Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).

Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.

Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.

Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.

Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586

Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).

Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.

Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.

Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.

Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586

Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).

Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.

Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.

Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.

Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586

Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.

Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).

Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.

Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.

Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447

Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.

Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).

Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.

Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.

Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447

Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.

Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).

Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.

Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.

Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447

Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.

Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).

Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.

Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.

Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013

Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.

Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).

Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.

Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.

Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013

Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.

Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).

Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.

Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.

Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013

Key clinical point: Crisaborole was effective in reducing sleep disturbance in pediatric patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At day 29, a significantly lower proportion of patients reported sleep disturbance in the crisaborole vs vehicle group (48.5% vs 57.7%; P = .001). Crisaborole led to a 32.2% decrease in the proportion of infants with ≥1 night of disturbed sleep.

Study details: This post hoc analysis included infants aged 3 to <24 months (CARE 1; n = 137), patients aged 2 to <16 years (pooled CORE 1/CORE 2; n = 1227), and families of patients aged 2 to <18 years (pooled CORE 1/CORE 2; n = 1313) with mild-to-moderate AD who received crisaborole or vehicle twice daily for 28 days.

Disclosures: This study was sponsored by Pfizer Inc. Some authors declared serving as speakers and consultants for or receiving speaker and consulting fees from various sources, including Pfizer. Six authors declared being employees of and holding stocks in Pfizer Inc.

Source: Fowler J et al. Impact of crisaborole on sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 22). Doi: 10.1007/s13555-023-00899-y

Key clinical point: Crisaborole was effective in reducing sleep disturbance in pediatric patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At day 29, a significantly lower proportion of patients reported sleep disturbance in the crisaborole vs vehicle group (48.5% vs 57.7%; P = .001). Crisaborole led to a 32.2% decrease in the proportion of infants with ≥1 night of disturbed sleep.

Study details: This post hoc analysis included infants aged 3 to <24 months (CARE 1; n = 137), patients aged 2 to <16 years (pooled CORE 1/CORE 2; n = 1227), and families of patients aged 2 to <18 years (pooled CORE 1/CORE 2; n = 1313) with mild-to-moderate AD who received crisaborole or vehicle twice daily for 28 days.

Disclosures: This study was sponsored by Pfizer Inc. Some authors declared serving as speakers and consultants for or receiving speaker and consulting fees from various sources, including Pfizer. Six authors declared being employees of and holding stocks in Pfizer Inc.

Source: Fowler J et al. Impact of crisaborole on sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 22). Doi: 10.1007/s13555-023-00899-y

Key clinical point: Crisaborole was effective in reducing sleep disturbance in pediatric patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At day 29, a significantly lower proportion of patients reported sleep disturbance in the crisaborole vs vehicle group (48.5% vs 57.7%; P = .001). Crisaborole led to a 32.2% decrease in the proportion of infants with ≥1 night of disturbed sleep.

Study details: This post hoc analysis included infants aged 3 to <24 months (CARE 1; n = 137), patients aged 2 to <16 years (pooled CORE 1/CORE 2; n = 1227), and families of patients aged 2 to <18 years (pooled CORE 1/CORE 2; n = 1313) with mild-to-moderate AD who received crisaborole or vehicle twice daily for 28 days.

Disclosures: This study was sponsored by Pfizer Inc. Some authors declared serving as speakers and consultants for or receiving speaker and consulting fees from various sources, including Pfizer. Six authors declared being employees of and holding stocks in Pfizer Inc.

Source: Fowler J et al. Impact of crisaborole on sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 22). Doi: 10.1007/s13555-023-00899-y

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883