VA Cancer Clinical Trials as a Strategy for Increasing Accrual of Racial and Ethnic Underrepresented Groups

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Background

Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.

Methods

We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.

Results

Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.

Conclusions

The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.

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Background

Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.

Methods

We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.

Results

Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.

Conclusions

The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.

Background

Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.

Methods

We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.

Results

Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.

Conclusions

The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.

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Wed, 09/18/2024 - 20:58

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

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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.

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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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Reassuring Data on GLP-1 RAs and Pancreatic Cancer Risk

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New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

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New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

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Building an AI Army of Digital Twins to Fight Cancer

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A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

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A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

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Smokeless Tobacco, Areca Nut Chewing Behind 1 in 3 Oral Cancers: IARC Report

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Wed, 11/13/2024 - 09:38

Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

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

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Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

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

Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

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

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Does Radiation Timing Affect QOL After Prostate Surgery?

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Wed, 11/13/2024 - 09:30

 

TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

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TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Receiving radiotherapy after prostatectomy does negatively affect long-term health-related quality of life, including sexual function, urinary incontinence, and urinary irritation, but the timing of radiation after prostatectomy — within a year or over a year from surgery — does not appear to significantly affect patients’ quality of life over the long term, a recent analysis finds.

METHODOLOGY:

  • Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
  • Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
  • Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
  • Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
  • The median follow-up duration was 85.6 months.

TAKEAWAY:

  • Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
  • Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
  • In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
  • Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.

IN PRACTICE:

“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”

 

 

SOURCE:

The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.

LIMITATIONS:

The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.

DISCLOSURES:

This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

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What Matters Most for Young Patients With CRC: Survey Highlights Top Concerns

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Changed
Fri, 11/15/2024 - 09:29

Mental health, family planning, and career aspirations are among the unique challenges faced by younger adults diagnosed with colorectal cancer (CRC) — issues that may not be adequately addressed by cancer care providers, a new survey showed.

“We tend to think of cancer as a disease of older populations, but it’s impacting younger people who are in important developmental stages of their lives,” said Samantha Savitch, MD, in a podcast from the American College of Surgeons (ACS) Clinical Congress 2024, where she presented her research.

In fact, since 1994, cases of young-onset CRC have increased by more than 50%, according to the National Cancer Institute.

“Our goal with the study was to better understand what young adults with colorectal cancer really care about, so that we can ensure that we’re properly addressing their needs as part of like comprehensive cancer care,” Savitch, with the University of Michigan, Ann Arbor, Michigan, explained.

The researchers interviewed a sample of 35 patients who were diagnosed with CRC before the age of 50 years. The researchers asked patients open-ended questions about the influence their CRC diagnosis had on their lives, the daily challenges they experienced, as well as concerns about the future.

Patients expressed the greatest concern about four areas of health and well-being: Physical health, mental health, family planning, and career.

For physical health, patients worried about incontinence, loss of vitality, and expenses related to healthcare. On the mental health front, patients expressed concern about the uncertainty surrounding long-term survival and anxiety about the timing of their diagnosis. Family planning was a key issue as well, with patients highlighting uncertainties about fertility after chemotherapy. On the career front, patients also noted concerns surrounding job security, challenges pursuing advanced degrees, and a reliance on benefits from employment.

These concerns were not gender-specific. Career, physical health, financial security, mental health, fertility, and family planning were equally important to men and women.

Savitch provided a sample of quotes from interviewees that illustrated their specific concerns in each category.

A 47-year-old man reflected on his physical health now that his rectum is gone. “I no longer have that feeling of sensation like in my cheeks; basically, the cheeks and the anus area is all dead,” he said. A 48-year-old woman discussed the havoc chemotherapy wrecked on her teeth. “I don’t want to get emotional, I just went to the dentist yesterday, and I just get so frustrated ... All these things to pay. I should be happy to be alive,” she said. But “I have so much money in my mouth.”

On the mental health front, a 34-year-old woman described the fear she felt about a cancer recurrence following the birth of her daughter. After a CT scan, she had to experience 2 weeks of limbo, thinking, “I have cancer again.” She had begun a journal dedicated to her daughter in case she had a recurrence and died. “I always think that I am going to die. I think about death every day.”

Reflecting on her future fertility, a 22-year-old woman recalled the uncertainty surrounding whether chemotherapy would affect her ability to have children. “I would get really nervous,” she said, “so I was like, ‘I will do the injections. I just want to save a few of my eggs just in case.’ ” A 33-year-old man opted not to freeze his sperm because “I didn’t know if I was going to live or die, I didn’t know anything ... I barely had any money. So, like, do I risk putting this money up to freeze something when I don’t even know if I am going to be here or not?”

On the career front, a 48-year-old man highlighted how his cancer completely changed his family’s life.”I went from being a provider for my family, making enough money to take care of my family, where my wife was staying home, to now not being able to work and her having to pick up little side jobs and stuff just to try to help make ends meet.”

“These aspects of cancer care are rarely discussed, so it is important to acknowledge that patients care about fertility and family planning, their career aspirations, building assets — all things they must put on hold because of their cancer diagnosis,” Savitch said in a news release.

“This goes beyond just colorectal cancer,” Savitch added. “There are a lot of patients experiencing similar challenges, so we need more research to better understand these issues in patients with colorectal cancer as well as other cancers and, ultimately, to restructure our comprehensive cancer programs to make sure we are treating the patient and not just the disease.”

Support for the study was provided by the Rogel Cancer Center at the University of Michigan. Savitch had no relevant disclosures.

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

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Mental health, family planning, and career aspirations are among the unique challenges faced by younger adults diagnosed with colorectal cancer (CRC) — issues that may not be adequately addressed by cancer care providers, a new survey showed.

“We tend to think of cancer as a disease of older populations, but it’s impacting younger people who are in important developmental stages of their lives,” said Samantha Savitch, MD, in a podcast from the American College of Surgeons (ACS) Clinical Congress 2024, where she presented her research.

In fact, since 1994, cases of young-onset CRC have increased by more than 50%, according to the National Cancer Institute.

“Our goal with the study was to better understand what young adults with colorectal cancer really care about, so that we can ensure that we’re properly addressing their needs as part of like comprehensive cancer care,” Savitch, with the University of Michigan, Ann Arbor, Michigan, explained.

The researchers interviewed a sample of 35 patients who were diagnosed with CRC before the age of 50 years. The researchers asked patients open-ended questions about the influence their CRC diagnosis had on their lives, the daily challenges they experienced, as well as concerns about the future.

Patients expressed the greatest concern about four areas of health and well-being: Physical health, mental health, family planning, and career.

For physical health, patients worried about incontinence, loss of vitality, and expenses related to healthcare. On the mental health front, patients expressed concern about the uncertainty surrounding long-term survival and anxiety about the timing of their diagnosis. Family planning was a key issue as well, with patients highlighting uncertainties about fertility after chemotherapy. On the career front, patients also noted concerns surrounding job security, challenges pursuing advanced degrees, and a reliance on benefits from employment.

These concerns were not gender-specific. Career, physical health, financial security, mental health, fertility, and family planning were equally important to men and women.

Savitch provided a sample of quotes from interviewees that illustrated their specific concerns in each category.

A 47-year-old man reflected on his physical health now that his rectum is gone. “I no longer have that feeling of sensation like in my cheeks; basically, the cheeks and the anus area is all dead,” he said. A 48-year-old woman discussed the havoc chemotherapy wrecked on her teeth. “I don’t want to get emotional, I just went to the dentist yesterday, and I just get so frustrated ... All these things to pay. I should be happy to be alive,” she said. But “I have so much money in my mouth.”

On the mental health front, a 34-year-old woman described the fear she felt about a cancer recurrence following the birth of her daughter. After a CT scan, she had to experience 2 weeks of limbo, thinking, “I have cancer again.” She had begun a journal dedicated to her daughter in case she had a recurrence and died. “I always think that I am going to die. I think about death every day.”

Reflecting on her future fertility, a 22-year-old woman recalled the uncertainty surrounding whether chemotherapy would affect her ability to have children. “I would get really nervous,” she said, “so I was like, ‘I will do the injections. I just want to save a few of my eggs just in case.’ ” A 33-year-old man opted not to freeze his sperm because “I didn’t know if I was going to live or die, I didn’t know anything ... I barely had any money. So, like, do I risk putting this money up to freeze something when I don’t even know if I am going to be here or not?”

On the career front, a 48-year-old man highlighted how his cancer completely changed his family’s life.”I went from being a provider for my family, making enough money to take care of my family, where my wife was staying home, to now not being able to work and her having to pick up little side jobs and stuff just to try to help make ends meet.”

“These aspects of cancer care are rarely discussed, so it is important to acknowledge that patients care about fertility and family planning, their career aspirations, building assets — all things they must put on hold because of their cancer diagnosis,” Savitch said in a news release.

“This goes beyond just colorectal cancer,” Savitch added. “There are a lot of patients experiencing similar challenges, so we need more research to better understand these issues in patients with colorectal cancer as well as other cancers and, ultimately, to restructure our comprehensive cancer programs to make sure we are treating the patient and not just the disease.”

Support for the study was provided by the Rogel Cancer Center at the University of Michigan. Savitch had no relevant disclosures.

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

Mental health, family planning, and career aspirations are among the unique challenges faced by younger adults diagnosed with colorectal cancer (CRC) — issues that may not be adequately addressed by cancer care providers, a new survey showed.

“We tend to think of cancer as a disease of older populations, but it’s impacting younger people who are in important developmental stages of their lives,” said Samantha Savitch, MD, in a podcast from the American College of Surgeons (ACS) Clinical Congress 2024, where she presented her research.

In fact, since 1994, cases of young-onset CRC have increased by more than 50%, according to the National Cancer Institute.

“Our goal with the study was to better understand what young adults with colorectal cancer really care about, so that we can ensure that we’re properly addressing their needs as part of like comprehensive cancer care,” Savitch, with the University of Michigan, Ann Arbor, Michigan, explained.

The researchers interviewed a sample of 35 patients who were diagnosed with CRC before the age of 50 years. The researchers asked patients open-ended questions about the influence their CRC diagnosis had on their lives, the daily challenges they experienced, as well as concerns about the future.

Patients expressed the greatest concern about four areas of health and well-being: Physical health, mental health, family planning, and career.

For physical health, patients worried about incontinence, loss of vitality, and expenses related to healthcare. On the mental health front, patients expressed concern about the uncertainty surrounding long-term survival and anxiety about the timing of their diagnosis. Family planning was a key issue as well, with patients highlighting uncertainties about fertility after chemotherapy. On the career front, patients also noted concerns surrounding job security, challenges pursuing advanced degrees, and a reliance on benefits from employment.

These concerns were not gender-specific. Career, physical health, financial security, mental health, fertility, and family planning were equally important to men and women.

Savitch provided a sample of quotes from interviewees that illustrated their specific concerns in each category.

A 47-year-old man reflected on his physical health now that his rectum is gone. “I no longer have that feeling of sensation like in my cheeks; basically, the cheeks and the anus area is all dead,” he said. A 48-year-old woman discussed the havoc chemotherapy wrecked on her teeth. “I don’t want to get emotional, I just went to the dentist yesterday, and I just get so frustrated ... All these things to pay. I should be happy to be alive,” she said. But “I have so much money in my mouth.”

On the mental health front, a 34-year-old woman described the fear she felt about a cancer recurrence following the birth of her daughter. After a CT scan, she had to experience 2 weeks of limbo, thinking, “I have cancer again.” She had begun a journal dedicated to her daughter in case she had a recurrence and died. “I always think that I am going to die. I think about death every day.”

Reflecting on her future fertility, a 22-year-old woman recalled the uncertainty surrounding whether chemotherapy would affect her ability to have children. “I would get really nervous,” she said, “so I was like, ‘I will do the injections. I just want to save a few of my eggs just in case.’ ” A 33-year-old man opted not to freeze his sperm because “I didn’t know if I was going to live or die, I didn’t know anything ... I barely had any money. So, like, do I risk putting this money up to freeze something when I don’t even know if I am going to be here or not?”

On the career front, a 48-year-old man highlighted how his cancer completely changed his family’s life.”I went from being a provider for my family, making enough money to take care of my family, where my wife was staying home, to now not being able to work and her having to pick up little side jobs and stuff just to try to help make ends meet.”

“These aspects of cancer care are rarely discussed, so it is important to acknowledge that patients care about fertility and family planning, their career aspirations, building assets — all things they must put on hold because of their cancer diagnosis,” Savitch said in a news release.

“This goes beyond just colorectal cancer,” Savitch added. “There are a lot of patients experiencing similar challenges, so we need more research to better understand these issues in patients with colorectal cancer as well as other cancers and, ultimately, to restructure our comprehensive cancer programs to make sure we are treating the patient and not just the disease.”

Support for the study was provided by the Rogel Cancer Center at the University of Michigan. Savitch had no relevant disclosures.

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

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Many Patients With Cancer Visit EDs Before Diagnosis

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More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

 

 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

 

 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

 

 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Registered Dieticians Sparse in VA Cancer Care

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Mon, 11/11/2024 - 13:00

Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

 

Katherine Petersen, MS, RDN, CSO has no disclosures.

 

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Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

 

Katherine Petersen, MS, RDN, CSO has no disclosures.

 

Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

 

Katherine Petersen, MS, RDN, CSO has no disclosures.

 

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Prostate Cancer Treatment Associated With More Complications

Article Type
Changed
Wed, 11/13/2024 - 03:31

 

TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

  • Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
  • They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
  • Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
  • The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinenceerectile dysfunction, and secondary cancers. 
  • Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

  • At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
  • Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
  • The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
  • The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. 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 appeared on Medscape.com.

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TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

  • Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
  • They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
  • Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
  • The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinenceerectile dysfunction, and secondary cancers. 
  • Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

  • At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
  • Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
  • The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
  • The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. 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 appeared on Medscape.com.

 

TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

  • Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
  • They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
  • Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
  • The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinenceerectile dysfunction, and secondary cancers. 
  • Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

  • At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
  • Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
  • The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
  • The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. 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 appeared on Medscape.com.

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