties like benzoyl peroxide.”
This observation “suggests that topical retinoids may have an effect on the local microbiome through alterations in the cutaneous microenvironment rather than having direct effects on resident microorganisms,” they added.
The authors also pointed out that in the microbiome of adults with acne, Propionibacterium has been found to be more prevalent, indicating that different treatments may be indicated in preadolescents.
The study was funded with a clinical research grant from the American Acne and Rosacea Society.
Recent work has highlighted distinct differences in the cutaneous microbiota of acne sufferers versus those who tend not to “break out,” specifically, decreased bacterial diversity, increased Propionibacterium acnes and Staphylococcus aureus, and importantly, specific ribotypes of P. acnes (not all P. acnes is created equal in the eyes of acne vulgaris). There are also emerging data highlighting the impact of both topical and systemic acne medications on this altered bacterial community, though the significance of such changes has yet to be determined. However, these findings are predominantly derived from the adult population, and just as pediatric skin is not just little adult skin, acne can be morphologically different in this population. And no question, the microbiota here is different from adults.
In their pilot study, Coughlin et al. set out to evaluate the alterations in cutaneous microbiota in adolescents with acne versus healthy controls. Interestingly, as opposed to adults, adolescent acne sufferers have greater bacterial diversity, with a high predominance of streptococcus in addition to P. acnes and S. aureus. No surprise, benzoyl peroxide brought diversity down as it is “-cidal” to everything (even our cells).
While a small sample size, two big questions emerge from this study: Why does bacterial diversity increase in pediatric acne patients but decreases in adults with acne? And what is the significance of streptococcus in pediatric acne? Certainly, the clinical morphology of pediatric acne (more comedonal as per the authors) is different than that of adult female acne (cystic and clinically inflamed nodules), for example. Do specific alterations in the skin microbiome directly impact lesion type? We shall see.
Adam Friedman, MD, is residency program director, and director of translational research, in the department of dermatology, George Washington University, Washington. He had no relevant disclosures. Dr. Friedman is a member of the Dermatology News editorial board.
Recent work has highlighted distinct differences in the cutaneous microbiota of acne sufferers versus those who tend not to “break out,” specifically, decreased bacterial diversity, increased Propionibacterium acnes and Staphylococcus aureus, and importantly, specific ribotypes of P. acnes (not all P. acnes is created equal in the eyes of acne vulgaris). There are also emerging data highlighting the impact of both topical and systemic acne medications on this altered bacterial community, though the significance of such changes has yet to be determined. However, these findings are predominantly derived from the adult population, and just as pediatric skin is not just little adult skin, acne can be morphologically different in this population. And no question, the microbiota here is different from adults.
In their pilot study, Coughlin et al. set out to evaluate the alterations in cutaneous microbiota in adolescents with acne versus healthy controls. Interestingly, as opposed to adults, adolescent acne sufferers have greater bacterial diversity, with a high predominance of streptococcus in addition to P. acnes and S. aureus. No surprise, benzoyl peroxide brought diversity down as it is “-cidal” to everything (even our cells).
While a small sample size, two big questions emerge from this study: Why does bacterial diversity increase in pediatric acne patients but decreases in adults with acne? And what is the significance of streptococcus in pediatric acne? Certainly, the clinical morphology of pediatric acne (more comedonal as per the authors) is different than that of adult female acne (cystic and clinically inflamed nodules), for example. Do specific alterations in the skin microbiome directly impact lesion type? We shall see.
Adam Friedman, MD, is residency program director, and director of translational research, in the department of dermatology, George Washington University, Washington. He had no relevant disclosures. Dr. Friedman is a member of the Dermatology News editorial board.
Recent work has highlighted distinct differences in the cutaneous microbiota of acne sufferers versus those who tend not to “break out,” specifically, decreased bacterial diversity, increased Propionibacterium acnes and Staphylococcus aureus, and importantly, specific ribotypes of P. acnes (not all P. acnes is created equal in the eyes of acne vulgaris). There are also emerging data highlighting the impact of both topical and systemic acne medications on this altered bacterial community, though the significance of such changes has yet to be determined. However, these findings are predominantly derived from the adult population, and just as pediatric skin is not just little adult skin, acne can be morphologically different in this population. And no question, the microbiota here is different from adults.
In their pilot study, Coughlin et al. set out to evaluate the alterations in cutaneous microbiota in adolescents with acne versus healthy controls. Interestingly, as opposed to adults, adolescent acne sufferers have greater bacterial diversity, with a high predominance of streptococcus in addition to P. acnes and S. aureus. No surprise, benzoyl peroxide brought diversity down as it is “-cidal” to everything (even our cells).
While a small sample size, two big questions emerge from this study: Why does bacterial diversity increase in pediatric acne patients but decreases in adults with acne? And what is the significance of streptococcus in pediatric acne? Certainly, the clinical morphology of pediatric acne (more comedonal as per the authors) is different than that of adult female acne (cystic and clinically inflamed nodules), for example. Do specific alterations in the skin microbiome directly impact lesion type? We shall see.
Adam Friedman, MD, is residency program director, and director of translational research, in the department of dermatology, George Washington University, Washington. He had no relevant disclosures. Dr. Friedman is a member of the Dermatology News editorial board.
The skin microbiome in preadolescents with acne was more diverse than that of controls, and showed some differences from what is known about the microbiome in adults with acne, in a prospective pilot study.
The results have possible treatment implications, suggesting that preadolescents may require a different treatment approach than adults, although additional, larger studies are needed, according to Carrie C. Coughlin, MD, of the division of dermatology in the departments of medicine and pediatrics at Washington University in St. Louis, and her coauthors (Pediatr Dermatol. 2017 Oct 11. doi: 10.1111/pde.13261).
The study enrolled 13 children aged 7-10 years: 5 with acne (3 randomized to treatment with benzoyl peroxide 5% gel or cream and 2 to treatment with tretinoin 0.025% cream), treated for 7-10 weeks; and 8 controls, matched for sex and age.
At baseline, microbiome samples of facial and retroauricular skin among the controls with no acne showed that Streptococcus “was the genus present in highest relative abundance, followed by Propionibacterium,” the authors wrote. In addition to high levels of Streptococcus, those with acne also “had more Staphylococcus and Propionibacterium than controls at all sites before treatment.”
Among those with acne, average Comprehensive Acne Severity Scale values at baseline were 1.3-1.4, among those with acne, dropping to an average of 1 with treatment, which was not statistically significant at follow-up.
But among those with acne, the diversity of cutaneous bacteria decreased with both treatments, down to levels similar to controls, which was a significant effect (P less than .001). This was a “notable” finding, they wrote, “because benzoyl peroxide and tretinoin are known as comedolytic, but tretinoin is not typically thought of as having antibacterial properties like benzoyl peroxide.”
This observation “suggests that topical retinoids may have an effect on the local microbiome through alterations in the cutaneous microenvironment rather than having direct effects on resident microorganisms,” they added.
The authors also pointed out that in the microbiome of adults with acne, Propionibacterium has been found to be more prevalent, indicating that different treatments may be indicated in preadolescents.
The study was funded with a clinical research grant from the American Acne and Rosacea Society.
The skin microbiome in preadolescents with acne was more diverse than that of controls, and showed some differences from what is known about the microbiome in adults with acne, in a prospective pilot study.
The results have possible treatment implications, suggesting that preadolescents may require a different treatment approach than adults, although additional, larger studies are needed, according to Carrie C. Coughlin, MD, of the division of dermatology in the departments of medicine and pediatrics at Washington University in St. Louis, and her coauthors (Pediatr Dermatol. 2017 Oct 11. doi: 10.1111/pde.13261).
The study enrolled 13 children aged 7-10 years: 5 with acne (3 randomized to treatment with benzoyl peroxide 5% gel or cream and 2 to treatment with tretinoin 0.025% cream), treated for 7-10 weeks; and 8 controls, matched for sex and age.
At baseline, microbiome samples of facial and retroauricular skin among the controls with no acne showed that Streptococcus “was the genus present in highest relative abundance, followed by Propionibacterium,” the authors wrote. In addition to high levels of Streptococcus, those with acne also “had more Staphylococcus and Propionibacterium than controls at all sites before treatment.”
Among those with acne, average Comprehensive Acne Severity Scale values at baseline were 1.3-1.4, among those with acne, dropping to an average of 1 with treatment, which was not statistically significant at follow-up.
But among those with acne, the diversity of cutaneous bacteria decreased with both treatments, down to levels similar to controls, which was a significant effect (P less than .001). This was a “notable” finding, they wrote, “because benzoyl peroxide and tretinoin are known as comedolytic, but tretinoin is not typically thought of as having antibacterial properties like benzoyl peroxide.”
This observation “suggests that topical retinoids may have an effect on the local microbiome through alterations in the cutaneous microenvironment rather than having direct effects on resident microorganisms,” they added.
The authors also pointed out that in the microbiome of adults with acne, Propionibacterium has been found to be more prevalent, indicating that different treatments may be indicated in preadolescents.
The study was funded with a clinical research grant from the American Acne and Rosacea Society.
FROM PEDIATRIC DERMATOLOGY
Key clinical point:
Major finding: The skin microbiome was more diverse among preadolescents with acne, compared with age-matched controls without acne, and Streptococcus was the predominant bacterium.
Data source: A prospective randomized pilot study that evaluated the skin microbiome of five preadolescents with acne, before and after treatment, and eight without acne.
Disclosures: The study was supported with a grant from the American Acne and Rosacea Society.
VIDEO: Revised guidelines raise lung cancer screening age ceiling
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations. 
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations.
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations.
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM CHEST 2017
Dasatinib approved to treat kids with CML
The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel®).
The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
This approval was granted under priority review, and the drug received orphan designation for this indication.
The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.
The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.
For more details, see the full prescribing information.
Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Pediatric studies
The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.
There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.
Ninety-one patients received dasatinib at 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.
The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.
The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).
At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.
At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.
The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.
Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%). 
The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel®).
The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
This approval was granted under priority review, and the drug received orphan designation for this indication.
The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.
The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.
For more details, see the full prescribing information.
Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Pediatric studies
The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.
There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.
Ninety-one patients received dasatinib at 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.
The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.
The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).
At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.
At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.
The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.
Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).
The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel®).
The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
This approval was granted under priority review, and the drug received orphan designation for this indication.
The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.
The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.
For more details, see the full prescribing information.
Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Pediatric studies
The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.
There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.
Ninety-one patients received dasatinib at 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.
The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.
The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).
At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.
At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.
The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.
Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).
Omalizumab helps asthma COPD overlap patients
TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.
While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.
Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).
Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.
“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported.
Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.
Postbronchodilator FEV1 at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV1 was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.
Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.
Adverse events were consistent with the known safety profile of omalizumab.
“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.
Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.
TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.
While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.
Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).
Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.
“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported.
Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.
Postbronchodilator FEV1 at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV1 was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.
Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.
Adverse events were consistent with the known safety profile of omalizumab.
“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.
Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.
TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.
While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.
Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).
Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.
“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported.
Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.
Postbronchodilator FEV1 at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV1 was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.
Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.
Adverse events were consistent with the known safety profile of omalizumab.
“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.
Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.
AT CHEST 2017
Key clinical point: In patients with asthma COPD overlap (ACO), treatment with omalizumab was associated with decreased asthma exacerbations and improved symptom control, similar to that seen in non-ACO asthma patients.
Major finding: Asthma exacerbation numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.
Data source: Subgroup analysis from a prospective observational study of omalizumab that focused on 78 patients (from 737 total) that had asthma and comorbid COPD according to one of two definitions.
Disclosures: Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Genentech sponsored the study and employs three of the investigators.
VIDEO: Light-based scar treatments improve more than just cosmetic appearance
LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.
In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.
In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.
In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Laparoscopic management of chronic pelvic pain utilizing J-Plasma
Dr. McCoy is Adjunct Assistant Professor, Obstetrics and Gynecology, University of Missouri—Columbia.
Dr. McCoy reports that he is a consultant, speaker, and serves on the medical advisory board of Bovie Medical Corporation.
Dr. McCoy is Adjunct Assistant Professor, Obstetrics and Gynecology, University of Missouri—Columbia.
Dr. McCoy reports that he is a consultant, speaker, and serves on the medical advisory board of Bovie Medical Corporation.
Dr. McCoy is Adjunct Assistant Professor, Obstetrics and Gynecology, University of Missouri—Columbia.
Dr. McCoy reports that he is a consultant, speaker, and serves on the medical advisory board of Bovie Medical Corporation.
VIDEO: MBSAQIP data looks at sleeve gastrectomy outcomes
Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.