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Improving Colorectal Cancer Screening via Mailed Fecal Immunochemical Testing in a Veterans Affairs Health System

Article Type
Changed

Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6

Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11

The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.

 

Program Description

A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.

The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.

 

 

Letter Templates

Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.

The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.

Staff Education

A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.

 

Program Launch

The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.

Program Metrics

At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.

At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.

In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.

 

 

Discussion

Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.

Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.

Limitations

Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.

Conclusions

CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.

References

1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884

3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x

4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034

5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508

6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238

7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025

8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484

9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013

10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927

11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042

12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7

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Jin Xu, MDa,b; Jeffrey Kravetz, MDa,b; Juliette Spelman, MDa,b; Kimberley Roy, MSNa; Vincent Lilly, RNa; Danielle Cosentinoa;  Christopher Ruser, MDa,b

Correspondence:  Jin Xu  ([email protected])

aVeterans Affairs Connecticut Healthcare System, West Haven

bYale University School of Medicine, New Haven, Connecticut

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This quality improvement project was not reviewed by an institutional review board.

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Jin Xu, MDa,b; Jeffrey Kravetz, MDa,b; Juliette Spelman, MDa,b; Kimberley Roy, MSNa; Vincent Lilly, RNa; Danielle Cosentinoa;  Christopher Ruser, MDa,b

Correspondence:  Jin Xu  ([email protected])

aVeterans Affairs Connecticut Healthcare System, West Haven

bYale University School of Medicine, New Haven, Connecticut

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This quality improvement project was not reviewed by an institutional review board.

Author and Disclosure Information

Jin Xu, MDa,b; Jeffrey Kravetz, MDa,b; Juliette Spelman, MDa,b; Kimberley Roy, MSNa; Vincent Lilly, RNa; Danielle Cosentinoa;  Christopher Ruser, MDa,b

Correspondence:  Jin Xu  ([email protected])

aVeterans Affairs Connecticut Healthcare System, West Haven

bYale University School of Medicine, New Haven, Connecticut

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This quality improvement project was not reviewed by an institutional review board.

Article PDF
Article PDF

Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6

Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11

The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.

 

Program Description

A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.

The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.

 

 

Letter Templates

Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.

The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.

Staff Education

A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.

 

Program Launch

The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.

Program Metrics

At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.

At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.

In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.

 

 

Discussion

Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.

Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.

Limitations

Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.

Conclusions

CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.

Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6

Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11

The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.

 

Program Description

A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.

The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.

 

 

Letter Templates

Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.

The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.

Staff Education

A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.

 

Program Launch

The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.

Program Metrics

At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.

At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.

In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.

 

 

Discussion

Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.

Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.

Limitations

Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.

Conclusions

CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.

References

1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884

3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x

4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034

5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508

6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238

7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025

8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484

9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013

10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927

11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042

12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7

References

1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884

3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x

4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034

5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508

6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238

7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025

8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484

9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013

10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927

11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042

12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7

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GLP-1 Drugs Tied to Lower CRC Risk and Better Outcomes

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GLP-1 Drugs Tied to Lower CRC Risk and Better Outcomes

The GLP-1 drugs widely prescribed for diabetes and weight loss might also help reduce the risk for colorectal cancer and possibly improve outcomes in people who have the disease, according to a series of studies presented at ASCO Gastrointestinal Cancers Symposium 2026.

In one study, researchers observed a 36% lower risk for colorectal cancer among people who used GLP-1 receptor agonists vs those who used aspirin — a drug long investigated for colorectal cancer primary prevention.

While aspirin has shown “modest efficacy” in that regard, it also carries a bleeding risk that limits its use, Colton Jones, MD, a hematology and oncology fellow with The University of Texas San Antonio, told conference attendees.

Emerging evidence suggests that GLP-1s possess anti-inflammatory and anti-neoplastic properties, while some recent observational studies have linked the medications to reduced risks for certain cancers, particularly obesity-related types.

However, Jones said, research into a possible role for GLP-1s in cancer risk reduction is still in the early stages.

Prevention Potential

To conduct a “real-world” analysis, Jones and his colleagues turned to the TriNetX database, which contains electronic health records from about 150 million patients at more than 100 US healthcare organizations.

The researchers created two propensity score-matched cohorts of GLP-1 users and aspirin users, with 140,828 patients (average age, 58 years) in each. None had a history of colorectal cancer, and none were using anti-inflammatory medications other than aspirin or glucose-lowering drugs other than a GLP-1.

During a median follow-up of 5-6 years, GLP-1 use was significantly associated with reduced colorectal cancer incidence compared with aspirin use (hazard ratio [HR], 0.64). The findings were similar among people considered to be at an increased colorectal cancer risk due to health or family history: In that group, GLP-1 users had a roughly 42% lower risk of the disease (HR, 0.58).

Overall, the risk reduction with GLP-1 use was seen regardless of obesity or diabetes status, but the association was strongest among people who began treatment before age 45.

When the researchers examined individual GLP-1 medications, only semaglutide (Ozempic), liraglutide (Saxenda/Victoza), and dulaglutide (Trulicity) were associated with significant risk reductions.

As for safety outcomes, aspirin users had slightly higher rates of gastrointestinal bleeding and gastric ulcers and were more likely to suffer acute kidney injury (2.8% vs 1.15% among GLP-1 users; HR, 0.37). GLP-1 users experienced more diarrhea (6.8% vs 5.4%) and abdominal pain (19% vs 16.3%) than aspirin users did.

Jones said that both the risk reduction and safety profile associated with GLP-1s “underscore a potential public health impact” and warrant prospective validation.

Study discussant Joel Saltzman, MD, an ASCO gastrointestinal cancer expert, called the findings “thought-provoking.”

Broadly, he said, the study raises important questions about how metabolic disease, obesity, and cancer risk are interconnected — and how prevention strategies might evolve as more data emerge.

“It will certainly be interesting over the upcoming years to see how [GLP-1s] fit into colorectal cancer prevention,” said Saltzman, of Taussig Cancer Center, Cleveland Clinic, Cleveland.

Improved CRC Outcomes?

Looking beyond prevention, Jones and his colleagues conducted a separate analysis of patients diagnosed with colorectal cancer, to see whether GLP-1 therapy was associated with outcomes.

In that analysis, also using the TriNetX database, they matched 5170 patients with colorectal cancer who were on GLP-1 therapy with the same number of patients who were not on a GLP-1 medication.

Over 10 years, GLP-1 use was associated with a 53% reduction in all-cause mortality compared with nonuse (HR, 0.47), corresponding to an absolute risk reduction of 5.6% and a number needed to treat of 18.

The survival benefit was consistent across age, diabetes status, BMI, cancer stage, and treatment subgroups. GLP-1 use was not associated with a statistically significant change in the risk for metastases (HR, 0.895).

Meanwhile, another study presented at the meeting, by researchers at Mayo Clinic, Jacksonville, Florida, yielded similar findings.

Researchers led by Yajur Arya, MD, focused specifically on patients with colon cancer and comorbid obesity comparing outcomes in nearly 2000 patients taking a GLP-1 with more than 16,000 matched patients who were not on a GLP-1 agent.

Over 5 years of follow-up, GLP-1 users had a lower risk for overall mortality (HR, 0.46). They also showed decreased risks for myocardial infarction (HR, 0.83), sepsis (risk difference, -3.48%), and need for mechanical ventilation (HR, 0.49).

Both Jones and Arya stressed, however, that the findings only serve to highlight possible benefits of GLP-1 use beyond diabetes and weight management. Prospective studies, they said, are needed to better understand why these associations exist, and to potentially guide practice in the future.

None of the studies had commercial funding. Jones, Arya, and Saltzman had no relevant disclosures.

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

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The GLP-1 drugs widely prescribed for diabetes and weight loss might also help reduce the risk for colorectal cancer and possibly improve outcomes in people who have the disease, according to a series of studies presented at ASCO Gastrointestinal Cancers Symposium 2026.

In one study, researchers observed a 36% lower risk for colorectal cancer among people who used GLP-1 receptor agonists vs those who used aspirin — a drug long investigated for colorectal cancer primary prevention.

While aspirin has shown “modest efficacy” in that regard, it also carries a bleeding risk that limits its use, Colton Jones, MD, a hematology and oncology fellow with The University of Texas San Antonio, told conference attendees.

Emerging evidence suggests that GLP-1s possess anti-inflammatory and anti-neoplastic properties, while some recent observational studies have linked the medications to reduced risks for certain cancers, particularly obesity-related types.

However, Jones said, research into a possible role for GLP-1s in cancer risk reduction is still in the early stages.

Prevention Potential

To conduct a “real-world” analysis, Jones and his colleagues turned to the TriNetX database, which contains electronic health records from about 150 million patients at more than 100 US healthcare organizations.

The researchers created two propensity score-matched cohorts of GLP-1 users and aspirin users, with 140,828 patients (average age, 58 years) in each. None had a history of colorectal cancer, and none were using anti-inflammatory medications other than aspirin or glucose-lowering drugs other than a GLP-1.

During a median follow-up of 5-6 years, GLP-1 use was significantly associated with reduced colorectal cancer incidence compared with aspirin use (hazard ratio [HR], 0.64). The findings were similar among people considered to be at an increased colorectal cancer risk due to health or family history: In that group, GLP-1 users had a roughly 42% lower risk of the disease (HR, 0.58).

Overall, the risk reduction with GLP-1 use was seen regardless of obesity or diabetes status, but the association was strongest among people who began treatment before age 45.

When the researchers examined individual GLP-1 medications, only semaglutide (Ozempic), liraglutide (Saxenda/Victoza), and dulaglutide (Trulicity) were associated with significant risk reductions.

As for safety outcomes, aspirin users had slightly higher rates of gastrointestinal bleeding and gastric ulcers and were more likely to suffer acute kidney injury (2.8% vs 1.15% among GLP-1 users; HR, 0.37). GLP-1 users experienced more diarrhea (6.8% vs 5.4%) and abdominal pain (19% vs 16.3%) than aspirin users did.

Jones said that both the risk reduction and safety profile associated with GLP-1s “underscore a potential public health impact” and warrant prospective validation.

Study discussant Joel Saltzman, MD, an ASCO gastrointestinal cancer expert, called the findings “thought-provoking.”

Broadly, he said, the study raises important questions about how metabolic disease, obesity, and cancer risk are interconnected — and how prevention strategies might evolve as more data emerge.

“It will certainly be interesting over the upcoming years to see how [GLP-1s] fit into colorectal cancer prevention,” said Saltzman, of Taussig Cancer Center, Cleveland Clinic, Cleveland.

Improved CRC Outcomes?

Looking beyond prevention, Jones and his colleagues conducted a separate analysis of patients diagnosed with colorectal cancer, to see whether GLP-1 therapy was associated with outcomes.

In that analysis, also using the TriNetX database, they matched 5170 patients with colorectal cancer who were on GLP-1 therapy with the same number of patients who were not on a GLP-1 medication.

Over 10 years, GLP-1 use was associated with a 53% reduction in all-cause mortality compared with nonuse (HR, 0.47), corresponding to an absolute risk reduction of 5.6% and a number needed to treat of 18.

The survival benefit was consistent across age, diabetes status, BMI, cancer stage, and treatment subgroups. GLP-1 use was not associated with a statistically significant change in the risk for metastases (HR, 0.895).

Meanwhile, another study presented at the meeting, by researchers at Mayo Clinic, Jacksonville, Florida, yielded similar findings.

Researchers led by Yajur Arya, MD, focused specifically on patients with colon cancer and comorbid obesity comparing outcomes in nearly 2000 patients taking a GLP-1 with more than 16,000 matched patients who were not on a GLP-1 agent.

Over 5 years of follow-up, GLP-1 users had a lower risk for overall mortality (HR, 0.46). They also showed decreased risks for myocardial infarction (HR, 0.83), sepsis (risk difference, -3.48%), and need for mechanical ventilation (HR, 0.49).

Both Jones and Arya stressed, however, that the findings only serve to highlight possible benefits of GLP-1 use beyond diabetes and weight management. Prospective studies, they said, are needed to better understand why these associations exist, and to potentially guide practice in the future.

None of the studies had commercial funding. Jones, Arya, and Saltzman had no relevant disclosures.

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

The GLP-1 drugs widely prescribed for diabetes and weight loss might also help reduce the risk for colorectal cancer and possibly improve outcomes in people who have the disease, according to a series of studies presented at ASCO Gastrointestinal Cancers Symposium 2026.

In one study, researchers observed a 36% lower risk for colorectal cancer among people who used GLP-1 receptor agonists vs those who used aspirin — a drug long investigated for colorectal cancer primary prevention.

While aspirin has shown “modest efficacy” in that regard, it also carries a bleeding risk that limits its use, Colton Jones, MD, a hematology and oncology fellow with The University of Texas San Antonio, told conference attendees.

Emerging evidence suggests that GLP-1s possess anti-inflammatory and anti-neoplastic properties, while some recent observational studies have linked the medications to reduced risks for certain cancers, particularly obesity-related types.

However, Jones said, research into a possible role for GLP-1s in cancer risk reduction is still in the early stages.

Prevention Potential

To conduct a “real-world” analysis, Jones and his colleagues turned to the TriNetX database, which contains electronic health records from about 150 million patients at more than 100 US healthcare organizations.

The researchers created two propensity score-matched cohorts of GLP-1 users and aspirin users, with 140,828 patients (average age, 58 years) in each. None had a history of colorectal cancer, and none were using anti-inflammatory medications other than aspirin or glucose-lowering drugs other than a GLP-1.

During a median follow-up of 5-6 years, GLP-1 use was significantly associated with reduced colorectal cancer incidence compared with aspirin use (hazard ratio [HR], 0.64). The findings were similar among people considered to be at an increased colorectal cancer risk due to health or family history: In that group, GLP-1 users had a roughly 42% lower risk of the disease (HR, 0.58).

Overall, the risk reduction with GLP-1 use was seen regardless of obesity or diabetes status, but the association was strongest among people who began treatment before age 45.

When the researchers examined individual GLP-1 medications, only semaglutide (Ozempic), liraglutide (Saxenda/Victoza), and dulaglutide (Trulicity) were associated with significant risk reductions.

As for safety outcomes, aspirin users had slightly higher rates of gastrointestinal bleeding and gastric ulcers and were more likely to suffer acute kidney injury (2.8% vs 1.15% among GLP-1 users; HR, 0.37). GLP-1 users experienced more diarrhea (6.8% vs 5.4%) and abdominal pain (19% vs 16.3%) than aspirin users did.

Jones said that both the risk reduction and safety profile associated with GLP-1s “underscore a potential public health impact” and warrant prospective validation.

Study discussant Joel Saltzman, MD, an ASCO gastrointestinal cancer expert, called the findings “thought-provoking.”

Broadly, he said, the study raises important questions about how metabolic disease, obesity, and cancer risk are interconnected — and how prevention strategies might evolve as more data emerge.

“It will certainly be interesting over the upcoming years to see how [GLP-1s] fit into colorectal cancer prevention,” said Saltzman, of Taussig Cancer Center, Cleveland Clinic, Cleveland.

Improved CRC Outcomes?

Looking beyond prevention, Jones and his colleagues conducted a separate analysis of patients diagnosed with colorectal cancer, to see whether GLP-1 therapy was associated with outcomes.

In that analysis, also using the TriNetX database, they matched 5170 patients with colorectal cancer who were on GLP-1 therapy with the same number of patients who were not on a GLP-1 medication.

Over 10 years, GLP-1 use was associated with a 53% reduction in all-cause mortality compared with nonuse (HR, 0.47), corresponding to an absolute risk reduction of 5.6% and a number needed to treat of 18.

The survival benefit was consistent across age, diabetes status, BMI, cancer stage, and treatment subgroups. GLP-1 use was not associated with a statistically significant change in the risk for metastases (HR, 0.895).

Meanwhile, another study presented at the meeting, by researchers at Mayo Clinic, Jacksonville, Florida, yielded similar findings.

Researchers led by Yajur Arya, MD, focused specifically on patients with colon cancer and comorbid obesity comparing outcomes in nearly 2000 patients taking a GLP-1 with more than 16,000 matched patients who were not on a GLP-1 agent.

Over 5 years of follow-up, GLP-1 users had a lower risk for overall mortality (HR, 0.46). They also showed decreased risks for myocardial infarction (HR, 0.83), sepsis (risk difference, -3.48%), and need for mechanical ventilation (HR, 0.49).

Both Jones and Arya stressed, however, that the findings only serve to highlight possible benefits of GLP-1 use beyond diabetes and weight management. Prospective studies, they said, are needed to better understand why these associations exist, and to potentially guide practice in the future.

None of the studies had commercial funding. Jones, Arya, and Saltzman had no relevant disclosures.

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

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Cannabis May Ease Symptoms in Advanced Pancreatic Cancer

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Cannabis May Ease Symptoms in Advanced Pancreatic Cancer

TOPLINE:

A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.

METHODOLOGY:

  • Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
  • Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
  • Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
  • Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.

TAKEAWAY:

  • At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
  • The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
  • At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
  • Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”

IN PRACTICE:

“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.

“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.

SOURCE:

The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.

LIMITATIONS:

The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.

DISCLOSURES:

The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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.

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TOPLINE:

A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.

METHODOLOGY:

  • Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
  • Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
  • Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
  • Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.

TAKEAWAY:

  • At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
  • The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
  • At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
  • Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”

IN PRACTICE:

“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.

“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.

SOURCE:

The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.

LIMITATIONS:

The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.

DISCLOSURES:

The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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:

A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.

METHODOLOGY:

  • Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
  • Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
  • Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
  • Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.

TAKEAWAY:

  • At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
  • The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
  • At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
  • Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”

IN PRACTICE:

“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.

“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.

SOURCE:

The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.

LIMITATIONS:

The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.

DISCLOSURES:

The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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.

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Cannabis May Ease Symptoms in Advanced Pancreatic Cancer

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Home Screening Cost-Effective for Anal Cancer

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Home Screening Cost-Effective for Anal Cancer

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.

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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.

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Home Screening Cost-Effective for Anal Cancer

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Simple Steps: Walking May Ease Colorectal Cancer Fatigue

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Simple Steps: Walking May Ease Colorectal Cancer Fatigue

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.

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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.

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Simple Steps: Walking May Ease Colorectal Cancer Fatigue

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Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer

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Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer

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%; = .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.

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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%; = .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%; = .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.

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Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer

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Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer

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Is It Safe to Skip Surgery After Malignant Colorectal Polyp Removal?

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Is It Safe to Skip Surgery After Malignant Colorectal Polyp Removal?

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.

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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.

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FDA OKs Subcutaneous Mosunetuzumab for Follicular Lymphoma

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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.

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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.

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Rural Cancer Survivors Are More Likely to Have Chronic Pain

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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.

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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.

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Novel Treatment Combo Ups Survival in Multiple Myeloma

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Novel Treatment Combo Ups Survival in Multiple Myeloma

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 [email protected] or on X: @SW_MedReporter.

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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 [email protected] 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 [email protected] or on X: @SW_MedReporter.

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Novel Treatment Combo Ups Survival in Multiple Myeloma

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Novel Treatment Combo Ups Survival in Multiple Myeloma

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