SGLT2 Inhibitors Reduce Portal Hypertension From Cirrhosis

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SAN DIEGO — Patients with cirrhosis treated with sodium-glucose cotransporter 2 (SGLT2) inhibitors show significant reductions in a range of portal hypertension complications and all-cause mortality compared with those not receiving the drugs, new research shows.

“Our study found that SGLT2 inhibitors were associated with fewer portal hypertension complications and lower mortality, suggesting they may be a valuable addition to cirrhosis management,” first author Abhinav K. Rao, MD, of the Medical University of South Carolina, Charleston, South Carolina, told GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

Portal hypertension, a potentially life-threatening complication of cirrhosis, can be a key driver of additional complications including ascites and gastro-esophageal varices in cirrhosis.

Current treatments such as beta-blockers can prevent some complications, however, more effective therapies are needed.

SGLT2 inhibitors are often used in the treatment of cardiovascular disease as well as metabolic dysfunction–associated steatohepatitis (MASH)–mediated liver disease; research is lacking regarding their effects in portal hypertension in the broader population of people with cirrhosis.

“The therapeutic efficacy of SGLT2 inhibitors might be related to their ability to improve vascular function, making them attractive in portal hypertension,” Rao explained.

To investigate, Rao and colleagues evaluated data on 637,079 patients with cirrhosis in the TriNetX database, which includes patients in the United States from 66 healthcare organizations.

Patients were divided into three subgroups, including those with MASH, alcohol-associated, and other etiologies of cirrhosis.

Using robust 1:1 propensity score matching, patients in each subgroup were stratified as either having or not having been treated with SGLT2 inhibitors, limited to those who initiated the drugs within 1 year of their cirrhosis diagnosis to prevent immortal time bias. Patients were matched on other characteristics.

For the primary outcome of all-cause mortality, with an overall median follow-up of 2 years, patients prescribed SGLT2 inhibitors in the MASH cirrhosis (n = 47,385), alcohol-associated cirrhosis (n = 107,844), and other etiologies of cirrhosis (n = 59,499) groups all had a significantly lower risk for all-cause mortality than those not prescribed SGLT2 inhibitors (P < .05 for all).

 

SGLT2 Inhibitors in MASH Cirrhosis

Specifically looking at the MASH cirrhosis group, Rao described outcomes of the two groups of 3026 patients each who were and were not treated with SGLT2 inhibitors.

The patients had similar rates of esophageal varices (25% in the SGLT2 group and 22% in the no SGLT2 group), ascites (19% in each group), and a similar rate of 19% had hepatic encephalopathy (HE).

About 57% of patients in each treatment group used beta-blockers and 33% used glucagon-like peptide 1 (GLP-1) receptor agonists. Those with a history of liver transplantation, hemodialysis, or transjugular intrahepatic portosystemic shunt placement were excluded.

The secondary outcome results in those patients showed that treatment with SGLT2 inhibitors was associated with significantly reduced risks of developing portal hypertension complications including ascites, HE, spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (P < .05 for all).

Esophageal variceal bleeding was also reduced with SGLT-2 inhibitors; however the difference was not statistically significant.

 

Effects Diminished With Beta-Blocker Treatment

In a secondary analysis of patients in the MASH cirrhosis group treated with one type of a nonselective beta-blockers (n = 509) and another nonselective beta-blockers (n = 2561), the beneficial effects of SGLT2 inhibitors on portal hypertension, with the exception of HE and SBP, were found to be somewhat diminished, likely because patients were already benefitting from the beta-blockers, Rao noted.

Other Groups

In outcomes of the non–MASH-related cirrhosis groups, patients prescribed SGLT2 inhibitors also had a reduced risk for specific, as well as any portal hypertension complications (P < .05), Rao noted.

Overall, the findings add to previous studies on SGLT2 inhibitors in MASH and expand on the possible benefits, he said.

“Our findings validate these [previous] results and suggest potential benefits across for patients with other types of liver disease and raise the possibility of a beneficial effect in portal hypertension,” he said.

“Given the marked reduction in portal hypertension complications after SGLT2 inhibitor initiation, the associated survival benefit may not be surprising,” he noted.

“However, we were intrigued by the consistent reduction in portal hypertension complications across all cirrhosis types, especially since SGLT-2 inhibitors are most commonly used in patients with diabetes who have MASH-mediated liver disease.”

 

‘Real World Glimpse’ at SGLT2 Inhibitors; Limitations Need Noting 

Commenting on the study, Rotonya M. Carr, MD, Division Head of Gastroenterology at the University of Washington, Seattle, said the study sheds important light on an issue previously addressed only in smaller cohorts.

Dr. Rotonya M. Carr

“To date, there have only been a few small prospective, retrospective, and case series studies investigating SGTL2 inhibitors in patients with cirrhosis,” she told GI & Hepatology Newsv.

“This retrospective study is a real-world glimpse at how patients with cirrhosis may fare on these drugs — very exciting data.”

Carr cautioned, however, that, in addition to the retrospective study design, limitations included that the study doesn’t provide details on the duration of therapy, preventing an understanding of whether the results represent chronic, sustained use of SGLT2 inhibitors.

“[Therefore], we cannot interpret these results to mean that chronic, sustained use of SGTL2 inh is beneficial, or does not cause harm, in patients with cirrhosis.”

“While these data are provocative, more work needs to be done before we understand the full safety and efficacy of SGTL2 inhibitors for patients with cirrhosis,” Carr added.

“However, these data are very encouraging, and I am optimistic that we will indeed see both SGTL2 inhibitors and GLP-1s among the group of medications we use in the future for the primary management of patients with liver disease.”

The authors had no disclosures to report. Carr’s disclosures included relationships with Intercept and Novo Nordisk and research funding from Merck.

A version of this article appeared on Medscape.com.

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SAN DIEGO — Patients with cirrhosis treated with sodium-glucose cotransporter 2 (SGLT2) inhibitors show significant reductions in a range of portal hypertension complications and all-cause mortality compared with those not receiving the drugs, new research shows.

“Our study found that SGLT2 inhibitors were associated with fewer portal hypertension complications and lower mortality, suggesting they may be a valuable addition to cirrhosis management,” first author Abhinav K. Rao, MD, of the Medical University of South Carolina, Charleston, South Carolina, told GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

Portal hypertension, a potentially life-threatening complication of cirrhosis, can be a key driver of additional complications including ascites and gastro-esophageal varices in cirrhosis.

Current treatments such as beta-blockers can prevent some complications, however, more effective therapies are needed.

SGLT2 inhibitors are often used in the treatment of cardiovascular disease as well as metabolic dysfunction–associated steatohepatitis (MASH)–mediated liver disease; research is lacking regarding their effects in portal hypertension in the broader population of people with cirrhosis.

“The therapeutic efficacy of SGLT2 inhibitors might be related to their ability to improve vascular function, making them attractive in portal hypertension,” Rao explained.

To investigate, Rao and colleagues evaluated data on 637,079 patients with cirrhosis in the TriNetX database, which includes patients in the United States from 66 healthcare organizations.

Patients were divided into three subgroups, including those with MASH, alcohol-associated, and other etiologies of cirrhosis.

Using robust 1:1 propensity score matching, patients in each subgroup were stratified as either having or not having been treated with SGLT2 inhibitors, limited to those who initiated the drugs within 1 year of their cirrhosis diagnosis to prevent immortal time bias. Patients were matched on other characteristics.

For the primary outcome of all-cause mortality, with an overall median follow-up of 2 years, patients prescribed SGLT2 inhibitors in the MASH cirrhosis (n = 47,385), alcohol-associated cirrhosis (n = 107,844), and other etiologies of cirrhosis (n = 59,499) groups all had a significantly lower risk for all-cause mortality than those not prescribed SGLT2 inhibitors (P < .05 for all).

 

SGLT2 Inhibitors in MASH Cirrhosis

Specifically looking at the MASH cirrhosis group, Rao described outcomes of the two groups of 3026 patients each who were and were not treated with SGLT2 inhibitors.

The patients had similar rates of esophageal varices (25% in the SGLT2 group and 22% in the no SGLT2 group), ascites (19% in each group), and a similar rate of 19% had hepatic encephalopathy (HE).

About 57% of patients in each treatment group used beta-blockers and 33% used glucagon-like peptide 1 (GLP-1) receptor agonists. Those with a history of liver transplantation, hemodialysis, or transjugular intrahepatic portosystemic shunt placement were excluded.

The secondary outcome results in those patients showed that treatment with SGLT2 inhibitors was associated with significantly reduced risks of developing portal hypertension complications including ascites, HE, spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (P < .05 for all).

Esophageal variceal bleeding was also reduced with SGLT-2 inhibitors; however the difference was not statistically significant.

 

Effects Diminished With Beta-Blocker Treatment

In a secondary analysis of patients in the MASH cirrhosis group treated with one type of a nonselective beta-blockers (n = 509) and another nonselective beta-blockers (n = 2561), the beneficial effects of SGLT2 inhibitors on portal hypertension, with the exception of HE and SBP, were found to be somewhat diminished, likely because patients were already benefitting from the beta-blockers, Rao noted.

Other Groups

In outcomes of the non–MASH-related cirrhosis groups, patients prescribed SGLT2 inhibitors also had a reduced risk for specific, as well as any portal hypertension complications (P < .05), Rao noted.

Overall, the findings add to previous studies on SGLT2 inhibitors in MASH and expand on the possible benefits, he said.

“Our findings validate these [previous] results and suggest potential benefits across for patients with other types of liver disease and raise the possibility of a beneficial effect in portal hypertension,” he said.

“Given the marked reduction in portal hypertension complications after SGLT2 inhibitor initiation, the associated survival benefit may not be surprising,” he noted.

“However, we were intrigued by the consistent reduction in portal hypertension complications across all cirrhosis types, especially since SGLT-2 inhibitors are most commonly used in patients with diabetes who have MASH-mediated liver disease.”

 

‘Real World Glimpse’ at SGLT2 Inhibitors; Limitations Need Noting 

Commenting on the study, Rotonya M. Carr, MD, Division Head of Gastroenterology at the University of Washington, Seattle, said the study sheds important light on an issue previously addressed only in smaller cohorts.

Dr. Rotonya M. Carr

“To date, there have only been a few small prospective, retrospective, and case series studies investigating SGTL2 inhibitors in patients with cirrhosis,” she told GI & Hepatology Newsv.

“This retrospective study is a real-world glimpse at how patients with cirrhosis may fare on these drugs — very exciting data.”

Carr cautioned, however, that, in addition to the retrospective study design, limitations included that the study doesn’t provide details on the duration of therapy, preventing an understanding of whether the results represent chronic, sustained use of SGLT2 inhibitors.

“[Therefore], we cannot interpret these results to mean that chronic, sustained use of SGTL2 inh is beneficial, or does not cause harm, in patients with cirrhosis.”

“While these data are provocative, more work needs to be done before we understand the full safety and efficacy of SGTL2 inhibitors for patients with cirrhosis,” Carr added.

“However, these data are very encouraging, and I am optimistic that we will indeed see both SGTL2 inhibitors and GLP-1s among the group of medications we use in the future for the primary management of patients with liver disease.”

The authors had no disclosures to report. Carr’s disclosures included relationships with Intercept and Novo Nordisk and research funding from Merck.

A version of this article appeared on Medscape.com.

SAN DIEGO — Patients with cirrhosis treated with sodium-glucose cotransporter 2 (SGLT2) inhibitors show significant reductions in a range of portal hypertension complications and all-cause mortality compared with those not receiving the drugs, new research shows.

“Our study found that SGLT2 inhibitors were associated with fewer portal hypertension complications and lower mortality, suggesting they may be a valuable addition to cirrhosis management,” first author Abhinav K. Rao, MD, of the Medical University of South Carolina, Charleston, South Carolina, told GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

Portal hypertension, a potentially life-threatening complication of cirrhosis, can be a key driver of additional complications including ascites and gastro-esophageal varices in cirrhosis.

Current treatments such as beta-blockers can prevent some complications, however, more effective therapies are needed.

SGLT2 inhibitors are often used in the treatment of cardiovascular disease as well as metabolic dysfunction–associated steatohepatitis (MASH)–mediated liver disease; research is lacking regarding their effects in portal hypertension in the broader population of people with cirrhosis.

“The therapeutic efficacy of SGLT2 inhibitors might be related to their ability to improve vascular function, making them attractive in portal hypertension,” Rao explained.

To investigate, Rao and colleagues evaluated data on 637,079 patients with cirrhosis in the TriNetX database, which includes patients in the United States from 66 healthcare organizations.

Patients were divided into three subgroups, including those with MASH, alcohol-associated, and other etiologies of cirrhosis.

Using robust 1:1 propensity score matching, patients in each subgroup were stratified as either having or not having been treated with SGLT2 inhibitors, limited to those who initiated the drugs within 1 year of their cirrhosis diagnosis to prevent immortal time bias. Patients were matched on other characteristics.

For the primary outcome of all-cause mortality, with an overall median follow-up of 2 years, patients prescribed SGLT2 inhibitors in the MASH cirrhosis (n = 47,385), alcohol-associated cirrhosis (n = 107,844), and other etiologies of cirrhosis (n = 59,499) groups all had a significantly lower risk for all-cause mortality than those not prescribed SGLT2 inhibitors (P < .05 for all).

 

SGLT2 Inhibitors in MASH Cirrhosis

Specifically looking at the MASH cirrhosis group, Rao described outcomes of the two groups of 3026 patients each who were and were not treated with SGLT2 inhibitors.

The patients had similar rates of esophageal varices (25% in the SGLT2 group and 22% in the no SGLT2 group), ascites (19% in each group), and a similar rate of 19% had hepatic encephalopathy (HE).

About 57% of patients in each treatment group used beta-blockers and 33% used glucagon-like peptide 1 (GLP-1) receptor agonists. Those with a history of liver transplantation, hemodialysis, or transjugular intrahepatic portosystemic shunt placement were excluded.

The secondary outcome results in those patients showed that treatment with SGLT2 inhibitors was associated with significantly reduced risks of developing portal hypertension complications including ascites, HE, spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (P < .05 for all).

Esophageal variceal bleeding was also reduced with SGLT-2 inhibitors; however the difference was not statistically significant.

 

Effects Diminished With Beta-Blocker Treatment

In a secondary analysis of patients in the MASH cirrhosis group treated with one type of a nonselective beta-blockers (n = 509) and another nonselective beta-blockers (n = 2561), the beneficial effects of SGLT2 inhibitors on portal hypertension, with the exception of HE and SBP, were found to be somewhat diminished, likely because patients were already benefitting from the beta-blockers, Rao noted.

Other Groups

In outcomes of the non–MASH-related cirrhosis groups, patients prescribed SGLT2 inhibitors also had a reduced risk for specific, as well as any portal hypertension complications (P < .05), Rao noted.

Overall, the findings add to previous studies on SGLT2 inhibitors in MASH and expand on the possible benefits, he said.

“Our findings validate these [previous] results and suggest potential benefits across for patients with other types of liver disease and raise the possibility of a beneficial effect in portal hypertension,” he said.

“Given the marked reduction in portal hypertension complications after SGLT2 inhibitor initiation, the associated survival benefit may not be surprising,” he noted.

“However, we were intrigued by the consistent reduction in portal hypertension complications across all cirrhosis types, especially since SGLT-2 inhibitors are most commonly used in patients with diabetes who have MASH-mediated liver disease.”

 

‘Real World Glimpse’ at SGLT2 Inhibitors; Limitations Need Noting 

Commenting on the study, Rotonya M. Carr, MD, Division Head of Gastroenterology at the University of Washington, Seattle, said the study sheds important light on an issue previously addressed only in smaller cohorts.

Dr. Rotonya M. Carr

“To date, there have only been a few small prospective, retrospective, and case series studies investigating SGTL2 inhibitors in patients with cirrhosis,” she told GI & Hepatology Newsv.

“This retrospective study is a real-world glimpse at how patients with cirrhosis may fare on these drugs — very exciting data.”

Carr cautioned, however, that, in addition to the retrospective study design, limitations included that the study doesn’t provide details on the duration of therapy, preventing an understanding of whether the results represent chronic, sustained use of SGLT2 inhibitors.

“[Therefore], we cannot interpret these results to mean that chronic, sustained use of SGTL2 inh is beneficial, or does not cause harm, in patients with cirrhosis.”

“While these data are provocative, more work needs to be done before we understand the full safety and efficacy of SGTL2 inhibitors for patients with cirrhosis,” Carr added.

“However, these data are very encouraging, and I am optimistic that we will indeed see both SGTL2 inhibitors and GLP-1s among the group of medications we use in the future for the primary management of patients with liver disease.”

The authors had no disclosures to report. Carr’s disclosures included relationships with Intercept and Novo Nordisk and research funding from Merck.

A version of this article appeared on Medscape.com.

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AI-Enhanced Digital Collaborative Care Improves IBS Symptoms

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SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Stephen Lupe, PsyD

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

Dr. Kyle Staller

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

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SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Stephen Lupe, PsyD

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

Dr. Kyle Staller

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Stephen Lupe, PsyD

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

Dr. Kyle Staller

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

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Study Investigates Non-Hodgkin Lymphoma in Air Force Missileers

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Individuals working near intercontinental ballistic missiles (ICBMs), may be at higher risk of developing non-Hodgkin lymphoma (NHL) according to a preprint analysis conducted on missileers at Malmstrom Air Force Base in Montana. The study, which has not undergone peer review, found higher rates of NHL diagnosis at younger ages compared with the general population. The study also found a statistically significant increase in NHL diagnoses among older missileers, with such rates surpassing expected benchmarks.

The findings build on anecdotal and evidentiary data gathered in the last 50-plus years, including from the Torchlight Initiative, established in 2023 to collect self-reported cancer diagnoses and related fatalities from personnel and family members associated with the ICBM community. 

The report shows patterns that “warranted a detailed statistical analysis,” leading to a granular examination of the registry and categorization of the data by cancer type, geographical location, and specific demographics. This narrowed the focus to 18 missileers who served at Malmstrom and were diagnosed with NHL.

In 2001, the Air Force Institute for Operational Health did a site evaluation and sampled for potential chemical and biological contaminants at Malmstrom following various reports of cancers from missileers, including 2 who died after being diagnosed with NHL. In a 2005 review, the Air Force said, “there is not sufficient evidence to consider the possibility of a cancer clustering to justify further investigation.” 

In 2022, Lt. Col. Daniel Sebeck, a vice commander of Space Delta 8 in Colorado who served at Malmstrom and a close friend and fellow missileer were diagnosed with NHL. Sebeck discovered 36 cancer cases among missileers who had been stationed at Malmstrom. Ten developed NHL, 2 developed Hodgkin lymphoma, and 24 developed another form of cancer. The Air Force has acknowledged the concerns. 

In 2023, US Air Force School of Aerospace Medicine (USAFSAM) approved the Missile Community Cancer Study (MCCS) to assess “specific cancer concerns raised by missile community members across related career fields and also examines the possibility of clusters of non-Hodgkin’s lymphoma at intercontinental ballistic missile bases.” The study compares 14 common cancers in the general population with that of missile-related career fields. The USAFSAM is reviewing records from former and current Missile Community members on active duty from 1976-2010, as well as state and national cancer data from multiple registries.

Early results from the MCCS suggested elevated rates of some cancers—mainly breast and prostate cancer—among missileers, maintainers, and other ICMB-related job positions, which aligns with other national cancer data.

At a June 2024 AFGSC town hall, officials announced that missileers would now have their information submitted to the Defense Occupational and Environmental Health Readiness System (DOEHRS), a Pentagon database for reporting occupational and exposure hazards.

"This info from DOEHRS flows into the recently developed Individual Longitudinal Exposure Record, a system that compiles occupational and environmental health data throughout a person's career," Lt. Col. John Severns, a spokesperson for Air Force Global Strike Command, said. DOEHRS, which has tracked Air Force records since 2010, allows US Department of Defense and US Department of Veterans Affairs clinical staff to access the information.

MCCS considers potential PCB exposures an occupational hazard. The Air Force says researchers are working with the System Program Offices and leadership to determine the timeframe of PCB removal from bases.

The lack of incontrovertible evidence connecting workplace toxins to NHL has often stymied patients and their family members from receiving appropriate benefits. An “informal talk” in April led by Rep. Mark Takano (D-CA) and Sen. Richard Blumenthal (D-CT) focused on exposures to hazardous materials at US military bases. Participants included various advocacy groups like the Torchlight Initiative, the Invisible Enemy, and Burn Pits 360.

More than a dozen veterans spoke about serving at military bases where they were exposed to a variety of harmful substances, and issues they faced in receiving coverage. David Crete, a veteran and chairman of The Invisible Enemy, said, “I am asking Congress to please allow us to get the benefits every other veteran earned. We are not asking to be special but to be treated equal.”

Rep. Takano called for greater focus on toxic exposures at US military bases: “We must push back against the idea that service members are only in harm’s way in war zones.”

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Individuals working near intercontinental ballistic missiles (ICBMs), may be at higher risk of developing non-Hodgkin lymphoma (NHL) according to a preprint analysis conducted on missileers at Malmstrom Air Force Base in Montana. The study, which has not undergone peer review, found higher rates of NHL diagnosis at younger ages compared with the general population. The study also found a statistically significant increase in NHL diagnoses among older missileers, with such rates surpassing expected benchmarks.

The findings build on anecdotal and evidentiary data gathered in the last 50-plus years, including from the Torchlight Initiative, established in 2023 to collect self-reported cancer diagnoses and related fatalities from personnel and family members associated with the ICBM community. 

The report shows patterns that “warranted a detailed statistical analysis,” leading to a granular examination of the registry and categorization of the data by cancer type, geographical location, and specific demographics. This narrowed the focus to 18 missileers who served at Malmstrom and were diagnosed with NHL.

In 2001, the Air Force Institute for Operational Health did a site evaluation and sampled for potential chemical and biological contaminants at Malmstrom following various reports of cancers from missileers, including 2 who died after being diagnosed with NHL. In a 2005 review, the Air Force said, “there is not sufficient evidence to consider the possibility of a cancer clustering to justify further investigation.” 

In 2022, Lt. Col. Daniel Sebeck, a vice commander of Space Delta 8 in Colorado who served at Malmstrom and a close friend and fellow missileer were diagnosed with NHL. Sebeck discovered 36 cancer cases among missileers who had been stationed at Malmstrom. Ten developed NHL, 2 developed Hodgkin lymphoma, and 24 developed another form of cancer. The Air Force has acknowledged the concerns. 

In 2023, US Air Force School of Aerospace Medicine (USAFSAM) approved the Missile Community Cancer Study (MCCS) to assess “specific cancer concerns raised by missile community members across related career fields and also examines the possibility of clusters of non-Hodgkin’s lymphoma at intercontinental ballistic missile bases.” The study compares 14 common cancers in the general population with that of missile-related career fields. The USAFSAM is reviewing records from former and current Missile Community members on active duty from 1976-2010, as well as state and national cancer data from multiple registries.

Early results from the MCCS suggested elevated rates of some cancers—mainly breast and prostate cancer—among missileers, maintainers, and other ICMB-related job positions, which aligns with other national cancer data.

At a June 2024 AFGSC town hall, officials announced that missileers would now have their information submitted to the Defense Occupational and Environmental Health Readiness System (DOEHRS), a Pentagon database for reporting occupational and exposure hazards.

"This info from DOEHRS flows into the recently developed Individual Longitudinal Exposure Record, a system that compiles occupational and environmental health data throughout a person's career," Lt. Col. John Severns, a spokesperson for Air Force Global Strike Command, said. DOEHRS, which has tracked Air Force records since 2010, allows US Department of Defense and US Department of Veterans Affairs clinical staff to access the information.

MCCS considers potential PCB exposures an occupational hazard. The Air Force says researchers are working with the System Program Offices and leadership to determine the timeframe of PCB removal from bases.

The lack of incontrovertible evidence connecting workplace toxins to NHL has often stymied patients and their family members from receiving appropriate benefits. An “informal talk” in April led by Rep. Mark Takano (D-CA) and Sen. Richard Blumenthal (D-CT) focused on exposures to hazardous materials at US military bases. Participants included various advocacy groups like the Torchlight Initiative, the Invisible Enemy, and Burn Pits 360.

More than a dozen veterans spoke about serving at military bases where they were exposed to a variety of harmful substances, and issues they faced in receiving coverage. David Crete, a veteran and chairman of The Invisible Enemy, said, “I am asking Congress to please allow us to get the benefits every other veteran earned. We are not asking to be special but to be treated equal.”

Rep. Takano called for greater focus on toxic exposures at US military bases: “We must push back against the idea that service members are only in harm’s way in war zones.”

Individuals working near intercontinental ballistic missiles (ICBMs), may be at higher risk of developing non-Hodgkin lymphoma (NHL) according to a preprint analysis conducted on missileers at Malmstrom Air Force Base in Montana. The study, which has not undergone peer review, found higher rates of NHL diagnosis at younger ages compared with the general population. The study also found a statistically significant increase in NHL diagnoses among older missileers, with such rates surpassing expected benchmarks.

The findings build on anecdotal and evidentiary data gathered in the last 50-plus years, including from the Torchlight Initiative, established in 2023 to collect self-reported cancer diagnoses and related fatalities from personnel and family members associated with the ICBM community. 

The report shows patterns that “warranted a detailed statistical analysis,” leading to a granular examination of the registry and categorization of the data by cancer type, geographical location, and specific demographics. This narrowed the focus to 18 missileers who served at Malmstrom and were diagnosed with NHL.

In 2001, the Air Force Institute for Operational Health did a site evaluation and sampled for potential chemical and biological contaminants at Malmstrom following various reports of cancers from missileers, including 2 who died after being diagnosed with NHL. In a 2005 review, the Air Force said, “there is not sufficient evidence to consider the possibility of a cancer clustering to justify further investigation.” 

In 2022, Lt. Col. Daniel Sebeck, a vice commander of Space Delta 8 in Colorado who served at Malmstrom and a close friend and fellow missileer were diagnosed with NHL. Sebeck discovered 36 cancer cases among missileers who had been stationed at Malmstrom. Ten developed NHL, 2 developed Hodgkin lymphoma, and 24 developed another form of cancer. The Air Force has acknowledged the concerns. 

In 2023, US Air Force School of Aerospace Medicine (USAFSAM) approved the Missile Community Cancer Study (MCCS) to assess “specific cancer concerns raised by missile community members across related career fields and also examines the possibility of clusters of non-Hodgkin’s lymphoma at intercontinental ballistic missile bases.” The study compares 14 common cancers in the general population with that of missile-related career fields. The USAFSAM is reviewing records from former and current Missile Community members on active duty from 1976-2010, as well as state and national cancer data from multiple registries.

Early results from the MCCS suggested elevated rates of some cancers—mainly breast and prostate cancer—among missileers, maintainers, and other ICMB-related job positions, which aligns with other national cancer data.

At a June 2024 AFGSC town hall, officials announced that missileers would now have their information submitted to the Defense Occupational and Environmental Health Readiness System (DOEHRS), a Pentagon database for reporting occupational and exposure hazards.

"This info from DOEHRS flows into the recently developed Individual Longitudinal Exposure Record, a system that compiles occupational and environmental health data throughout a person's career," Lt. Col. John Severns, a spokesperson for Air Force Global Strike Command, said. DOEHRS, which has tracked Air Force records since 2010, allows US Department of Defense and US Department of Veterans Affairs clinical staff to access the information.

MCCS considers potential PCB exposures an occupational hazard. The Air Force says researchers are working with the System Program Offices and leadership to determine the timeframe of PCB removal from bases.

The lack of incontrovertible evidence connecting workplace toxins to NHL has often stymied patients and their family members from receiving appropriate benefits. An “informal talk” in April led by Rep. Mark Takano (D-CA) and Sen. Richard Blumenthal (D-CT) focused on exposures to hazardous materials at US military bases. Participants included various advocacy groups like the Torchlight Initiative, the Invisible Enemy, and Burn Pits 360.

More than a dozen veterans spoke about serving at military bases where they were exposed to a variety of harmful substances, and issues they faced in receiving coverage. David Crete, a veteran and chairman of The Invisible Enemy, said, “I am asking Congress to please allow us to get the benefits every other veteran earned. We are not asking to be special but to be treated equal.”

Rep. Takano called for greater focus on toxic exposures at US military bases: “We must push back against the idea that service members are only in harm’s way in war zones.”

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Exercise Can Help Protect Against Cancer Fatigue, Depression

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Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.

However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.

The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.

Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”

Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.

Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.

To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).

After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.

Du said there are likely multiple reasons behind the sex differences observed.

Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.

In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.

The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.

For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.

Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.

Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.

Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.

However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.

In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.

“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.

The study had no specific funding. Du and Ligibel had no disclosures.

A version of this article first appeared on Medscape.com.

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Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.

However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.

The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.

Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”

Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.

Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.

To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).

After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.

Du said there are likely multiple reasons behind the sex differences observed.

Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.

In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.

The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.

For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.

Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.

Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.

Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.

However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.

In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.

“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.

The study had no specific funding. Du and Ligibel had no disclosures.

A version of this article first appeared on Medscape.com.

Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.

However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.

The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.

Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”

Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.

Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.

To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).

After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.

Du said there are likely multiple reasons behind the sex differences observed.

Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.

In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.

The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.

For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.

Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.

Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.

Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.

However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.

In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.

“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.

The study had no specific funding. Du and Ligibel had no disclosures.

A version of this article first appeared on Medscape.com.

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Single Antiplatelet After TAVR Lowers Risk

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Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.

“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.

Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.

In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.

 

Balancing Risks and Benefits

The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.

A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.

Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.

Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.

 

By the Numbers

Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.

Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.

“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.

A version of this article first appeared on Medscape.com.

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Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.

“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.

Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.

In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.

 

Balancing Risks and Benefits

The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.

A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.

Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.

Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.

 

By the Numbers

Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.

Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.

“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.

A version of this article first appeared on Medscape.com.

Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.

“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.

Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.

In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.

 

Balancing Risks and Benefits

The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.

A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.

Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.

Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.

 

By the Numbers

Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.

Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.

“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.

A version of this article first appeared on Medscape.com.

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Rethinking the Scalpel: Advancing Non-Surgical Strategies for Early Breast Cancer

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Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.

Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.

 

Reassessing the Role of Surgery in the Early Stages 

Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity. 

Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM. 

Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference. 

 

A Shift in Practice: Moving Away From Routine Node Dissection

Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.

Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation. 

The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.

 

SLNB: A Less Invasive Alternative to ALND

Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.

 

Rethinking First Steps: Non-Surgical Strategies

While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease. 

 

The Clinician’s Role in Shaping Conservative Surgical Approaches

De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life. 

Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.

Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.

Nameera Temkar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.

Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.

 

Reassessing the Role of Surgery in the Early Stages 

Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity. 

Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM. 

Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference. 

 

A Shift in Practice: Moving Away From Routine Node Dissection

Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.

Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation. 

The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.

 

SLNB: A Less Invasive Alternative to ALND

Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.

 

Rethinking First Steps: Non-Surgical Strategies

While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease. 

 

The Clinician’s Role in Shaping Conservative Surgical Approaches

De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life. 

Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.

Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.

Nameera Temkar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.

Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.

 

Reassessing the Role of Surgery in the Early Stages 

Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity. 

Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM. 

Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference. 

 

A Shift in Practice: Moving Away From Routine Node Dissection

Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.

Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation. 

The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.

 

SLNB: A Less Invasive Alternative to ALND

Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.

 

Rethinking First Steps: Non-Surgical Strategies

While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease. 

 

The Clinician’s Role in Shaping Conservative Surgical Approaches

De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life. 

Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.

Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.

Nameera Temkar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Gastric Cancer Prevention: New AGA Update Reflects Latest High-Risk Screening and Surveillance Advice

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Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Dr. Douglas R. Morgan



Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

Dr. Hashem El-Serag



“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Dr. Douglas R. Morgan



Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

Dr. Hashem El-Serag



“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Dr. Douglas R. Morgan



Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

Dr. Hashem El-Serag



“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Autoimmune Pancreatitis: What’s Really Behind Those Symptoms

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“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.

Autoimmune Pancreatitis

AIP has two forms of involvement: Type 1 AIP, linked to immunoglobulin G4–related disease (IgG4-RD), and type 2 AIP, primarily associated with inflammatory bowel disease (IBD). These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.

Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.

A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.

Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.

 

Evolving Treatment

Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.

The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.

Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”

 

Monitoring IgG4

Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”

This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.

A version of this article appeared on Medscape.com.

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“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.

Autoimmune Pancreatitis

AIP has two forms of involvement: Type 1 AIP, linked to immunoglobulin G4–related disease (IgG4-RD), and type 2 AIP, primarily associated with inflammatory bowel disease (IBD). These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.

Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.

A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.

Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.

 

Evolving Treatment

Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.

The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.

Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”

 

Monitoring IgG4

Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”

This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.

A version of this article appeared on Medscape.com.

“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.

Autoimmune Pancreatitis

AIP has two forms of involvement: Type 1 AIP, linked to immunoglobulin G4–related disease (IgG4-RD), and type 2 AIP, primarily associated with inflammatory bowel disease (IBD). These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.

Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.

A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.

Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.

 

Evolving Treatment

Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.

The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.

Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”

 

Monitoring IgG4

Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”

This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.

A version of this article appeared on Medscape.com.

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New Fecal Product Expected to Enhance Microbiome Research

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The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

Scott A. Jackson

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

Dr. Sudhir K. Dutta


As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Dr. Lori Holtz



Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

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The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

Scott A. Jackson

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

Dr. Sudhir K. Dutta


As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Dr. Lori Holtz



Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

Scott A. Jackson

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

Dr. Sudhir K. Dutta


As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Dr. Lori Holtz



Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

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Veterans and Nonveterans Show Similar Mammogram Rates

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TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).

METHODOLOGY:

  • Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.

  • Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.

  • Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.

  • Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.

TAKEAWAY:

  • Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.

  • Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).

  • Veteran status showed no significant association with differences in mammography screening percentages (P = .96).

  • Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).

  • The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.

IN PRACTICE: Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.

SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017

LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.

DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).

METHODOLOGY:

  • Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.

  • Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.

  • Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.

  • Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.

TAKEAWAY:

  • Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.

  • Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).

  • Veteran status showed no significant association with differences in mammography screening percentages (P = .96).

  • Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).

  • The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.

IN PRACTICE: Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.

SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017

LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.

DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).

METHODOLOGY:

  • Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.

  • Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.

  • Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.

  • Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.

TAKEAWAY:

  • Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.

  • Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).

  • Veteran status showed no significant association with differences in mammography screening percentages (P = .96).

  • Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).

  • The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.

IN PRACTICE: Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.

SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017

LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.

DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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