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MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
IV Thrombolysis Offers No Benefit for Mild Stroke
BASEL, SWITZERLAND — , a new trial has concluded.
Results from the randomized controlled trial TEMPO-2 showed no benefit from treatment with tenecteplase following ischemic stroke. In addition, investigators found a small increased risk for symptomatic intracranial hemorrhage (ICH) and more deaths in the tenecteplase group compared with the control group.
The research suggests that although it makes sense to open up vessels in patients with minor stroke, they didn’t do better with thrombolysis.
“This is not the result we were hoping for, but I think the question of whether to treat these minor stroke patients who are not disabled has now been answered,” said lead investigator Shelagh B. Coutts, MD, University of Calgary, Alberta, Canada.
“After these results, I think we should scan these patients, admit them, give them dual antiplatelet therapy and IV fluids, and watch them like a hawk. If they deteriorate, we can intervene at that point.”
The findings were presented at the European Stroke Organization Conference (ESOC) 2024 annual meeting and published online simultaneously in The Lancet.
Very Little Data
Up to half of patients with ischemic stroke initially present with minimal symptoms, which are not disabling, investigators noted. Despite having low scores on the National Institutes of Health Stroke Scale (NIHSS) that typically range from 0 to 5, a third of these patients are dead or disabled at 90-day follow-up if thrombolysis is withheld.
Patients with minor deficits and evidence of an intracranial occlusion are a subpopulation at a high risk for early neurological deterioration, which most often occurs within the first 24 hours after presentation.
However, many physicians have concerns about giving thrombolysis to these patients because of the potential harm from bleeding in the absence of major deficits, and most trials of thrombolysis have excluded patients with minor stroke. That leaves very little high-quality data to guide practice for these patients.
Two previous studies have compared alteplase with antiplatelet agents in minor stroke, but no trial has specifically looked at the subset of patients with minor stroke who have intracranial occlusion. The TEMPO-2 trial was conducted to evaluate the use of tenecteplase in this patient population.
The multicenter, parallel group, open-label study was conducted at 48 hospitals in Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, and the United Kingdom.
The trial included patients with minor acute ischemic stroke (NIHSS score of 0-5) and intracranial occlusion or focal perfusion abnormality who were within 12 hours from stroke onset.
Patients received IV tenecteplase (0.25 mg/kg) or non-thrombolytic standard of care (control). Most patients in the control group were treated with dual antiplatelet therapy with aspirin and clopidogrel (57%) or aspirin monotherapy (23%).
The trial was stopped early for futility after 886 patients had been enrolled. The median NIHSS score was 2.
The primary outcome — a return to baseline functioning on the modified Rankin Scale score at 90 days — occurred in 75% of the control group and in 72% of the tenecteplase group (risk ratio [RR], 0.96; P = .29).
Although there were significantly more patients with early recanalization and an NIHSS score of 0 at day 5 or discharge after tenecteplase treatment, this did not translate into improved functional outcomes at 90 days.
More patients died in the tenecteplase group compared with the control group (5% vs 1%; adjusted hazard ratio, 3.8; P = .0085).
There were eight (2%) symptomatic ICHs in the tenecteplase group versus two (< 1%) in the control group (RR, 4.2; P = .059).
The ICH rate was not different in patients treated after 4.5 hours versus before 4.5 hours. The subgroup of patients treated at 4.5-12.0 hours showed weaker evidence of better outcomes with thrombolysis than those treated before 4.5 hours, suggesting that the 12-hour window for TEMPO-2 did not explain the absence of benefit seen with tenecteplase.
Patients in the control group did better than expected, which may have been the result of chance, patient selection, or greater use of dual antiplatelet therapy, researchers noted.
Despite higher recanalization rates in the tenecteplase group (48% vs 22%), there was no change in the rate of stroke progression between groups, with an 8% rate of progression seen overall in the study.
Noting that previous studies have shown that patients with minor stroke and intracranial occlusion are at a risk for both progression and disability, the authors suggested that good supportive care may have improved outcomes in both groups.
More Trials Needed
Commenting on the study at the ESOC meeting, Urs Fischer, MD, Basel University Hospital, Switzerland, said “What should we do for patients with mild stroke with vessel occlusion has been a huge unanswered question. The TEMPO-2 study did not show a benefit with thrombolysis, and there was a tendency toward an increased risk of ICH. This is an important finding.”
In an accompanying editorial, Simona Sacco, MD, University of L’Aquila, Italy, and Guillaume Turc, MD, Université Paris Cité, France, noted that different minor ischemic stroke populations pose different therapeutic challenges.
Observational data suggest a benefit of endovascular treatment for minor stroke with large vessel occlusion, and dedicated randomized controlled trials in this group are ongoing, they added.
Early dual antiplatelet treatment is now the recommended treatment of minor stroke and should therefore be the active comparator for non-cardioembolic strokes in future trials.
While TEMPO-2 did not prove that tenecteplase is better than the standard of care for the acute treatment of minor stroke, Dr. Sacco and Dr. Turc said the study confirms that tenecteplase is associated with a high rate of recanalization.
“Fast recanalization with intravenous thrombolysis, endovascular treatment, proper patient selection, and combination with dual antiplatelet treatment or early initiation of anticoagulants may translate into tangible clinical benefits for patients with minor ischemic stroke, which should be tested in future studies,” they wrote.
This trial was funded by grants from the Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and the British Heart Foundation. Boehringer Ingelheim provided tenecteplase for the study. Dr. Coutts reported no conflicts of interest. Dr. Sacco reported receiving grants for research from Novartis and Uriach; consulting fees from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; payment for lectures from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; and support for attending conferences from Lilly, Novartis, Teva, Lundbeck, and Pfizer. She is president elect of the European Stroke Organization and editor-in-chief of Cephalalgia. Dr. Turc reported payment for lectures from Guerbet France, is a member of the scientific advisory board of AI-Stroke, and is the Secretary General of the European Stroke Organisation.
A version of this article appeared on Medscape.com.
BASEL, SWITZERLAND — , a new trial has concluded.
Results from the randomized controlled trial TEMPO-2 showed no benefit from treatment with tenecteplase following ischemic stroke. In addition, investigators found a small increased risk for symptomatic intracranial hemorrhage (ICH) and more deaths in the tenecteplase group compared with the control group.
The research suggests that although it makes sense to open up vessels in patients with minor stroke, they didn’t do better with thrombolysis.
“This is not the result we were hoping for, but I think the question of whether to treat these minor stroke patients who are not disabled has now been answered,” said lead investigator Shelagh B. Coutts, MD, University of Calgary, Alberta, Canada.
“After these results, I think we should scan these patients, admit them, give them dual antiplatelet therapy and IV fluids, and watch them like a hawk. If they deteriorate, we can intervene at that point.”
The findings were presented at the European Stroke Organization Conference (ESOC) 2024 annual meeting and published online simultaneously in The Lancet.
Very Little Data
Up to half of patients with ischemic stroke initially present with minimal symptoms, which are not disabling, investigators noted. Despite having low scores on the National Institutes of Health Stroke Scale (NIHSS) that typically range from 0 to 5, a third of these patients are dead or disabled at 90-day follow-up if thrombolysis is withheld.
Patients with minor deficits and evidence of an intracranial occlusion are a subpopulation at a high risk for early neurological deterioration, which most often occurs within the first 24 hours after presentation.
However, many physicians have concerns about giving thrombolysis to these patients because of the potential harm from bleeding in the absence of major deficits, and most trials of thrombolysis have excluded patients with minor stroke. That leaves very little high-quality data to guide practice for these patients.
Two previous studies have compared alteplase with antiplatelet agents in minor stroke, but no trial has specifically looked at the subset of patients with minor stroke who have intracranial occlusion. The TEMPO-2 trial was conducted to evaluate the use of tenecteplase in this patient population.
The multicenter, parallel group, open-label study was conducted at 48 hospitals in Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, and the United Kingdom.
The trial included patients with minor acute ischemic stroke (NIHSS score of 0-5) and intracranial occlusion or focal perfusion abnormality who were within 12 hours from stroke onset.
Patients received IV tenecteplase (0.25 mg/kg) or non-thrombolytic standard of care (control). Most patients in the control group were treated with dual antiplatelet therapy with aspirin and clopidogrel (57%) or aspirin monotherapy (23%).
The trial was stopped early for futility after 886 patients had been enrolled. The median NIHSS score was 2.
The primary outcome — a return to baseline functioning on the modified Rankin Scale score at 90 days — occurred in 75% of the control group and in 72% of the tenecteplase group (risk ratio [RR], 0.96; P = .29).
Although there were significantly more patients with early recanalization and an NIHSS score of 0 at day 5 or discharge after tenecteplase treatment, this did not translate into improved functional outcomes at 90 days.
More patients died in the tenecteplase group compared with the control group (5% vs 1%; adjusted hazard ratio, 3.8; P = .0085).
There were eight (2%) symptomatic ICHs in the tenecteplase group versus two (< 1%) in the control group (RR, 4.2; P = .059).
The ICH rate was not different in patients treated after 4.5 hours versus before 4.5 hours. The subgroup of patients treated at 4.5-12.0 hours showed weaker evidence of better outcomes with thrombolysis than those treated before 4.5 hours, suggesting that the 12-hour window for TEMPO-2 did not explain the absence of benefit seen with tenecteplase.
Patients in the control group did better than expected, which may have been the result of chance, patient selection, or greater use of dual antiplatelet therapy, researchers noted.
Despite higher recanalization rates in the tenecteplase group (48% vs 22%), there was no change in the rate of stroke progression between groups, with an 8% rate of progression seen overall in the study.
Noting that previous studies have shown that patients with minor stroke and intracranial occlusion are at a risk for both progression and disability, the authors suggested that good supportive care may have improved outcomes in both groups.
More Trials Needed
Commenting on the study at the ESOC meeting, Urs Fischer, MD, Basel University Hospital, Switzerland, said “What should we do for patients with mild stroke with vessel occlusion has been a huge unanswered question. The TEMPO-2 study did not show a benefit with thrombolysis, and there was a tendency toward an increased risk of ICH. This is an important finding.”
In an accompanying editorial, Simona Sacco, MD, University of L’Aquila, Italy, and Guillaume Turc, MD, Université Paris Cité, France, noted that different minor ischemic stroke populations pose different therapeutic challenges.
Observational data suggest a benefit of endovascular treatment for minor stroke with large vessel occlusion, and dedicated randomized controlled trials in this group are ongoing, they added.
Early dual antiplatelet treatment is now the recommended treatment of minor stroke and should therefore be the active comparator for non-cardioembolic strokes in future trials.
While TEMPO-2 did not prove that tenecteplase is better than the standard of care for the acute treatment of minor stroke, Dr. Sacco and Dr. Turc said the study confirms that tenecteplase is associated with a high rate of recanalization.
“Fast recanalization with intravenous thrombolysis, endovascular treatment, proper patient selection, and combination with dual antiplatelet treatment or early initiation of anticoagulants may translate into tangible clinical benefits for patients with minor ischemic stroke, which should be tested in future studies,” they wrote.
This trial was funded by grants from the Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and the British Heart Foundation. Boehringer Ingelheim provided tenecteplase for the study. Dr. Coutts reported no conflicts of interest. Dr. Sacco reported receiving grants for research from Novartis and Uriach; consulting fees from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; payment for lectures from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; and support for attending conferences from Lilly, Novartis, Teva, Lundbeck, and Pfizer. She is president elect of the European Stroke Organization and editor-in-chief of Cephalalgia. Dr. Turc reported payment for lectures from Guerbet France, is a member of the scientific advisory board of AI-Stroke, and is the Secretary General of the European Stroke Organisation.
A version of this article appeared on Medscape.com.
BASEL, SWITZERLAND — , a new trial has concluded.
Results from the randomized controlled trial TEMPO-2 showed no benefit from treatment with tenecteplase following ischemic stroke. In addition, investigators found a small increased risk for symptomatic intracranial hemorrhage (ICH) and more deaths in the tenecteplase group compared with the control group.
The research suggests that although it makes sense to open up vessels in patients with minor stroke, they didn’t do better with thrombolysis.
“This is not the result we were hoping for, but I think the question of whether to treat these minor stroke patients who are not disabled has now been answered,” said lead investigator Shelagh B. Coutts, MD, University of Calgary, Alberta, Canada.
“After these results, I think we should scan these patients, admit them, give them dual antiplatelet therapy and IV fluids, and watch them like a hawk. If they deteriorate, we can intervene at that point.”
The findings were presented at the European Stroke Organization Conference (ESOC) 2024 annual meeting and published online simultaneously in The Lancet.
Very Little Data
Up to half of patients with ischemic stroke initially present with minimal symptoms, which are not disabling, investigators noted. Despite having low scores on the National Institutes of Health Stroke Scale (NIHSS) that typically range from 0 to 5, a third of these patients are dead or disabled at 90-day follow-up if thrombolysis is withheld.
Patients with minor deficits and evidence of an intracranial occlusion are a subpopulation at a high risk for early neurological deterioration, which most often occurs within the first 24 hours after presentation.
However, many physicians have concerns about giving thrombolysis to these patients because of the potential harm from bleeding in the absence of major deficits, and most trials of thrombolysis have excluded patients with minor stroke. That leaves very little high-quality data to guide practice for these patients.
Two previous studies have compared alteplase with antiplatelet agents in minor stroke, but no trial has specifically looked at the subset of patients with minor stroke who have intracranial occlusion. The TEMPO-2 trial was conducted to evaluate the use of tenecteplase in this patient population.
The multicenter, parallel group, open-label study was conducted at 48 hospitals in Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, and the United Kingdom.
The trial included patients with minor acute ischemic stroke (NIHSS score of 0-5) and intracranial occlusion or focal perfusion abnormality who were within 12 hours from stroke onset.
Patients received IV tenecteplase (0.25 mg/kg) or non-thrombolytic standard of care (control). Most patients in the control group were treated with dual antiplatelet therapy with aspirin and clopidogrel (57%) or aspirin monotherapy (23%).
The trial was stopped early for futility after 886 patients had been enrolled. The median NIHSS score was 2.
The primary outcome — a return to baseline functioning on the modified Rankin Scale score at 90 days — occurred in 75% of the control group and in 72% of the tenecteplase group (risk ratio [RR], 0.96; P = .29).
Although there were significantly more patients with early recanalization and an NIHSS score of 0 at day 5 or discharge after tenecteplase treatment, this did not translate into improved functional outcomes at 90 days.
More patients died in the tenecteplase group compared with the control group (5% vs 1%; adjusted hazard ratio, 3.8; P = .0085).
There were eight (2%) symptomatic ICHs in the tenecteplase group versus two (< 1%) in the control group (RR, 4.2; P = .059).
The ICH rate was not different in patients treated after 4.5 hours versus before 4.5 hours. The subgroup of patients treated at 4.5-12.0 hours showed weaker evidence of better outcomes with thrombolysis than those treated before 4.5 hours, suggesting that the 12-hour window for TEMPO-2 did not explain the absence of benefit seen with tenecteplase.
Patients in the control group did better than expected, which may have been the result of chance, patient selection, or greater use of dual antiplatelet therapy, researchers noted.
Despite higher recanalization rates in the tenecteplase group (48% vs 22%), there was no change in the rate of stroke progression between groups, with an 8% rate of progression seen overall in the study.
Noting that previous studies have shown that patients with minor stroke and intracranial occlusion are at a risk for both progression and disability, the authors suggested that good supportive care may have improved outcomes in both groups.
More Trials Needed
Commenting on the study at the ESOC meeting, Urs Fischer, MD, Basel University Hospital, Switzerland, said “What should we do for patients with mild stroke with vessel occlusion has been a huge unanswered question. The TEMPO-2 study did not show a benefit with thrombolysis, and there was a tendency toward an increased risk of ICH. This is an important finding.”
In an accompanying editorial, Simona Sacco, MD, University of L’Aquila, Italy, and Guillaume Turc, MD, Université Paris Cité, France, noted that different minor ischemic stroke populations pose different therapeutic challenges.
Observational data suggest a benefit of endovascular treatment for minor stroke with large vessel occlusion, and dedicated randomized controlled trials in this group are ongoing, they added.
Early dual antiplatelet treatment is now the recommended treatment of minor stroke and should therefore be the active comparator for non-cardioembolic strokes in future trials.
While TEMPO-2 did not prove that tenecteplase is better than the standard of care for the acute treatment of minor stroke, Dr. Sacco and Dr. Turc said the study confirms that tenecteplase is associated with a high rate of recanalization.
“Fast recanalization with intravenous thrombolysis, endovascular treatment, proper patient selection, and combination with dual antiplatelet treatment or early initiation of anticoagulants may translate into tangible clinical benefits for patients with minor ischemic stroke, which should be tested in future studies,” they wrote.
This trial was funded by grants from the Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and the British Heart Foundation. Boehringer Ingelheim provided tenecteplase for the study. Dr. Coutts reported no conflicts of interest. Dr. Sacco reported receiving grants for research from Novartis and Uriach; consulting fees from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; payment for lectures from Novartis, Allergan-AbbVie, Teva, Lilly, Lundbeck, Pfizer, Novo Nordisk, Abbott, and AstraZeneca; and support for attending conferences from Lilly, Novartis, Teva, Lundbeck, and Pfizer. She is president elect of the European Stroke Organization and editor-in-chief of Cephalalgia. Dr. Turc reported payment for lectures from Guerbet France, is a member of the scientific advisory board of AI-Stroke, and is the Secretary General of the European Stroke Organisation.
A version of this article appeared on Medscape.com.
FROM ESOC 2024
Reimbursement for Mohs Surgery Not Keeping Up With Health Care Costs
PHOENIX — Medicare cuts, which are expected to continue, have exacerbated this issue even further.
“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”
Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.
“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.
Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.
The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”
However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.
Decreased Reimbursement for All Procedures
Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.
The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.
Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.
When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.
“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
Dangerous Trend
The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.
“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”
The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
PHOENIX — Medicare cuts, which are expected to continue, have exacerbated this issue even further.
“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”
Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.
“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.
Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.
The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”
However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.
Decreased Reimbursement for All Procedures
Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.
The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.
Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.
When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.
“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
Dangerous Trend
The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.
“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”
The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
PHOENIX — Medicare cuts, which are expected to continue, have exacerbated this issue even further.
“This ongoing downward trend in inflation-adjusted reimbursement may lead to delayed patient access to quality dermatology surgical care,” said lead study author Lily Park, DO, a resident in the Department of Dermatology, Larkin Community Hospital, Miami. “This trend will lead to reduced access.”
Dr. Park emphasized that reimbursement for Mohs surgery has also been further affected by the multiple surgery reduction rule, which is where Medicare pays less for the second and subsequent procedures performed during the same patient encounter. Reductions may be calculated in several ways, depending on what kind of procedure or service is involved.
“The Mohs surgery community needs to be aware of this financial trend and actively engage with healthcare policymakers to ensure the establishment of a sustainable payment infrastructure,” she said.
Dr. Park presented the study results at the annual meeting of the American College of Mohs Surgery.
The landscape of healthcare economics continues to evolve and has been further complicated by rising inflation. In addition, a 2% cut to the Medicare payment conversion factor was implemented in 2023, followed by a further 3.37% cut in early 2024 — which was cut by half in March 2024, with an additional cut expected this year, she noted. “This has presented more challenges for dermatologic surgeons who are already dealing with the rising healthcare costs.”
However, despite these financial challenges, there is a lack of research on physician reimbursement for dermatologic procedures, including surgery.
Decreased Reimbursement for All Procedures
Dr. Park and colleagues analyzed trends in Medicare reimbursement rates for Mohs micrographic surgery and several other common dermatologic procedures. Beginning with 2007, they calculated the inflation-adjusted values for each year’s non-facility prices for all codes except Current Procedural Terminology (CPT) codes 11102 and 11104. For those two codes, inflation-adjusted prices were based on the prices in 2019, the year when the codes were first introduced. The authors estimated the inflation adjusted value for each year based on the non-facility price for 2007, and the difference between the rate of inflation and the change in physician reimbursement over time was calculated.
The six most commonly performed procedures in 2023, ranked in descending order of frequency, were identified as CPT 17000, used for the removal of actinic keratosis; CPT 11102, used for biopsy of skin; CPT 17110, used for the destruction of benign lesions such as seborrheic keratoses and warts; CPT 17311, used for the destruction of malignant lesions (including Mohs surgery); CPT 11104, which is also related to biopsy of skin; and CPT 10060, used for incision and drainage of abscess.
Their analysis showed that all CPT codes experienced a decline when compared with their inflation-adjusted values. Both Mohs surgery (17311) and benign destruction of premalignant lesions (17000) showed a decrease of 46% in reimbursement during an inflation-adjusted 18-year time span between 2007 and 2024.
When adjusted for inflation, Dr. Park noted, reimbursement for CPT 17311 and 17000 should actually be increased by 42% and 41% in 2024, respectively. The greatest declines in reimbursement were seen during the last 4 years.
“Future legislation, such as H.R.2474, a bill proposing inflation-based updates to physician pay, would aid us in the future if implemented,” said Dr. Park.
Dangerous Trend
The finding that payments have declined for many common dermatologic procedures since 2007 “is particularly important given the rising cost of healthcare delivery,” said Jesse M. Lewin, MD, who was asked to comment on the study results. “The administrative burden of electronic medical records, filing, and following up insurance claims has necessitated the employment of more non-physician staff to support these tasks,” he told this news organization.
“Declining reimbursement for Mohs surgery and other cancer-related procedures is a dangerous trend, as the ultimate impact will be the effect it has on quality and accessibility of skin cancer care for patients,” added Dr. Lewin, chief of Mohs micrographic and dermatologic surgery and vice chair of surgical operations at the Icahn School of Medicine at Mount Sinai, New York City. “This is an important study that reinforces physician engagement in healthcare policy and legislation to advocate for our specialty and patients.”
The study was independently supported. Dr. Park and Dr. Lewin, who was not involved with the study, reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM ACMS 2024
Ob.Gyns. Can Help Patients Manage Weight With Anti-Obesity Medications
SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.
Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.
Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.
“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”
Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
Starting With the Basics
Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”
Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.
“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.
Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.
“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”
Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
Three Pharmacotherapy Categories
Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.
The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.
These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.
Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.
Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”
Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
The GLP-1 Receptor Agonists
Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.
“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”
The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.
- Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
- Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
- Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.
The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.
“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.
It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
Getting Patients Started
All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.
Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.
For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.
”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.
This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”
A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.
“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”
Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.
Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.
Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.
No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.
SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.
Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.
Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.
“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”
Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
Starting With the Basics
Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”
Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.
“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.
Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.
“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”
Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
Three Pharmacotherapy Categories
Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.
The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.
These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.
Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.
Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”
Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
The GLP-1 Receptor Agonists
Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.
“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”
The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.
- Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
- Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
- Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.
The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.
“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.
It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
Getting Patients Started
All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.
Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.
For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.
”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.
This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”
A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.
“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”
Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.
Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.
Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.
No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.
SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.
Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.
Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.
“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”
Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
Starting With the Basics
Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”
Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.
“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.
Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.
“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”
Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
Three Pharmacotherapy Categories
Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.
The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.
These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.
Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.
Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”
Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
The GLP-1 Receptor Agonists
Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.
“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”
The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.
- Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
- Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
- Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.
The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.
“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.
It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
Getting Patients Started
All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.
Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.
For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.
”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.
This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”
A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.
“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”
Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.
Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.
Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.
No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.
FROM ACOG 2024
Debate on pulmonary safety of gas stoves: Is the risk just hot air?
SAN DIEGO — While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.
The debate was held at the American Thoracic Society’s international conference.
PRO: Gas stoves cause lung disease
Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”
Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.
“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.
The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.
The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.
Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
Con: More evidence needed
Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”
But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).
The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.
Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.
Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.
Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.
And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
On common ground
Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.
Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.
“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
End indoor combustion
George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.
Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.
“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.
Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.
SAN DIEGO — While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.
The debate was held at the American Thoracic Society’s international conference.
PRO: Gas stoves cause lung disease
Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”
Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.
“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.
The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.
The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.
Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
Con: More evidence needed
Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”
But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).
The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.
Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.
Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.
Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.
And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
On common ground
Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.
Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.
“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
End indoor combustion
George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.
Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.
“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.
Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.
SAN DIEGO — While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.
The debate was held at the American Thoracic Society’s international conference.
PRO: Gas stoves cause lung disease
Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”
Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.
“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.
The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.
The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.
Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
Con: More evidence needed
Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”
But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).
The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.
Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.
Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.
Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.
And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
On common ground
Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.
Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.
“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
End indoor combustion
George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.
Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.
“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.
Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.
FROM ATS 2024
Genetic Test Can Predict Response to Semaglutide for Weight Loss
TOPLINE:
, new evidence reveals.
METHODOLOGY:
- A machine learning genetic risk score can identify people with the hungry gut obesity phenotype, which has been found to be associated with greater weight loss with the glucagon-like peptide 1 receptor agonists (GLP-1 RA) liraglutide and exenatide.
- For this study, researchers calculated the genetic risk score for 84 adults undergoing weight loss interventions at Mayo Clinic who were prescribed the GLP-1 RA semaglutide.
- Study participants were classified as the obesity phenotype hungry gut positive (n = 51) or hungry gut negative (n = 33).
- The researchers measured total body weight loss at 3, 6, 9, and 12 months and assessed the ability of the score to predict the response to semaglutide (defined as ≥ 5% of total body weight loss measured at 12 months).
TAKEAWAY:
- At 3 and 6 months, there were no significant differences in weight loss between the hungry gut positive and hungry gut negative groups.
- By 9 months, participants in the positive group lost 14.4% of their total body weight compared with 10.3% in case of participants in the negative group (P = .045).
- After a total of 12 months, the positive group lost 19.5% of their total body weight compared with 10.0% in case of participants in the negative group (P = .01).
- When used to predict the response to semaglutide, the area under the curve for the machine-learning genetic risk score was 0.76 (95% CI, 0.57-0.94; P = .04).
IN PRACTICE:
We can now tell with confidence who is going to respond to semaglutide, said Andres Acosta, MD, PhD, associate professor of medicine at Mayo Clinic. “For nonresponders, we can think about other interventions or medications that we have available.”
SOURCE:
This study was presented on May 20, 2024, at the annual Digestive Disease Week® (DDW) (Abstract 638).
LIMITATIONS:
Further prospective studies are needed to assess the validity of the test in a more diverse population and with different weight loss interventions.
DISCLOSURES:
This study was supported by a partnership between Mayo Clinic and Phenomix Sciences. Dr. Acosta is a cofounder of Phenomix Sciences.
A version of this article appeared on Medscape.com.
TOPLINE:
, new evidence reveals.
METHODOLOGY:
- A machine learning genetic risk score can identify people with the hungry gut obesity phenotype, which has been found to be associated with greater weight loss with the glucagon-like peptide 1 receptor agonists (GLP-1 RA) liraglutide and exenatide.
- For this study, researchers calculated the genetic risk score for 84 adults undergoing weight loss interventions at Mayo Clinic who were prescribed the GLP-1 RA semaglutide.
- Study participants were classified as the obesity phenotype hungry gut positive (n = 51) or hungry gut negative (n = 33).
- The researchers measured total body weight loss at 3, 6, 9, and 12 months and assessed the ability of the score to predict the response to semaglutide (defined as ≥ 5% of total body weight loss measured at 12 months).
TAKEAWAY:
- At 3 and 6 months, there were no significant differences in weight loss between the hungry gut positive and hungry gut negative groups.
- By 9 months, participants in the positive group lost 14.4% of their total body weight compared with 10.3% in case of participants in the negative group (P = .045).
- After a total of 12 months, the positive group lost 19.5% of their total body weight compared with 10.0% in case of participants in the negative group (P = .01).
- When used to predict the response to semaglutide, the area under the curve for the machine-learning genetic risk score was 0.76 (95% CI, 0.57-0.94; P = .04).
IN PRACTICE:
We can now tell with confidence who is going to respond to semaglutide, said Andres Acosta, MD, PhD, associate professor of medicine at Mayo Clinic. “For nonresponders, we can think about other interventions or medications that we have available.”
SOURCE:
This study was presented on May 20, 2024, at the annual Digestive Disease Week® (DDW) (Abstract 638).
LIMITATIONS:
Further prospective studies are needed to assess the validity of the test in a more diverse population and with different weight loss interventions.
DISCLOSURES:
This study was supported by a partnership between Mayo Clinic and Phenomix Sciences. Dr. Acosta is a cofounder of Phenomix Sciences.
A version of this article appeared on Medscape.com.
TOPLINE:
, new evidence reveals.
METHODOLOGY:
- A machine learning genetic risk score can identify people with the hungry gut obesity phenotype, which has been found to be associated with greater weight loss with the glucagon-like peptide 1 receptor agonists (GLP-1 RA) liraglutide and exenatide.
- For this study, researchers calculated the genetic risk score for 84 adults undergoing weight loss interventions at Mayo Clinic who were prescribed the GLP-1 RA semaglutide.
- Study participants were classified as the obesity phenotype hungry gut positive (n = 51) or hungry gut negative (n = 33).
- The researchers measured total body weight loss at 3, 6, 9, and 12 months and assessed the ability of the score to predict the response to semaglutide (defined as ≥ 5% of total body weight loss measured at 12 months).
TAKEAWAY:
- At 3 and 6 months, there were no significant differences in weight loss between the hungry gut positive and hungry gut negative groups.
- By 9 months, participants in the positive group lost 14.4% of their total body weight compared with 10.3% in case of participants in the negative group (P = .045).
- After a total of 12 months, the positive group lost 19.5% of their total body weight compared with 10.0% in case of participants in the negative group (P = .01).
- When used to predict the response to semaglutide, the area under the curve for the machine-learning genetic risk score was 0.76 (95% CI, 0.57-0.94; P = .04).
IN PRACTICE:
We can now tell with confidence who is going to respond to semaglutide, said Andres Acosta, MD, PhD, associate professor of medicine at Mayo Clinic. “For nonresponders, we can think about other interventions or medications that we have available.”
SOURCE:
This study was presented on May 20, 2024, at the annual Digestive Disease Week® (DDW) (Abstract 638).
LIMITATIONS:
Further prospective studies are needed to assess the validity of the test in a more diverse population and with different weight loss interventions.
DISCLOSURES:
This study was supported by a partnership between Mayo Clinic and Phenomix Sciences. Dr. Acosta is a cofounder of Phenomix Sciences.
A version of this article appeared on Medscape.com.
Research Highlights From ESMO Breast Cancer
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
FROM ESMO BREAST CANCER 2024
Merkel Cell: Immunotherapy Not Used for Many Patients With Metastatic Disease
PHOENIX — Immunotherapy has revolutionized outcomes for patients are better at high-volume centers.
The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.
MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.
“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”
Real World vs Clinical Trials
Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.
The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.
“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”
Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.
Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.
From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.
Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
Implications Going Forward
Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”
Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.
“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”
Dr. Cheraghlou and Dr. Farma had no disclosures.
A version of this article appeared on Medscape.com.
PHOENIX — Immunotherapy has revolutionized outcomes for patients are better at high-volume centers.
The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.
MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.
“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”
Real World vs Clinical Trials
Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.
The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.
“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”
Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.
Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.
From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.
Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
Implications Going Forward
Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”
Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.
“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”
Dr. Cheraghlou and Dr. Farma had no disclosures.
A version of this article appeared on Medscape.com.
PHOENIX — Immunotherapy has revolutionized outcomes for patients are better at high-volume centers.
The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.
MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.
“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”
Real World vs Clinical Trials
Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.
The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.
“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”
Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.
Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.
From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.
Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
Implications Going Forward
Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”
Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.
“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”
Dr. Cheraghlou and Dr. Farma had no disclosures.
A version of this article appeared on Medscape.com.
FROM ACMS 2024
Use of Radiotherapy for Nonmelanoma Skin Cancer Increasing, Study Finds
PHOENIX — More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.
“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”
He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.
Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.
“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”
Steady Expansion of Use
Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.
Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.
There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.
When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).
Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).
Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.
Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.
The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.
“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”
Surgical Management Standard, but SRT Has a Role
Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.
“The Academy supports continued research and studies for therapies that can help improve patient outcomes and offer treatment options, as well as further studies on long-term outcomes for treatments like superficial radiation therapy,” he said.
“Well-designed studies can certainly be helpful to better assess efficacy and outcomes,” Dr. Desai continued. “This is why the Academy supports the idea of scientific studies that continue to expand the body of literature and data, which can help dermatologists tailor therapeutic options for their patients.”
As for general dermatologists using radiation therapy, he pointed out that SRT was developed within the dermatology specialty with dermatologists being the experts in delivering SRT for patients with NMSCs when indicated. “SRT has been used for over 100 years to treat skin cancer,” said Dr. Desai, of the department of dermatology, UT Southwestern Medical Center, Dallas. “While certain radiation devices have historically been used by dermatologists, dermatologists engaged in providing superficial radiation therapy must have adequate education and training to administer this therapy safely and effectively.”
The AAD Association (AADA) has a position statement that supports the use of SRT as an option for the treatment of basal cell carcinoma and squamous cell carcinoma in certain circumstances. “This could be when surgical intervention is contraindicated or refused and after the benefits and risk of treatment alternatives have been discussed with the patient,” he said. “Based on current evidence, surgical management remains the most effective treatment for NMSC.”
Dr. Desai added that the AADA is also concerned that if the Proposed LCD is finalized by CMS, it “could restrict dermatologists from performing SRT and impede patient access to SRT as a potential treatment when indicated.”
The study was independently supported. Dr. Gronbeck and Dr. Desai reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
PHOENIX — More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.
“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”
He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.
Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.
“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”
Steady Expansion of Use
Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.
Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.
There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.
When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).
Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).
Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.
Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.
The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.
“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”
Surgical Management Standard, but SRT Has a Role
Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.
“The Academy supports continued research and studies for therapies that can help improve patient outcomes and offer treatment options, as well as further studies on long-term outcomes for treatments like superficial radiation therapy,” he said.
“Well-designed studies can certainly be helpful to better assess efficacy and outcomes,” Dr. Desai continued. “This is why the Academy supports the idea of scientific studies that continue to expand the body of literature and data, which can help dermatologists tailor therapeutic options for their patients.”
As for general dermatologists using radiation therapy, he pointed out that SRT was developed within the dermatology specialty with dermatologists being the experts in delivering SRT for patients with NMSCs when indicated. “SRT has been used for over 100 years to treat skin cancer,” said Dr. Desai, of the department of dermatology, UT Southwestern Medical Center, Dallas. “While certain radiation devices have historically been used by dermatologists, dermatologists engaged in providing superficial radiation therapy must have adequate education and training to administer this therapy safely and effectively.”
The AAD Association (AADA) has a position statement that supports the use of SRT as an option for the treatment of basal cell carcinoma and squamous cell carcinoma in certain circumstances. “This could be when surgical intervention is contraindicated or refused and after the benefits and risk of treatment alternatives have been discussed with the patient,” he said. “Based on current evidence, surgical management remains the most effective treatment for NMSC.”
Dr. Desai added that the AADA is also concerned that if the Proposed LCD is finalized by CMS, it “could restrict dermatologists from performing SRT and impede patient access to SRT as a potential treatment when indicated.”
The study was independently supported. Dr. Gronbeck and Dr. Desai reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
PHOENIX — More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.
“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”
He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.
Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.
“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”
Steady Expansion of Use
Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.
Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.
There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.
When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).
Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).
Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.
Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.
The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.
“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”
Surgical Management Standard, but SRT Has a Role
Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.
“The Academy supports continued research and studies for therapies that can help improve patient outcomes and offer treatment options, as well as further studies on long-term outcomes for treatments like superficial radiation therapy,” he said.
“Well-designed studies can certainly be helpful to better assess efficacy and outcomes,” Dr. Desai continued. “This is why the Academy supports the idea of scientific studies that continue to expand the body of literature and data, which can help dermatologists tailor therapeutic options for their patients.”
As for general dermatologists using radiation therapy, he pointed out that SRT was developed within the dermatology specialty with dermatologists being the experts in delivering SRT for patients with NMSCs when indicated. “SRT has been used for over 100 years to treat skin cancer,” said Dr. Desai, of the department of dermatology, UT Southwestern Medical Center, Dallas. “While certain radiation devices have historically been used by dermatologists, dermatologists engaged in providing superficial radiation therapy must have adequate education and training to administer this therapy safely and effectively.”
The AAD Association (AADA) has a position statement that supports the use of SRT as an option for the treatment of basal cell carcinoma and squamous cell carcinoma in certain circumstances. “This could be when surgical intervention is contraindicated or refused and after the benefits and risk of treatment alternatives have been discussed with the patient,” he said. “Based on current evidence, surgical management remains the most effective treatment for NMSC.”
Dr. Desai added that the AADA is also concerned that if the Proposed LCD is finalized by CMS, it “could restrict dermatologists from performing SRT and impede patient access to SRT as a potential treatment when indicated.”
The study was independently supported. Dr. Gronbeck and Dr. Desai reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM ACMS 2024
Post–Mohs Surgery Opioid Prescribing More Common in Some Patient Groups
PHOENIX — The study also found that patients who do receive opioids postoperatively are at an increased risk for chronic opioid use and complications.
This report represents the largest analysis to date of opioid prescribing after dermatologic surgery, said lead author Kyle C. Lauck, MD, a dermatology resident at Baylor University Medical Center, Dallas, Texas. “Females, African Americans, and Latino patients may be at a higher risk of opioid prescription after dermatologic surgery. Surgeons should be aware of these populations and the risks they face when determining candidacy for postsurgical opioid analgesia.”
He presented the results at the annual meeting of the American College of Mohs Surgery.
The opioid epidemic is a concern across all areas of medicine, and the majority of opioid prescriptions in dermatology are given following surgery. Dr. Lauck noted that even though guidelines delegate opioids as second line for pain control, the existing data on opioid prescribing in dermatologic surgery is mixed. For example, some reports have shown that up to 58% of patients receive opioids postoperatively. “No consensus exists when we should routinely give opioids to these patients,” he said.
Even though most surgeons prescribe short courses of opioids, even brief regimens are associated with increased risks for overuse and substance abuse. Population-level data are limited concerning opioid prescriptions in dermatologic surgery, and in particular, there is an absence of data on the risk for long-term complications associated with use.
Certain Populations at Risk
To evaluate opioid prescription rates in dermatologic surgery, focusing on disparities between demographic populations, as well as the risk for long-term complications of postoperative opioid prescriptions, Dr. Lauck and colleagues conducted a retrospective study that included 914,721 dermatologic surgery patients, with billing codes for Mohs micrographic surgery. Patient data were obtained from TriNetX, a federated health research network.
The mean age of patients in this cohort was 54 years, and 124,494 (13.6%) were prescribed postsurgical oral opioids. The most common was oxycodone, prescribed to 43% of patients. Dr. Lauck noted that, according to their data, certain groups appeared more likely to receive a prescription for opioids following surgery. These included Black or African American patients (23.75% vs 12.86% for White patients), females (13.73% vs 13.16% for males), and Latino or Hispanic patients (17.02% vs 13.61% non-Latino/Hispanic patients).
Patients with a history of prior oral opioid prescription, prior opioid abuse or dependence, and any type of substance abuse had a significant increase in absolute risk of being prescribed postsurgical opioids (P < .0001).
The type of surgery also was associated with prescribed postop opioids. For a malignant excision, 18.29% of patients were prescribed postop opioids compared with 14.9% for a benign excision. About a third of patients (34.9%) undergoing a graft repair received opioids.
There was an elevated rate of postop opioid prescribing that was specific to the site of surgery, with the highest rates observed with eyelids, scalp and neck, trunk, and genital sites. The highest overall rates of opioid prescriptions were for patients who underwent excisions in the genital area (54.5%).
Long-Term Consequences
The authors also looked at the longer-term consequences of postop opioid use. “Nearly one in three patients who were prescribed opioids needed subsequent prescriptions down the line,” said Dr. Lauck.
From 3 months to 5 years after surgery, patients who received postsurgical opioids were at significantly higher risk for not only subsequent oral opioid prescription but also opiate abuse, any substance abuse, overdose by opioid narcotics, constipation, and chronic pain. “An opioid prescription may confer further risks of longitudinal complications of chronic opioid use,” he concluded.
Commenting on the study, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery at Icahn School of Medicine at Mount Sinai, New York City, noted an important finding of this study was the long-term sequelae of patients who did receive postop opioids.
“This is striking given that postsurgical opiate prescriptions are for short durations and limited number of pills,” he told this news organization. “This study highlights the potential danger of even short course of opiates and should serve as a reminder to dermatologic surgeons to be judicious about opiate prescribing.”
Dr. Lauck and Dr. Lewin had no disclosures.
A version of this article appeared on Medscape.com.
PHOENIX — The study also found that patients who do receive opioids postoperatively are at an increased risk for chronic opioid use and complications.
This report represents the largest analysis to date of opioid prescribing after dermatologic surgery, said lead author Kyle C. Lauck, MD, a dermatology resident at Baylor University Medical Center, Dallas, Texas. “Females, African Americans, and Latino patients may be at a higher risk of opioid prescription after dermatologic surgery. Surgeons should be aware of these populations and the risks they face when determining candidacy for postsurgical opioid analgesia.”
He presented the results at the annual meeting of the American College of Mohs Surgery.
The opioid epidemic is a concern across all areas of medicine, and the majority of opioid prescriptions in dermatology are given following surgery. Dr. Lauck noted that even though guidelines delegate opioids as second line for pain control, the existing data on opioid prescribing in dermatologic surgery is mixed. For example, some reports have shown that up to 58% of patients receive opioids postoperatively. “No consensus exists when we should routinely give opioids to these patients,” he said.
Even though most surgeons prescribe short courses of opioids, even brief regimens are associated with increased risks for overuse and substance abuse. Population-level data are limited concerning opioid prescriptions in dermatologic surgery, and in particular, there is an absence of data on the risk for long-term complications associated with use.
Certain Populations at Risk
To evaluate opioid prescription rates in dermatologic surgery, focusing on disparities between demographic populations, as well as the risk for long-term complications of postoperative opioid prescriptions, Dr. Lauck and colleagues conducted a retrospective study that included 914,721 dermatologic surgery patients, with billing codes for Mohs micrographic surgery. Patient data were obtained from TriNetX, a federated health research network.
The mean age of patients in this cohort was 54 years, and 124,494 (13.6%) were prescribed postsurgical oral opioids. The most common was oxycodone, prescribed to 43% of patients. Dr. Lauck noted that, according to their data, certain groups appeared more likely to receive a prescription for opioids following surgery. These included Black or African American patients (23.75% vs 12.86% for White patients), females (13.73% vs 13.16% for males), and Latino or Hispanic patients (17.02% vs 13.61% non-Latino/Hispanic patients).
Patients with a history of prior oral opioid prescription, prior opioid abuse or dependence, and any type of substance abuse had a significant increase in absolute risk of being prescribed postsurgical opioids (P < .0001).
The type of surgery also was associated with prescribed postop opioids. For a malignant excision, 18.29% of patients were prescribed postop opioids compared with 14.9% for a benign excision. About a third of patients (34.9%) undergoing a graft repair received opioids.
There was an elevated rate of postop opioid prescribing that was specific to the site of surgery, with the highest rates observed with eyelids, scalp and neck, trunk, and genital sites. The highest overall rates of opioid prescriptions were for patients who underwent excisions in the genital area (54.5%).
Long-Term Consequences
The authors also looked at the longer-term consequences of postop opioid use. “Nearly one in three patients who were prescribed opioids needed subsequent prescriptions down the line,” said Dr. Lauck.
From 3 months to 5 years after surgery, patients who received postsurgical opioids were at significantly higher risk for not only subsequent oral opioid prescription but also opiate abuse, any substance abuse, overdose by opioid narcotics, constipation, and chronic pain. “An opioid prescription may confer further risks of longitudinal complications of chronic opioid use,” he concluded.
Commenting on the study, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery at Icahn School of Medicine at Mount Sinai, New York City, noted an important finding of this study was the long-term sequelae of patients who did receive postop opioids.
“This is striking given that postsurgical opiate prescriptions are for short durations and limited number of pills,” he told this news organization. “This study highlights the potential danger of even short course of opiates and should serve as a reminder to dermatologic surgeons to be judicious about opiate prescribing.”
Dr. Lauck and Dr. Lewin had no disclosures.
A version of this article appeared on Medscape.com.
PHOENIX — The study also found that patients who do receive opioids postoperatively are at an increased risk for chronic opioid use and complications.
This report represents the largest analysis to date of opioid prescribing after dermatologic surgery, said lead author Kyle C. Lauck, MD, a dermatology resident at Baylor University Medical Center, Dallas, Texas. “Females, African Americans, and Latino patients may be at a higher risk of opioid prescription after dermatologic surgery. Surgeons should be aware of these populations and the risks they face when determining candidacy for postsurgical opioid analgesia.”
He presented the results at the annual meeting of the American College of Mohs Surgery.
The opioid epidemic is a concern across all areas of medicine, and the majority of opioid prescriptions in dermatology are given following surgery. Dr. Lauck noted that even though guidelines delegate opioids as second line for pain control, the existing data on opioid prescribing in dermatologic surgery is mixed. For example, some reports have shown that up to 58% of patients receive opioids postoperatively. “No consensus exists when we should routinely give opioids to these patients,” he said.
Even though most surgeons prescribe short courses of opioids, even brief regimens are associated with increased risks for overuse and substance abuse. Population-level data are limited concerning opioid prescriptions in dermatologic surgery, and in particular, there is an absence of data on the risk for long-term complications associated with use.
Certain Populations at Risk
To evaluate opioid prescription rates in dermatologic surgery, focusing on disparities between demographic populations, as well as the risk for long-term complications of postoperative opioid prescriptions, Dr. Lauck and colleagues conducted a retrospective study that included 914,721 dermatologic surgery patients, with billing codes for Mohs micrographic surgery. Patient data were obtained from TriNetX, a federated health research network.
The mean age of patients in this cohort was 54 years, and 124,494 (13.6%) were prescribed postsurgical oral opioids. The most common was oxycodone, prescribed to 43% of patients. Dr. Lauck noted that, according to their data, certain groups appeared more likely to receive a prescription for opioids following surgery. These included Black or African American patients (23.75% vs 12.86% for White patients), females (13.73% vs 13.16% for males), and Latino or Hispanic patients (17.02% vs 13.61% non-Latino/Hispanic patients).
Patients with a history of prior oral opioid prescription, prior opioid abuse or dependence, and any type of substance abuse had a significant increase in absolute risk of being prescribed postsurgical opioids (P < .0001).
The type of surgery also was associated with prescribed postop opioids. For a malignant excision, 18.29% of patients were prescribed postop opioids compared with 14.9% for a benign excision. About a third of patients (34.9%) undergoing a graft repair received opioids.
There was an elevated rate of postop opioid prescribing that was specific to the site of surgery, with the highest rates observed with eyelids, scalp and neck, trunk, and genital sites. The highest overall rates of opioid prescriptions were for patients who underwent excisions in the genital area (54.5%).
Long-Term Consequences
The authors also looked at the longer-term consequences of postop opioid use. “Nearly one in three patients who were prescribed opioids needed subsequent prescriptions down the line,” said Dr. Lauck.
From 3 months to 5 years after surgery, patients who received postsurgical opioids were at significantly higher risk for not only subsequent oral opioid prescription but also opiate abuse, any substance abuse, overdose by opioid narcotics, constipation, and chronic pain. “An opioid prescription may confer further risks of longitudinal complications of chronic opioid use,” he concluded.
Commenting on the study, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery at Icahn School of Medicine at Mount Sinai, New York City, noted an important finding of this study was the long-term sequelae of patients who did receive postop opioids.
“This is striking given that postsurgical opiate prescriptions are for short durations and limited number of pills,” he told this news organization. “This study highlights the potential danger of even short course of opiates and should serve as a reminder to dermatologic surgeons to be judicious about opiate prescribing.”
Dr. Lauck and Dr. Lewin had no disclosures.
A version of this article appeared on Medscape.com.
FROM ACMS 2024
Mirikizumab Shows Promise for Moderate to Severe Crohn’s Disease
WASHINGTON — , according to results of the phase 3 randomized, double blind, treat-through VIVID-1 study.
Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York, reported the findings in a poster (Abstract Su1801) at the annual Digestive Disease Week® (DDW).
The FDA approved mirikizumab (Omvoh, Eli Lilly) to treat moderate to severe ulcerative colitis in October 2023.
Dr. Sands and a team of US and international collaborators studied 1065 adults with Crohn’s disease or fistulizing Crohn’s disease for 3 months or more, with a mean duration of more than 7 years. At baseline, participants had a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 7 or more and reported an inadequate response, lost response, or intolerance to other therapy.
A total of 579 people were randomly assigned to mirikizumab and another 199 to placebo. Another 287 patients received ustekinumab; though they were not included in this current analysis, the findings were presented separately at DDW 2024.
Mean age of study participants was 30 years, and men comprised 57%-59% of the groups. Nearly half (49%) of each group previously failed biologic therapy.
A primary composite endpoint was clinical response at 12 weeks according to patient reported outcome and endoscopic response at 52 weeks measured with the SES-CD. A second primary endpoint was clinical response at 12 weeks by patient reported outcome combined with clinical remission on Crohn’s Disease Activity Index (CDAI) at 52 weeks.
Researchers also tracked 12 major secondary endpoints for mirikizumab vs placebo, including clinical response, endoscopic response, and clinical remission at week 12 and week 52.
Efficacy Findings
A higher percentage of participants in the mirikizumab group achieved 12-week secondary endpoints compared with placebo. In the treatment group, 32.5% reached endoscopic response vs 12.6% in the placebo group, a statistically significant difference (P < .000001). In addition, 17.6% achieved endoscopic remission in the treatment group vs 7.0% in the placebo group at 12 weeks (P < .000213).
The “treat-through” results at 52 weeks revealed that a higher proportion of the group taking mirikizumab met the co-primary endpoints compared with placebo. A total of 48.4% in the mirikizumab group vs 9.0% in the placebo group achieved endoscopic response (P < .000001). Similarly, a higher proportion met clinical remission on the CDAI, 54.1% in the treatment group vs 19.6% in the placebo group (P < .000001).
Overall, 38% of mirikizumab-treated patients vs 9% of the placebo group reached a composite endpoint of patient reported clinical response at week 12 and endoscopic response by SES-CD at week 52 (P < .000001).
Dr. Sands and colleagues also combined clinical response reported by patients at 12 weeks with CDAI findings for clinical remission at week 52. A total of 45.4% in the treatment group met the combined endpoint compared with 19.6% of the placebo group (P < .000001).
In an additional analysis, the researchers looked at this composite endpoint in patients in both groups who had failed or not failed a prior biologic for a total of 43.4% vs 12.4%, and 47.3% vs 26.5%, respectively.
“Mirikizumab demonstrated statistically significant and clinically meaningful improvements” in the study co-primary endpoints and secondary endpoints compared with placebo, the researchers concluded.
Safety Findings
Safety outcomes during the 52-week study were “consistent with the known safety profile” of mirikizumab, the researchers noted.
Treatment-emergent adverse events occurred in 78.6% of mirikizumab participants vs 73.0% of the placebo group. The most common were COVID-19, anemia, and arthralgia. Serious adverse events were reported in 10.3% of the mirikizumab group vs 17.1% of the placebo group. There were seven opportunistic infections in the treatment group, including herpes zoster and Candida, compared with none in the placebo group.
One person in the placebo cohort died of a pulmonary embolism; there were no deaths in the mirikizumab group.
People randomly assigned to placebo without a response at 12 weeks were switched over to mirikizumab. However, the findings from this group between 12 and 52 weeks were excluded from the 1-year data presented at DDW 2024, including one death from worsening Crohn’s disease during that time.
Mirikizumab looked particularly robust in this study, and it may turn out to be a critically important option for our patients, said Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City. Dr. Axelrad was not involved in this study.
Of importance, effect sizes were similar for “bio-naive and previously biologic-exposed patients,” he added.
These data “really underscore that therapies targeting IL-23 may be clinically useful for Crohn’s disease patients with prior biologic failure, representing a significant departure from our previous experience with other biologic classes,” Dr. Axelrad said.
The study was funded by Eli Lilly and Company. Dr. Sands is a consultant and receives grant funding from Lilly. Dr. Axelrad had no relevant disclosures.
A version of this article appeared on Medscape.com.
WASHINGTON — , according to results of the phase 3 randomized, double blind, treat-through VIVID-1 study.
Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York, reported the findings in a poster (Abstract Su1801) at the annual Digestive Disease Week® (DDW).
The FDA approved mirikizumab (Omvoh, Eli Lilly) to treat moderate to severe ulcerative colitis in October 2023.
Dr. Sands and a team of US and international collaborators studied 1065 adults with Crohn’s disease or fistulizing Crohn’s disease for 3 months or more, with a mean duration of more than 7 years. At baseline, participants had a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 7 or more and reported an inadequate response, lost response, or intolerance to other therapy.
A total of 579 people were randomly assigned to mirikizumab and another 199 to placebo. Another 287 patients received ustekinumab; though they were not included in this current analysis, the findings were presented separately at DDW 2024.
Mean age of study participants was 30 years, and men comprised 57%-59% of the groups. Nearly half (49%) of each group previously failed biologic therapy.
A primary composite endpoint was clinical response at 12 weeks according to patient reported outcome and endoscopic response at 52 weeks measured with the SES-CD. A second primary endpoint was clinical response at 12 weeks by patient reported outcome combined with clinical remission on Crohn’s Disease Activity Index (CDAI) at 52 weeks.
Researchers also tracked 12 major secondary endpoints for mirikizumab vs placebo, including clinical response, endoscopic response, and clinical remission at week 12 and week 52.
Efficacy Findings
A higher percentage of participants in the mirikizumab group achieved 12-week secondary endpoints compared with placebo. In the treatment group, 32.5% reached endoscopic response vs 12.6% in the placebo group, a statistically significant difference (P < .000001). In addition, 17.6% achieved endoscopic remission in the treatment group vs 7.0% in the placebo group at 12 weeks (P < .000213).
The “treat-through” results at 52 weeks revealed that a higher proportion of the group taking mirikizumab met the co-primary endpoints compared with placebo. A total of 48.4% in the mirikizumab group vs 9.0% in the placebo group achieved endoscopic response (P < .000001). Similarly, a higher proportion met clinical remission on the CDAI, 54.1% in the treatment group vs 19.6% in the placebo group (P < .000001).
Overall, 38% of mirikizumab-treated patients vs 9% of the placebo group reached a composite endpoint of patient reported clinical response at week 12 and endoscopic response by SES-CD at week 52 (P < .000001).
Dr. Sands and colleagues also combined clinical response reported by patients at 12 weeks with CDAI findings for clinical remission at week 52. A total of 45.4% in the treatment group met the combined endpoint compared with 19.6% of the placebo group (P < .000001).
In an additional analysis, the researchers looked at this composite endpoint in patients in both groups who had failed or not failed a prior biologic for a total of 43.4% vs 12.4%, and 47.3% vs 26.5%, respectively.
“Mirikizumab demonstrated statistically significant and clinically meaningful improvements” in the study co-primary endpoints and secondary endpoints compared with placebo, the researchers concluded.
Safety Findings
Safety outcomes during the 52-week study were “consistent with the known safety profile” of mirikizumab, the researchers noted.
Treatment-emergent adverse events occurred in 78.6% of mirikizumab participants vs 73.0% of the placebo group. The most common were COVID-19, anemia, and arthralgia. Serious adverse events were reported in 10.3% of the mirikizumab group vs 17.1% of the placebo group. There were seven opportunistic infections in the treatment group, including herpes zoster and Candida, compared with none in the placebo group.
One person in the placebo cohort died of a pulmonary embolism; there were no deaths in the mirikizumab group.
People randomly assigned to placebo without a response at 12 weeks were switched over to mirikizumab. However, the findings from this group between 12 and 52 weeks were excluded from the 1-year data presented at DDW 2024, including one death from worsening Crohn’s disease during that time.
Mirikizumab looked particularly robust in this study, and it may turn out to be a critically important option for our patients, said Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City. Dr. Axelrad was not involved in this study.
Of importance, effect sizes were similar for “bio-naive and previously biologic-exposed patients,” he added.
These data “really underscore that therapies targeting IL-23 may be clinically useful for Crohn’s disease patients with prior biologic failure, representing a significant departure from our previous experience with other biologic classes,” Dr. Axelrad said.
The study was funded by Eli Lilly and Company. Dr. Sands is a consultant and receives grant funding from Lilly. Dr. Axelrad had no relevant disclosures.
A version of this article appeared on Medscape.com.
WASHINGTON — , according to results of the phase 3 randomized, double blind, treat-through VIVID-1 study.
Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York, reported the findings in a poster (Abstract Su1801) at the annual Digestive Disease Week® (DDW).
The FDA approved mirikizumab (Omvoh, Eli Lilly) to treat moderate to severe ulcerative colitis in October 2023.
Dr. Sands and a team of US and international collaborators studied 1065 adults with Crohn’s disease or fistulizing Crohn’s disease for 3 months or more, with a mean duration of more than 7 years. At baseline, participants had a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 7 or more and reported an inadequate response, lost response, or intolerance to other therapy.
A total of 579 people were randomly assigned to mirikizumab and another 199 to placebo. Another 287 patients received ustekinumab; though they were not included in this current analysis, the findings were presented separately at DDW 2024.
Mean age of study participants was 30 years, and men comprised 57%-59% of the groups. Nearly half (49%) of each group previously failed biologic therapy.
A primary composite endpoint was clinical response at 12 weeks according to patient reported outcome and endoscopic response at 52 weeks measured with the SES-CD. A second primary endpoint was clinical response at 12 weeks by patient reported outcome combined with clinical remission on Crohn’s Disease Activity Index (CDAI) at 52 weeks.
Researchers also tracked 12 major secondary endpoints for mirikizumab vs placebo, including clinical response, endoscopic response, and clinical remission at week 12 and week 52.
Efficacy Findings
A higher percentage of participants in the mirikizumab group achieved 12-week secondary endpoints compared with placebo. In the treatment group, 32.5% reached endoscopic response vs 12.6% in the placebo group, a statistically significant difference (P < .000001). In addition, 17.6% achieved endoscopic remission in the treatment group vs 7.0% in the placebo group at 12 weeks (P < .000213).
The “treat-through” results at 52 weeks revealed that a higher proportion of the group taking mirikizumab met the co-primary endpoints compared with placebo. A total of 48.4% in the mirikizumab group vs 9.0% in the placebo group achieved endoscopic response (P < .000001). Similarly, a higher proportion met clinical remission on the CDAI, 54.1% in the treatment group vs 19.6% in the placebo group (P < .000001).
Overall, 38% of mirikizumab-treated patients vs 9% of the placebo group reached a composite endpoint of patient reported clinical response at week 12 and endoscopic response by SES-CD at week 52 (P < .000001).
Dr. Sands and colleagues also combined clinical response reported by patients at 12 weeks with CDAI findings for clinical remission at week 52. A total of 45.4% in the treatment group met the combined endpoint compared with 19.6% of the placebo group (P < .000001).
In an additional analysis, the researchers looked at this composite endpoint in patients in both groups who had failed or not failed a prior biologic for a total of 43.4% vs 12.4%, and 47.3% vs 26.5%, respectively.
“Mirikizumab demonstrated statistically significant and clinically meaningful improvements” in the study co-primary endpoints and secondary endpoints compared with placebo, the researchers concluded.
Safety Findings
Safety outcomes during the 52-week study were “consistent with the known safety profile” of mirikizumab, the researchers noted.
Treatment-emergent adverse events occurred in 78.6% of mirikizumab participants vs 73.0% of the placebo group. The most common were COVID-19, anemia, and arthralgia. Serious adverse events were reported in 10.3% of the mirikizumab group vs 17.1% of the placebo group. There were seven opportunistic infections in the treatment group, including herpes zoster and Candida, compared with none in the placebo group.
One person in the placebo cohort died of a pulmonary embolism; there were no deaths in the mirikizumab group.
People randomly assigned to placebo without a response at 12 weeks were switched over to mirikizumab. However, the findings from this group between 12 and 52 weeks were excluded from the 1-year data presented at DDW 2024, including one death from worsening Crohn’s disease during that time.
Mirikizumab looked particularly robust in this study, and it may turn out to be a critically important option for our patients, said Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City. Dr. Axelrad was not involved in this study.
Of importance, effect sizes were similar for “bio-naive and previously biologic-exposed patients,” he added.
These data “really underscore that therapies targeting IL-23 may be clinically useful for Crohn’s disease patients with prior biologic failure, representing a significant departure from our previous experience with other biologic classes,” Dr. Axelrad said.
The study was funded by Eli Lilly and Company. Dr. Sands is a consultant and receives grant funding from Lilly. Dr. Axelrad had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM DDW 2024