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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
Improving Colorectal Cancer Screening via Mailed Fecal Immunochemical Testing in a Veterans Affairs Health System
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.
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
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.
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
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
In Early-Stage DLBCL, One Size No Longer Fits All
In Early-Stage DLBCL, One Size No Longer Fits All
SAN FRANCISCO – The treatment of early-stage diffuse large B-cell lymphoma (DLBCL) is evolving after decades of failed attempts to improve on the standard treatment of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), a hematologist-oncologist said at the Association of Veterans Affairs (VA) Hematology/Oncology regional meeting on lymphoma on March 21.
A combination therapy known as pola-R-CHP is now the preferred option for many patients but has limited additional benefit, said Solomon A. Graf, MD, of the University of Washington and VA Puget Sound Health Care System. Pola-R-CHP is a modified regimen of R-CHOP that replaced vincristine in R-CHOP with polatuzumab vedotin.
The keys to treatment, Graf said, include consideration of disease variations that can affect therapy efficacy and understanding the special needs of older patients.
Understanding DLBCL
DLBCL is the most common non-Hodgkin lymphoma in the US with about 30,000 new cases per year; the median age at diagnosis is 67 years, Graf said.
“The overall incidence of DLBCL has been relatively stable over the last decades,” he said. “But gratifyingly, the rate of death from this disease has steadily been declining since about the turn of the century.”
Pola-R-CHP: A New Standard, Significant Limitations
From 2002-2022, “many attempts to improve on first-line DLBCL therapy did not pan out,” Graf said, as more than a dozen large phase 3 trials failed to dethrone R-CHOP as the standard. Most of the trials attempted to add an agent to R-CHOP but showed no additional benefit.
Then, in 2021, the landmark POLARIX study was published. The double-blind, randomized trial on the new regime showed a progression-free survival benefit (PFS) vs R-CHOP (76.7% vs 70.2% at 2 years, respectively). Safety profiles were similar between the 2 combination therapies.
However, overall survival (OS) did not differ.
"Pola-R-CHP is now considered a preferred standard, despite no overall survival benefit and despite increased upfront cost,” Graf said. (A 2023 analysis found that pola-R-CHP is more cost-effective than R-CHOP in DLBCL.)
Pola-R-CHP or Not Pola-R-CHP?
Pola-R-CHP is not for all patients with DLBCL. In advanced cases, Graf said, genomic analyses provide important information that helps clinicians understand whether patients will fare better with R-CHOP. Cell-of-origin classifications include germinal center B-cell like (GCB), activated B-cell like (ABC), and unclassifiable.
“If it’s GCB type, there's no clear benefit for pola-R-CHP,” Graf said. “On the other hand, the ABC subtype does much better when treated with pola-R-CHP.”
Graf highlighted the recently updated VA Oncology Clinical Pathway for DLBCL, which recommends cell-of-origin testing by the Hans algorithm for certain advanced-stage patients. The guidelines suggest R-CHOP for GCB-type patients and pola-R-CHP for non–GCB-type patients. However, he cautioned that the Hans algorithm comes with an increased risk of misclassification.
Early-Stage Disease: Radiation or No Radiation?
About 25% to 30% of patients have stage I or II disease, and the landmark 1998 SWOG trial initially suggested that 3 cycles of CHOP plus radiation had superior PFS and OS compared with 8 cycles of CHOP alone, Graf said. This trial was conducted prior to the R-CHOP era. However, follow-up revealed that the benefit vanished over time and the risk of secondary cancers grew. “Both strategies are perfectly viable, but there isn’t as much of a preference anymore,” Graf said.
A pair of recent trials – a 2019 European study and a 2020 US study – support eliminating radiation and lowering the number of cycles of therapy in certain patients, he said.
Managing Older Patients
Patients with DLBCL tend to be older, Graf said, and many have comorbidities and other limitations. A standard course of 6 cycles of therapy may be too much for them, he said. Graf highlighted the Elderly Prognostic Index, a tool created by an Italian group that allows clinicians to predict outcomes based on patient fitness levels.
Graf offered additional guidance for this population:
- Consider corticosteroids in the prephase setting, which can be “very valuable” and improve a patient’s ECOG performance status, “giving you better confidence about proceeding with more standard therapy.”
- Include anthracycline-based therapies such as R-CHOP if appropriate, such as in patients who are focused on living longer, since they “are really crucial to achieving cure in patients with DLBCL.” Graf noted that he has “a low threshold to involve cardiology if there’s anthracycline use and some underlying cardiac comorbidity.”
- Adjust dosage as appropriate: “You can adjust in the middle, be rather flexible and creative about these doses and dosing levels as you get going with your patient and see just what they can tolerate,” he said. “Sometimes you can ramp it up over the course, and sometimes you have to ramp it down to respond to toxicities.”
- Be aware that older patients are at much higher risk of suffering from toxicities due to the vincristine component of R-CHOP. These include neurotoxicities and constipation.
Graf highlighted the phase 3 Polar Bear study, which may offer more insight into therapy options in patients aged ≥ 75 years who are frail or those aged ≥ 80 years. The trial is scheduled to end in early 2027.
Graf discloses relationships with Janssen, TG Therapeutics, BeOne, AstraZeneca, Genentech, Incyte, Eli Lilly, and Pfizer.
SAN FRANCISCO – The treatment of early-stage diffuse large B-cell lymphoma (DLBCL) is evolving after decades of failed attempts to improve on the standard treatment of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), a hematologist-oncologist said at the Association of Veterans Affairs (VA) Hematology/Oncology regional meeting on lymphoma on March 21.
A combination therapy known as pola-R-CHP is now the preferred option for many patients but has limited additional benefit, said Solomon A. Graf, MD, of the University of Washington and VA Puget Sound Health Care System. Pola-R-CHP is a modified regimen of R-CHOP that replaced vincristine in R-CHOP with polatuzumab vedotin.
The keys to treatment, Graf said, include consideration of disease variations that can affect therapy efficacy and understanding the special needs of older patients.
Understanding DLBCL
DLBCL is the most common non-Hodgkin lymphoma in the US with about 30,000 new cases per year; the median age at diagnosis is 67 years, Graf said.
“The overall incidence of DLBCL has been relatively stable over the last decades,” he said. “But gratifyingly, the rate of death from this disease has steadily been declining since about the turn of the century.”
Pola-R-CHP: A New Standard, Significant Limitations
From 2002-2022, “many attempts to improve on first-line DLBCL therapy did not pan out,” Graf said, as more than a dozen large phase 3 trials failed to dethrone R-CHOP as the standard. Most of the trials attempted to add an agent to R-CHOP but showed no additional benefit.
Then, in 2021, the landmark POLARIX study was published. The double-blind, randomized trial on the new regime showed a progression-free survival benefit (PFS) vs R-CHOP (76.7% vs 70.2% at 2 years, respectively). Safety profiles were similar between the 2 combination therapies.
However, overall survival (OS) did not differ.
"Pola-R-CHP is now considered a preferred standard, despite no overall survival benefit and despite increased upfront cost,” Graf said. (A 2023 analysis found that pola-R-CHP is more cost-effective than R-CHOP in DLBCL.)
Pola-R-CHP or Not Pola-R-CHP?
Pola-R-CHP is not for all patients with DLBCL. In advanced cases, Graf said, genomic analyses provide important information that helps clinicians understand whether patients will fare better with R-CHOP. Cell-of-origin classifications include germinal center B-cell like (GCB), activated B-cell like (ABC), and unclassifiable.
“If it’s GCB type, there's no clear benefit for pola-R-CHP,” Graf said. “On the other hand, the ABC subtype does much better when treated with pola-R-CHP.”
Graf highlighted the recently updated VA Oncology Clinical Pathway for DLBCL, which recommends cell-of-origin testing by the Hans algorithm for certain advanced-stage patients. The guidelines suggest R-CHOP for GCB-type patients and pola-R-CHP for non–GCB-type patients. However, he cautioned that the Hans algorithm comes with an increased risk of misclassification.
Early-Stage Disease: Radiation or No Radiation?
About 25% to 30% of patients have stage I or II disease, and the landmark 1998 SWOG trial initially suggested that 3 cycles of CHOP plus radiation had superior PFS and OS compared with 8 cycles of CHOP alone, Graf said. This trial was conducted prior to the R-CHOP era. However, follow-up revealed that the benefit vanished over time and the risk of secondary cancers grew. “Both strategies are perfectly viable, but there isn’t as much of a preference anymore,” Graf said.
A pair of recent trials – a 2019 European study and a 2020 US study – support eliminating radiation and lowering the number of cycles of therapy in certain patients, he said.
Managing Older Patients
Patients with DLBCL tend to be older, Graf said, and many have comorbidities and other limitations. A standard course of 6 cycles of therapy may be too much for them, he said. Graf highlighted the Elderly Prognostic Index, a tool created by an Italian group that allows clinicians to predict outcomes based on patient fitness levels.
Graf offered additional guidance for this population:
- Consider corticosteroids in the prephase setting, which can be “very valuable” and improve a patient’s ECOG performance status, “giving you better confidence about proceeding with more standard therapy.”
- Include anthracycline-based therapies such as R-CHOP if appropriate, such as in patients who are focused on living longer, since they “are really crucial to achieving cure in patients with DLBCL.” Graf noted that he has “a low threshold to involve cardiology if there’s anthracycline use and some underlying cardiac comorbidity.”
- Adjust dosage as appropriate: “You can adjust in the middle, be rather flexible and creative about these doses and dosing levels as you get going with your patient and see just what they can tolerate,” he said. “Sometimes you can ramp it up over the course, and sometimes you have to ramp it down to respond to toxicities.”
- Be aware that older patients are at much higher risk of suffering from toxicities due to the vincristine component of R-CHOP. These include neurotoxicities and constipation.
Graf highlighted the phase 3 Polar Bear study, which may offer more insight into therapy options in patients aged ≥ 75 years who are frail or those aged ≥ 80 years. The trial is scheduled to end in early 2027.
Graf discloses relationships with Janssen, TG Therapeutics, BeOne, AstraZeneca, Genentech, Incyte, Eli Lilly, and Pfizer.
SAN FRANCISCO – The treatment of early-stage diffuse large B-cell lymphoma (DLBCL) is evolving after decades of failed attempts to improve on the standard treatment of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), a hematologist-oncologist said at the Association of Veterans Affairs (VA) Hematology/Oncology regional meeting on lymphoma on March 21.
A combination therapy known as pola-R-CHP is now the preferred option for many patients but has limited additional benefit, said Solomon A. Graf, MD, of the University of Washington and VA Puget Sound Health Care System. Pola-R-CHP is a modified regimen of R-CHOP that replaced vincristine in R-CHOP with polatuzumab vedotin.
The keys to treatment, Graf said, include consideration of disease variations that can affect therapy efficacy and understanding the special needs of older patients.
Understanding DLBCL
DLBCL is the most common non-Hodgkin lymphoma in the US with about 30,000 new cases per year; the median age at diagnosis is 67 years, Graf said.
“The overall incidence of DLBCL has been relatively stable over the last decades,” he said. “But gratifyingly, the rate of death from this disease has steadily been declining since about the turn of the century.”
Pola-R-CHP: A New Standard, Significant Limitations
From 2002-2022, “many attempts to improve on first-line DLBCL therapy did not pan out,” Graf said, as more than a dozen large phase 3 trials failed to dethrone R-CHOP as the standard. Most of the trials attempted to add an agent to R-CHOP but showed no additional benefit.
Then, in 2021, the landmark POLARIX study was published. The double-blind, randomized trial on the new regime showed a progression-free survival benefit (PFS) vs R-CHOP (76.7% vs 70.2% at 2 years, respectively). Safety profiles were similar between the 2 combination therapies.
However, overall survival (OS) did not differ.
"Pola-R-CHP is now considered a preferred standard, despite no overall survival benefit and despite increased upfront cost,” Graf said. (A 2023 analysis found that pola-R-CHP is more cost-effective than R-CHOP in DLBCL.)
Pola-R-CHP or Not Pola-R-CHP?
Pola-R-CHP is not for all patients with DLBCL. In advanced cases, Graf said, genomic analyses provide important information that helps clinicians understand whether patients will fare better with R-CHOP. Cell-of-origin classifications include germinal center B-cell like (GCB), activated B-cell like (ABC), and unclassifiable.
“If it’s GCB type, there's no clear benefit for pola-R-CHP,” Graf said. “On the other hand, the ABC subtype does much better when treated with pola-R-CHP.”
Graf highlighted the recently updated VA Oncology Clinical Pathway for DLBCL, which recommends cell-of-origin testing by the Hans algorithm for certain advanced-stage patients. The guidelines suggest R-CHOP for GCB-type patients and pola-R-CHP for non–GCB-type patients. However, he cautioned that the Hans algorithm comes with an increased risk of misclassification.
Early-Stage Disease: Radiation or No Radiation?
About 25% to 30% of patients have stage I or II disease, and the landmark 1998 SWOG trial initially suggested that 3 cycles of CHOP plus radiation had superior PFS and OS compared with 8 cycles of CHOP alone, Graf said. This trial was conducted prior to the R-CHOP era. However, follow-up revealed that the benefit vanished over time and the risk of secondary cancers grew. “Both strategies are perfectly viable, but there isn’t as much of a preference anymore,” Graf said.
A pair of recent trials – a 2019 European study and a 2020 US study – support eliminating radiation and lowering the number of cycles of therapy in certain patients, he said.
Managing Older Patients
Patients with DLBCL tend to be older, Graf said, and many have comorbidities and other limitations. A standard course of 6 cycles of therapy may be too much for them, he said. Graf highlighted the Elderly Prognostic Index, a tool created by an Italian group that allows clinicians to predict outcomes based on patient fitness levels.
Graf offered additional guidance for this population:
- Consider corticosteroids in the prephase setting, which can be “very valuable” and improve a patient’s ECOG performance status, “giving you better confidence about proceeding with more standard therapy.”
- Include anthracycline-based therapies such as R-CHOP if appropriate, such as in patients who are focused on living longer, since they “are really crucial to achieving cure in patients with DLBCL.” Graf noted that he has “a low threshold to involve cardiology if there’s anthracycline use and some underlying cardiac comorbidity.”
- Adjust dosage as appropriate: “You can adjust in the middle, be rather flexible and creative about these doses and dosing levels as you get going with your patient and see just what they can tolerate,” he said. “Sometimes you can ramp it up over the course, and sometimes you have to ramp it down to respond to toxicities.”
- Be aware that older patients are at much higher risk of suffering from toxicities due to the vincristine component of R-CHOP. These include neurotoxicities and constipation.
Graf highlighted the phase 3 Polar Bear study, which may offer more insight into therapy options in patients aged ≥ 75 years who are frail or those aged ≥ 80 years. The trial is scheduled to end in early 2027.
Graf discloses relationships with Janssen, TG Therapeutics, BeOne, AstraZeneca, Genentech, Incyte, Eli Lilly, and Pfizer.
In Early-Stage DLBCL, One Size No Longer Fits All
In Early-Stage DLBCL, One Size No Longer Fits All
Vet Prostate Cancer Survivors Face Hidden Breast Cancer Risk
Vet Prostate Cancer Survivors Face Hidden Breast Cancer Risk
TOPLINE:
Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.
METHODOLOGY:
- Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
- Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
- Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
- Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.
TAKEAWAY:
- Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
- Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
- Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
- Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).
IN PRACTICE:
"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."
SOURCE:
The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.
LIMITATIONS:
Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.
DISCLOSURES:
The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.
METHODOLOGY:
- Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
- Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
- Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
- Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.
TAKEAWAY:
- Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
- Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
- Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
- Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).
IN PRACTICE:
"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."
SOURCE:
The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.
LIMITATIONS:
Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.
DISCLOSURES:
The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.
METHODOLOGY:
- Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
- Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
- Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
- Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.
TAKEAWAY:
- Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
- Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
- Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
- Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).
IN PRACTICE:
"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."
SOURCE:
The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.
LIMITATIONS:
Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.
DISCLOSURES:
The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Vet Prostate Cancer Survivors Face Hidden Breast Cancer Risk
Vet Prostate Cancer Survivors Face Hidden Breast Cancer Risk
Is Ken Kizer’s Legacy at Risk? The Future of the Veterans Health Administration
Is Ken Kizer’s Legacy at Risk? The Future of the Veterans Health Administration
Mostly it is loss that teaches us about the worth of things.
Arthur Schopenhauer1
One of the leaders I most respected in my US Department of Veterans Affairs (VA) career was a man who had worked his way up through the ranks to become a medical center director. Usually calm, cool, and collected, he would wax poetic when discussing the hero of the VA Health Care System revolution, Ken Kizer, MD, MPH.
In this issue of Federal Practitioner, journalist Randy Dotinga interviews Kizer about the current challenges facing the VA. Though many readers will have participated in or at least know about Kizer’s unprecedented overhaul of the agency, many others, especially those new to VA, may not. It seemed a fitting time to offer an outline of the immense and positive accomplishments that occurred in the agency during his tenure, especially as, under the current administration, many of his most forward-thinking initiatives seem to be moving backward.2
When President Clinton nominated Kizer to serve as the Under Secretary for Health for the Veterans Health Administration in 1994, the poor quality care the agency delivered was castigated in popular movies like Born on the Fourth of July. Veterans who were seen in that era, and who eventually returned to a far better, kinder VA thanks to Kizer, would often tell me, “Doc, the VA was really bad then, and I was afraid to come back.” The critique of VA health care in the mid-1990s sounds like a bureaucratic déjà vu of many of the concerns Kizer raised in his interview, including fragmentation of care, access barriers, and poor coordination of treatment.3
If anyone was prepared and qualified to take on this seeming mission impossible, it was Kizer. A US Navy veteran with 6 board certifications, he came to the VA following a brave and innovative stint as the top health official in California, where he successfully took on the tobacco lobby and dramatically reduced the state’s rates of smoking and related diseases.4
Long before it was the subject of reality TV shows, Kizer dubbed his major renovation of the VA’s antiquated structure an “extreme makeover.”3 Though this description is an oversimplification of Kizer’s monumental efforts, the makeover can be considered in 4 to 6 buckets, depending on how various health policy experts parse the re-engineering efforts.5-7
Decentralization. Kizer instituted the Veterans Integrated Service Network (VISN) system to coordinate the management and operations of all the hospitals, clinics, and other VA health care entities in what is roughly a region. The locus of decision-making shifted from the VA Central Office to the VISNs, intended to promote more efficient, economical, and streamlined health care delivery.
Capitation. Accompanying this restructuring was a shift to a capitated system focused on preventive care. The Veterans Equitable Resource Allocation system was designed to logically link workload and funding. This was a major shift away from VA’s previous emphasis on inpatient and specialty care and resulted in the closing of multiple hospitals.4
Information Systems. I can still remember the first time I sat down at a prehistoric computer to use the Computerized Patient Record System (CPRS). Though now much maligned, then it was like something out of Star Trek, at a time when almost every other health care institution was buried in paper charts. With CPRS, VA suddenly had a pioneering and much-envied electronic medical record that facilitated continuity of care, communication between professionals, and accuracy and completeness of documentation.
Data Driven Performance Improvement. The VISNs and information systems inaugurated a new era of data-driven quality improvement. The assembly and analysis of data enabled VISNs to have real-time input about comparative facility performance.
Performance Measures. The data enabled evidence-based performance measures to be developed and monitored. Though these have now become the bane of many Federal Practitioner readers’ existence, they were originally intended for VISN directors and members of the senior executive service at VA central office. These were tied to incentives that, though recently the subject of watchdog investigation, were intended to motivate and reward high-quality care.6
Even this cursory look at Kizer’s accomplishments is more than enough to demonstrate the magnitude of the makeover, and when the time frame of the achievements is factored in, the transformation is the equivalent of a planet changing its orbit at light speed. Rhetoric aside, there are now hundreds of research articles published in top medical and health policy journals, many of them authored by Kizer,7,8 that have amply demonstrated that when he departed the VA in 1999, it had become “the best care anywhere.” 9 For example, a 2000 New England Journal of Medicine article found that from 1994 to 2000, the percentage of veterans whose care met ≥ 90% of 9 of 17 quality standards was > 70% for 13 of the measures, outperforming fee-for-service Medicare.10
There had been uncertainty about whether Kizer would seek a second term as Under Secretary when he announced that he was leaving. With concise modesty, Kizer said he had met his charge to, “re-engineer the veterans’ health care system so that it could effectively function in the 21st century.”11
Despite openly and critically discussing the many difficulties the VA currently confronts, Kizer ends his interview on a note of hope. Since he likely knows more about VA than any person alive, we need to trust his judgment that his legacy, which currently seems more in jeopardy than ever before, will somehow prevail. Perhaps I am too melancholic, but I believe it will take a professional of the stature of Dr. Kizer to take us back to that future, and I fear we will not see his likes again.
- Schopenhaur A, translated by Saunders TB. Parerga and Paralipomena: A Collection of Philosophical Essays. Cosimo Classics: 2007.
- Spotswood, S. Massive VA restructuring would cut number of VISNS, reduce high-level leadership. U.S. Medicine. January 15, 2026. Accessed March 23, 2026. https://www .usmedicine.com/non-clinical-topics/policy/massive -va-restructuring-would-cut-number-of-visns-reduce-high -level-leadership/
- Kizer KW, Dudley RA. Extreme makeover: transformation of the veterans health ca re system. Annu Rev Public Health. 2009;30:313-339. doi:10.1146/annurev.publhealth.29.020907.090940
- Payne D. How Kizer healed the VA. BMJ. 2012;344:e3324. doi:10.1136/bmj.e3324
- Jha AK. What can the rest of the health care system learn from VA’s quality and safety transformation? Agency for Healthcare Research and Quality. Patient Safety Network. September 1, 2006. Accessed March 23, 2026. https://psnet .ahrq.gov/perspective/what-can-rest-health-care-system -learn-vas-quality-and-safety-transformation
- US Department of Veterans Affairs, Office of Inspector General. VA improperly awarded 10.8 million in incentives to central office senior executives. Report # 23-03773-169. May 9, 2024. Accessed March 23, 2026. https://www.vaoig.gov /reports/administrative-investigation/va-improperly-awarded -108-million-incentives-central-office
- Kizer KW. The “new VA”: a national laboratory for health care quality management. Am J Med Qual. 1999;14:3-20. doi:10.1177/106286069901400103
- Kizer KW, Pane GA. The “new VA”: delivering health care value through integrated service networks. Ann Emerg Med. 1997;30:804-807. doi:10.1016/s0196-0644(97)70053-2
- Longman P. Best Care Anywhere: Why VA Health Care is Better than Yours. 3rd ed. Berrett-Koehler Publishers; 2012.
- Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003;348:2218-2227. doi:10.1056/NEJMsa021899
- US Department of Veterans Affairs. Kizer withdraws name from consideration for second term as VA Under Secretary for Health. Vanguard. June/July 1999. Accessed March 23, 2026. https://www.va.gov/opa/publications/archives /vanguard/99junjulvg.pdf
Mostly it is loss that teaches us about the worth of things.
Arthur Schopenhauer1
One of the leaders I most respected in my US Department of Veterans Affairs (VA) career was a man who had worked his way up through the ranks to become a medical center director. Usually calm, cool, and collected, he would wax poetic when discussing the hero of the VA Health Care System revolution, Ken Kizer, MD, MPH.
In this issue of Federal Practitioner, journalist Randy Dotinga interviews Kizer about the current challenges facing the VA. Though many readers will have participated in or at least know about Kizer’s unprecedented overhaul of the agency, many others, especially those new to VA, may not. It seemed a fitting time to offer an outline of the immense and positive accomplishments that occurred in the agency during his tenure, especially as, under the current administration, many of his most forward-thinking initiatives seem to be moving backward.2
When President Clinton nominated Kizer to serve as the Under Secretary for Health for the Veterans Health Administration in 1994, the poor quality care the agency delivered was castigated in popular movies like Born on the Fourth of July. Veterans who were seen in that era, and who eventually returned to a far better, kinder VA thanks to Kizer, would often tell me, “Doc, the VA was really bad then, and I was afraid to come back.” The critique of VA health care in the mid-1990s sounds like a bureaucratic déjà vu of many of the concerns Kizer raised in his interview, including fragmentation of care, access barriers, and poor coordination of treatment.3
If anyone was prepared and qualified to take on this seeming mission impossible, it was Kizer. A US Navy veteran with 6 board certifications, he came to the VA following a brave and innovative stint as the top health official in California, where he successfully took on the tobacco lobby and dramatically reduced the state’s rates of smoking and related diseases.4
Long before it was the subject of reality TV shows, Kizer dubbed his major renovation of the VA’s antiquated structure an “extreme makeover.”3 Though this description is an oversimplification of Kizer’s monumental efforts, the makeover can be considered in 4 to 6 buckets, depending on how various health policy experts parse the re-engineering efforts.5-7
Decentralization. Kizer instituted the Veterans Integrated Service Network (VISN) system to coordinate the management and operations of all the hospitals, clinics, and other VA health care entities in what is roughly a region. The locus of decision-making shifted from the VA Central Office to the VISNs, intended to promote more efficient, economical, and streamlined health care delivery.
Capitation. Accompanying this restructuring was a shift to a capitated system focused on preventive care. The Veterans Equitable Resource Allocation system was designed to logically link workload and funding. This was a major shift away from VA’s previous emphasis on inpatient and specialty care and resulted in the closing of multiple hospitals.4
Information Systems. I can still remember the first time I sat down at a prehistoric computer to use the Computerized Patient Record System (CPRS). Though now much maligned, then it was like something out of Star Trek, at a time when almost every other health care institution was buried in paper charts. With CPRS, VA suddenly had a pioneering and much-envied electronic medical record that facilitated continuity of care, communication between professionals, and accuracy and completeness of documentation.
Data Driven Performance Improvement. The VISNs and information systems inaugurated a new era of data-driven quality improvement. The assembly and analysis of data enabled VISNs to have real-time input about comparative facility performance.
Performance Measures. The data enabled evidence-based performance measures to be developed and monitored. Though these have now become the bane of many Federal Practitioner readers’ existence, they were originally intended for VISN directors and members of the senior executive service at VA central office. These were tied to incentives that, though recently the subject of watchdog investigation, were intended to motivate and reward high-quality care.6
Even this cursory look at Kizer’s accomplishments is more than enough to demonstrate the magnitude of the makeover, and when the time frame of the achievements is factored in, the transformation is the equivalent of a planet changing its orbit at light speed. Rhetoric aside, there are now hundreds of research articles published in top medical and health policy journals, many of them authored by Kizer,7,8 that have amply demonstrated that when he departed the VA in 1999, it had become “the best care anywhere.” 9 For example, a 2000 New England Journal of Medicine article found that from 1994 to 2000, the percentage of veterans whose care met ≥ 90% of 9 of 17 quality standards was > 70% for 13 of the measures, outperforming fee-for-service Medicare.10
There had been uncertainty about whether Kizer would seek a second term as Under Secretary when he announced that he was leaving. With concise modesty, Kizer said he had met his charge to, “re-engineer the veterans’ health care system so that it could effectively function in the 21st century.”11
Despite openly and critically discussing the many difficulties the VA currently confronts, Kizer ends his interview on a note of hope. Since he likely knows more about VA than any person alive, we need to trust his judgment that his legacy, which currently seems more in jeopardy than ever before, will somehow prevail. Perhaps I am too melancholic, but I believe it will take a professional of the stature of Dr. Kizer to take us back to that future, and I fear we will not see his likes again.
Mostly it is loss that teaches us about the worth of things.
Arthur Schopenhauer1
One of the leaders I most respected in my US Department of Veterans Affairs (VA) career was a man who had worked his way up through the ranks to become a medical center director. Usually calm, cool, and collected, he would wax poetic when discussing the hero of the VA Health Care System revolution, Ken Kizer, MD, MPH.
In this issue of Federal Practitioner, journalist Randy Dotinga interviews Kizer about the current challenges facing the VA. Though many readers will have participated in or at least know about Kizer’s unprecedented overhaul of the agency, many others, especially those new to VA, may not. It seemed a fitting time to offer an outline of the immense and positive accomplishments that occurred in the agency during his tenure, especially as, under the current administration, many of his most forward-thinking initiatives seem to be moving backward.2
When President Clinton nominated Kizer to serve as the Under Secretary for Health for the Veterans Health Administration in 1994, the poor quality care the agency delivered was castigated in popular movies like Born on the Fourth of July. Veterans who were seen in that era, and who eventually returned to a far better, kinder VA thanks to Kizer, would often tell me, “Doc, the VA was really bad then, and I was afraid to come back.” The critique of VA health care in the mid-1990s sounds like a bureaucratic déjà vu of many of the concerns Kizer raised in his interview, including fragmentation of care, access barriers, and poor coordination of treatment.3
If anyone was prepared and qualified to take on this seeming mission impossible, it was Kizer. A US Navy veteran with 6 board certifications, he came to the VA following a brave and innovative stint as the top health official in California, where he successfully took on the tobacco lobby and dramatically reduced the state’s rates of smoking and related diseases.4
Long before it was the subject of reality TV shows, Kizer dubbed his major renovation of the VA’s antiquated structure an “extreme makeover.”3 Though this description is an oversimplification of Kizer’s monumental efforts, the makeover can be considered in 4 to 6 buckets, depending on how various health policy experts parse the re-engineering efforts.5-7
Decentralization. Kizer instituted the Veterans Integrated Service Network (VISN) system to coordinate the management and operations of all the hospitals, clinics, and other VA health care entities in what is roughly a region. The locus of decision-making shifted from the VA Central Office to the VISNs, intended to promote more efficient, economical, and streamlined health care delivery.
Capitation. Accompanying this restructuring was a shift to a capitated system focused on preventive care. The Veterans Equitable Resource Allocation system was designed to logically link workload and funding. This was a major shift away from VA’s previous emphasis on inpatient and specialty care and resulted in the closing of multiple hospitals.4
Information Systems. I can still remember the first time I sat down at a prehistoric computer to use the Computerized Patient Record System (CPRS). Though now much maligned, then it was like something out of Star Trek, at a time when almost every other health care institution was buried in paper charts. With CPRS, VA suddenly had a pioneering and much-envied electronic medical record that facilitated continuity of care, communication between professionals, and accuracy and completeness of documentation.
Data Driven Performance Improvement. The VISNs and information systems inaugurated a new era of data-driven quality improvement. The assembly and analysis of data enabled VISNs to have real-time input about comparative facility performance.
Performance Measures. The data enabled evidence-based performance measures to be developed and monitored. Though these have now become the bane of many Federal Practitioner readers’ existence, they were originally intended for VISN directors and members of the senior executive service at VA central office. These were tied to incentives that, though recently the subject of watchdog investigation, were intended to motivate and reward high-quality care.6
Even this cursory look at Kizer’s accomplishments is more than enough to demonstrate the magnitude of the makeover, and when the time frame of the achievements is factored in, the transformation is the equivalent of a planet changing its orbit at light speed. Rhetoric aside, there are now hundreds of research articles published in top medical and health policy journals, many of them authored by Kizer,7,8 that have amply demonstrated that when he departed the VA in 1999, it had become “the best care anywhere.” 9 For example, a 2000 New England Journal of Medicine article found that from 1994 to 2000, the percentage of veterans whose care met ≥ 90% of 9 of 17 quality standards was > 70% for 13 of the measures, outperforming fee-for-service Medicare.10
There had been uncertainty about whether Kizer would seek a second term as Under Secretary when he announced that he was leaving. With concise modesty, Kizer said he had met his charge to, “re-engineer the veterans’ health care system so that it could effectively function in the 21st century.”11
Despite openly and critically discussing the many difficulties the VA currently confronts, Kizer ends his interview on a note of hope. Since he likely knows more about VA than any person alive, we need to trust his judgment that his legacy, which currently seems more in jeopardy than ever before, will somehow prevail. Perhaps I am too melancholic, but I believe it will take a professional of the stature of Dr. Kizer to take us back to that future, and I fear we will not see his likes again.
- Schopenhaur A, translated by Saunders TB. Parerga and Paralipomena: A Collection of Philosophical Essays. Cosimo Classics: 2007.
- Spotswood, S. Massive VA restructuring would cut number of VISNS, reduce high-level leadership. U.S. Medicine. January 15, 2026. Accessed March 23, 2026. https://www .usmedicine.com/non-clinical-topics/policy/massive -va-restructuring-would-cut-number-of-visns-reduce-high -level-leadership/
- Kizer KW, Dudley RA. Extreme makeover: transformation of the veterans health ca re system. Annu Rev Public Health. 2009;30:313-339. doi:10.1146/annurev.publhealth.29.020907.090940
- Payne D. How Kizer healed the VA. BMJ. 2012;344:e3324. doi:10.1136/bmj.e3324
- Jha AK. What can the rest of the health care system learn from VA’s quality and safety transformation? Agency for Healthcare Research and Quality. Patient Safety Network. September 1, 2006. Accessed March 23, 2026. https://psnet .ahrq.gov/perspective/what-can-rest-health-care-system -learn-vas-quality-and-safety-transformation
- US Department of Veterans Affairs, Office of Inspector General. VA improperly awarded 10.8 million in incentives to central office senior executives. Report # 23-03773-169. May 9, 2024. Accessed March 23, 2026. https://www.vaoig.gov /reports/administrative-investigation/va-improperly-awarded -108-million-incentives-central-office
- Kizer KW. The “new VA”: a national laboratory for health care quality management. Am J Med Qual. 1999;14:3-20. doi:10.1177/106286069901400103
- Kizer KW, Pane GA. The “new VA”: delivering health care value through integrated service networks. Ann Emerg Med. 1997;30:804-807. doi:10.1016/s0196-0644(97)70053-2
- Longman P. Best Care Anywhere: Why VA Health Care is Better than Yours. 3rd ed. Berrett-Koehler Publishers; 2012.
- Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003;348:2218-2227. doi:10.1056/NEJMsa021899
- US Department of Veterans Affairs. Kizer withdraws name from consideration for second term as VA Under Secretary for Health. Vanguard. June/July 1999. Accessed March 23, 2026. https://www.va.gov/opa/publications/archives /vanguard/99junjulvg.pdf
- Schopenhaur A, translated by Saunders TB. Parerga and Paralipomena: A Collection of Philosophical Essays. Cosimo Classics: 2007.
- Spotswood, S. Massive VA restructuring would cut number of VISNS, reduce high-level leadership. U.S. Medicine. January 15, 2026. Accessed March 23, 2026. https://www .usmedicine.com/non-clinical-topics/policy/massive -va-restructuring-would-cut-number-of-visns-reduce-high -level-leadership/
- Kizer KW, Dudley RA. Extreme makeover: transformation of the veterans health ca re system. Annu Rev Public Health. 2009;30:313-339. doi:10.1146/annurev.publhealth.29.020907.090940
- Payne D. How Kizer healed the VA. BMJ. 2012;344:e3324. doi:10.1136/bmj.e3324
- Jha AK. What can the rest of the health care system learn from VA’s quality and safety transformation? Agency for Healthcare Research and Quality. Patient Safety Network. September 1, 2006. Accessed March 23, 2026. https://psnet .ahrq.gov/perspective/what-can-rest-health-care-system -learn-vas-quality-and-safety-transformation
- US Department of Veterans Affairs, Office of Inspector General. VA improperly awarded 10.8 million in incentives to central office senior executives. Report # 23-03773-169. May 9, 2024. Accessed March 23, 2026. https://www.vaoig.gov /reports/administrative-investigation/va-improperly-awarded -108-million-incentives-central-office
- Kizer KW. The “new VA”: a national laboratory for health care quality management. Am J Med Qual. 1999;14:3-20. doi:10.1177/106286069901400103
- Kizer KW, Pane GA. The “new VA”: delivering health care value through integrated service networks. Ann Emerg Med. 1997;30:804-807. doi:10.1016/s0196-0644(97)70053-2
- Longman P. Best Care Anywhere: Why VA Health Care is Better than Yours. 3rd ed. Berrett-Koehler Publishers; 2012.
- Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003;348:2218-2227. doi:10.1056/NEJMsa021899
- US Department of Veterans Affairs. Kizer withdraws name from consideration for second term as VA Under Secretary for Health. Vanguard. June/July 1999. Accessed March 23, 2026. https://www.va.gov/opa/publications/archives /vanguard/99junjulvg.pdf
Is Ken Kizer’s Legacy at Risk? The Future of the Veterans Health Administration
Is Ken Kizer’s Legacy at Risk? The Future of the Veterans Health Administration
Weight Loss May Cut Cancer Risk in Adults With Obesity
Weight Loss May Cut Cancer Risk in Adults With Obesity
TOPLINE:
Among adults with obesity, nonsurgical weight loss was significantly associated with reduced odds for developing obesity-related and other cancers at 3 and 5 years, a study of real-world data found.
METHODOLOGY:
- Although weight loss after bariatric surgery is linked to a reduced risk for cancer, the effect of nonsurgical weight loss on cancer risk remains unclear.
- Researchers conducted a retrospective observational study using electronic health record data from a US health system to assess the association between nonsurgical weight loss and the risk for cancer among adults with obesity.
- The inclusion criteria were age of ≥ 20 years, BMI > 30, and at least seven health system visits over 3 years. Patients with a history of alcohol or substance abuse, amputations, HIV infection, organ transplant, thyroid problems, or those who underwent bariatric surgery were excluded.
- The 143,630 patients who met inclusion criteria (7703 cancer cases and 135,927 controls) were divided into 3 cohorts based on weight change over time intervals of 3 years (115,942 patients), 5 years (105,472 patients), and 10 years (59,112 patients).
- Primary endpoints included obesity-related cancers (esophageal cancer, liver cancer, gallbladder cancer, pancreatic cancer, colorectal cancer, renal cell carcinoma, endometrial cancer, multiple myeloma, and postmenopausal breast cancer), and secondary endpoints included all malignant neoplasms.
TAKEAWAY:
- Each 1% reduction in BMI was associated with reduced odds of obesity-related cancers at 3 years and 5 years (odds ratio [OR], 0.99 and 0.989, respectively; P < .001 for both). These results translate to 5% weight loss corresponding to 4.9% and 5.4% reductions in obesity-related cancer odds at 3 and 5 years, respectively.
- Weight loss was associated with reduced odds of endometrial cancer at 3, 5, and 10 years (OR, 0.978; P < .05), of renal cell carcinoma at 3 and 5 years (OR, 0.983; P < .05), and of multiple myeloma at 10 years (OR, 0.969; P = .004).
- Weight loss was also associated with reduced odds of developing any malignancy at 3 years (OR, 0.992), 5 years (OR, 0.994), and 10 years (OR, 0.991; P = .001 for all). These results translate into a 5% weight loss corresponding to 3.9%, 3%, and 4.4% lower odds of any malignancy at 3, 5, and 10 years, respectively.
IN PRACTICE:
"Real-world weight loss was associated with a decreased risk of developing obesity-related cancers and all other cancers. Our study serves as a call for action and a strong public health message to healthcare stakeholders to intensify efforts and resources to treat obesity as a chronic disease to help reduce the risk of developing cancer," the author wrote.
SOURCE:
This study, led by endocrinologist Kenda Alkwatli, MD, Starling Physicians, Wethersfield, Connecticut, was published online in Obesity.
LIMITATIONS:
The study included only individuals with sufficient longitudinal health records, which may have introduced selection bias. It could not distinguish between intentional and unintentional weight loss or differentiate between fat and lean mass. Due to its observational nature, the study could not assess whether weight loss preceding cancer diagnosis was related to delay in diagnosis.
DISCLOSURES:
The study was funded in part by the Cleveland Clinic Center for Quantitative Metabolic Research. Three authors reported receiving research funding, consulting fees, honoraria, grants, or research support and holding patent applications, license agreements, leadership roles, or equity in healthcare and biotechnology companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among adults with obesity, nonsurgical weight loss was significantly associated with reduced odds for developing obesity-related and other cancers at 3 and 5 years, a study of real-world data found.
METHODOLOGY:
- Although weight loss after bariatric surgery is linked to a reduced risk for cancer, the effect of nonsurgical weight loss on cancer risk remains unclear.
- Researchers conducted a retrospective observational study using electronic health record data from a US health system to assess the association between nonsurgical weight loss and the risk for cancer among adults with obesity.
- The inclusion criteria were age of ≥ 20 years, BMI > 30, and at least seven health system visits over 3 years. Patients with a history of alcohol or substance abuse, amputations, HIV infection, organ transplant, thyroid problems, or those who underwent bariatric surgery were excluded.
- The 143,630 patients who met inclusion criteria (7703 cancer cases and 135,927 controls) were divided into 3 cohorts based on weight change over time intervals of 3 years (115,942 patients), 5 years (105,472 patients), and 10 years (59,112 patients).
- Primary endpoints included obesity-related cancers (esophageal cancer, liver cancer, gallbladder cancer, pancreatic cancer, colorectal cancer, renal cell carcinoma, endometrial cancer, multiple myeloma, and postmenopausal breast cancer), and secondary endpoints included all malignant neoplasms.
TAKEAWAY:
- Each 1% reduction in BMI was associated with reduced odds of obesity-related cancers at 3 years and 5 years (odds ratio [OR], 0.99 and 0.989, respectively; P < .001 for both). These results translate to 5% weight loss corresponding to 4.9% and 5.4% reductions in obesity-related cancer odds at 3 and 5 years, respectively.
- Weight loss was associated with reduced odds of endometrial cancer at 3, 5, and 10 years (OR, 0.978; P < .05), of renal cell carcinoma at 3 and 5 years (OR, 0.983; P < .05), and of multiple myeloma at 10 years (OR, 0.969; P = .004).
- Weight loss was also associated with reduced odds of developing any malignancy at 3 years (OR, 0.992), 5 years (OR, 0.994), and 10 years (OR, 0.991; P = .001 for all). These results translate into a 5% weight loss corresponding to 3.9%, 3%, and 4.4% lower odds of any malignancy at 3, 5, and 10 years, respectively.
IN PRACTICE:
"Real-world weight loss was associated with a decreased risk of developing obesity-related cancers and all other cancers. Our study serves as a call for action and a strong public health message to healthcare stakeholders to intensify efforts and resources to treat obesity as a chronic disease to help reduce the risk of developing cancer," the author wrote.
SOURCE:
This study, led by endocrinologist Kenda Alkwatli, MD, Starling Physicians, Wethersfield, Connecticut, was published online in Obesity.
LIMITATIONS:
The study included only individuals with sufficient longitudinal health records, which may have introduced selection bias. It could not distinguish between intentional and unintentional weight loss or differentiate between fat and lean mass. Due to its observational nature, the study could not assess whether weight loss preceding cancer diagnosis was related to delay in diagnosis.
DISCLOSURES:
The study was funded in part by the Cleveland Clinic Center for Quantitative Metabolic Research. Three authors reported receiving research funding, consulting fees, honoraria, grants, or research support and holding patent applications, license agreements, leadership roles, or equity in healthcare and biotechnology companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among adults with obesity, nonsurgical weight loss was significantly associated with reduced odds for developing obesity-related and other cancers at 3 and 5 years, a study of real-world data found.
METHODOLOGY:
- Although weight loss after bariatric surgery is linked to a reduced risk for cancer, the effect of nonsurgical weight loss on cancer risk remains unclear.
- Researchers conducted a retrospective observational study using electronic health record data from a US health system to assess the association between nonsurgical weight loss and the risk for cancer among adults with obesity.
- The inclusion criteria were age of ≥ 20 years, BMI > 30, and at least seven health system visits over 3 years. Patients with a history of alcohol or substance abuse, amputations, HIV infection, organ transplant, thyroid problems, or those who underwent bariatric surgery were excluded.
- The 143,630 patients who met inclusion criteria (7703 cancer cases and 135,927 controls) were divided into 3 cohorts based on weight change over time intervals of 3 years (115,942 patients), 5 years (105,472 patients), and 10 years (59,112 patients).
- Primary endpoints included obesity-related cancers (esophageal cancer, liver cancer, gallbladder cancer, pancreatic cancer, colorectal cancer, renal cell carcinoma, endometrial cancer, multiple myeloma, and postmenopausal breast cancer), and secondary endpoints included all malignant neoplasms.
TAKEAWAY:
- Each 1% reduction in BMI was associated with reduced odds of obesity-related cancers at 3 years and 5 years (odds ratio [OR], 0.99 and 0.989, respectively; P < .001 for both). These results translate to 5% weight loss corresponding to 4.9% and 5.4% reductions in obesity-related cancer odds at 3 and 5 years, respectively.
- Weight loss was associated with reduced odds of endometrial cancer at 3, 5, and 10 years (OR, 0.978; P < .05), of renal cell carcinoma at 3 and 5 years (OR, 0.983; P < .05), and of multiple myeloma at 10 years (OR, 0.969; P = .004).
- Weight loss was also associated with reduced odds of developing any malignancy at 3 years (OR, 0.992), 5 years (OR, 0.994), and 10 years (OR, 0.991; P = .001 for all). These results translate into a 5% weight loss corresponding to 3.9%, 3%, and 4.4% lower odds of any malignancy at 3, 5, and 10 years, respectively.
IN PRACTICE:
"Real-world weight loss was associated with a decreased risk of developing obesity-related cancers and all other cancers. Our study serves as a call for action and a strong public health message to healthcare stakeholders to intensify efforts and resources to treat obesity as a chronic disease to help reduce the risk of developing cancer," the author wrote.
SOURCE:
This study, led by endocrinologist Kenda Alkwatli, MD, Starling Physicians, Wethersfield, Connecticut, was published online in Obesity.
LIMITATIONS:
The study included only individuals with sufficient longitudinal health records, which may have introduced selection bias. It could not distinguish between intentional and unintentional weight loss or differentiate between fat and lean mass. Due to its observational nature, the study could not assess whether weight loss preceding cancer diagnosis was related to delay in diagnosis.
DISCLOSURES:
The study was funded in part by the Cleveland Clinic Center for Quantitative Metabolic Research. Three authors reported receiving research funding, consulting fees, honoraria, grants, or research support and holding patent applications, license agreements, leadership roles, or equity in healthcare and biotechnology companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Weight Loss May Cut Cancer Risk in Adults With Obesity
Weight Loss May Cut Cancer Risk in Adults With Obesity
“Noteworthy” Link Between Agent Orange and Acral Melanoma Found
Recent research has revealed potential links between Agent Orange (AO) exposure and risk of acral melanoma (AM) among Vietnam War-era veterans, providing strong evidence of a relationship between the chemical and this type of cancer.
Localized to the palms, soles, and nail units, AM is a melanoma subtype less associated with UV radiation. From 1962 to 1971, the US military sprayed an estimated 18 million gallons of herbicides, including AO, over the fields and forests of Vietnam. Those herbicides have since been connected to numerous health issues, including cancer, though evidence of a relationship between AO and skin cancers has been weak.
Vietnam War-era veterans have a higher melanoma burden than the general population, with the disease being the fourth-most common cancer among those who served. AM, however, is rare, representing about 2% to 3% of all melanomas.
In a nested case-control study, Hwang et al used US Department of Veterans Affairs (VA) health care system data, including the VA Cancer Registry. The authors compared 1292 patients with AM and 2 pair-matched control groups: a group matched 4:1 to nonacral cutaneous melanoma controls, and a group without a melanoma diagnosis.
Hwang et al found AO exposure was associated with increased odds of AM compared with each control group. In an accompanying editorial, Andrew Olshan, PhD, from Department of Epidemiology at the University of North Carolina Gillings School of Global Public Health, wrote, “The magnitude of the effects was modest (about 30%) but noteworthy.”
A limitation of the study was that presumptive AOE status was based on whether the veteran filed a disability claim with evidence of officially recognized service in a period and place where Agent Orange was used—not on an assessment of the veteran’s individual AOE potential, including level of exposure. Because melanoma has never been included on the VA list of cancers presumed to be related to AO exposure, veterans do not automatically gain benefits by filing AOE claims after diagnosis. Even so, Olshan says, the reported study findings may underestimate the true effect of AO exposure on the risk of AM.
Given the rarity of AM, the association (if causal) would translate to 0.4 to 0.8 new annual cases of AM per 1,000,000 veterans, according to the study. Narrowed down to Vietnam War-era veterans—who are dwindling in number—the attributable cases would be scarce.
Nevertheless, the search for a better understanding of a potential link between AOE and melanomas among Vietnam War-era veterans is important, Olshan wrote.
“The Hwang et al study provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community.”
Recent research has revealed potential links between Agent Orange (AO) exposure and risk of acral melanoma (AM) among Vietnam War-era veterans, providing strong evidence of a relationship between the chemical and this type of cancer.
Localized to the palms, soles, and nail units, AM is a melanoma subtype less associated with UV radiation. From 1962 to 1971, the US military sprayed an estimated 18 million gallons of herbicides, including AO, over the fields and forests of Vietnam. Those herbicides have since been connected to numerous health issues, including cancer, though evidence of a relationship between AO and skin cancers has been weak.
Vietnam War-era veterans have a higher melanoma burden than the general population, with the disease being the fourth-most common cancer among those who served. AM, however, is rare, representing about 2% to 3% of all melanomas.
In a nested case-control study, Hwang et al used US Department of Veterans Affairs (VA) health care system data, including the VA Cancer Registry. The authors compared 1292 patients with AM and 2 pair-matched control groups: a group matched 4:1 to nonacral cutaneous melanoma controls, and a group without a melanoma diagnosis.
Hwang et al found AO exposure was associated with increased odds of AM compared with each control group. In an accompanying editorial, Andrew Olshan, PhD, from Department of Epidemiology at the University of North Carolina Gillings School of Global Public Health, wrote, “The magnitude of the effects was modest (about 30%) but noteworthy.”
A limitation of the study was that presumptive AOE status was based on whether the veteran filed a disability claim with evidence of officially recognized service in a period and place where Agent Orange was used—not on an assessment of the veteran’s individual AOE potential, including level of exposure. Because melanoma has never been included on the VA list of cancers presumed to be related to AO exposure, veterans do not automatically gain benefits by filing AOE claims after diagnosis. Even so, Olshan says, the reported study findings may underestimate the true effect of AO exposure on the risk of AM.
Given the rarity of AM, the association (if causal) would translate to 0.4 to 0.8 new annual cases of AM per 1,000,000 veterans, according to the study. Narrowed down to Vietnam War-era veterans—who are dwindling in number—the attributable cases would be scarce.
Nevertheless, the search for a better understanding of a potential link between AOE and melanomas among Vietnam War-era veterans is important, Olshan wrote.
“The Hwang et al study provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community.”
Recent research has revealed potential links between Agent Orange (AO) exposure and risk of acral melanoma (AM) among Vietnam War-era veterans, providing strong evidence of a relationship between the chemical and this type of cancer.
Localized to the palms, soles, and nail units, AM is a melanoma subtype less associated with UV radiation. From 1962 to 1971, the US military sprayed an estimated 18 million gallons of herbicides, including AO, over the fields and forests of Vietnam. Those herbicides have since been connected to numerous health issues, including cancer, though evidence of a relationship between AO and skin cancers has been weak.
Vietnam War-era veterans have a higher melanoma burden than the general population, with the disease being the fourth-most common cancer among those who served. AM, however, is rare, representing about 2% to 3% of all melanomas.
In a nested case-control study, Hwang et al used US Department of Veterans Affairs (VA) health care system data, including the VA Cancer Registry. The authors compared 1292 patients with AM and 2 pair-matched control groups: a group matched 4:1 to nonacral cutaneous melanoma controls, and a group without a melanoma diagnosis.
Hwang et al found AO exposure was associated with increased odds of AM compared with each control group. In an accompanying editorial, Andrew Olshan, PhD, from Department of Epidemiology at the University of North Carolina Gillings School of Global Public Health, wrote, “The magnitude of the effects was modest (about 30%) but noteworthy.”
A limitation of the study was that presumptive AOE status was based on whether the veteran filed a disability claim with evidence of officially recognized service in a period and place where Agent Orange was used—not on an assessment of the veteran’s individual AOE potential, including level of exposure. Because melanoma has never been included on the VA list of cancers presumed to be related to AO exposure, veterans do not automatically gain benefits by filing AOE claims after diagnosis. Even so, Olshan says, the reported study findings may underestimate the true effect of AO exposure on the risk of AM.
Given the rarity of AM, the association (if causal) would translate to 0.4 to 0.8 new annual cases of AM per 1,000,000 veterans, according to the study. Narrowed down to Vietnam War-era veterans—who are dwindling in number—the attributable cases would be scarce.
Nevertheless, the search for a better understanding of a potential link between AOE and melanomas among Vietnam War-era veterans is important, Olshan wrote.
“The Hwang et al study provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community.”
AVAHO Regional Meeting Addresses Complex World of Peripheral T-Cell Lymphoma
AVAHO Regional Meeting Addresses Complex World of Peripheral T-Cell Lymphoma
SAN FRANCISCO – Peripheral T-cell lymphoma (PTCL) accounts for 4% of mature non-Hodgkin lymphoma cases in the US, or only about 4000 cases a year. While the number of patients is small, however, treatment for PTCL is complex due to wide variations in subtypes and survival rates, a hematologist-oncologist said at the March 21 Association of VA Hematology/Oncology (AVAHO) regional meeting on lymphoma.
Weiyun Ai, MD, PhD, a clinical professor of medicine at University of California, San Francisco who specializes in lymphoma, explained that there are multiple subtypes of PTCL based on their location within the body. Ai discussed a 2008 analysis of North American cases of PTCL and natural killer/T-cell lymphoma from 1990-2002, of which:
34% were PTCL, not otherwise specified;
16% were angioimmunoblastic T-cell lymphoma (AITL);
16% were anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase (ALK)-positive;
7.8% were ALCL, ALK-negative;
5.8% were enteropathy-type;
5.4% were primary cutaneous ALCL; and
5.1% were extranodal natural killer/T-cell lymphoma, nasal type.
The remaining cases were adult T-cell leukemia/lymphoma, hepatosplenic, subcutaneous panniculitis-like, and unclassified.
International Prognostic Index Predicts Outcomes
“The subtype with the best outcome is ALCL, ALK-positive with a 5-year overall survival rate of 70% followed by ALK-negative ALCL at 50%, and all the other common subtypes at 30%,” Ai said.
Ai outlined the International Prognostic Index (IPI), a tool to predict clinical outcomes in patients with aggressive non-Hodgkin lymphoma based on risk factors. IPI assigns worse scores to patients aged > 60 years; patients who have higher (worse) performance scores, higher lactate dehydrogenase (LDH) levels, and more extranodal sites; and patients at stages III-IV.
First-Line Therapy: Consider Subtypes and CD30 Levels
Subtypes and CD30 expression levels are important factors in choosing therapy, Ai said, and 2019’s landmark ECHELON-2 study (updated in 2022) defines the standard.
Newly diagnosed patients who strongly express CD30 (ie, those with both types of ALCL) are recommended to be treated with A+CHP (brentuximab vedotin [BV] plus cyclophosphamide, doxorubicin, and prednisone).
Combination therapy of cyclophosphamide, doxorubicin, hydroxydaunorubicin, vincristine, and prednisone (CHOP) was the prior standard of care until the ECHELON-2 study, Ai said.
That trial, which randomized 452 patients with untreated PTCL (CD30 ≥ 10%) to A+CHP or CHOP, found that 5-year progression-free rates were 51.4% vs 43.0%, respectively (hazard ratio [HR], 0.70; 95% CI, 0.53-0.91). Five-year overall survival rates were 70.1% vs. 61.0%, respectively (HR, 0.72; 95% CI, 0.53-0.99).
The threshold CD30 level at which to turn to A+CHP—1%, 5%, or 10%—“is kind of a dealer’s choice,” Ai said. Her own cutoff is 1%.
“If they're < 1%, I tend not to do it,” Ai said. “It's usually much more expensive, as you can imagine.”
If CD30 < 1%, Ai recommends CHOP or, in younger patients, CHOP plus etoposide (CHOEP).
Follow-up treatments include autologous stem cell transplant (ASCT) and observation/maintenance, depending on factors such as subtype, fitness, and remission.
Transplant: Still Relevant
When ECHELON-2 was released, some clinicians wondered if ASCT was still warranted, Ai said. A posthoc exploratory analysis found a 62% reduction in relative risk for progression in patients who underwent transplants after reaching complete remission with A+CHP.
The findings provide support for transplant, she said.
For transplant-ineligible patients, a small analysis of BV and CHP followed by BV maintenance showed a progression-free survival curve that appeared to plateau after 18-24 months.
“You don't see this kind of curve very often. I was quite impressed,” Ai said. “If the patient is willing and able, I will give them BV cycles.”
Ai discloses relationships with ADC, AbbVie, Acrotech, Kite, and Kyowa Kirin.
SAN FRANCISCO – Peripheral T-cell lymphoma (PTCL) accounts for 4% of mature non-Hodgkin lymphoma cases in the US, or only about 4000 cases a year. While the number of patients is small, however, treatment for PTCL is complex due to wide variations in subtypes and survival rates, a hematologist-oncologist said at the March 21 Association of VA Hematology/Oncology (AVAHO) regional meeting on lymphoma.
Weiyun Ai, MD, PhD, a clinical professor of medicine at University of California, San Francisco who specializes in lymphoma, explained that there are multiple subtypes of PTCL based on their location within the body. Ai discussed a 2008 analysis of North American cases of PTCL and natural killer/T-cell lymphoma from 1990-2002, of which:
34% were PTCL, not otherwise specified;
16% were angioimmunoblastic T-cell lymphoma (AITL);
16% were anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase (ALK)-positive;
7.8% were ALCL, ALK-negative;
5.8% were enteropathy-type;
5.4% were primary cutaneous ALCL; and
5.1% were extranodal natural killer/T-cell lymphoma, nasal type.
The remaining cases were adult T-cell leukemia/lymphoma, hepatosplenic, subcutaneous panniculitis-like, and unclassified.
International Prognostic Index Predicts Outcomes
“The subtype with the best outcome is ALCL, ALK-positive with a 5-year overall survival rate of 70% followed by ALK-negative ALCL at 50%, and all the other common subtypes at 30%,” Ai said.
Ai outlined the International Prognostic Index (IPI), a tool to predict clinical outcomes in patients with aggressive non-Hodgkin lymphoma based on risk factors. IPI assigns worse scores to patients aged > 60 years; patients who have higher (worse) performance scores, higher lactate dehydrogenase (LDH) levels, and more extranodal sites; and patients at stages III-IV.
First-Line Therapy: Consider Subtypes and CD30 Levels
Subtypes and CD30 expression levels are important factors in choosing therapy, Ai said, and 2019’s landmark ECHELON-2 study (updated in 2022) defines the standard.
Newly diagnosed patients who strongly express CD30 (ie, those with both types of ALCL) are recommended to be treated with A+CHP (brentuximab vedotin [BV] plus cyclophosphamide, doxorubicin, and prednisone).
Combination therapy of cyclophosphamide, doxorubicin, hydroxydaunorubicin, vincristine, and prednisone (CHOP) was the prior standard of care until the ECHELON-2 study, Ai said.
That trial, which randomized 452 patients with untreated PTCL (CD30 ≥ 10%) to A+CHP or CHOP, found that 5-year progression-free rates were 51.4% vs 43.0%, respectively (hazard ratio [HR], 0.70; 95% CI, 0.53-0.91). Five-year overall survival rates were 70.1% vs. 61.0%, respectively (HR, 0.72; 95% CI, 0.53-0.99).
The threshold CD30 level at which to turn to A+CHP—1%, 5%, or 10%—“is kind of a dealer’s choice,” Ai said. Her own cutoff is 1%.
“If they're < 1%, I tend not to do it,” Ai said. “It's usually much more expensive, as you can imagine.”
If CD30 < 1%, Ai recommends CHOP or, in younger patients, CHOP plus etoposide (CHOEP).
Follow-up treatments include autologous stem cell transplant (ASCT) and observation/maintenance, depending on factors such as subtype, fitness, and remission.
Transplant: Still Relevant
When ECHELON-2 was released, some clinicians wondered if ASCT was still warranted, Ai said. A posthoc exploratory analysis found a 62% reduction in relative risk for progression in patients who underwent transplants after reaching complete remission with A+CHP.
The findings provide support for transplant, she said.
For transplant-ineligible patients, a small analysis of BV and CHP followed by BV maintenance showed a progression-free survival curve that appeared to plateau after 18-24 months.
“You don't see this kind of curve very often. I was quite impressed,” Ai said. “If the patient is willing and able, I will give them BV cycles.”
Ai discloses relationships with ADC, AbbVie, Acrotech, Kite, and Kyowa Kirin.
SAN FRANCISCO – Peripheral T-cell lymphoma (PTCL) accounts for 4% of mature non-Hodgkin lymphoma cases in the US, or only about 4000 cases a year. While the number of patients is small, however, treatment for PTCL is complex due to wide variations in subtypes and survival rates, a hematologist-oncologist said at the March 21 Association of VA Hematology/Oncology (AVAHO) regional meeting on lymphoma.
Weiyun Ai, MD, PhD, a clinical professor of medicine at University of California, San Francisco who specializes in lymphoma, explained that there are multiple subtypes of PTCL based on their location within the body. Ai discussed a 2008 analysis of North American cases of PTCL and natural killer/T-cell lymphoma from 1990-2002, of which:
34% were PTCL, not otherwise specified;
16% were angioimmunoblastic T-cell lymphoma (AITL);
16% were anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase (ALK)-positive;
7.8% were ALCL, ALK-negative;
5.8% were enteropathy-type;
5.4% were primary cutaneous ALCL; and
5.1% were extranodal natural killer/T-cell lymphoma, nasal type.
The remaining cases were adult T-cell leukemia/lymphoma, hepatosplenic, subcutaneous panniculitis-like, and unclassified.
International Prognostic Index Predicts Outcomes
“The subtype with the best outcome is ALCL, ALK-positive with a 5-year overall survival rate of 70% followed by ALK-negative ALCL at 50%, and all the other common subtypes at 30%,” Ai said.
Ai outlined the International Prognostic Index (IPI), a tool to predict clinical outcomes in patients with aggressive non-Hodgkin lymphoma based on risk factors. IPI assigns worse scores to patients aged > 60 years; patients who have higher (worse) performance scores, higher lactate dehydrogenase (LDH) levels, and more extranodal sites; and patients at stages III-IV.
First-Line Therapy: Consider Subtypes and CD30 Levels
Subtypes and CD30 expression levels are important factors in choosing therapy, Ai said, and 2019’s landmark ECHELON-2 study (updated in 2022) defines the standard.
Newly diagnosed patients who strongly express CD30 (ie, those with both types of ALCL) are recommended to be treated with A+CHP (brentuximab vedotin [BV] plus cyclophosphamide, doxorubicin, and prednisone).
Combination therapy of cyclophosphamide, doxorubicin, hydroxydaunorubicin, vincristine, and prednisone (CHOP) was the prior standard of care until the ECHELON-2 study, Ai said.
That trial, which randomized 452 patients with untreated PTCL (CD30 ≥ 10%) to A+CHP or CHOP, found that 5-year progression-free rates were 51.4% vs 43.0%, respectively (hazard ratio [HR], 0.70; 95% CI, 0.53-0.91). Five-year overall survival rates were 70.1% vs. 61.0%, respectively (HR, 0.72; 95% CI, 0.53-0.99).
The threshold CD30 level at which to turn to A+CHP—1%, 5%, or 10%—“is kind of a dealer’s choice,” Ai said. Her own cutoff is 1%.
“If they're < 1%, I tend not to do it,” Ai said. “It's usually much more expensive, as you can imagine.”
If CD30 < 1%, Ai recommends CHOP or, in younger patients, CHOP plus etoposide (CHOEP).
Follow-up treatments include autologous stem cell transplant (ASCT) and observation/maintenance, depending on factors such as subtype, fitness, and remission.
Transplant: Still Relevant
When ECHELON-2 was released, some clinicians wondered if ASCT was still warranted, Ai said. A posthoc exploratory analysis found a 62% reduction in relative risk for progression in patients who underwent transplants after reaching complete remission with A+CHP.
The findings provide support for transplant, she said.
For transplant-ineligible patients, a small analysis of BV and CHP followed by BV maintenance showed a progression-free survival curve that appeared to plateau after 18-24 months.
“You don't see this kind of curve very often. I was quite impressed,” Ai said. “If the patient is willing and able, I will give them BV cycles.”
Ai discloses relationships with ADC, AbbVie, Acrotech, Kite, and Kyowa Kirin.
AVAHO Regional Meeting Addresses Complex World of Peripheral T-Cell Lymphoma
AVAHO Regional Meeting Addresses Complex World of Peripheral T-Cell Lymphoma
VHA CRC Screening Has Blind Spots, Disparities
TOPLINE:
More than 1 in 8 colorectal cancer (CRC) cases among veterans occur outside the standard screening age of 50-75 years or those with high-risk personal or family history. High-risk patients face > 6 times the risk for CRC compared with average-risk patients aged 50-75 years who are up to date with screening, while Black patients have > 50% higher risk compared with White patients.
METHODOLOGY:
Researchers conducted a case-control analysis using Veterans Health Administration (VHA) Corporate Data Warehouse data from 2012-2018 at 2 sites: Veterans Affairs (VA) New York Harbor Health Care System and VA Puget Sound Health Care System.
Participants included 3714 cases among veterans with CRC matched to 14,856 controls (4:1), with matching on age (± 3 years), sex, and facility site; each control was used once.
Screening categories included 5 groups by age (50-75 years vs < 50 years or > 75 years), screening up-to-date status, and high-risk status (inflammatory bowel disease, hereditary cancer syndromes, or family history).
CRC screening was considered up to date if US Preventive Services Task Force-recommended tests were completed on time (colonoscopy ≤ 10 years; guaiac-based fecal occult blood test or fecal immunochemical test ≤ 1 year).
TAKEAWAY:
Compared with category 1 (age 50-75 years and up-to-date with screening), CRC was associated with category 4 (age < 50 years or > 75 years and not up to date) (odds ratio [OR], 1.40; 95% CI, 1.11-1.78), and category 5 (high risk) (OR, 6.23; 95% CI, 5.06-7.66).
Race and comorbidity associations included higher CRC risk for Black vs White patients (OR, 1.54; 95% CI, 1.37-1.73), and higher CRC risk with diabetes (OR, 1.65; 95% CI, 1.51-1.81) and alcohol use disorder (OR, 1.53; 95% CI, 1.35-1.73).
Among 3714 CRC cases, 71.1% occurred in individuals aged 50-75 years not up to date with screening.
A total of 12.5% of CRC cases occurred in people outside age 50-75 or with high-risk personal or family history, suggesting that conventional screening-adherence metrics may miss a clinically relevant minority.
IN PRACTICE:
“The conventional measure of CRC screening, focused on average-risk individuals aged 50 to 75, does not reflect screening status in an important minority of CRC patients," the authors wrote.
SOURCE:
The study was led by researchers at NYU Grossman School of Medicine and Veterans Affairs New York Harbor Health Care System, and published online July 9, 2026 in Medicine.
LIMITATIONS:
The study population consisted predominantly of male veterans (97.1%), who tend to be older and have more comorbidities compared with the US population, which may limit the generalizability of findings to other populations. Researchers defined screening status cross-sectionally relative to a single point in time rather than assessing longitudinal screening adherence, which may not fully capture the consistency of screening over time that is likely important for defining CRC risk. Veterans may receive screening at non-VA medical facilities, potentially leading to incomplete documentation of screening status and important covariates such as race, ethnicity, and comorbidities. The possibility of residual confounding cannot be excluded despite adjustment for multiple risk factors in the analysis.
DISCLOSURES:
This study received support from NIH grant K08 CA230162 and the AGA Caroline Craig Augustyn & Damian Augustyn Award in Digestive Cancer, both awarded to Peter S. Liang. Liang disclosed receiving research support from Freenome and serving on the advisory boards for Guardant Health and Natera. The remaining authors reported no funding or conflicts of interest to disclose.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
More than 1 in 8 colorectal cancer (CRC) cases among veterans occur outside the standard screening age of 50-75 years or those with high-risk personal or family history. High-risk patients face > 6 times the risk for CRC compared with average-risk patients aged 50-75 years who are up to date with screening, while Black patients have > 50% higher risk compared with White patients.
METHODOLOGY:
Researchers conducted a case-control analysis using Veterans Health Administration (VHA) Corporate Data Warehouse data from 2012-2018 at 2 sites: Veterans Affairs (VA) New York Harbor Health Care System and VA Puget Sound Health Care System.
Participants included 3714 cases among veterans with CRC matched to 14,856 controls (4:1), with matching on age (± 3 years), sex, and facility site; each control was used once.
Screening categories included 5 groups by age (50-75 years vs < 50 years or > 75 years), screening up-to-date status, and high-risk status (inflammatory bowel disease, hereditary cancer syndromes, or family history).
CRC screening was considered up to date if US Preventive Services Task Force-recommended tests were completed on time (colonoscopy ≤ 10 years; guaiac-based fecal occult blood test or fecal immunochemical test ≤ 1 year).
TAKEAWAY:
Compared with category 1 (age 50-75 years and up-to-date with screening), CRC was associated with category 4 (age < 50 years or > 75 years and not up to date) (odds ratio [OR], 1.40; 95% CI, 1.11-1.78), and category 5 (high risk) (OR, 6.23; 95% CI, 5.06-7.66).
Race and comorbidity associations included higher CRC risk for Black vs White patients (OR, 1.54; 95% CI, 1.37-1.73), and higher CRC risk with diabetes (OR, 1.65; 95% CI, 1.51-1.81) and alcohol use disorder (OR, 1.53; 95% CI, 1.35-1.73).
Among 3714 CRC cases, 71.1% occurred in individuals aged 50-75 years not up to date with screening.
A total of 12.5% of CRC cases occurred in people outside age 50-75 or with high-risk personal or family history, suggesting that conventional screening-adherence metrics may miss a clinically relevant minority.
IN PRACTICE:
“The conventional measure of CRC screening, focused on average-risk individuals aged 50 to 75, does not reflect screening status in an important minority of CRC patients," the authors wrote.
SOURCE:
The study was led by researchers at NYU Grossman School of Medicine and Veterans Affairs New York Harbor Health Care System, and published online July 9, 2026 in Medicine.
LIMITATIONS:
The study population consisted predominantly of male veterans (97.1%), who tend to be older and have more comorbidities compared with the US population, which may limit the generalizability of findings to other populations. Researchers defined screening status cross-sectionally relative to a single point in time rather than assessing longitudinal screening adherence, which may not fully capture the consistency of screening over time that is likely important for defining CRC risk. Veterans may receive screening at non-VA medical facilities, potentially leading to incomplete documentation of screening status and important covariates such as race, ethnicity, and comorbidities. The possibility of residual confounding cannot be excluded despite adjustment for multiple risk factors in the analysis.
DISCLOSURES:
This study received support from NIH grant K08 CA230162 and the AGA Caroline Craig Augustyn & Damian Augustyn Award in Digestive Cancer, both awarded to Peter S. Liang. Liang disclosed receiving research support from Freenome and serving on the advisory boards for Guardant Health and Natera. The remaining authors reported no funding or conflicts of interest to disclose.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
More than 1 in 8 colorectal cancer (CRC) cases among veterans occur outside the standard screening age of 50-75 years or those with high-risk personal or family history. High-risk patients face > 6 times the risk for CRC compared with average-risk patients aged 50-75 years who are up to date with screening, while Black patients have > 50% higher risk compared with White patients.
METHODOLOGY:
Researchers conducted a case-control analysis using Veterans Health Administration (VHA) Corporate Data Warehouse data from 2012-2018 at 2 sites: Veterans Affairs (VA) New York Harbor Health Care System and VA Puget Sound Health Care System.
Participants included 3714 cases among veterans with CRC matched to 14,856 controls (4:1), with matching on age (± 3 years), sex, and facility site; each control was used once.
Screening categories included 5 groups by age (50-75 years vs < 50 years or > 75 years), screening up-to-date status, and high-risk status (inflammatory bowel disease, hereditary cancer syndromes, or family history).
CRC screening was considered up to date if US Preventive Services Task Force-recommended tests were completed on time (colonoscopy ≤ 10 years; guaiac-based fecal occult blood test or fecal immunochemical test ≤ 1 year).
TAKEAWAY:
Compared with category 1 (age 50-75 years and up-to-date with screening), CRC was associated with category 4 (age < 50 years or > 75 years and not up to date) (odds ratio [OR], 1.40; 95% CI, 1.11-1.78), and category 5 (high risk) (OR, 6.23; 95% CI, 5.06-7.66).
Race and comorbidity associations included higher CRC risk for Black vs White patients (OR, 1.54; 95% CI, 1.37-1.73), and higher CRC risk with diabetes (OR, 1.65; 95% CI, 1.51-1.81) and alcohol use disorder (OR, 1.53; 95% CI, 1.35-1.73).
Among 3714 CRC cases, 71.1% occurred in individuals aged 50-75 years not up to date with screening.
A total of 12.5% of CRC cases occurred in people outside age 50-75 or with high-risk personal or family history, suggesting that conventional screening-adherence metrics may miss a clinically relevant minority.
IN PRACTICE:
“The conventional measure of CRC screening, focused on average-risk individuals aged 50 to 75, does not reflect screening status in an important minority of CRC patients," the authors wrote.
SOURCE:
The study was led by researchers at NYU Grossman School of Medicine and Veterans Affairs New York Harbor Health Care System, and published online July 9, 2026 in Medicine.
LIMITATIONS:
The study population consisted predominantly of male veterans (97.1%), who tend to be older and have more comorbidities compared with the US population, which may limit the generalizability of findings to other populations. Researchers defined screening status cross-sectionally relative to a single point in time rather than assessing longitudinal screening adherence, which may not fully capture the consistency of screening over time that is likely important for defining CRC risk. Veterans may receive screening at non-VA medical facilities, potentially leading to incomplete documentation of screening status and important covariates such as race, ethnicity, and comorbidities. The possibility of residual confounding cannot be excluded despite adjustment for multiple risk factors in the analysis.
DISCLOSURES:
This study received support from NIH grant K08 CA230162 and the AGA Caroline Craig Augustyn & Damian Augustyn Award in Digestive Cancer, both awarded to Peter S. Liang. Liang disclosed receiving research support from Freenome and serving on the advisory boards for Guardant Health and Natera. The remaining authors reported no funding or conflicts of interest to disclose.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Hidradenitis Suppurativa Associated With Elevated Risks for Multiple Cancer Types
Hidradenitis Suppurativa Associated With Elevated Risks for Multiple Cancer Types
TOPLINE:
In a meta-analysis, patients with hidradenitis suppurativa (HS) faced a more than 80% higher risk for cancer overall than the general population, with particularly elevated risks for gastrointestinal, head and neck, hematologic, and respiratory system cancers.
METHODOLOGY:
- Researchers conducted a meta-analysis including 11 studies from PubMed, Embase, and Web of Science databases published between 2001 and 2024; these studies examined the risk for cancer in patients with HS compared with that in the general population.
- These studies included 624,721 patients diagnosed with HS (mean age, 33.6-43.8 years) and 393,691,636 control individuals from the general population.
- Researchers performed an inverse variance-weighted random-effects analysis to calculate pooled odds ratios (ORs) for cancer overall and specific cancer subtypes.
- Cancer types were categorized into 11 groups for subgroup analysis: bone and soft tissue cancers, breast cancer, central nervous system cancers, endocrine-related cancers, gastrointestinal cancers, head and neck cancers, hematologic cancers, respiratory system cancers, skin cancers, urogenital cancers, and unspecified cancers.
TAKEAWAY:
- Patients with HS demonstrated a significantly higher risk for cancer overall than control individuals (crude OR, 1.82; P = .018).
- Patients with HS showed an increased risk for gastrointestinal cancers (crude OR, 1.61; P = .0002), head and neck cancers (crude OR, 2.41; P = .00001), hematologic cancers (crude OR, 1.71; P = .00005), and respiratory system cancers (crude OR, 1.81; P = .04).
- Patients with HS demonstrated significantly elevated risks for both Hodgkin lymphoma (OR, 2.44; P = .0001) and non-Hodgkin lymphoma (OR, 1.15; P = .012).
- A non-significant increased risk for skin cancer was observed in patients with HS (crude OR, 1.48; P = .08). No increased risks for bone and soft tissue cancers, central nervous system cancers, breast cancer, or urogenital cancers were observed in patients with HS.
IN PRACTICE:
"HS was associated with an increased overall risk of cancer, including several specific subtypes, compared with controls," the authors wrote, suggesting that "studies are adjusting for confounders and assess long-term associations between HS and cancer risk are highly needed to investigate which factors contribute to this cancer risk."
SOURCE:
This study was led by Daniel Isufi, Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. It was published online on March 11, 2026, in Dermatology and Therapy.
LIMITATIONS:
Limited data on cancer subtypes hindered meta-analyses of rare cancers, and the lack of reporting on anti‑inflammatory treatment and disease severity prevented subgroup analyses. Most studies originated from North America, introducing potential geographic bias. No study reported BMI, and ethnicity was poorly documented. Only few studies adjusted for key confounders (smoking, obesity, and alcohol intake), limiting the determination of whether the increased risk for cancer was due to HS itself or shared lifestyle and metabolic factors.
DISCLOSURES:
This study did not receive any funding or sponsorship. Two authors reported receiving research grant funding from the LEO Foundation and having other ties with various other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
In a meta-analysis, patients with hidradenitis suppurativa (HS) faced a more than 80% higher risk for cancer overall than the general population, with particularly elevated risks for gastrointestinal, head and neck, hematologic, and respiratory system cancers.
METHODOLOGY:
- Researchers conducted a meta-analysis including 11 studies from PubMed, Embase, and Web of Science databases published between 2001 and 2024; these studies examined the risk for cancer in patients with HS compared with that in the general population.
- These studies included 624,721 patients diagnosed with HS (mean age, 33.6-43.8 years) and 393,691,636 control individuals from the general population.
- Researchers performed an inverse variance-weighted random-effects analysis to calculate pooled odds ratios (ORs) for cancer overall and specific cancer subtypes.
- Cancer types were categorized into 11 groups for subgroup analysis: bone and soft tissue cancers, breast cancer, central nervous system cancers, endocrine-related cancers, gastrointestinal cancers, head and neck cancers, hematologic cancers, respiratory system cancers, skin cancers, urogenital cancers, and unspecified cancers.
TAKEAWAY:
- Patients with HS demonstrated a significantly higher risk for cancer overall than control individuals (crude OR, 1.82; P = .018).
- Patients with HS showed an increased risk for gastrointestinal cancers (crude OR, 1.61; P = .0002), head and neck cancers (crude OR, 2.41; P = .00001), hematologic cancers (crude OR, 1.71; P = .00005), and respiratory system cancers (crude OR, 1.81; P = .04).
- Patients with HS demonstrated significantly elevated risks for both Hodgkin lymphoma (OR, 2.44; P = .0001) and non-Hodgkin lymphoma (OR, 1.15; P = .012).
- A non-significant increased risk for skin cancer was observed in patients with HS (crude OR, 1.48; P = .08). No increased risks for bone and soft tissue cancers, central nervous system cancers, breast cancer, or urogenital cancers were observed in patients with HS.
IN PRACTICE:
"HS was associated with an increased overall risk of cancer, including several specific subtypes, compared with controls," the authors wrote, suggesting that "studies are adjusting for confounders and assess long-term associations between HS and cancer risk are highly needed to investigate which factors contribute to this cancer risk."
SOURCE:
This study was led by Daniel Isufi, Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. It was published online on March 11, 2026, in Dermatology and Therapy.
LIMITATIONS:
Limited data on cancer subtypes hindered meta-analyses of rare cancers, and the lack of reporting on anti‑inflammatory treatment and disease severity prevented subgroup analyses. Most studies originated from North America, introducing potential geographic bias. No study reported BMI, and ethnicity was poorly documented. Only few studies adjusted for key confounders (smoking, obesity, and alcohol intake), limiting the determination of whether the increased risk for cancer was due to HS itself or shared lifestyle and metabolic factors.
DISCLOSURES:
This study did not receive any funding or sponsorship. Two authors reported receiving research grant funding from the LEO Foundation and having other ties with various other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
In a meta-analysis, patients with hidradenitis suppurativa (HS) faced a more than 80% higher risk for cancer overall than the general population, with particularly elevated risks for gastrointestinal, head and neck, hematologic, and respiratory system cancers.
METHODOLOGY:
- Researchers conducted a meta-analysis including 11 studies from PubMed, Embase, and Web of Science databases published between 2001 and 2024; these studies examined the risk for cancer in patients with HS compared with that in the general population.
- These studies included 624,721 patients diagnosed with HS (mean age, 33.6-43.8 years) and 393,691,636 control individuals from the general population.
- Researchers performed an inverse variance-weighted random-effects analysis to calculate pooled odds ratios (ORs) for cancer overall and specific cancer subtypes.
- Cancer types were categorized into 11 groups for subgroup analysis: bone and soft tissue cancers, breast cancer, central nervous system cancers, endocrine-related cancers, gastrointestinal cancers, head and neck cancers, hematologic cancers, respiratory system cancers, skin cancers, urogenital cancers, and unspecified cancers.
TAKEAWAY:
- Patients with HS demonstrated a significantly higher risk for cancer overall than control individuals (crude OR, 1.82; P = .018).
- Patients with HS showed an increased risk for gastrointestinal cancers (crude OR, 1.61; P = .0002), head and neck cancers (crude OR, 2.41; P = .00001), hematologic cancers (crude OR, 1.71; P = .00005), and respiratory system cancers (crude OR, 1.81; P = .04).
- Patients with HS demonstrated significantly elevated risks for both Hodgkin lymphoma (OR, 2.44; P = .0001) and non-Hodgkin lymphoma (OR, 1.15; P = .012).
- A non-significant increased risk for skin cancer was observed in patients with HS (crude OR, 1.48; P = .08). No increased risks for bone and soft tissue cancers, central nervous system cancers, breast cancer, or urogenital cancers were observed in patients with HS.
IN PRACTICE:
"HS was associated with an increased overall risk of cancer, including several specific subtypes, compared with controls," the authors wrote, suggesting that "studies are adjusting for confounders and assess long-term associations between HS and cancer risk are highly needed to investigate which factors contribute to this cancer risk."
SOURCE:
This study was led by Daniel Isufi, Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. It was published online on March 11, 2026, in Dermatology and Therapy.
LIMITATIONS:
Limited data on cancer subtypes hindered meta-analyses of rare cancers, and the lack of reporting on anti‑inflammatory treatment and disease severity prevented subgroup analyses. Most studies originated from North America, introducing potential geographic bias. No study reported BMI, and ethnicity was poorly documented. Only few studies adjusted for key confounders (smoking, obesity, and alcohol intake), limiting the determination of whether the increased risk for cancer was due to HS itself or shared lifestyle and metabolic factors.
DISCLOSURES:
This study did not receive any funding or sponsorship. Two authors reported receiving research grant funding from the LEO Foundation and having other ties with various other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Hidradenitis Suppurativa Associated With Elevated Risks for Multiple Cancer Types
Hidradenitis Suppurativa Associated With Elevated Risks for Multiple Cancer Types