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Exercise Can Help Protect Against Cancer Fatigue, Depression
Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.
However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.
Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”
Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.
Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.
To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).
After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.
Du said there are likely multiple reasons behind the sex differences observed.
Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.
In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.
The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.
For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.
Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.
Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.
Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.
However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.
In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.
“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.
The study had no specific funding. Du and Ligibel had no disclosures.
A version of this article first appeared on Medscape.com.
Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.
However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.
Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”
Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.
Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.
To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).
After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.
Du said there are likely multiple reasons behind the sex differences observed.
Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.
In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.
The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.
For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.
Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.
Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.
Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.
However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.
In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.
“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.
The study had no specific funding. Du and Ligibel had no disclosures.
A version of this article first appeared on Medscape.com.
Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.
However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.
Du noted that, during her residency, cancer-related fatigue was a common complaint among patients, affecting “not just their daily activities but also their overall quality of life and mental health, making tasks like climbing stairs, doing groceries, or laundry overwhelming.”
Cancer-related fatigue affects more than 80% of patients who receive chemotherapy or radiation therapy, while depression affects around 25% of patients. Unlike typical fatigue, cancer-related fatigue can linger for weeks, months, or even years after treatment, Du explained.
Despite its high prevalence, cancer-related fatigue remains “overlooked and undertreated,” she noted during a conference press briefing. In addition, cancer-related fatigue can affect men and women differently.
To investigate further, Du and her colleagues analyzed National Health and Nutrition Examination Survey (NHANES) data from 1552 cancer survivors (736 men and 816 women).
After adjusting for age, race, socioeconomic status, and comorbidities, women cancer survivors were more likely to experience fatigue (odds ratio [OR], 1.54; P < .017) and depression (OR, 1.32; P = .341) related to their cancer compared with men cancer survivors.
Du said there are likely multiple reasons behind the sex differences observed.
Women may, for instance, be more likely to experience side effects from chemotherapy, radiation, and long-term use of endocrine treatments because of slower drug clearance, which can lead to higher concentrations and a stronger immune response that may heighten inflammatory side effects.
In multivariate logistic regression analysis, cancer-related fatigue (OR, 1.93; P = .002) and depression (OR, 2.28; P = .011) were both strongly associated with reduced moderate recreational activities, such as brisk walking, biking, golfing, and light yard work.
The data also showed a protective role for physical activity. For patients who engaged in moderate physical activity, their risk for cancer-related fatigue (OR, 0.52; P = .002) and depression (OR, 0.41; P = .006) was significantly reduced, Du reported.
For depression (but not cancer-related fatigue), “the higher the intensity of physical activity, the higher the protective effects, with almost 4-5 times the reduction of the depression,” Du noted.
Although the NHANES uses standardized protocols designed to minimize biases, Du said a limitation of the current study is the use of self-reported data and the fact that women could potentially overreport fatigue symptoms and men could potentially underreport symptoms of depression.
Looking ahead, Du and her colleagues are planning studies to assess the effectiveness of tailored interventions on cancer-related fatigue and explore the connection between cancer-related fatigue and different mechanisms, such as inflammatory markers, to see if gender modifies the association.
Commenting on the study for this news organization, Jennifer Ligibel, MD, a senior physician at the Dana-Farber Cancer Institute in Boston, said that, because the dataset is cross-sectional, it is unclear whether people who were more tired weren’t exercising or if people who weren’t exercising were more tired.
However, Ligibel explained, a huge body of literature has demonstrated that exercise is “the most efficient remedy for fatigue,” and it likely helps with depression too.
In fact, in a recent survey of patients with cancer conducted by the American Society for Clinical Oncology, slightly more than half of patients reported that their oncologist talked about exercise and diet during clinic visits, Ligibel said. Provider recommendations for exercise and diet were associated with positive changes in these behaviors.
“Roughly half of oncologists now give exercise advice; that figure is a lot more than it was a few years ago, but it’s still not universal,” Ligibel said.
The study had no specific funding. Du and Ligibel had no disclosures.
A version of this article first appeared on Medscape.com.
FROM AACR 2025
Single Antiplatelet After TAVR Lowers Risk
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
FROM SCAI 2025
Rethinking the Scalpel: Advancing Non-Surgical Strategies for Early Breast Cancer
Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.
Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.
Reassessing the Role of Surgery in the Early Stages
Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity.
Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM.
Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference.
A Shift in Practice: Moving Away From Routine Node Dissection
Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.
Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation.
The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.
SLNB: A Less Invasive Alternative to ALND
Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.
Rethinking First Steps: Non-Surgical Strategies
While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease.
The Clinician’s Role in Shaping Conservative Surgical Approaches
De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life.
Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.
Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.
Nameera Temkar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.
Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.
Reassessing the Role of Surgery in the Early Stages
Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity.
Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM.
Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference.
A Shift in Practice: Moving Away From Routine Node Dissection
Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.
Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation.
The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.
SLNB: A Less Invasive Alternative to ALND
Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.
Rethinking First Steps: Non-Surgical Strategies
While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease.
The Clinician’s Role in Shaping Conservative Surgical Approaches
De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life.
Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.
Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.
Nameera Temkar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Breast cancer is the most common cancer in women worldwide and a leading cause of cancer-related deaths. The most common form of breast cancer is invasive ductal carcinoma, which accounts for 75%-80% of breast cancers. The second most common form is invasive lobular carcinoma, which accounts for 10%-15% of cases.
Surgical treatment of breast cancer involves removal and pathological staging of the cancerous tissue. Breast-conserving surgery and mastectomy are two surgical treatment options for patients with breast cancer. Breast-conserving surgery, which involves resection of the tumor and the surrounding margin of healthy tissue to achieve clean margins, is usually combined with radiotherapy. Mastectomy is considered in patients with relative and absolute contraindications to breast-conserving therapeutic options (eg, patients with a genetic predisposition to breast cancer, tumors > 5 cm, extensive margins, prior radiation to breast or chest wall, first-trimester pregnancy, extensive ductal carcinoma in situ, inflammatory breast cancer). Although surgical treatment of breast cancer is widely used, there have been calls to minimize unnecessary invasive surgical interventions in patients with early-stage breast cancer.
Reassessing the Role of Surgery in the Early Stages
Some surgical procedures, including axillary lymph node dissection (ALND) and contralateral prophylactic mastectomy (CPM), once considered standard treatment for early-stage breast cancer, are now being recognized as unnecessary in most cases of early-stage breast cancer without sentinel node metastases. Although ALND, which involves removal of all lymphatic tissue in the axilla, has been used for decades in the surgical management of early-stage breast cancer, this intervention typically results in lymphedema and significant morbidity.
Contralateral prophylactic mastectomy is a surgical option chosen by some women with early-stage unilateral breast cancer. However, this procedure is considered controversial in this patient population since evidence shows no survival advantage with CPM. A large-scale survey by Jagsi et al of female patients with in situ or early-stage breast cancer concluded that CPM was more common in patients who were White, had a higher level of education, and had private health insurance. In the study, 598 of the 1569 patients without an identified mutation or high genetic risk reported that a surgeon recommended against CPM. Of this group, only 1.9% underwent CPM. In contrast, of the 746 patients who reported that they did not receive any recommendation from a surgeon, 19% underwent CPM.
Re-excision and mastectomy are considered in patients with early-stage breast cancer when clear margins are not achieved with breast-conserving surgery. To prevent unnecessary reoperations and mastectomies, the 2013 invasive cancer margin consensus guideline by the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology, defined adequate margins in breast-conserving surgery in invasive breast cancer as “no ink on tumor.” The guideline is endorsed by the American Society of Breast Surgeons, ASTRO, and the St Gallen Consensus Conference.
A Shift in Practice: Moving Away From Routine Node Dissection
Based on findings from multiple clinical trials, experts recommend sentinel lymph node biopsy (SLNB) over ANLD and omit axillary surgery in certain patients. Findings from ACOSOG Z1071, SENTINA, and SN FNAC prospective multi-institutional trials support the use of SLNB as the initial diagnostic procedure. Sentinel lobe biopsy involves removal and evaluation of the first lymph node which receives lymphatic drainage from the breast cancer site. Negative biopsy findings on SLNB can avoid ALND as it is less likely that metastasis has occurred.
Although SLNB is preferred in younger patients with early-stage breast cancer, it is not routinely recommended for women aged ≥ 70 years of age with clinically node-negative, early-stage, HR-positive and HER2-negative breast cancer. This recommendation is based on study findings showing no difference in survival of women aged > 70 years with HR-positive clinical stage I breast cancer who did and did not undergo axillary evaluation.
The Z0011 trial by the American College of Surgeons Oncology Group found SLNB alone was not inferior to ALND regarding overall and disease-free survival in patients with clinically node-negative cancer undergoing breast conservation surgery and radiation therapy.
SLNB: A Less Invasive Alternative to ALND
Compared to SLNB, ALND is associated with more morbidity, physical symptoms, and poorer quality of life. A systemic review by Bakri et al evaluating the impact of ALND vs SLNB found higher rates of lymphedema, pain, reduced strength, and range of motion in patients who underwent ALND. In addition, an analysis of the National Cancer Database by Cocco et al found that patients with limited CN+ T1-2 breast cancer had favorable survival outcomes after undergoing SLNB and regional node irradiation vs ALND.
Rethinking First Steps: Non-Surgical Strategies
While surgical intervention with or without radiation therapy remains a primary treatment in early-stage breast cancer, there is an increased emphasis on de-escalation to minimize surgery and consider nonsurgical options in this patient population. A neoadjuvant systemic therapeutic approach by Kuerer et al for HER2-positive breast cancer and triple-negative breast cancer yielded a pathological complete response in 62% of patients. This multicenter, single-arm, phase 2 trial evaluated patients with HER2-positive breast cancer and a residual breast lesion < 2 cm or unicentric cT1-2N0-1M0 triple-negative breast cancer. Patients in the study underwent radiotherapy alone after excluding invasive in-situ disease.
The Clinician’s Role in Shaping Conservative Surgical Approaches
De-escalating surgery in breast cancer should involve acknowledging the patient’s fears and misperceptions regarding the risks of cancer recurrence that can lead them to opt for more invasive surgical treatments. Patients may not or fully regard the long-term effects of electing an invasive procedure in the absence of clinical indications. For example, patients undergoing more invasive interventions may experience worse body image and quality of life.
Clinicians may also not adequately estimate other harms associated with unnecessary surgical interventions. Providing clinicians with data that focuses on the psychological outcomes and satisfaction of patients post surgery may help them to better interpret and consider patient values and wishes and minimize future unnecessary surgeries.
Breast cancer remains one of the best-studied cancers with multiple high-quality randomized controlled trials supporting de-escalation of surgery. De-escalation of breast cancer surgery has been successful in multiple ways, including the implementation of ALND in early-stage breast cancer. However, other options such as CPM remain common. Proper patient and physician education involving data from clinical trials and reports of patient satisfaction may further decrease unnecessary surgical interventions.
Nameera Temkar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gastric Cancer Prevention: New AGA Update Reflects Latest High-Risk Screening and Surveillance Advice
Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.
The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).
“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.
Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.
“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”
The clinical practice update was published in Gastroenterology.
Gastric Cancer Screening
, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.
High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.
Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.
In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.
As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.
Endoscopic Biopsy and Diagnosis
In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.
Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.
Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.
Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.
Endoscopic Management and Surveillance
If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.
Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.
Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.
In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.
Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.
Patient-Centered Approach
The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.
In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.
“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.
El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.
“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”
The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.
The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).
“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.
Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.
“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”
The clinical practice update was published in Gastroenterology.
Gastric Cancer Screening
, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.
High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.
Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.
In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.
As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.
Endoscopic Biopsy and Diagnosis
In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.
Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.
Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.
Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.
Endoscopic Management and Surveillance
If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.
Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.
Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.
In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.
Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.
Patient-Centered Approach
The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.
In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.
“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.
El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.
“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”
The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.
The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).
“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.
Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.
“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”
The clinical practice update was published in Gastroenterology.
Gastric Cancer Screening
, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.
High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.
Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.
In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.
As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.
Endoscopic Biopsy and Diagnosis
In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.
Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.
Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.
Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.
Endoscopic Management and Surveillance
If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.
Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.
Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.
In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.
Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.
Patient-Centered Approach
The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.
In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.
“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.
El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.
“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”
The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Autoimmune Pancreatitis: What’s Really Behind Those Symptoms
“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.
Autoimmune Pancreatitis
These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.
Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.
A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.
Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.
Evolving Treatment
Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.
The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.
Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”
Monitoring IgG4
Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”
This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.
A version of this article appeared on Medscape.com.
“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.
Autoimmune Pancreatitis
These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.
Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.
A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.
Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.
Evolving Treatment
Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.
The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.
Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”
Monitoring IgG4
Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”
This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.
A version of this article appeared on Medscape.com.
“Defined about 30 years ago, autoimmune pancreatitis [AIP] remains a diagnostic challenge,” said Vinciane Rebours, MD, PhD, professor and head of the Pancreatology and Digestive Oncology Department, Beaujon Hospital in Clichy, France. She spoke at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology 2025, held in Paris. The challenge lies in the fact that AIP includes two distinct clinical entities, neither of which is truly autoimmune. However, much remains unknown, including its natural history, cancer risk, and optimal treatment strategies. However, some aspects are now better understood.
Autoimmune Pancreatitis
These forms differ in their histological characteristics. Type 1 exhibits lymphoplasmacytic infiltration, extensive fibrosis, and IgG4-positive plasma cells. Type 2 presents with granulocytic lesions similar to those in Crohn’s disease.
Type 1 AIP typically affects men aged 50 years or older and is often associated with jaundice, pseudotumor formation, diabetes, and exocrine pancreatic insufficiency. “It is a systemic disease where lymphoplasmacytic infiltration can affect multiple organs, with the pancreas and lymph nodes most commonly involved,” said Rebours.
A definitive diagnosis of type 1 AIP requires three criteria: Organ involvement, serum IgG4 levels more than twice the normal level, and histological abnormalities on biopsy. If one of these criteria is missing, the diagnosis is considered probable or possible.
Diagnosing type 1 AIP is challenging because it can affect multiple organs, often with few symptoms, leading to significant clinical variability. Type 2 AIP, in contrast, generally affects younger individuals, with no gender preference. It is pathophysiologically distinct and is linked to IBD in 87% of cases. Diagnosis relies on clinical criteria, imaging abnormalities (parenchymal or ductal changes identifiable on scans), response to corticosteroids in symptomatic patients, and the presence of IBD. The absence of IgG4 can also aid in the diagnosis. However, gathering all these elements can be difficult.
Evolving Treatment
Symptomatic patients and those at risk for organ failure, particularly lung and kidney failure, are eligible for induction treatment. This involves the administration of full-dose corticosteroids for 4 weeks, followed by a tapering regimen. Remission was achieved in 99% of type 1 and 92% of type 2 cases. Corticosteroids can also be used as a “trial treatment” to assess corticosteroid sensitivity in patients with type 2 AIP.
The risk for recurrence (in case of nonresponse or recurrence before 12 months posttreatment) is higher in type 1 (one third of cases) than in type 2 (15%). In such cases, immunomodulators, primarily rituximab, are recommended for type 1 AIP. Rituximab can also be used as an induction treatment, either alone or in combination, or as maintenance therapy. Alternatives include mycophenolate mofetil or inebilizumab, which showed an 87% reduction in relapse risk according to data published in 2024.
Maintenance treatment for type 2 AIP is not yet fully standardized. The disease is often managed in a manner similar to that of IBD treatment. Rebours cautioned, “Management cannot stop at the pancreas; it is essential to detect all other paucisymptomatic manifestations through comprehensive annual imaging and biannual biological and functional screenings.”
Monitoring IgG4
Monitoring IgG4 levels is important for therapeutic follow-up but is not the “holy grail” for diagnosis, Rebours acknowledged. For instance, 20% of IgG4-RD cases have normal IgG4 levels, 20% of pancreatic cancers show elevated IgG4 levels, and some patients achieve clinical remission despite persistently abnormal IgG4 levels. Without strong suspicion of type 1 AIP, measuring IgG4 levels is “zero cost-effective.”
This disease, which is associated with the risk for underlying cancer, requires extensive imaging (CT, MRI, and endoscopic ultrasound) to differentiate between AIP and cancer. This step is essential to avoid unnecessary surgery on organs affected by IgG4-RD or for treating cancer with corticosteroids.
A version of this article appeared on Medscape.com.
New Fecal Product Expected to Enhance Microbiome Research
According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.”
Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).
The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria.
Development
According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced.
“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.”
As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods.
The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses.
Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”
And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”
The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”
Jackson, Dutta, and Holtz disclosed having no relevant competing interests.
A version of this article appeared on Medscape.com.
According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.”
Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).
The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria.
Development
According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced.
“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.”
As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods.
The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses.
Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”
And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”
The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”
Jackson, Dutta, and Holtz disclosed having no relevant competing interests.
A version of this article appeared on Medscape.com.
According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.”
Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).
The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria.
Development
According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced.
“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.”
As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods.
The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses.
Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”
And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”
The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”
Jackson, Dutta, and Holtz disclosed having no relevant competing interests.
A version of this article appeared on Medscape.com.
Veterans and Nonveterans Show Similar Mammogram Rates
TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).
METHODOLOGY:
Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.
Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.
Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.
Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.
TAKEAWAY:
Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.
Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).
Veteran status showed no significant association with differences in mammography screening percentages (P = .96).
Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).
The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.
IN PRACTICE: “Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.
SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017
LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.
DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).
METHODOLOGY:
Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.
Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.
Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.
Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.
TAKEAWAY:
Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.
Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).
Veteran status showed no significant association with differences in mammography screening percentages (P = .96).
Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).
The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.
IN PRACTICE: “Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.
SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017
LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.
DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: A national survey of 8996 females reveals comparable mammography screening rates between those who identify as veterans (57.9%) and nonveterans (55.2%).
METHODOLOGY:
Researchers analyzed data from the 2019 National Health Interview Survey, a cross-sectional national survey tracking health information.
Female respondents aged 40 to 74 years without history of breast cancer were included in the analysis.
Analysis evaluated the association between screening and veteran status through logistic regression, adjusting for potential confounders.
Survey procedures accounted for complex sampling design to obtain valid estimates for the civilian, noninstitutionalized US population.
TAKEAWAY:
Analysis included 8996 female survey respondents, including 169 veterans (1.9%) and 320 (3.2%) reported having military health coverage.
Mammography screening rates within the last year were comparable between veterans (57.9%) and nonveterans (55.2%).
Veteran status showed no significant association with differences in mammography screening percentages (P = .96).
Among insured participants, military health insurance demonstrated no significant association with mammography screening percentages (P = .13).
The authors suggest that radiology practices should design proactive outreach strategies to address the needs of the growing number of female veterans who may face increased breast cancer risk due to military environmental exposures.
IN PRACTICE: “Although the results from our study demonstrate comparable mammography screening percentages, veterans may face additional risk factors for breast cancer due to occupational,” the authors argue.
SOURCE: This summary is based on a preprint published online in the Journal of the American College of Radiology: Milton A, Miles R, Gettle LM, Van Geertruyden P, Narayan AK. Utilization of Mammography Screening in Female Veterans: Cross-Sectional Survey Results from the National Health Interview Survey. J Am Coll Radiol. Published online April 24, 2025. doi:10.1016/j.jacr.2025.04.017
LIMITATIONS: The study relied on self-reported adherence data, which could overestimate screening percentages. Data collection occurred prior to updated United States Preventive Services Task Force guidelines recommending routine mammography screening for women starting at age 40 years every 2 years. The relatively small number of female veteran respondents limited the precision of population estimates. Additionally, the data were collected before the COVID-19 pandemic, which has been associated with reduced mammographic screening, particularly in medically underserved populations.
DISCLOSURES: Anand Narayan disclosed receiving financial support from Susan G. Komen Breast Cancer Foundation and National Academy of Medicine. The study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The remaining authors reported no potential conflicts of interest. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
UK Funds AI Blood Test for Early Cancer Detection
A clinical trial of a promising blood test that could offer faster and more accurate diagnoses for common cancers has received funding from the Department of Health and Social Care (DHSC).
The miONCO-Dx test detects cancer at an early stage by analysing microRNA expression in blood.
It uses artificial intelligence to identify the presence and origin of the disease.
The test was developed by Xgenera, a University of Southampton spinout, in collaboration with the National Institute for Health and Care Research.
Initial analysis of data from more than 20,000 patients showed that the test detected 12 of the most common and lethal cancers at an early stage and with over 99% accuracy.
Bowel Cancer Among Key Targets
Bowel cancer, the fourth most common cancer in the United Kingdom, is a principal target for the test.
Around 44,000 people in the UK are diagnosed with bowel cancer each year. At stage 1, approximately 90% of people survive for 5 years or more, but this drops to around 10% at stage 4.
Wes Streeting, Secretary of State for Health and Social Care, said in a press release, “The key to surviving cancer is catching it as early as possible, so this government is taking the urgent action needed to make sure that happens.”
£2.4 Million Awarded for Clinical Trial
The DHSC has awarded Xgenera £2.4 million to advance development of the test, which has now been refined into a cheaper, faster, and more scalable version.
The funding will support a clinical trial involving 8000 patients. The DHSC described this as “a formal and significant step towards bringing the test closer to patients by ensuring it is fit for purpose in the NHS.”
The trial will be run by Cancer Research UK Southampton Clinical Trials Unit.
Potential for NHS Use
Dr Victoria Goss, head of early diagnosis and translational research at the trials unit, said in a press release, “A reliable test such as this could have the potential to see a major shift in cancer screening, making it easier and cheaper to provide on the NHS, cutting health inequalities, and ultimately reducing the number of people who die from the disease.”
Xgenera co-founder Dr Andy Shapanis, a research fellow at the University of Southampton, said that the new study would evaluate the useability, accuracy, and cost-effectiveness of the test for use within the NHS in future.
“The hope is that if the test is shown to be successful in the early diagnosis of the 12 cancers we have currently identified biomarkers for, then it could be expanded to look at over 50 other cancers in the future,” he said.
Comparison With Other Tests
The miONCO-Dx test follows other attempts at multicancer early detection, such as the Galleri test from Grail, which is already being trialled in the NHS.
Galleri screens for altered DNA methylation patterns in blood and claims to detect more than 50 types of cancer. It raised hopes for earlier diagnosis, less invasive treatment, and potential cost savings.
However, critics have raised concerns about low detection rates in early-stage cancers, high false-positive rates, imprecise cancer origin analysis, cost, and unproven mortality gains. Questions have also been expressed about possible political influence in its selection for NHS trials.
A Broader Screening Platform
Xgenera co-founder Professor Paul Skipp, director of the Centre for Proteomic Research at the University of Southampton, said earlier this year that the miONCO-Dx test was “a real game-changer.”
The test can detect lung, breast, prostate, pancreatic, colorectal, ovarian, liver, brain, oesophageal, bladder, and gastric cancer and bone and soft-tissue sarcoma. It works by identifying imbalances in microRNAs, a class of small noncoding RNAs with functions in posttranscriptional regulation of gene expression, influencing cellular activities including cell growth, differentiation, development, and apoptosis.
The presence of microRNA imbalances can be identified from just 10-15 drops of blood, across all stages of tumour growth.
In comparison, according to Skipp, screening is only available currently for three types of cancer in the UK, and each test targets a single type.
Xgenera has also received external investment from the innovation investment companies Qantx, Empirical Ventures, and Ascension Ventures to further develop the test.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
A clinical trial of a promising blood test that could offer faster and more accurate diagnoses for common cancers has received funding from the Department of Health and Social Care (DHSC).
The miONCO-Dx test detects cancer at an early stage by analysing microRNA expression in blood.
It uses artificial intelligence to identify the presence and origin of the disease.
The test was developed by Xgenera, a University of Southampton spinout, in collaboration with the National Institute for Health and Care Research.
Initial analysis of data from more than 20,000 patients showed that the test detected 12 of the most common and lethal cancers at an early stage and with over 99% accuracy.
Bowel Cancer Among Key Targets
Bowel cancer, the fourth most common cancer in the United Kingdom, is a principal target for the test.
Around 44,000 people in the UK are diagnosed with bowel cancer each year. At stage 1, approximately 90% of people survive for 5 years or more, but this drops to around 10% at stage 4.
Wes Streeting, Secretary of State for Health and Social Care, said in a press release, “The key to surviving cancer is catching it as early as possible, so this government is taking the urgent action needed to make sure that happens.”
£2.4 Million Awarded for Clinical Trial
The DHSC has awarded Xgenera £2.4 million to advance development of the test, which has now been refined into a cheaper, faster, and more scalable version.
The funding will support a clinical trial involving 8000 patients. The DHSC described this as “a formal and significant step towards bringing the test closer to patients by ensuring it is fit for purpose in the NHS.”
The trial will be run by Cancer Research UK Southampton Clinical Trials Unit.
Potential for NHS Use
Dr Victoria Goss, head of early diagnosis and translational research at the trials unit, said in a press release, “A reliable test such as this could have the potential to see a major shift in cancer screening, making it easier and cheaper to provide on the NHS, cutting health inequalities, and ultimately reducing the number of people who die from the disease.”
Xgenera co-founder Dr Andy Shapanis, a research fellow at the University of Southampton, said that the new study would evaluate the useability, accuracy, and cost-effectiveness of the test for use within the NHS in future.
“The hope is that if the test is shown to be successful in the early diagnosis of the 12 cancers we have currently identified biomarkers for, then it could be expanded to look at over 50 other cancers in the future,” he said.
Comparison With Other Tests
The miONCO-Dx test follows other attempts at multicancer early detection, such as the Galleri test from Grail, which is already being trialled in the NHS.
Galleri screens for altered DNA methylation patterns in blood and claims to detect more than 50 types of cancer. It raised hopes for earlier diagnosis, less invasive treatment, and potential cost savings.
However, critics have raised concerns about low detection rates in early-stage cancers, high false-positive rates, imprecise cancer origin analysis, cost, and unproven mortality gains. Questions have also been expressed about possible political influence in its selection for NHS trials.
A Broader Screening Platform
Xgenera co-founder Professor Paul Skipp, director of the Centre for Proteomic Research at the University of Southampton, said earlier this year that the miONCO-Dx test was “a real game-changer.”
The test can detect lung, breast, prostate, pancreatic, colorectal, ovarian, liver, brain, oesophageal, bladder, and gastric cancer and bone and soft-tissue sarcoma. It works by identifying imbalances in microRNAs, a class of small noncoding RNAs with functions in posttranscriptional regulation of gene expression, influencing cellular activities including cell growth, differentiation, development, and apoptosis.
The presence of microRNA imbalances can be identified from just 10-15 drops of blood, across all stages of tumour growth.
In comparison, according to Skipp, screening is only available currently for three types of cancer in the UK, and each test targets a single type.
Xgenera has also received external investment from the innovation investment companies Qantx, Empirical Ventures, and Ascension Ventures to further develop the test.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
A clinical trial of a promising blood test that could offer faster and more accurate diagnoses for common cancers has received funding from the Department of Health and Social Care (DHSC).
The miONCO-Dx test detects cancer at an early stage by analysing microRNA expression in blood.
It uses artificial intelligence to identify the presence and origin of the disease.
The test was developed by Xgenera, a University of Southampton spinout, in collaboration with the National Institute for Health and Care Research.
Initial analysis of data from more than 20,000 patients showed that the test detected 12 of the most common and lethal cancers at an early stage and with over 99% accuracy.
Bowel Cancer Among Key Targets
Bowel cancer, the fourth most common cancer in the United Kingdom, is a principal target for the test.
Around 44,000 people in the UK are diagnosed with bowel cancer each year. At stage 1, approximately 90% of people survive for 5 years or more, but this drops to around 10% at stage 4.
Wes Streeting, Secretary of State for Health and Social Care, said in a press release, “The key to surviving cancer is catching it as early as possible, so this government is taking the urgent action needed to make sure that happens.”
£2.4 Million Awarded for Clinical Trial
The DHSC has awarded Xgenera £2.4 million to advance development of the test, which has now been refined into a cheaper, faster, and more scalable version.
The funding will support a clinical trial involving 8000 patients. The DHSC described this as “a formal and significant step towards bringing the test closer to patients by ensuring it is fit for purpose in the NHS.”
The trial will be run by Cancer Research UK Southampton Clinical Trials Unit.
Potential for NHS Use
Dr Victoria Goss, head of early diagnosis and translational research at the trials unit, said in a press release, “A reliable test such as this could have the potential to see a major shift in cancer screening, making it easier and cheaper to provide on the NHS, cutting health inequalities, and ultimately reducing the number of people who die from the disease.”
Xgenera co-founder Dr Andy Shapanis, a research fellow at the University of Southampton, said that the new study would evaluate the useability, accuracy, and cost-effectiveness of the test for use within the NHS in future.
“The hope is that if the test is shown to be successful in the early diagnosis of the 12 cancers we have currently identified biomarkers for, then it could be expanded to look at over 50 other cancers in the future,” he said.
Comparison With Other Tests
The miONCO-Dx test follows other attempts at multicancer early detection, such as the Galleri test from Grail, which is already being trialled in the NHS.
Galleri screens for altered DNA methylation patterns in blood and claims to detect more than 50 types of cancer. It raised hopes for earlier diagnosis, less invasive treatment, and potential cost savings.
However, critics have raised concerns about low detection rates in early-stage cancers, high false-positive rates, imprecise cancer origin analysis, cost, and unproven mortality gains. Questions have also been expressed about possible political influence in its selection for NHS trials.
A Broader Screening Platform
Xgenera co-founder Professor Paul Skipp, director of the Centre for Proteomic Research at the University of Southampton, said earlier this year that the miONCO-Dx test was “a real game-changer.”
The test can detect lung, breast, prostate, pancreatic, colorectal, ovarian, liver, brain, oesophageal, bladder, and gastric cancer and bone and soft-tissue sarcoma. It works by identifying imbalances in microRNAs, a class of small noncoding RNAs with functions in posttranscriptional regulation of gene expression, influencing cellular activities including cell growth, differentiation, development, and apoptosis.
The presence of microRNA imbalances can be identified from just 10-15 drops of blood, across all stages of tumour growth.
In comparison, according to Skipp, screening is only available currently for three types of cancer in the UK, and each test targets a single type.
Xgenera has also received external investment from the innovation investment companies Qantx, Empirical Ventures, and Ascension Ventures to further develop the test.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
Can a Polygenic Risk Score Turn the Tide on Prostate Cancer Screening?
Incorporating a polygenic risk score into prostate cancer screening could enhance the detection of clinically significant prostate cancer that conventional screening may miss, according to results of the BARCODE 1 clinical trial conducted in the United Kingdom.
The study found that about 72% of participants with high polygenic risk scores were diagnosed with clinically significant prostate cancers, which would not have been detected with prostate-specific antigen (PSA) testing or MRI.
“With this test, it could be possible to turn the tide on prostate cancer,” study author Ros Eeles, PhD, professor of oncogenetics at The Institute of Cancer Research, London, England, said in a statement following the publication of the analysis in The New England Journal of Medicine.
Prostate cancer remains the second most commonly diagnosed cancer among men. As a screening tool, PSA testing has been criticized for leading to a high rate of false positive results and overdiagnosis — defined as a screen-detected cancer that would take longer to progress to clinical cancer than the patient’s lifetime. Both issues can result in overtreatment.
Given prostate cancer’s high heritability and the proliferation of genome-wide association studies identifying common genetic variants, there has been growing interest in using polygenic risk scores to improve risk stratification and guide screening.
“Building on decades of research into the genetic markers of prostate cancer, our study shows that the theory does work in practice — we can identify men at risk of aggressive cancers who need further tests and spare the men who are at lower risk from unnecessary treatments,” said Eeles.
An Adjunct to Screening?
The BARCODE 1 study, conducted in the United Kingdom, tested the clinical utility of a polygenic risk score as an adjunct to screening.
The researchers recruited men aged 55-69 years from primary care centers in the United Kingdom. Using germline DNA extracted from saliva, they derived polygenic risk scores from 130 genetic variants known to be associated with an increased risk for prostate cancer.
Among a total of 6393 men who had their scores calculated, 745 (12%) had a score in the top 10% of genetic risk (≥ 90th percentile) and were invited to undergo further screening.
Of these, 468 (63%) accepted the invite and underwent multiparametric MRI and transperineal prostate biopsy, irrespective of the PSA level. Overall, 187 (40%) were diagnosed with prostate cancer following biopsy. Of the 187 men with prostate cancer, 55% (n = 103) had disease classified as intermediate or high risk (Gleason score ≥ 7) per National Comprehensive Cancer Network criteria and therefore warranted further treatment.
Researchers then compared screening that incorporated polygenic risk scores with standard screening with PSA levels and MRI.
When participants’ risk was stratified by their polygenic risk score, 103 patients (55%) with prostate cancer could be classified as intermediate or higher risk, thus warranting treatment. Overall, 74 (71.8%) of those cancers would have been missed using the standard diagnostic pathway in the United Kingdom, which requires patients to have a high PSA level (> 3.0 μg/L) as well as a positive MRI result. These 74 patients either had PSA levels ≤ 3.0 μg/L or negative MRIs, which would mean these patients would typically fall below the action threshold for further testing.
Of the 103 participants warranting treatment, 40 of these men would have been classified as unfavorable intermediate, high, or very high risk, which would require radical treatment. Among this group, roughly 43% would have been missed using the UK diagnostic pathway.
However, the investigators estimated a rate of overdiagnosis with the use of polygenic risk scores of 16%-21%, similar to the overdiagnosis estimates in two prior PSA-based screening studies, signaling that the addition of polygenic risk scores does not necessarily reduce the risk for overdiagnosis.
Overall, “this study is the strongest evidence to date on the clinical utility of a polygenic score for prostate cancer screening,” commented Michael Inouye, professor of systems genomics & population health, University of Cambridge, Cambridge, England, in a statement from the UK nonprofit Science Media Centre (SMC).
“I suspect we will look back on this as a landmark study that really made the clinical case for polygenic scores as a new tool that moved health systems from disease management to early detection and prevention,” said Inouye, who was not involved in the study.
However, other experts were more cautious about the findings.
Dusko Ilic, MD, professor of stem cell sciences, King’s College London, London, England, said the results are “promising, especially in identifying significant cancers that would otherwise be missed,” but cautioned that “there is no direct evidence yet that using [polygenic risk scores] improves long-term outcomes such as mortality or quality-adjusted life years.”
“Modeling suggests benefit, but empirical confirmation is needed,” Ilic said in the SMC statement.
The hope is that the recently launched TRANSFORM trial will help answer some of these outstanding questions.
The current study suggests that polygenic risk scores for prostate cancer “would be a useful component of a multimodality screening program that assesses age, family history of prostate cancer, PSA, and MRI results as triage tools before biopsy is recommended,” David Hunter, MPH, ScD, with Harvard T. H. Chan School of Public Health, Boston, and University of Oxford, Oxford, England, wrote in an editorial accompanying the study.
“To make this integrated program a reality, however, changes to infrastructure would be needed to make running and analyzing a regulated genome array as easy as requesting a PSA level or ordering an MRI. Clearly, we are far from that future,” Hunter cautioned.
“A possible first step that would require less infrastructure could be to order a polygenic risk score only for men with a positive PSA result, then use the polygenic risk score to determine who should undergo an MRI, and then use all the information to determine whether biopsy is recommended,” Hunter said.
In his view, the current study is a “first step on a long road to evaluating new components of any disease screening pathway.”
The research received funding from the European Research Council, the Bob Willis Fund, Cancer Research UK, the Peacock Trust, and the National Institute for Health and Care Research Biomedical Research Centre at The Royal Marsden and The Institute of Cancer Research. Disclosures for authors and editorialists are available with the original article. Inouye and Ilic reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Incorporating a polygenic risk score into prostate cancer screening could enhance the detection of clinically significant prostate cancer that conventional screening may miss, according to results of the BARCODE 1 clinical trial conducted in the United Kingdom.
The study found that about 72% of participants with high polygenic risk scores were diagnosed with clinically significant prostate cancers, which would not have been detected with prostate-specific antigen (PSA) testing or MRI.
“With this test, it could be possible to turn the tide on prostate cancer,” study author Ros Eeles, PhD, professor of oncogenetics at The Institute of Cancer Research, London, England, said in a statement following the publication of the analysis in The New England Journal of Medicine.
Prostate cancer remains the second most commonly diagnosed cancer among men. As a screening tool, PSA testing has been criticized for leading to a high rate of false positive results and overdiagnosis — defined as a screen-detected cancer that would take longer to progress to clinical cancer than the patient’s lifetime. Both issues can result in overtreatment.
Given prostate cancer’s high heritability and the proliferation of genome-wide association studies identifying common genetic variants, there has been growing interest in using polygenic risk scores to improve risk stratification and guide screening.
“Building on decades of research into the genetic markers of prostate cancer, our study shows that the theory does work in practice — we can identify men at risk of aggressive cancers who need further tests and spare the men who are at lower risk from unnecessary treatments,” said Eeles.
An Adjunct to Screening?
The BARCODE 1 study, conducted in the United Kingdom, tested the clinical utility of a polygenic risk score as an adjunct to screening.
The researchers recruited men aged 55-69 years from primary care centers in the United Kingdom. Using germline DNA extracted from saliva, they derived polygenic risk scores from 130 genetic variants known to be associated with an increased risk for prostate cancer.
Among a total of 6393 men who had their scores calculated, 745 (12%) had a score in the top 10% of genetic risk (≥ 90th percentile) and were invited to undergo further screening.
Of these, 468 (63%) accepted the invite and underwent multiparametric MRI and transperineal prostate biopsy, irrespective of the PSA level. Overall, 187 (40%) were diagnosed with prostate cancer following biopsy. Of the 187 men with prostate cancer, 55% (n = 103) had disease classified as intermediate or high risk (Gleason score ≥ 7) per National Comprehensive Cancer Network criteria and therefore warranted further treatment.
Researchers then compared screening that incorporated polygenic risk scores with standard screening with PSA levels and MRI.
When participants’ risk was stratified by their polygenic risk score, 103 patients (55%) with prostate cancer could be classified as intermediate or higher risk, thus warranting treatment. Overall, 74 (71.8%) of those cancers would have been missed using the standard diagnostic pathway in the United Kingdom, which requires patients to have a high PSA level (> 3.0 μg/L) as well as a positive MRI result. These 74 patients either had PSA levels ≤ 3.0 μg/L or negative MRIs, which would mean these patients would typically fall below the action threshold for further testing.
Of the 103 participants warranting treatment, 40 of these men would have been classified as unfavorable intermediate, high, or very high risk, which would require radical treatment. Among this group, roughly 43% would have been missed using the UK diagnostic pathway.
However, the investigators estimated a rate of overdiagnosis with the use of polygenic risk scores of 16%-21%, similar to the overdiagnosis estimates in two prior PSA-based screening studies, signaling that the addition of polygenic risk scores does not necessarily reduce the risk for overdiagnosis.
Overall, “this study is the strongest evidence to date on the clinical utility of a polygenic score for prostate cancer screening,” commented Michael Inouye, professor of systems genomics & population health, University of Cambridge, Cambridge, England, in a statement from the UK nonprofit Science Media Centre (SMC).
“I suspect we will look back on this as a landmark study that really made the clinical case for polygenic scores as a new tool that moved health systems from disease management to early detection and prevention,” said Inouye, who was not involved in the study.
However, other experts were more cautious about the findings.
Dusko Ilic, MD, professor of stem cell sciences, King’s College London, London, England, said the results are “promising, especially in identifying significant cancers that would otherwise be missed,” but cautioned that “there is no direct evidence yet that using [polygenic risk scores] improves long-term outcomes such as mortality or quality-adjusted life years.”
“Modeling suggests benefit, but empirical confirmation is needed,” Ilic said in the SMC statement.
The hope is that the recently launched TRANSFORM trial will help answer some of these outstanding questions.
The current study suggests that polygenic risk scores for prostate cancer “would be a useful component of a multimodality screening program that assesses age, family history of prostate cancer, PSA, and MRI results as triage tools before biopsy is recommended,” David Hunter, MPH, ScD, with Harvard T. H. Chan School of Public Health, Boston, and University of Oxford, Oxford, England, wrote in an editorial accompanying the study.
“To make this integrated program a reality, however, changes to infrastructure would be needed to make running and analyzing a regulated genome array as easy as requesting a PSA level or ordering an MRI. Clearly, we are far from that future,” Hunter cautioned.
“A possible first step that would require less infrastructure could be to order a polygenic risk score only for men with a positive PSA result, then use the polygenic risk score to determine who should undergo an MRI, and then use all the information to determine whether biopsy is recommended,” Hunter said.
In his view, the current study is a “first step on a long road to evaluating new components of any disease screening pathway.”
The research received funding from the European Research Council, the Bob Willis Fund, Cancer Research UK, the Peacock Trust, and the National Institute for Health and Care Research Biomedical Research Centre at The Royal Marsden and The Institute of Cancer Research. Disclosures for authors and editorialists are available with the original article. Inouye and Ilic reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Incorporating a polygenic risk score into prostate cancer screening could enhance the detection of clinically significant prostate cancer that conventional screening may miss, according to results of the BARCODE 1 clinical trial conducted in the United Kingdom.
The study found that about 72% of participants with high polygenic risk scores were diagnosed with clinically significant prostate cancers, which would not have been detected with prostate-specific antigen (PSA) testing or MRI.
“With this test, it could be possible to turn the tide on prostate cancer,” study author Ros Eeles, PhD, professor of oncogenetics at The Institute of Cancer Research, London, England, said in a statement following the publication of the analysis in The New England Journal of Medicine.
Prostate cancer remains the second most commonly diagnosed cancer among men. As a screening tool, PSA testing has been criticized for leading to a high rate of false positive results and overdiagnosis — defined as a screen-detected cancer that would take longer to progress to clinical cancer than the patient’s lifetime. Both issues can result in overtreatment.
Given prostate cancer’s high heritability and the proliferation of genome-wide association studies identifying common genetic variants, there has been growing interest in using polygenic risk scores to improve risk stratification and guide screening.
“Building on decades of research into the genetic markers of prostate cancer, our study shows that the theory does work in practice — we can identify men at risk of aggressive cancers who need further tests and spare the men who are at lower risk from unnecessary treatments,” said Eeles.
An Adjunct to Screening?
The BARCODE 1 study, conducted in the United Kingdom, tested the clinical utility of a polygenic risk score as an adjunct to screening.
The researchers recruited men aged 55-69 years from primary care centers in the United Kingdom. Using germline DNA extracted from saliva, they derived polygenic risk scores from 130 genetic variants known to be associated with an increased risk for prostate cancer.
Among a total of 6393 men who had their scores calculated, 745 (12%) had a score in the top 10% of genetic risk (≥ 90th percentile) and were invited to undergo further screening.
Of these, 468 (63%) accepted the invite and underwent multiparametric MRI and transperineal prostate biopsy, irrespective of the PSA level. Overall, 187 (40%) were diagnosed with prostate cancer following biopsy. Of the 187 men with prostate cancer, 55% (n = 103) had disease classified as intermediate or high risk (Gleason score ≥ 7) per National Comprehensive Cancer Network criteria and therefore warranted further treatment.
Researchers then compared screening that incorporated polygenic risk scores with standard screening with PSA levels and MRI.
When participants’ risk was stratified by their polygenic risk score, 103 patients (55%) with prostate cancer could be classified as intermediate or higher risk, thus warranting treatment. Overall, 74 (71.8%) of those cancers would have been missed using the standard diagnostic pathway in the United Kingdom, which requires patients to have a high PSA level (> 3.0 μg/L) as well as a positive MRI result. These 74 patients either had PSA levels ≤ 3.0 μg/L or negative MRIs, which would mean these patients would typically fall below the action threshold for further testing.
Of the 103 participants warranting treatment, 40 of these men would have been classified as unfavorable intermediate, high, or very high risk, which would require radical treatment. Among this group, roughly 43% would have been missed using the UK diagnostic pathway.
However, the investigators estimated a rate of overdiagnosis with the use of polygenic risk scores of 16%-21%, similar to the overdiagnosis estimates in two prior PSA-based screening studies, signaling that the addition of polygenic risk scores does not necessarily reduce the risk for overdiagnosis.
Overall, “this study is the strongest evidence to date on the clinical utility of a polygenic score for prostate cancer screening,” commented Michael Inouye, professor of systems genomics & population health, University of Cambridge, Cambridge, England, in a statement from the UK nonprofit Science Media Centre (SMC).
“I suspect we will look back on this as a landmark study that really made the clinical case for polygenic scores as a new tool that moved health systems from disease management to early detection and prevention,” said Inouye, who was not involved in the study.
However, other experts were more cautious about the findings.
Dusko Ilic, MD, professor of stem cell sciences, King’s College London, London, England, said the results are “promising, especially in identifying significant cancers that would otherwise be missed,” but cautioned that “there is no direct evidence yet that using [polygenic risk scores] improves long-term outcomes such as mortality or quality-adjusted life years.”
“Modeling suggests benefit, but empirical confirmation is needed,” Ilic said in the SMC statement.
The hope is that the recently launched TRANSFORM trial will help answer some of these outstanding questions.
The current study suggests that polygenic risk scores for prostate cancer “would be a useful component of a multimodality screening program that assesses age, family history of prostate cancer, PSA, and MRI results as triage tools before biopsy is recommended,” David Hunter, MPH, ScD, with Harvard T. H. Chan School of Public Health, Boston, and University of Oxford, Oxford, England, wrote in an editorial accompanying the study.
“To make this integrated program a reality, however, changes to infrastructure would be needed to make running and analyzing a regulated genome array as easy as requesting a PSA level or ordering an MRI. Clearly, we are far from that future,” Hunter cautioned.
“A possible first step that would require less infrastructure could be to order a polygenic risk score only for men with a positive PSA result, then use the polygenic risk score to determine who should undergo an MRI, and then use all the information to determine whether biopsy is recommended,” Hunter said.
In his view, the current study is a “first step on a long road to evaluating new components of any disease screening pathway.”
The research received funding from the European Research Council, the Bob Willis Fund, Cancer Research UK, the Peacock Trust, and the National Institute for Health and Care Research Biomedical Research Centre at The Royal Marsden and The Institute of Cancer Research. Disclosures for authors and editorialists are available with the original article. Inouye and Ilic reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Experts Recommend Medication for Pediatric MASLD Management
, according to a new joint perspective paper.
Pediatric MASLD is the number-one cause of chronic liver disease in children and the number-one reason for liver transplant listing in young adults aged 18-40 years, said corresponding author Jennifer A. Panganiban, MD, Children’s Hospital of Philadelphia, Philadelphia.
The paper, published in Obesity Pillars, represents “a call to action that has been long overdue,” Panganiban told GI & Hepatology News.
The goal of the authors was to bring global awareness to the recent changes in the pediatric MASLD landscape — especially in medication use — and to empower clinicians treating the disease, she explained.
The recommendations are based on a combination of the latest published evidence and clinical expertise from eight hepatologists/gastroenterologists and two physicians from the Obesity Medicine Association, Centennial, Colorado.
One of the major barriers to MASLD management in children is suboptimal screening resulting in underdiagnosis, said Panganiban. “Unfortunately, only up to 30% of children are being screened in their pediatrician’s office.”
The new guideline outlines the patient care process from screening, referral to a subspecialist, and workup; however, the primary focus is on treatment with medication options that were previously not available or underutilized, she said.
Successful and Sustainable Weight Loss
Adiposity and weight gain make MASLD worse, but weight reduction has been shown to improve the condition, the authors noted. Previous strategies for curbing MASLD in children with obesity have focused mainly on lifestyle changes, but with limited success.
Nevertheless, the authors recommend continuing physical activity and nutrition as treatments for MASLD in children, with a plan tailored specifically to the patient.
In addition, however, they suggest that anti-obesity medications started early in the disease may help reduce costs and improve future outcomes.
Although glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have not yet been studied specifically for pediatric MASLD, data from studies of pediatric obesity, diabetes, and other retrospective studies are encouraging, the authors wrote.
The GLP-1 RAs liraglutide and semaglutide are both approved by the US Food and Drug Administration (FDA) for managing obesity in children and adolescents aged 12 years or older, they noted. And a recent phase 3a randomized trial showed that liraglutide, not yet approved for children younger than 12 years, led to a mean change in body mass index of 5.8% from baseline to 56 weeks in children aged 6-11 years with obesity.
GLP-1 RAs not only are effective for weight management but also improve other metabolic dysfunction indicators including cholesterol and blood pressure, which makes these medications an even more beneficial option for individuals with obesity and MASLD, Panganiban and colleagues wrote.
For example, a recent single-center study of 111 children with MASLD (mean age, 15 years) showed a significant improvement in alanine aminotransferase levels with the use of GLP-1 RAs, although body mass index and weight were unchanged.
Regaining weight after discontinuing GLP-1 RAs is the main barrier to their use for MASLD, the authors noted. In addition, GLP-1 RAs are contraindicated in some situations, such as in those with a history of serious hypersensitivity, and in patients with a personal or family history of either medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 based on animal studies showing an association with the medications and thyroid C–cell tumors.
Other FDA-approved medication options for obesity in children include metformin, topiramate, and phentermine, as well as bupropion, lisdexamfetamine, and setmelanotide, the authors said.
Resmetirom, a thyroid hormone receptor-beta agonist, which is another significant breakthrough in MASLD for adults, has not yet been tested or approved for pediatric use.
In addition to medications, metabolic bariatric surgery has shown effectiveness in children with obesity and/or MASLD by reducing liver fat and reversing fibrosis, as shown in the Teen-LABS study, the authors wrote. However, long-term data on fibrosis reversal are limited, and cost and access remain barriers.
More Research Needed
The joint expert review is intended as an educational tool that may require updates and should not be interpreted as rules for individual patient care, the authors cautioned. And physical activity and nutrition remain the primary treatment of MASLD and should be continued in conjunction with other treatment modalities, they emphasized.
Looking ahead, research is needed to develop accurate and reliable noninvasive biomarkers to diagnose and assess obesity treatment efficacy, Panganiban told GI & Hepatology News.
Also needed are multicenter randomized control trials in children with obesity involving different medications that have been successful in the treatment of metabolic dysfunction–associated steatohepatitis/fibrosis in adults, such as GLP-1 RAs or resmetirom, she added.
Educating Clinicians on Early Identification
When obesity occurs in childhood, it starts a process of additional complications that arise in earlier ages in adults, said Saul J. Karpen, MD, chief scientific officer at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia, in an interview.“Given the epidemic of obesity, altered diets, and reduced physical activities during younger ages, it is not easy to identify which children are at greater risk of MASLD,” said Karpen.
“It requires insight from the care providers and often imaging, a blood test, or a referral to a pediatric hepatologist, and not every region has easy access to such expertise,” Karpen said.
The new review is important because it highlights the fact that obesity and its consequences are not limited to adulthood, and that educated clinicians are in a position to get an early start on treatment in children, Karpen noted.
The guideline received no outside funding. Panganiban and Karpen had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to a new joint perspective paper.
Pediatric MASLD is the number-one cause of chronic liver disease in children and the number-one reason for liver transplant listing in young adults aged 18-40 years, said corresponding author Jennifer A. Panganiban, MD, Children’s Hospital of Philadelphia, Philadelphia.
The paper, published in Obesity Pillars, represents “a call to action that has been long overdue,” Panganiban told GI & Hepatology News.
The goal of the authors was to bring global awareness to the recent changes in the pediatric MASLD landscape — especially in medication use — and to empower clinicians treating the disease, she explained.
The recommendations are based on a combination of the latest published evidence and clinical expertise from eight hepatologists/gastroenterologists and two physicians from the Obesity Medicine Association, Centennial, Colorado.
One of the major barriers to MASLD management in children is suboptimal screening resulting in underdiagnosis, said Panganiban. “Unfortunately, only up to 30% of children are being screened in their pediatrician’s office.”
The new guideline outlines the patient care process from screening, referral to a subspecialist, and workup; however, the primary focus is on treatment with medication options that were previously not available or underutilized, she said.
Successful and Sustainable Weight Loss
Adiposity and weight gain make MASLD worse, but weight reduction has been shown to improve the condition, the authors noted. Previous strategies for curbing MASLD in children with obesity have focused mainly on lifestyle changes, but with limited success.
Nevertheless, the authors recommend continuing physical activity and nutrition as treatments for MASLD in children, with a plan tailored specifically to the patient.
In addition, however, they suggest that anti-obesity medications started early in the disease may help reduce costs and improve future outcomes.
Although glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have not yet been studied specifically for pediatric MASLD, data from studies of pediatric obesity, diabetes, and other retrospective studies are encouraging, the authors wrote.
The GLP-1 RAs liraglutide and semaglutide are both approved by the US Food and Drug Administration (FDA) for managing obesity in children and adolescents aged 12 years or older, they noted. And a recent phase 3a randomized trial showed that liraglutide, not yet approved for children younger than 12 years, led to a mean change in body mass index of 5.8% from baseline to 56 weeks in children aged 6-11 years with obesity.
GLP-1 RAs not only are effective for weight management but also improve other metabolic dysfunction indicators including cholesterol and blood pressure, which makes these medications an even more beneficial option for individuals with obesity and MASLD, Panganiban and colleagues wrote.
For example, a recent single-center study of 111 children with MASLD (mean age, 15 years) showed a significant improvement in alanine aminotransferase levels with the use of GLP-1 RAs, although body mass index and weight were unchanged.
Regaining weight after discontinuing GLP-1 RAs is the main barrier to their use for MASLD, the authors noted. In addition, GLP-1 RAs are contraindicated in some situations, such as in those with a history of serious hypersensitivity, and in patients with a personal or family history of either medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 based on animal studies showing an association with the medications and thyroid C–cell tumors.
Other FDA-approved medication options for obesity in children include metformin, topiramate, and phentermine, as well as bupropion, lisdexamfetamine, and setmelanotide, the authors said.
Resmetirom, a thyroid hormone receptor-beta agonist, which is another significant breakthrough in MASLD for adults, has not yet been tested or approved for pediatric use.
In addition to medications, metabolic bariatric surgery has shown effectiveness in children with obesity and/or MASLD by reducing liver fat and reversing fibrosis, as shown in the Teen-LABS study, the authors wrote. However, long-term data on fibrosis reversal are limited, and cost and access remain barriers.
More Research Needed
The joint expert review is intended as an educational tool that may require updates and should not be interpreted as rules for individual patient care, the authors cautioned. And physical activity and nutrition remain the primary treatment of MASLD and should be continued in conjunction with other treatment modalities, they emphasized.
Looking ahead, research is needed to develop accurate and reliable noninvasive biomarkers to diagnose and assess obesity treatment efficacy, Panganiban told GI & Hepatology News.
Also needed are multicenter randomized control trials in children with obesity involving different medications that have been successful in the treatment of metabolic dysfunction–associated steatohepatitis/fibrosis in adults, such as GLP-1 RAs or resmetirom, she added.
Educating Clinicians on Early Identification
When obesity occurs in childhood, it starts a process of additional complications that arise in earlier ages in adults, said Saul J. Karpen, MD, chief scientific officer at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia, in an interview.“Given the epidemic of obesity, altered diets, and reduced physical activities during younger ages, it is not easy to identify which children are at greater risk of MASLD,” said Karpen.
“It requires insight from the care providers and often imaging, a blood test, or a referral to a pediatric hepatologist, and not every region has easy access to such expertise,” Karpen said.
The new review is important because it highlights the fact that obesity and its consequences are not limited to adulthood, and that educated clinicians are in a position to get an early start on treatment in children, Karpen noted.
The guideline received no outside funding. Panganiban and Karpen had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to a new joint perspective paper.
Pediatric MASLD is the number-one cause of chronic liver disease in children and the number-one reason for liver transplant listing in young adults aged 18-40 years, said corresponding author Jennifer A. Panganiban, MD, Children’s Hospital of Philadelphia, Philadelphia.
The paper, published in Obesity Pillars, represents “a call to action that has been long overdue,” Panganiban told GI & Hepatology News.
The goal of the authors was to bring global awareness to the recent changes in the pediatric MASLD landscape — especially in medication use — and to empower clinicians treating the disease, she explained.
The recommendations are based on a combination of the latest published evidence and clinical expertise from eight hepatologists/gastroenterologists and two physicians from the Obesity Medicine Association, Centennial, Colorado.
One of the major barriers to MASLD management in children is suboptimal screening resulting in underdiagnosis, said Panganiban. “Unfortunately, only up to 30% of children are being screened in their pediatrician’s office.”
The new guideline outlines the patient care process from screening, referral to a subspecialist, and workup; however, the primary focus is on treatment with medication options that were previously not available or underutilized, she said.
Successful and Sustainable Weight Loss
Adiposity and weight gain make MASLD worse, but weight reduction has been shown to improve the condition, the authors noted. Previous strategies for curbing MASLD in children with obesity have focused mainly on lifestyle changes, but with limited success.
Nevertheless, the authors recommend continuing physical activity and nutrition as treatments for MASLD in children, with a plan tailored specifically to the patient.
In addition, however, they suggest that anti-obesity medications started early in the disease may help reduce costs and improve future outcomes.
Although glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have not yet been studied specifically for pediatric MASLD, data from studies of pediatric obesity, diabetes, and other retrospective studies are encouraging, the authors wrote.
The GLP-1 RAs liraglutide and semaglutide are both approved by the US Food and Drug Administration (FDA) for managing obesity in children and adolescents aged 12 years or older, they noted. And a recent phase 3a randomized trial showed that liraglutide, not yet approved for children younger than 12 years, led to a mean change in body mass index of 5.8% from baseline to 56 weeks in children aged 6-11 years with obesity.
GLP-1 RAs not only are effective for weight management but also improve other metabolic dysfunction indicators including cholesterol and blood pressure, which makes these medications an even more beneficial option for individuals with obesity and MASLD, Panganiban and colleagues wrote.
For example, a recent single-center study of 111 children with MASLD (mean age, 15 years) showed a significant improvement in alanine aminotransferase levels with the use of GLP-1 RAs, although body mass index and weight were unchanged.
Regaining weight after discontinuing GLP-1 RAs is the main barrier to their use for MASLD, the authors noted. In addition, GLP-1 RAs are contraindicated in some situations, such as in those with a history of serious hypersensitivity, and in patients with a personal or family history of either medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 based on animal studies showing an association with the medications and thyroid C–cell tumors.
Other FDA-approved medication options for obesity in children include metformin, topiramate, and phentermine, as well as bupropion, lisdexamfetamine, and setmelanotide, the authors said.
Resmetirom, a thyroid hormone receptor-beta agonist, which is another significant breakthrough in MASLD for adults, has not yet been tested or approved for pediatric use.
In addition to medications, metabolic bariatric surgery has shown effectiveness in children with obesity and/or MASLD by reducing liver fat and reversing fibrosis, as shown in the Teen-LABS study, the authors wrote. However, long-term data on fibrosis reversal are limited, and cost and access remain barriers.
More Research Needed
The joint expert review is intended as an educational tool that may require updates and should not be interpreted as rules for individual patient care, the authors cautioned. And physical activity and nutrition remain the primary treatment of MASLD and should be continued in conjunction with other treatment modalities, they emphasized.
Looking ahead, research is needed to develop accurate and reliable noninvasive biomarkers to diagnose and assess obesity treatment efficacy, Panganiban told GI & Hepatology News.
Also needed are multicenter randomized control trials in children with obesity involving different medications that have been successful in the treatment of metabolic dysfunction–associated steatohepatitis/fibrosis in adults, such as GLP-1 RAs or resmetirom, she added.
Educating Clinicians on Early Identification
When obesity occurs in childhood, it starts a process of additional complications that arise in earlier ages in adults, said Saul J. Karpen, MD, chief scientific officer at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia, in an interview.“Given the epidemic of obesity, altered diets, and reduced physical activities during younger ages, it is not easy to identify which children are at greater risk of MASLD,” said Karpen.
“It requires insight from the care providers and often imaging, a blood test, or a referral to a pediatric hepatologist, and not every region has easy access to such expertise,” Karpen said.
The new review is important because it highlights the fact that obesity and its consequences are not limited to adulthood, and that educated clinicians are in a position to get an early start on treatment in children, Karpen noted.
The guideline received no outside funding. Panganiban and Karpen had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.