AVAHO

TOPLINE:

A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.

METHODOLOGY:

• Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
• Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
• Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
• Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
• The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.

TAKEAWAY:

• Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
• The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
• With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
• From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.

IN PRACTICE:

"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.

SOURCE:

The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.

LIMITATIONS:

The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.

DISCLOSURES:

Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.

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

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

TOPLINE:

A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.

METHODOLOGY:

• Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
• Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
• Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
• Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
• The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.

TAKEAWAY:

• Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
• The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
• With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
• From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.

IN PRACTICE:

"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.

SOURCE:

The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.

LIMITATIONS:

The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.

DISCLOSURES:

Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.

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

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

TOPLINE:

A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.

METHODOLOGY:

• Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
• Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
• Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
• Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
• The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.

TAKEAWAY:

• Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
• The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
• With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
• From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.

IN PRACTICE:

"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.

SOURCE:

The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.

LIMITATIONS:

The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.

DISCLOSURES:

Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.

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

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

Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.

The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.

The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.

“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.

The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”

Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.

This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.

That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.

“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”

Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.

“Yet,” Liu said, “our toolbox of effective interventions remains limited.”

Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.

In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.

“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.

To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.

Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.

Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).

Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.

Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.

Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.

Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.

Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.

So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”

Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.

“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”

The study had no commercial funding. Liu and Saltzman had no disclosures.

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

Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.

The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.

The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.

“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.

The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”

Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.

This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.

That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.

“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”

Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.

“Yet,” Liu said, “our toolbox of effective interventions remains limited.”

Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.

In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.

“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.

To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.

Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.

Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).

Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.

Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.

Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.

Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.

Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.

So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”

Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.

“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”

The study had no commercial funding. Liu and Saltzman had no disclosures.

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

Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.

The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.

The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.

“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.

The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”

Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.

This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.

That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.

“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”

Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.

“Yet,” Liu said, “our toolbox of effective interventions remains limited.”

Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.

In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.

“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.

To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.

Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.

Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).

Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.

Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.

Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.

Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.

Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.

So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”

Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.

“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”

The study had no commercial funding. Liu and Saltzman had no disclosures.

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

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

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

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

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

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

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

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

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

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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.

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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.

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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.

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

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

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

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

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

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

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

Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.

At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).

Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.

“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.

“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.

Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.

About Tec-Dara

Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.

Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.

Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).

The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.

About MajesTEC-3

Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.

The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.

Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.

The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.

For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.

Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).

The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.

Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.

Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.

Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).

Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.

“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.

Implications for Patients With RRMM

Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.

If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.

The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.

MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.

Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.

At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).

Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.

“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.

“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.

Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.

About Tec-Dara

Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.

Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.

Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).

The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.

About MajesTEC-3

Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.

The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.

Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.

The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.

For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.

Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).

The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.

Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.

Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.

Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).

Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.

“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.

Implications for Patients With RRMM

Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.

If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.

The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.

MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.

Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.

At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).

Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.

“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.

“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.

Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.

About Tec-Dara

Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.

Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.

Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).

The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.

About MajesTEC-3

Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.

The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.

Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.

The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.

For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.

Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).

The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.

Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.

Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.

Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).

Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.

“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.

Implications for Patients With RRMM

Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.

If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.

The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.

MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.

The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.

Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.

Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”

How Practice May Shift

The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.

Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.

Mechanism of Action and Clinical Evidence

Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.

The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.

The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis. 

A Medicines and Healthcare products Regulatory Agency-approved subcutaneous  formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.

Dosing, Access, and Implementation

Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet. 

Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.

Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.

The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.

Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.

Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”

How Practice May Shift

The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.

Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.

Mechanism of Action and Clinical Evidence

Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.

The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.

The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis. 

A Medicines and Healthcare products Regulatory Agency-approved subcutaneous  formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.

Dosing, Access, and Implementation

Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet. 

Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.

Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.

The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.

Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.

Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”

How Practice May Shift

The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.

Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.

Mechanism of Action and Clinical Evidence

Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.

The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.

The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis. 

A Medicines and Healthcare products Regulatory Agency-approved subcutaneous  formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.

Dosing, Access, and Implementation

Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet. 

Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.

Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.

Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.

Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.

The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).

The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.

"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."

Study Details

From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).

The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.

In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.

While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.

Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."

The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.

Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."

Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.

"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."

The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."

In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.

Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."

His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.

Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.

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

Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.

Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.

The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).

The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.

"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."

Study Details

From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).

The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.

In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.

While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.

Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."

The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.

Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."

Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.

"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."

The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."

In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.

Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."

His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.

Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.

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

Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.

Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.

The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).

The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.

"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."

Study Details

From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).

The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.

In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.

While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.

Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."

The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.

Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."

Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.

"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."

The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."

In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.

Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."

His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.

Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.

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

TOPLINE:

Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.

METHODOLOGY:

• Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
• Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m² orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
• The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
• The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).

TAKEAWAY:

• After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
• Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
• The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
• Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.

IN PRACTICE:

“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.

SOURCE:

This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .

LIMITATIONS:

This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.

DISCLOSURES:

This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full 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.A version of this article first appeared on Medscape.com.

TOPLINE:

Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.

METHODOLOGY:

• Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
• Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m² orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
• The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
• The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).

TAKEAWAY:

• After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
• Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
• The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
• Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.

IN PRACTICE:

“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.

SOURCE:

This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .

LIMITATIONS:

This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.

DISCLOSURES:

This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full 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.A version of this article first appeared on Medscape.com.

TOPLINE:

Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.

METHODOLOGY:

• Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
• Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m² orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
• The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
• The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).

TAKEAWAY:

• After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
• Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
• The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
• Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.

IN PRACTICE:

“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.

SOURCE:

This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .

LIMITATIONS:

This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.

DISCLOSURES:

This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full 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.A version of this article first appeared on Medscape.com.