Conference Coverage

CHICAGO – Improving access to preventive health care services, such as colorectal cancer screening, for the poor and uninsured has led to better health outcomes, shows a study presented on May 6 in Chicago at the annual Digestive Disease Week®.

Researchers from the University of California, Los Angeles, reported that states with expanded Medicaid coverage had significantly higher rates of colorectal cancer (CRC) screening than states where officials refused federal support for Medicaid expansion.

Led by Megan R. McLeod, MD, an internal medicine resident at the University of California, Los Angeles, researchers compared CRC screening rates in states that did not adopt Medicaid expansion in 2021 with screening rates in states that invested Medicaid expansion into 1,284 Federally Qualified Health Centers, which are nonprofit health centers or clinics that serve medically underserved areas and populations. In this study, 76% of these centers were in states that accepted Medicaid expansion. The median colorectal cancer screening rate was 42.1% in Medicaid expansion states, compared with 36.5% in nonexpansion states

“The impact of being uninsured on CRC screening participation was profound in nonexpansion states,” said Dr. McLeod, who will be a UCLA gastroenterology fellow this year.

The study adds to a growing body of evidence that shows Medicaid expansion, which increases access to health care services to previously uninsured or underinsured patients, can improve health outcomes and may reduce racial and economic disparities.

For example, a 2019 study based on electronic health record data presented at the annual meeting of the American Society of Clinical Oncology showed that, after Medicaid expansion, racial differences in timely cancer treatment effectively disappeared. Before Medicaid expansion, Black patients were 4.8% less likely than White patients to receive timely cancer treatment, which is defined as treatment starting within 30 days of the diagnosis of an advanced or metastatic solid tumor. After Medicaid expansion, however, the difference between the racial groups dwindled to 0.8% and was no longer statistically significant.

Researchers at Weill Cornell Medical Center in New York reported in 2020 at the virtual annual meeting of the American Association for the Study of Liver Diseases that, 1 year after Medicaid expansion began on Jan. 1, 2014, the rate of liver-related mortality began to decline in 18 states with expanded coverage, whereas the rate of liver-related deaths continued to climb in 14 states that did not expand Medicaid.

The U.S. Health Resources and Services Administration funds Federally Qualified Health Centers (FQHC) that serve nearly 29 million patients throughout the country, including a large proportion whose care is covered by Medicaid. Among patients cared for in these centers, one in three have incomes below the federal poverty line, and one in five are uninsured.

Screening rates compared

Dr. McLeod and colleagues sought to determine whether Medicaid expansion would have an effect on CRC screening rates at these centers. The final analysis included 6,940,879 patients (between 50 and 74 years), of whom 1.7% were unhoused and 17.6% were uninsured.

Medicaid expansion status appeared to have a direct impact on whether screenings were even offered to patients. Centers in rural areas and those with a high proportion of uninsured patients were found to have significantly higher odds for doing fewer CRC screenings. In Medicaid expansion states, CRC screening rates were significantly lower for patients who were male, Black, Hispanic, had low income, were unhoused, or were uninsured.

In a Q&A that followed the presentation, Steven Itzkowitz, MD, director of the GI fellowship program at the Icahn School of Medicine at Mount Sinai, New York, suggested the type of CRC test patients are offered is directly related to Medicaid expansion status.

“In New York, before Cologuard (a colon and rectal cancer screening test) was covered by Medicaid, it wasn’t used very much, but once it got paid for by Medicaid, rates went up,” he said.

The study was internally supported. Dr. McLeod reported no conflicts of interest. Dr. Itzkowitz has been a consultant for Exact Sciences, the maker of Cologuard.

DDW is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – Improving access to preventive health care services, such as colorectal cancer screening, for the poor and uninsured has led to better health outcomes, shows a study presented on May 6 in Chicago at the annual Digestive Disease Week®.

Researchers from the University of California, Los Angeles, reported that states with expanded Medicaid coverage had significantly higher rates of colorectal cancer (CRC) screening than states where officials refused federal support for Medicaid expansion.

Led by Megan R. McLeod, MD, an internal medicine resident at the University of California, Los Angeles, researchers compared CRC screening rates in states that did not adopt Medicaid expansion in 2021 with screening rates in states that invested Medicaid expansion into 1,284 Federally Qualified Health Centers, which are nonprofit health centers or clinics that serve medically underserved areas and populations. In this study, 76% of these centers were in states that accepted Medicaid expansion. The median colorectal cancer screening rate was 42.1% in Medicaid expansion states, compared with 36.5% in nonexpansion states

“The impact of being uninsured on CRC screening participation was profound in nonexpansion states,” said Dr. McLeod, who will be a UCLA gastroenterology fellow this year.

The study adds to a growing body of evidence that shows Medicaid expansion, which increases access to health care services to previously uninsured or underinsured patients, can improve health outcomes and may reduce racial and economic disparities.

For example, a 2019 study based on electronic health record data presented at the annual meeting of the American Society of Clinical Oncology showed that, after Medicaid expansion, racial differences in timely cancer treatment effectively disappeared. Before Medicaid expansion, Black patients were 4.8% less likely than White patients to receive timely cancer treatment, which is defined as treatment starting within 30 days of the diagnosis of an advanced or metastatic solid tumor. After Medicaid expansion, however, the difference between the racial groups dwindled to 0.8% and was no longer statistically significant.

Researchers at Weill Cornell Medical Center in New York reported in 2020 at the virtual annual meeting of the American Association for the Study of Liver Diseases that, 1 year after Medicaid expansion began on Jan. 1, 2014, the rate of liver-related mortality began to decline in 18 states with expanded coverage, whereas the rate of liver-related deaths continued to climb in 14 states that did not expand Medicaid.

The U.S. Health Resources and Services Administration funds Federally Qualified Health Centers (FQHC) that serve nearly 29 million patients throughout the country, including a large proportion whose care is covered by Medicaid. Among patients cared for in these centers, one in three have incomes below the federal poverty line, and one in five are uninsured.

Screening rates compared

Dr. McLeod and colleagues sought to determine whether Medicaid expansion would have an effect on CRC screening rates at these centers. The final analysis included 6,940,879 patients (between 50 and 74 years), of whom 1.7% were unhoused and 17.6% were uninsured.

Medicaid expansion status appeared to have a direct impact on whether screenings were even offered to patients. Centers in rural areas and those with a high proportion of uninsured patients were found to have significantly higher odds for doing fewer CRC screenings. In Medicaid expansion states, CRC screening rates were significantly lower for patients who were male, Black, Hispanic, had low income, were unhoused, or were uninsured.

In a Q&A that followed the presentation, Steven Itzkowitz, MD, director of the GI fellowship program at the Icahn School of Medicine at Mount Sinai, New York, suggested the type of CRC test patients are offered is directly related to Medicaid expansion status.

“In New York, before Cologuard (a colon and rectal cancer screening test) was covered by Medicaid, it wasn’t used very much, but once it got paid for by Medicaid, rates went up,” he said.

The study was internally supported. Dr. McLeod reported no conflicts of interest. Dr. Itzkowitz has been a consultant for Exact Sciences, the maker of Cologuard.

DDW is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – Improving access to preventive health care services, such as colorectal cancer screening, for the poor and uninsured has led to better health outcomes, shows a study presented on May 6 in Chicago at the annual Digestive Disease Week®.

Researchers from the University of California, Los Angeles, reported that states with expanded Medicaid coverage had significantly higher rates of colorectal cancer (CRC) screening than states where officials refused federal support for Medicaid expansion.

Led by Megan R. McLeod, MD, an internal medicine resident at the University of California, Los Angeles, researchers compared CRC screening rates in states that did not adopt Medicaid expansion in 2021 with screening rates in states that invested Medicaid expansion into 1,284 Federally Qualified Health Centers, which are nonprofit health centers or clinics that serve medically underserved areas and populations. In this study, 76% of these centers were in states that accepted Medicaid expansion. The median colorectal cancer screening rate was 42.1% in Medicaid expansion states, compared with 36.5% in nonexpansion states

“The impact of being uninsured on CRC screening participation was profound in nonexpansion states,” said Dr. McLeod, who will be a UCLA gastroenterology fellow this year.

The study adds to a growing body of evidence that shows Medicaid expansion, which increases access to health care services to previously uninsured or underinsured patients, can improve health outcomes and may reduce racial and economic disparities.

For example, a 2019 study based on electronic health record data presented at the annual meeting of the American Society of Clinical Oncology showed that, after Medicaid expansion, racial differences in timely cancer treatment effectively disappeared. Before Medicaid expansion, Black patients were 4.8% less likely than White patients to receive timely cancer treatment, which is defined as treatment starting within 30 days of the diagnosis of an advanced or metastatic solid tumor. After Medicaid expansion, however, the difference between the racial groups dwindled to 0.8% and was no longer statistically significant.

Researchers at Weill Cornell Medical Center in New York reported in 2020 at the virtual annual meeting of the American Association for the Study of Liver Diseases that, 1 year after Medicaid expansion began on Jan. 1, 2014, the rate of liver-related mortality began to decline in 18 states with expanded coverage, whereas the rate of liver-related deaths continued to climb in 14 states that did not expand Medicaid.

The U.S. Health Resources and Services Administration funds Federally Qualified Health Centers (FQHC) that serve nearly 29 million patients throughout the country, including a large proportion whose care is covered by Medicaid. Among patients cared for in these centers, one in three have incomes below the federal poverty line, and one in five are uninsured.

Screening rates compared

Dr. McLeod and colleagues sought to determine whether Medicaid expansion would have an effect on CRC screening rates at these centers. The final analysis included 6,940,879 patients (between 50 and 74 years), of whom 1.7% were unhoused and 17.6% were uninsured.

Medicaid expansion status appeared to have a direct impact on whether screenings were even offered to patients. Centers in rural areas and those with a high proportion of uninsured patients were found to have significantly higher odds for doing fewer CRC screenings. In Medicaid expansion states, CRC screening rates were significantly lower for patients who were male, Black, Hispanic, had low income, were unhoused, or were uninsured.

In a Q&A that followed the presentation, Steven Itzkowitz, MD, director of the GI fellowship program at the Icahn School of Medicine at Mount Sinai, New York, suggested the type of CRC test patients are offered is directly related to Medicaid expansion status.

“In New York, before Cologuard (a colon and rectal cancer screening test) was covered by Medicaid, it wasn’t used very much, but once it got paid for by Medicaid, rates went up,” he said.

The study was internally supported. Dr. McLeod reported no conflicts of interest. Dr. Itzkowitz has been a consultant for Exact Sciences, the maker of Cologuard.

DDW is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

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

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

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

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

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

SEATTLE – Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

SEATTLE – Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

SEATTLE – Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

No funding for the study was declared. The investigators have disclosed no relevant financial relationships.

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

No funding for the study was declared. The investigators have disclosed no relevant financial relationships.

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

No funding for the study was declared. The investigators have disclosed no relevant financial relationships.

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

SAN DIEGO – Gout is one of the most poorly managed diseases and is mostly treated by primary care providers, said a presenter at the annual meeting of the American College of Physicians. Failure to understand the disease process and goals of urate-lowering therapy (ULT) is a key barrier to achieving optimal gout therapy.

“There’s too much focus on the flare and too little focus on the urate burden of the disease. Regardless of the clinical setting, the goal should be to manage [high] serum uric acid levels,” said Lawrence Edwards, MD, professor at the University of Florida, Gainesville, during his talk.

Dr. Edwards, who specializes in treating patients with gout and rheumatoid arthritis, discussed the role of primary care providers in the treatment of gout. “We can and must do better,” he said.
 

Understanding the pathology of gout is key to effective treatment

Knowledge of the molecular pathology of gout has advanced drastically over the last few years. “The improved understanding of the molecules involved in disease initiation and progression can help us make better treatment decisions depending on the stage of the disease,” Dr. Edwards said.

Gout is caused by the deposition of monosodium urate (MSU) crystals, which starts as asymptomatic hyperuricemia, he said. Inflammatory responses to MSU crystals are responsible for gout flares, the frequency of which increases as the disease progresses.

Innate immune responses driven by macrophages and neutrophils play a crucial role in acute gout attacks. In the molecular pathway, proinflammatory cytokines IL-1 beta and IL-6 are the mediators of gout flares, whereas IL-8 accumulates over time and contributes to disease progression and systemic illness. If left untreated or undertreated, the repeated inflammatory reaction leads to advanced gout. The urate burden also increases with disease progression.

“Physicians need to better educate themselves on the destructive nature of this inflammatory arthritis and the need for effective urate-lowering therapy in the management of gout,” Dr. Edwards said.
 

Management of acute gout attacks

The management of gout flares involves the use of pharmacological agents to control pain and inflammation. The three most common anti-inflammatory therapies are colchicine, NSAIDs, and corticosteroids (either oral or intramuscular).

The choice of which of these should be used alone or in combination for a flare is based on previous tolerance of the medication or the presence of diabetes, kidney disease, heart disease, or a history of upper gastrointestinal bleeding. Dr. Edwards referred internists to the 2020 American College of Rheumatology gout management guideline.

“Regardless of which therapy is chosen, the more important consideration is how quickly the patients can start treatment after the flare begins,” said Dr. Edwards when asked about priorities in the management of gout flares. “This means that the patient should have ready access to whichever the chosen approach is. We call this the ‘pill-in-the-pocket’ approach,” he added.

Reducing the urate burden is also important for effective treatment. The serum urate level is the primary marker of how well a patient’s gout is being managed. ULT should be initiated in patients with subcutaneous tophi, gout-related radiographic damage, or frequent flares (≥ 2 per year). Allopurinol is typically the first-line ULT of choice.

Dr. Edwards noted that far too much focus is placed on flare treatment rather than addressing the underlying sources of gouty symptoms – the elevated serum levels of urate.
 

Management of advanced gout

“The management of advanced gout is challenging, and the dissolution of MSU is slow unless you take an aggressive approach,” Dr. Edwards said.

Switching to pegloticase is recommended for patients with frequent flares, nonresolving tophi, or high serum urate levels that persist despite treatment with xanthine oxidase inhibitors or other ULT agents.

“The frequency and severity of gout flares are what patients focus on, but if that’s the only focus of the treating physicians, then they are leaving the job less than halfway done. Getting the serum urate to below a level of 6.0 mg/dL is the most important aspect in the lifelong management of gout,” said Dr. Edwards.
 

Barriers to effective gout treatment

When asked during an interview after the session about the most important barriers to successful gout management, Allison M. Mays, MD, a geriatric medicine subspecialist at Cedars-Sinai Medical Center, Los Angeles, said that “the fact that gout mostly impacts quality of life and not necessarily mortality means that other things may take precedent.” She explained that gout typically coexists with other comorbidities, often multiple ones. Patients may also defer taking an additional medication for a disease like gout, which has only episodic discomfort.

She added that gout management involves shared decision-making between patients and the medical team – including the primary care physician, rheumatologist, orthopedist, and emergency physician. Following a visit to the urgent care or the ED for an acute flare of gout, the patient may not follow up with their primary care doctor or bring it up at their next visit for chronic management, she noted.

Dr. Edwards serves as a consultant to Horizon Pharmaceuticals, Atom Biosciences, Shanton Biosciences, and Aclaris Therapeutics. Horizon marketed pegloticase up until last month when Amgen bought the drug. Dr. Edwards is also president of Gout Education Society, and he has no financial agreement with any of the multiple companies that produce colchicine and allopurinol. Dr. Mays reported no conflicts.

SAN DIEGO – Gout is one of the most poorly managed diseases and is mostly treated by primary care providers, said a presenter at the annual meeting of the American College of Physicians. Failure to understand the disease process and goals of urate-lowering therapy (ULT) is a key barrier to achieving optimal gout therapy.

“There’s too much focus on the flare and too little focus on the urate burden of the disease. Regardless of the clinical setting, the goal should be to manage [high] serum uric acid levels,” said Lawrence Edwards, MD, professor at the University of Florida, Gainesville, during his talk.

Dr. Edwards, who specializes in treating patients with gout and rheumatoid arthritis, discussed the role of primary care providers in the treatment of gout. “We can and must do better,” he said.
 

Understanding the pathology of gout is key to effective treatment

Knowledge of the molecular pathology of gout has advanced drastically over the last few years. “The improved understanding of the molecules involved in disease initiation and progression can help us make better treatment decisions depending on the stage of the disease,” Dr. Edwards said.

Gout is caused by the deposition of monosodium urate (MSU) crystals, which starts as asymptomatic hyperuricemia, he said. Inflammatory responses to MSU crystals are responsible for gout flares, the frequency of which increases as the disease progresses.

Innate immune responses driven by macrophages and neutrophils play a crucial role in acute gout attacks. In the molecular pathway, proinflammatory cytokines IL-1 beta and IL-6 are the mediators of gout flares, whereas IL-8 accumulates over time and contributes to disease progression and systemic illness. If left untreated or undertreated, the repeated inflammatory reaction leads to advanced gout. The urate burden also increases with disease progression.

“Physicians need to better educate themselves on the destructive nature of this inflammatory arthritis and the need for effective urate-lowering therapy in the management of gout,” Dr. Edwards said.
 

Management of acute gout attacks

The management of gout flares involves the use of pharmacological agents to control pain and inflammation. The three most common anti-inflammatory therapies are colchicine, NSAIDs, and corticosteroids (either oral or intramuscular).

The choice of which of these should be used alone or in combination for a flare is based on previous tolerance of the medication or the presence of diabetes, kidney disease, heart disease, or a history of upper gastrointestinal bleeding. Dr. Edwards referred internists to the 2020 American College of Rheumatology gout management guideline.

“Regardless of which therapy is chosen, the more important consideration is how quickly the patients can start treatment after the flare begins,” said Dr. Edwards when asked about priorities in the management of gout flares. “This means that the patient should have ready access to whichever the chosen approach is. We call this the ‘pill-in-the-pocket’ approach,” he added.

Reducing the urate burden is also important for effective treatment. The serum urate level is the primary marker of how well a patient’s gout is being managed. ULT should be initiated in patients with subcutaneous tophi, gout-related radiographic damage, or frequent flares (≥ 2 per year). Allopurinol is typically the first-line ULT of choice.

Dr. Edwards noted that far too much focus is placed on flare treatment rather than addressing the underlying sources of gouty symptoms – the elevated serum levels of urate.
 

Management of advanced gout

“The management of advanced gout is challenging, and the dissolution of MSU is slow unless you take an aggressive approach,” Dr. Edwards said.

Switching to pegloticase is recommended for patients with frequent flares, nonresolving tophi, or high serum urate levels that persist despite treatment with xanthine oxidase inhibitors or other ULT agents.

“The frequency and severity of gout flares are what patients focus on, but if that’s the only focus of the treating physicians, then they are leaving the job less than halfway done. Getting the serum urate to below a level of 6.0 mg/dL is the most important aspect in the lifelong management of gout,” said Dr. Edwards.
 

Barriers to effective gout treatment

When asked during an interview after the session about the most important barriers to successful gout management, Allison M. Mays, MD, a geriatric medicine subspecialist at Cedars-Sinai Medical Center, Los Angeles, said that “the fact that gout mostly impacts quality of life and not necessarily mortality means that other things may take precedent.” She explained that gout typically coexists with other comorbidities, often multiple ones. Patients may also defer taking an additional medication for a disease like gout, which has only episodic discomfort.

She added that gout management involves shared decision-making between patients and the medical team – including the primary care physician, rheumatologist, orthopedist, and emergency physician. Following a visit to the urgent care or the ED for an acute flare of gout, the patient may not follow up with their primary care doctor or bring it up at their next visit for chronic management, she noted.

Dr. Edwards serves as a consultant to Horizon Pharmaceuticals, Atom Biosciences, Shanton Biosciences, and Aclaris Therapeutics. Horizon marketed pegloticase up until last month when Amgen bought the drug. Dr. Edwards is also president of Gout Education Society, and he has no financial agreement with any of the multiple companies that produce colchicine and allopurinol. Dr. Mays reported no conflicts.

SAN DIEGO – Gout is one of the most poorly managed diseases and is mostly treated by primary care providers, said a presenter at the annual meeting of the American College of Physicians. Failure to understand the disease process and goals of urate-lowering therapy (ULT) is a key barrier to achieving optimal gout therapy.

“There’s too much focus on the flare and too little focus on the urate burden of the disease. Regardless of the clinical setting, the goal should be to manage [high] serum uric acid levels,” said Lawrence Edwards, MD, professor at the University of Florida, Gainesville, during his talk.

Dr. Edwards, who specializes in treating patients with gout and rheumatoid arthritis, discussed the role of primary care providers in the treatment of gout. “We can and must do better,” he said.
 

Understanding the pathology of gout is key to effective treatment

Knowledge of the molecular pathology of gout has advanced drastically over the last few years. “The improved understanding of the molecules involved in disease initiation and progression can help us make better treatment decisions depending on the stage of the disease,” Dr. Edwards said.

Gout is caused by the deposition of monosodium urate (MSU) crystals, which starts as asymptomatic hyperuricemia, he said. Inflammatory responses to MSU crystals are responsible for gout flares, the frequency of which increases as the disease progresses.

Innate immune responses driven by macrophages and neutrophils play a crucial role in acute gout attacks. In the molecular pathway, proinflammatory cytokines IL-1 beta and IL-6 are the mediators of gout flares, whereas IL-8 accumulates over time and contributes to disease progression and systemic illness. If left untreated or undertreated, the repeated inflammatory reaction leads to advanced gout. The urate burden also increases with disease progression.

“Physicians need to better educate themselves on the destructive nature of this inflammatory arthritis and the need for effective urate-lowering therapy in the management of gout,” Dr. Edwards said.
 

Management of acute gout attacks

The management of gout flares involves the use of pharmacological agents to control pain and inflammation. The three most common anti-inflammatory therapies are colchicine, NSAIDs, and corticosteroids (either oral or intramuscular).

The choice of which of these should be used alone or in combination for a flare is based on previous tolerance of the medication or the presence of diabetes, kidney disease, heart disease, or a history of upper gastrointestinal bleeding. Dr. Edwards referred internists to the 2020 American College of Rheumatology gout management guideline.

“Regardless of which therapy is chosen, the more important consideration is how quickly the patients can start treatment after the flare begins,” said Dr. Edwards when asked about priorities in the management of gout flares. “This means that the patient should have ready access to whichever the chosen approach is. We call this the ‘pill-in-the-pocket’ approach,” he added.

Reducing the urate burden is also important for effective treatment. The serum urate level is the primary marker of how well a patient’s gout is being managed. ULT should be initiated in patients with subcutaneous tophi, gout-related radiographic damage, or frequent flares (≥ 2 per year). Allopurinol is typically the first-line ULT of choice.

Dr. Edwards noted that far too much focus is placed on flare treatment rather than addressing the underlying sources of gouty symptoms – the elevated serum levels of urate.
 

Management of advanced gout

“The management of advanced gout is challenging, and the dissolution of MSU is slow unless you take an aggressive approach,” Dr. Edwards said.

Switching to pegloticase is recommended for patients with frequent flares, nonresolving tophi, or high serum urate levels that persist despite treatment with xanthine oxidase inhibitors or other ULT agents.

“The frequency and severity of gout flares are what patients focus on, but if that’s the only focus of the treating physicians, then they are leaving the job less than halfway done. Getting the serum urate to below a level of 6.0 mg/dL is the most important aspect in the lifelong management of gout,” said Dr. Edwards.
 

Barriers to effective gout treatment

When asked during an interview after the session about the most important barriers to successful gout management, Allison M. Mays, MD, a geriatric medicine subspecialist at Cedars-Sinai Medical Center, Los Angeles, said that “the fact that gout mostly impacts quality of life and not necessarily mortality means that other things may take precedent.” She explained that gout typically coexists with other comorbidities, often multiple ones. Patients may also defer taking an additional medication for a disease like gout, which has only episodic discomfort.

She added that gout management involves shared decision-making between patients and the medical team – including the primary care physician, rheumatologist, orthopedist, and emergency physician. Following a visit to the urgent care or the ED for an acute flare of gout, the patient may not follow up with their primary care doctor or bring it up at their next visit for chronic management, she noted.

Dr. Edwards serves as a consultant to Horizon Pharmaceuticals, Atom Biosciences, Shanton Biosciences, and Aclaris Therapeutics. Horizon marketed pegloticase up until last month when Amgen bought the drug. Dr. Edwards is also president of Gout Education Society, and he has no financial agreement with any of the multiple companies that produce colchicine and allopurinol. Dr. Mays reported no conflicts.

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

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

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

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

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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