User login
Implementation of an Interdisciplinary Precision Oncology Program at the Madison VA
Background
The William S. Middleton Memorial Veterans Hospital (Madison VA) prioritized the goal of ensuring patients with cancer are receiving guideline-based precision oncology care, including comprehensive genomic profiling (CGP) and germline genomics consultation based on evidence-based medicine and the VA Clinical Pathways. A local Precision Oncology Program was created to assist in review of CGP results including documentation in the electronic medical record (EMR) and recommendations for treatment or additional testing as appropriate. The program, which began in February 2024, focused on patients with prostate cancer initially. This was expanded to all genitourinary cancers in April 2024, non-small cell lung cancers (NSCLC) in August 2024, and all cancers in Dec 2024.
Results
Since the implementation of the Madison VA Precision Oncology Program, CGP was reviewed for 73 unique Veterans leading to 281 recommendations including: 25 FDA approved therapies, 2 off-label standard of care treatment options, 11 patients with potential clinical trial eligibility at the Madison VA. Forty-eight patients had no actionable mutations and 44 were recommended for additional germline genetics counseling. For patients with metastatic prostate cancer, after 1 year of program implementation, an increase was seen in the percentage of patients receiving guideline-based CGP, the percentage of actionable alterations identified, and the percentage of patients identified as potentially eligible for a clinical trial open at the Madison VA based on CGP. The percentage of patients with an interfacility consult to the Clinical Cancer Genetics Service was also increased. For patients with metastatic NSCLC, after 6 months of program implementation, an increase was seen in the percentage of patients appropriately receiving CGP, the percentage of actionable alterations identified, and the percentage of patients on targeted therapy. In all cases where an actionable alteration was not being targeted, the treatment option was not yet appropriate for the stage of disease.
Conclusions
The implementation of preemptive review of all CGP results at the Madison VA through the Precision Oncology Program has increased uptake and awareness of CGP results and potential treatment options, improving the access of targeted treatments and clinical trial opportunities for Veterans with cancer.
Background
The William S. Middleton Memorial Veterans Hospital (Madison VA) prioritized the goal of ensuring patients with cancer are receiving guideline-based precision oncology care, including comprehensive genomic profiling (CGP) and germline genomics consultation based on evidence-based medicine and the VA Clinical Pathways. A local Precision Oncology Program was created to assist in review of CGP results including documentation in the electronic medical record (EMR) and recommendations for treatment or additional testing as appropriate. The program, which began in February 2024, focused on patients with prostate cancer initially. This was expanded to all genitourinary cancers in April 2024, non-small cell lung cancers (NSCLC) in August 2024, and all cancers in Dec 2024.
Results
Since the implementation of the Madison VA Precision Oncology Program, CGP was reviewed for 73 unique Veterans leading to 281 recommendations including: 25 FDA approved therapies, 2 off-label standard of care treatment options, 11 patients with potential clinical trial eligibility at the Madison VA. Forty-eight patients had no actionable mutations and 44 were recommended for additional germline genetics counseling. For patients with metastatic prostate cancer, after 1 year of program implementation, an increase was seen in the percentage of patients receiving guideline-based CGP, the percentage of actionable alterations identified, and the percentage of patients identified as potentially eligible for a clinical trial open at the Madison VA based on CGP. The percentage of patients with an interfacility consult to the Clinical Cancer Genetics Service was also increased. For patients with metastatic NSCLC, after 6 months of program implementation, an increase was seen in the percentage of patients appropriately receiving CGP, the percentage of actionable alterations identified, and the percentage of patients on targeted therapy. In all cases where an actionable alteration was not being targeted, the treatment option was not yet appropriate for the stage of disease.
Conclusions
The implementation of preemptive review of all CGP results at the Madison VA through the Precision Oncology Program has increased uptake and awareness of CGP results and potential treatment options, improving the access of targeted treatments and clinical trial opportunities for Veterans with cancer.
Background
The William S. Middleton Memorial Veterans Hospital (Madison VA) prioritized the goal of ensuring patients with cancer are receiving guideline-based precision oncology care, including comprehensive genomic profiling (CGP) and germline genomics consultation based on evidence-based medicine and the VA Clinical Pathways. A local Precision Oncology Program was created to assist in review of CGP results including documentation in the electronic medical record (EMR) and recommendations for treatment or additional testing as appropriate. The program, which began in February 2024, focused on patients with prostate cancer initially. This was expanded to all genitourinary cancers in April 2024, non-small cell lung cancers (NSCLC) in August 2024, and all cancers in Dec 2024.
Results
Since the implementation of the Madison VA Precision Oncology Program, CGP was reviewed for 73 unique Veterans leading to 281 recommendations including: 25 FDA approved therapies, 2 off-label standard of care treatment options, 11 patients with potential clinical trial eligibility at the Madison VA. Forty-eight patients had no actionable mutations and 44 were recommended for additional germline genetics counseling. For patients with metastatic prostate cancer, after 1 year of program implementation, an increase was seen in the percentage of patients receiving guideline-based CGP, the percentage of actionable alterations identified, and the percentage of patients identified as potentially eligible for a clinical trial open at the Madison VA based on CGP. The percentage of patients with an interfacility consult to the Clinical Cancer Genetics Service was also increased. For patients with metastatic NSCLC, after 6 months of program implementation, an increase was seen in the percentage of patients appropriately receiving CGP, the percentage of actionable alterations identified, and the percentage of patients on targeted therapy. In all cases where an actionable alteration was not being targeted, the treatment option was not yet appropriate for the stage of disease.
Conclusions
The implementation of preemptive review of all CGP results at the Madison VA through the Precision Oncology Program has increased uptake and awareness of CGP results and potential treatment options, improving the access of targeted treatments and clinical trial opportunities for Veterans with cancer.
Successful and Sustainable Implementation of a VA Cancer Survivorship Clinic
Background
There are an estimated 18 million cancer survivors in the US with unique needs including specific surveillance imaging, testing for recurrence, monitoring for and managing late effects of cancer treatments, and for second malignancies. Survivorship care is an unmet need in most VAHC. Purpose: Assess implementation outcomes of a Survivorship Clinic.
Methods
A Survivorship Clinic was initiated comprising of a Survivorship APRN and Nurse Navigator. A referral process and workflow were created. Medical and Radiation Oncology providers were educated regarding availability of survivorship services. We describe the results of the Survivorship Clinic 2021-2025 including demographics, diagnoses and referral patterns.
Results
1,332 visits were completed for 424 patients. 2021 (Oct-Dec): 21, 2022: 219, 2023: 424, 2024: 508, 2025 (Jan-Mar): 160. 364 men and 60 women. Cancer diagnoses seen: lung: 108, lymphoma: 62, colorectal: 52, breast: 45, head and neck: 40, melanoma: 28, NET: 23, testicular: 13, bladder: 13, esophageal: 10, renal: 7, sarcomas: 7, anal: 6, HCC: 6, hepatobiliary: 6, gastric/GIST: 5, leukemia: 5, pancreatic: 5, prostate: 5, Merkel cell: 3, SCC: 3, thymus: 3, uterine: 2, 1 each appendix, anaplastic astrocytoma, periosteal carcinoma, poorly differentiated basaloid chest wall carcinoma, and small intestine. For symptom management the following referrals were placed: Rehab (all departments) : 71, Psychology/Whole Health/THRIVE: 52, Gastroenterology: 43, Nutrition: 24, Dermatology: 20, Urology, ED: 16, Pulmonology: 15, Plastic Surgery: 15, ENT: 12, LIVESTRONG YMCA: 10, Genetics: 9, General Surgery: 4, Neurology: 4, Breast Clinic: 3, Dental: 3, Neurosurgery: 2, Ophthalmology: 2, Pain Management: 2, Radiation Oncology: 2, Wound Care: 2, Pharmacy: 1, and Rheumatology: 1. Survivorship care plans were created and provided to all patients.
Conclusions
Since 2021, the Cancer Survivorship Clinic, operated by an APRN, has successfully served 424 cancer survivors encompassing a wide range of cancers. The disproportionately low number of prostate cancer survivors referred may be reflective of their care being managed by Urology, and presents an opportunity for future growth.
Implications for VA
Having a Survivorship Clinic provides cancer survivors specialized services and meets their unique needs; at the same allowing for improved capacity for new active cancer referrals for the Oncology Clinics.
Background
There are an estimated 18 million cancer survivors in the US with unique needs including specific surveillance imaging, testing for recurrence, monitoring for and managing late effects of cancer treatments, and for second malignancies. Survivorship care is an unmet need in most VAHC. Purpose: Assess implementation outcomes of a Survivorship Clinic.
Methods
A Survivorship Clinic was initiated comprising of a Survivorship APRN and Nurse Navigator. A referral process and workflow were created. Medical and Radiation Oncology providers were educated regarding availability of survivorship services. We describe the results of the Survivorship Clinic 2021-2025 including demographics, diagnoses and referral patterns.
Results
1,332 visits were completed for 424 patients. 2021 (Oct-Dec): 21, 2022: 219, 2023: 424, 2024: 508, 2025 (Jan-Mar): 160. 364 men and 60 women. Cancer diagnoses seen: lung: 108, lymphoma: 62, colorectal: 52, breast: 45, head and neck: 40, melanoma: 28, NET: 23, testicular: 13, bladder: 13, esophageal: 10, renal: 7, sarcomas: 7, anal: 6, HCC: 6, hepatobiliary: 6, gastric/GIST: 5, leukemia: 5, pancreatic: 5, prostate: 5, Merkel cell: 3, SCC: 3, thymus: 3, uterine: 2, 1 each appendix, anaplastic astrocytoma, periosteal carcinoma, poorly differentiated basaloid chest wall carcinoma, and small intestine. For symptom management the following referrals were placed: Rehab (all departments) : 71, Psychology/Whole Health/THRIVE: 52, Gastroenterology: 43, Nutrition: 24, Dermatology: 20, Urology, ED: 16, Pulmonology: 15, Plastic Surgery: 15, ENT: 12, LIVESTRONG YMCA: 10, Genetics: 9, General Surgery: 4, Neurology: 4, Breast Clinic: 3, Dental: 3, Neurosurgery: 2, Ophthalmology: 2, Pain Management: 2, Radiation Oncology: 2, Wound Care: 2, Pharmacy: 1, and Rheumatology: 1. Survivorship care plans were created and provided to all patients.
Conclusions
Since 2021, the Cancer Survivorship Clinic, operated by an APRN, has successfully served 424 cancer survivors encompassing a wide range of cancers. The disproportionately low number of prostate cancer survivors referred may be reflective of their care being managed by Urology, and presents an opportunity for future growth.
Implications for VA
Having a Survivorship Clinic provides cancer survivors specialized services and meets their unique needs; at the same allowing for improved capacity for new active cancer referrals for the Oncology Clinics.
Background
There are an estimated 18 million cancer survivors in the US with unique needs including specific surveillance imaging, testing for recurrence, monitoring for and managing late effects of cancer treatments, and for second malignancies. Survivorship care is an unmet need in most VAHC. Purpose: Assess implementation outcomes of a Survivorship Clinic.
Methods
A Survivorship Clinic was initiated comprising of a Survivorship APRN and Nurse Navigator. A referral process and workflow were created. Medical and Radiation Oncology providers were educated regarding availability of survivorship services. We describe the results of the Survivorship Clinic 2021-2025 including demographics, diagnoses and referral patterns.
Results
1,332 visits were completed for 424 patients. 2021 (Oct-Dec): 21, 2022: 219, 2023: 424, 2024: 508, 2025 (Jan-Mar): 160. 364 men and 60 women. Cancer diagnoses seen: lung: 108, lymphoma: 62, colorectal: 52, breast: 45, head and neck: 40, melanoma: 28, NET: 23, testicular: 13, bladder: 13, esophageal: 10, renal: 7, sarcomas: 7, anal: 6, HCC: 6, hepatobiliary: 6, gastric/GIST: 5, leukemia: 5, pancreatic: 5, prostate: 5, Merkel cell: 3, SCC: 3, thymus: 3, uterine: 2, 1 each appendix, anaplastic astrocytoma, periosteal carcinoma, poorly differentiated basaloid chest wall carcinoma, and small intestine. For symptom management the following referrals were placed: Rehab (all departments) : 71, Psychology/Whole Health/THRIVE: 52, Gastroenterology: 43, Nutrition: 24, Dermatology: 20, Urology, ED: 16, Pulmonology: 15, Plastic Surgery: 15, ENT: 12, LIVESTRONG YMCA: 10, Genetics: 9, General Surgery: 4, Neurology: 4, Breast Clinic: 3, Dental: 3, Neurosurgery: 2, Ophthalmology: 2, Pain Management: 2, Radiation Oncology: 2, Wound Care: 2, Pharmacy: 1, and Rheumatology: 1. Survivorship care plans were created and provided to all patients.
Conclusions
Since 2021, the Cancer Survivorship Clinic, operated by an APRN, has successfully served 424 cancer survivors encompassing a wide range of cancers. The disproportionately low number of prostate cancer survivors referred may be reflective of their care being managed by Urology, and presents an opportunity for future growth.
Implications for VA
Having a Survivorship Clinic provides cancer survivors specialized services and meets their unique needs; at the same allowing for improved capacity for new active cancer referrals for the Oncology Clinics.
ACES Act to Study Cancer in Aviators Is Now Law
A bipartisan bill establishing research directives aimed at revealing cancer risks among military aviators and aircrews recently became law.
Spearheaded by Sen. Mark Kelly (D-AZ) and Sen. Tom Cotton (R-AR), as well as Rep. August Pfluger (R-TX-11) and Rep. Jimmy Panetta (D-CA-19), all of whom are veterans, the Aviator Cancer Examination Study (ACES) Act was signed into law on August 14. The ACES Act will address cancer rates among Army, Navy, Air Force, and Marine Corps aircrew members by directing the Secretary of the US Department of Veterans Affairs to study cancer incidence and mortality rates among these populations.
Military aviators and aircrews face a 15% to 24% higher rate of cancer compared with the general US population, including a 75% higher rate of melanoma, 31% higher rate of thyroid cancer, 20% higher rate of prostate cancer, and 11% higher rate of female breast cancer, with potential links to non-Hodgkin lymphoma and testicular cancer. These individuals are also diagnosed earlier in life, at the median age of 55 years compared with 67 years. However, further investigation is still needed to understand why.
“By better understanding the correlation between aviator service and cancer, we can better assist our military and provide more adequate care for our veterans,” Kelly said.
Some reasons for the higher rates of cancer in aviators seem clear, such as the association between dioxin exposure and cancer. In a study of cancer incidence and mortality in Air Force veterans of the Vietnam War, incidence of melanoma and prostate cancer was increased among White veterans who sprayed herbicides during Operation Ranch Hand. The risk of cancer at any site, prostate cancer, and melanoma was increased in the highest dioxin exposure category among veterans who spent ≤ 2 years in Southeast Asia.
However, some links between these veterans and increased cancer rates are less clear. In a review of 28 studies (including 18 studies in military settings), slight evidence was found for associations between jet fuel exposure and various outcomes including cancer. Cosmic ionizing radiation (CIR) exposure is another possible cause. Several epidemiological studies have documented elevated incidence and mortality for several cancers in flight crews, but a link between them and CIR exposure has not been established.
Certain occupations have been associated with increased risk of testicular germ cell tumors, including aircraft maintenance, military pilots, fighter pilots, and aircrews. Those associations led to hypotheses that job-related chemical exposures (eg, per- and polyfluoroalkyl substances, solvents, paints, hydrocarbons in degreasing/lubricating agents, lubricating oils) may increase risk. A study of young active-duty Air Force servicemen found that pilots and men with aircraft maintenance jobs had elevated tenosynovial giant cell tumor risk, but indicates that further research is needed to “elucidate specific occupational exposures underlying these associations.”
“As a former Navy pilot, there are certain risks that we know and accept come with our service, but we know far less about the health risks that are affecting many aviators and aircrews years later,” Kelly said in a statement. “Veteran aviators and aircrews deserve answers about the correlation between their job and cancer risks so we can reduce those risks for future pilots. Getting this across the finish line has been a bipartisan effort from the start, and I’m proud to see this bill become law so we can deliver real answers and accountability for those who served.”
“The ACES Act is now the law of the land,” Cotton added. “We owe it to past, present, and future aviators in the armed forces to study the prevalence of cancer among this group of veterans.”
The ACES Act complements Kelly’s bipartisan Counting Veterans’ Cancer Act, which requires Veterans Health Administration facilities to share cancer data with state cancer registries, thereby guaranteeing their inclusion in the national registries. Key provisions of the Counting Veterans’ Cancer Act were included in the first government funding package of fiscal year 2024.
A bipartisan bill establishing research directives aimed at revealing cancer risks among military aviators and aircrews recently became law.
Spearheaded by Sen. Mark Kelly (D-AZ) and Sen. Tom Cotton (R-AR), as well as Rep. August Pfluger (R-TX-11) and Rep. Jimmy Panetta (D-CA-19), all of whom are veterans, the Aviator Cancer Examination Study (ACES) Act was signed into law on August 14. The ACES Act will address cancer rates among Army, Navy, Air Force, and Marine Corps aircrew members by directing the Secretary of the US Department of Veterans Affairs to study cancer incidence and mortality rates among these populations.
Military aviators and aircrews face a 15% to 24% higher rate of cancer compared with the general US population, including a 75% higher rate of melanoma, 31% higher rate of thyroid cancer, 20% higher rate of prostate cancer, and 11% higher rate of female breast cancer, with potential links to non-Hodgkin lymphoma and testicular cancer. These individuals are also diagnosed earlier in life, at the median age of 55 years compared with 67 years. However, further investigation is still needed to understand why.
“By better understanding the correlation between aviator service and cancer, we can better assist our military and provide more adequate care for our veterans,” Kelly said.
Some reasons for the higher rates of cancer in aviators seem clear, such as the association between dioxin exposure and cancer. In a study of cancer incidence and mortality in Air Force veterans of the Vietnam War, incidence of melanoma and prostate cancer was increased among White veterans who sprayed herbicides during Operation Ranch Hand. The risk of cancer at any site, prostate cancer, and melanoma was increased in the highest dioxin exposure category among veterans who spent ≤ 2 years in Southeast Asia.
However, some links between these veterans and increased cancer rates are less clear. In a review of 28 studies (including 18 studies in military settings), slight evidence was found for associations between jet fuel exposure and various outcomes including cancer. Cosmic ionizing radiation (CIR) exposure is another possible cause. Several epidemiological studies have documented elevated incidence and mortality for several cancers in flight crews, but a link between them and CIR exposure has not been established.
Certain occupations have been associated with increased risk of testicular germ cell tumors, including aircraft maintenance, military pilots, fighter pilots, and aircrews. Those associations led to hypotheses that job-related chemical exposures (eg, per- and polyfluoroalkyl substances, solvents, paints, hydrocarbons in degreasing/lubricating agents, lubricating oils) may increase risk. A study of young active-duty Air Force servicemen found that pilots and men with aircraft maintenance jobs had elevated tenosynovial giant cell tumor risk, but indicates that further research is needed to “elucidate specific occupational exposures underlying these associations.”
“As a former Navy pilot, there are certain risks that we know and accept come with our service, but we know far less about the health risks that are affecting many aviators and aircrews years later,” Kelly said in a statement. “Veteran aviators and aircrews deserve answers about the correlation between their job and cancer risks so we can reduce those risks for future pilots. Getting this across the finish line has been a bipartisan effort from the start, and I’m proud to see this bill become law so we can deliver real answers and accountability for those who served.”
“The ACES Act is now the law of the land,” Cotton added. “We owe it to past, present, and future aviators in the armed forces to study the prevalence of cancer among this group of veterans.”
The ACES Act complements Kelly’s bipartisan Counting Veterans’ Cancer Act, which requires Veterans Health Administration facilities to share cancer data with state cancer registries, thereby guaranteeing their inclusion in the national registries. Key provisions of the Counting Veterans’ Cancer Act were included in the first government funding package of fiscal year 2024.
A bipartisan bill establishing research directives aimed at revealing cancer risks among military aviators and aircrews recently became law.
Spearheaded by Sen. Mark Kelly (D-AZ) and Sen. Tom Cotton (R-AR), as well as Rep. August Pfluger (R-TX-11) and Rep. Jimmy Panetta (D-CA-19), all of whom are veterans, the Aviator Cancer Examination Study (ACES) Act was signed into law on August 14. The ACES Act will address cancer rates among Army, Navy, Air Force, and Marine Corps aircrew members by directing the Secretary of the US Department of Veterans Affairs to study cancer incidence and mortality rates among these populations.
Military aviators and aircrews face a 15% to 24% higher rate of cancer compared with the general US population, including a 75% higher rate of melanoma, 31% higher rate of thyroid cancer, 20% higher rate of prostate cancer, and 11% higher rate of female breast cancer, with potential links to non-Hodgkin lymphoma and testicular cancer. These individuals are also diagnosed earlier in life, at the median age of 55 years compared with 67 years. However, further investigation is still needed to understand why.
“By better understanding the correlation between aviator service and cancer, we can better assist our military and provide more adequate care for our veterans,” Kelly said.
Some reasons for the higher rates of cancer in aviators seem clear, such as the association between dioxin exposure and cancer. In a study of cancer incidence and mortality in Air Force veterans of the Vietnam War, incidence of melanoma and prostate cancer was increased among White veterans who sprayed herbicides during Operation Ranch Hand. The risk of cancer at any site, prostate cancer, and melanoma was increased in the highest dioxin exposure category among veterans who spent ≤ 2 years in Southeast Asia.
However, some links between these veterans and increased cancer rates are less clear. In a review of 28 studies (including 18 studies in military settings), slight evidence was found for associations between jet fuel exposure and various outcomes including cancer. Cosmic ionizing radiation (CIR) exposure is another possible cause. Several epidemiological studies have documented elevated incidence and mortality for several cancers in flight crews, but a link between them and CIR exposure has not been established.
Certain occupations have been associated with increased risk of testicular germ cell tumors, including aircraft maintenance, military pilots, fighter pilots, and aircrews. Those associations led to hypotheses that job-related chemical exposures (eg, per- and polyfluoroalkyl substances, solvents, paints, hydrocarbons in degreasing/lubricating agents, lubricating oils) may increase risk. A study of young active-duty Air Force servicemen found that pilots and men with aircraft maintenance jobs had elevated tenosynovial giant cell tumor risk, but indicates that further research is needed to “elucidate specific occupational exposures underlying these associations.”
“As a former Navy pilot, there are certain risks that we know and accept come with our service, but we know far less about the health risks that are affecting many aviators and aircrews years later,” Kelly said in a statement. “Veteran aviators and aircrews deserve answers about the correlation between their job and cancer risks so we can reduce those risks for future pilots. Getting this across the finish line has been a bipartisan effort from the start, and I’m proud to see this bill become law so we can deliver real answers and accountability for those who served.”
“The ACES Act is now the law of the land,” Cotton added. “We owe it to past, present, and future aviators in the armed forces to study the prevalence of cancer among this group of veterans.”
The ACES Act complements Kelly’s bipartisan Counting Veterans’ Cancer Act, which requires Veterans Health Administration facilities to share cancer data with state cancer registries, thereby guaranteeing their inclusion in the national registries. Key provisions of the Counting Veterans’ Cancer Act were included in the first government funding package of fiscal year 2024.
Can Popular Weight-Loss Drugs Protect Against Obesity-Related Cancers?
Can Popular Weight-Loss Drugs Protect Against Obesity-Related Cancers?
New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.
In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.
This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.
Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.
'Intriguing Hypothesis'
Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.
About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.
To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.
Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.
Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.
During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).
When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).
“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.
Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.
“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.
During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).
Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.
Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).
Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”
Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.
In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.
Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”
This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.
A version of this article first appeared on Medscape.com.
New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.
In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.
This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.
Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.
'Intriguing Hypothesis'
Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.
About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.
To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.
Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.
Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.
During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).
When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).
“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.
Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.
“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.
During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).
Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.
Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).
Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”
Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.
In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.
Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”
This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.
A version of this article first appeared on Medscape.com.
New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.
In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.
This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.
Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.
'Intriguing Hypothesis'
Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.
About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.
To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.
Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.
Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.
During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).
When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).
“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.
Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.
“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.
During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).
Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.
Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).
Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”
Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.
In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.
Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”
This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.
A version of this article first appeared on Medscape.com.
Can Popular Weight-Loss Drugs Protect Against Obesity-Related Cancers?
Can Popular Weight-Loss Drugs Protect Against Obesity-Related Cancers?
Can Lifestyle Changes Save Lives in Colon Cancer?
Can Lifestyle Changes Save Lives in Colon Cancer?
Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.
“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.
Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.
The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.
The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.
“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.
Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.
It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.
Exercise and Survival
Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.
“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.
Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.
Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.
Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).
As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.
The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.
Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO2 max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.
Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.
In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.
Overall survival results were “even more impressive,” he said.
At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).
“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.
“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.
Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.
It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.
Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.
Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.
“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.
Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.
“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.
“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.
Diet and Survival
Diet can also affect outcomes in patients with colon cancer.
In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.
Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.
Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.
As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.
During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.
However, higher intake of proinflammatory foods was associated with significantly worse overall survival.
Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.
Combine Exercise and Diet for Best Results
To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.
In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).
Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.
Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”
Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”
The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.
“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.
Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.
The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.
The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.
“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.
Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.
It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.
Exercise and Survival
Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.
“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.
Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.
Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.
Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).
As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.
The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.
Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO2 max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.
Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.
In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.
Overall survival results were “even more impressive,” he said.
At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).
“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.
“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.
Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.
It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.
Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.
Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.
“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.
Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.
“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.
“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.
Diet and Survival
Diet can also affect outcomes in patients with colon cancer.
In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.
Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.
Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.
As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.
During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.
However, higher intake of proinflammatory foods was associated with significantly worse overall survival.
Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.
Combine Exercise and Diet for Best Results
To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.
In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).
Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.
Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”
Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”
The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.
In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.
“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.
Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.
The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.
The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.
“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.
Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.
It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.
Exercise and Survival
Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.
“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.
Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.
Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.
Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).
As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.
The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.
Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO2 max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.
Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.
In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.
Overall survival results were “even more impressive,” he said.
At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).
“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.
“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.
Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.
It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.
Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.
Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.
“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.
Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.
“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.
“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.
Diet and Survival
Diet can also affect outcomes in patients with colon cancer.
In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.
Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.
Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.
As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.
During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.
However, higher intake of proinflammatory foods was associated with significantly worse overall survival.
Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.
Combine Exercise and Diet for Best Results
To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.
In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).
Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.
Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”
Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”
The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Can Lifestyle Changes Save Lives in Colon Cancer?
Can Lifestyle Changes Save Lives in Colon Cancer?
Do PFAs Cause Kidney Cancer? VA to Investigate
The US Department of Veterans Affairs (VA) will conduct a scientific assessment to find out in whether kidney cancer should be considered a presumptive service-connected condition for veterans exposed to per- and polyfluoroalkyl substances (PFAs). This assessment is the first step in the VA presumptive condition investigative process, which could allow exposed veterans who were exposed to PFAs during their service to access more VA services.
A class of more than 12,000 chemicals, PFAs have been used in the military since the early 1970s in many items, including military-grade firefighting foam. Studies have already suggested links between the so-called forever chemicals and cancer, particularly kidney cancer.
The US Department of Defense (DoD) is assessing contamination at hundreds of sites, while the National Defense Authorization Act in Fiscal Year 2020 mandated that DoD stop using those foams starting in October and remove all stocks from active and former installations and equipment. That may not happen until next year, though, because the DoD has requested a waiver through October 2025 and may extend it through 2026.
When a condition is considered presumptive, eligible veterans do not need to prove their service caused their disease to receive benefits. As part of the Biden Administration’s efforts to expand benefits and services for toxin-exposed veterans and their families, the VA expedited health care and benefits eligibility under the PACT Act by several years—including extending presumptions for head cancer, neck cancer, gastrointestinal cancer, reproductive cancer, lymphoma, pancreatic cancer, kidney cancer, melanoma, and hypertension for Vietnam era veterans. The VA has also extended presumptions for > 300 new conditions, most recently for male breast cancer, urethral cancer, and cancer of the paraurethral glands.
Whether a condition is an established presumptive condition or not, the VA will consider claims on a case-by-case basis and can grant disability compensation benefits if sufficient evidence of service connection is found. “[M]ake no mistake: Veterans should not wait for the outcome of this review to apply for the benefits and care they deserve,” VA Secretary Denis McDonough said in a release. “If you’re a veteran and believe your military service has negatively impacted your health, we encourage you to apply for VA care and benefits today.”
The public has 30 days to comment on the proposed scientific assessment between PFAs exposure and kidney cancer via the Federal Register. The VA is set to host a listening session on Nov. 19, 2024, to allow individuals to share research and input. Interested individuals may register to participate. The public may also comment via either forum on other conditions that would benefit from review for potential service-connection.
The US Department of Veterans Affairs (VA) will conduct a scientific assessment to find out in whether kidney cancer should be considered a presumptive service-connected condition for veterans exposed to per- and polyfluoroalkyl substances (PFAs). This assessment is the first step in the VA presumptive condition investigative process, which could allow exposed veterans who were exposed to PFAs during their service to access more VA services.
A class of more than 12,000 chemicals, PFAs have been used in the military since the early 1970s in many items, including military-grade firefighting foam. Studies have already suggested links between the so-called forever chemicals and cancer, particularly kidney cancer.
The US Department of Defense (DoD) is assessing contamination at hundreds of sites, while the National Defense Authorization Act in Fiscal Year 2020 mandated that DoD stop using those foams starting in October and remove all stocks from active and former installations and equipment. That may not happen until next year, though, because the DoD has requested a waiver through October 2025 and may extend it through 2026.
When a condition is considered presumptive, eligible veterans do not need to prove their service caused their disease to receive benefits. As part of the Biden Administration’s efforts to expand benefits and services for toxin-exposed veterans and their families, the VA expedited health care and benefits eligibility under the PACT Act by several years—including extending presumptions for head cancer, neck cancer, gastrointestinal cancer, reproductive cancer, lymphoma, pancreatic cancer, kidney cancer, melanoma, and hypertension for Vietnam era veterans. The VA has also extended presumptions for > 300 new conditions, most recently for male breast cancer, urethral cancer, and cancer of the paraurethral glands.
Whether a condition is an established presumptive condition or not, the VA will consider claims on a case-by-case basis and can grant disability compensation benefits if sufficient evidence of service connection is found. “[M]ake no mistake: Veterans should not wait for the outcome of this review to apply for the benefits and care they deserve,” VA Secretary Denis McDonough said in a release. “If you’re a veteran and believe your military service has negatively impacted your health, we encourage you to apply for VA care and benefits today.”
The public has 30 days to comment on the proposed scientific assessment between PFAs exposure and kidney cancer via the Federal Register. The VA is set to host a listening session on Nov. 19, 2024, to allow individuals to share research and input. Interested individuals may register to participate. The public may also comment via either forum on other conditions that would benefit from review for potential service-connection.
The US Department of Veterans Affairs (VA) will conduct a scientific assessment to find out in whether kidney cancer should be considered a presumptive service-connected condition for veterans exposed to per- and polyfluoroalkyl substances (PFAs). This assessment is the first step in the VA presumptive condition investigative process, which could allow exposed veterans who were exposed to PFAs during their service to access more VA services.
A class of more than 12,000 chemicals, PFAs have been used in the military since the early 1970s in many items, including military-grade firefighting foam. Studies have already suggested links between the so-called forever chemicals and cancer, particularly kidney cancer.
The US Department of Defense (DoD) is assessing contamination at hundreds of sites, while the National Defense Authorization Act in Fiscal Year 2020 mandated that DoD stop using those foams starting in October and remove all stocks from active and former installations and equipment. That may not happen until next year, though, because the DoD has requested a waiver through October 2025 and may extend it through 2026.
When a condition is considered presumptive, eligible veterans do not need to prove their service caused their disease to receive benefits. As part of the Biden Administration’s efforts to expand benefits and services for toxin-exposed veterans and their families, the VA expedited health care and benefits eligibility under the PACT Act by several years—including extending presumptions for head cancer, neck cancer, gastrointestinal cancer, reproductive cancer, lymphoma, pancreatic cancer, kidney cancer, melanoma, and hypertension for Vietnam era veterans. The VA has also extended presumptions for > 300 new conditions, most recently for male breast cancer, urethral cancer, and cancer of the paraurethral glands.
Whether a condition is an established presumptive condition or not, the VA will consider claims on a case-by-case basis and can grant disability compensation benefits if sufficient evidence of service connection is found. “[M]ake no mistake: Veterans should not wait for the outcome of this review to apply for the benefits and care they deserve,” VA Secretary Denis McDonough said in a release. “If you’re a veteran and believe your military service has negatively impacted your health, we encourage you to apply for VA care and benefits today.”
The public has 30 days to comment on the proposed scientific assessment between PFAs exposure and kidney cancer via the Federal Register. The VA is set to host a listening session on Nov. 19, 2024, to allow individuals to share research and input. Interested individuals may register to participate. The public may also comment via either forum on other conditions that would benefit from review for potential service-connection.
Facial Angioedema, Rash, and “Mastitis” in a 31-Year-Old Female
A previously healthy 31-year-old female active-duty Navy sailor working as a calibration technician developed a painful, erythematous, pruritic, indurated plaque on her left breast. The sailor was not lactating and had no known family history of malignancy. Initially, she was treated by her primary care practitioner for presumed mastitis with oral cephalexin and then with oral clindamycin with no symptom improvement. About 2 weeks after the completion of both antibiotic courses, she developed angioedema and periorbital edema (Figure 1), requiring highdose corticosteroids and antihistamines with a corticosteroid course of prednisone 40 mg daily tapered to 10 mg daily over 12 days and diphenhydramine 25 mg to use up to 4 times daily. Workup for both was acquired and hereditary angioedema was unremarkable. Two months later, the patient developed patches of alopecia, oral ulcerations, and hypopigmented plaques with a peripheral hyperpigmented rim on the central face and bilateral conchal bowls (Figure 2). She also developed hypopigmented papules with peripheral hyperpigmentation on the bilateral dorsal hands overlying the metacarpal and proximal interphalangeal joints, which eventually ulcerated (Figure 3). Laboratory evaluation, including tests for creatine kinase, aldolase, transaminases, lactate dehydrogenase, and autoantibodies (antiJo-1, anti-Mi-2, anti-MDA-5, anti-TIF-1, anti-NXP-2, and anti-SAEP), were unremarkable. A punch biopsy from a papule on the right dorsal hand showed superficial perivascular lymphohistiocytic inflammation with a subtle focal increase in dermal mucin, highlighted by the colloidal iron stain. Further evaluation of the left breast plaque revealed ER/PR+ HER2- stage IIIB inflammatory breast cancer.
DISCUSSION
Based on the clinical presentation and diagnosis of inflammatory breast cancer, the patient was diagnosed with paraneoplastic clinically amyopathic dermatomyositis (CADM). She was treated for her breast cancer with an initial chemotherapy regimen consisting of dose-dense cyclophosphamide and doxorubicin followed by paclitaxel. The patient underwent a mastectomy, axillary lymph node dissection, and 25 sessions of radiation therapy, and is currently continuing therapy with anastrozole 1 mg daily and ovarian suppression with leuprorelin 11.25 mg every 3 months. For the severe angioedema and dermatomyositis-like cutaneous findings, the patient was continued on high-dose corticosteroids at prednisone 60 mg daily with a prolonged taper to prednisone 10 mg daily. After about 10 months, she transitioned from prednisone 10 mg daily to hydrocortisone 30 mg daily and is currently tapering her hydrocortisone dosing. She was additionally started on monthly intravenous immunoglobulin, hydroxychloroquine 300 mg daily, and amlodipine 5 mg daily. The ulcerated papules on her hands were treated with topical clobetasol 0.05% ointment applied daily, topical tacrolimus 0.1% ointment applied daily, and multiple intralesional triamcinolone 5 mg/mL injections. With this regimen, the patient experienced significant improvement in her cutaneous symptoms.
CADM is a rare autoimmune inflammatory disease featuring classic dermatomyositis-like cutaneous findings such as a heliotrope rash and Gottron papules. Ulcerative Gottron papules are less common than the typical erythematous papules and are associated more strongly with amyopathic disease.1 Paraneoplastic myositis poses a diagnostic challenge because it presents like an idiopathic dermatomyositis and often has a heterogeneous clinical presentation with additional manifestations, including periorbital edema, myalgias, dysphagia, and shortness of breath. If clinically suspected, laboratory tests (eg, creatine kinase, aldolase, transaminases, and lactate dehydrogenase) can assist in diagnosing paraneoplastic myositis. Additionally, serologic testing for autoantibodies such as anti-CADM-140, anti-Jo-1, anti-Mi-2, antiMDA-5, anti-TIF-1, anti-NXP-2, and antiSAE can assist the diagnosis and predict disease phenotype.1,2
Malignancy can precede, occur during, or develop after the diagnosis of CADM.3 Malignancies most often associated with CADM include ovarian, breast, and lung cancers.4 Despite the strong correlation with malignancy, there are currently no screening guidelines for malignancy upon inflammatory myositis diagnosis. Therefore, it is important to consider the entirety of a patient’s clinical presentation in establishing further evaluation in the initial diagnostic workup.
There are numerous systemic complications associated with inflammatory myositis and imaging modalities can help to rule out some of these conditions. CADM is strongly associated with the development of interstitial lung disease, so chest radiography and pulmonary function testing are often checked.1 Though cardiac and esophageal involvement are more commonly associated with classic dermatomyositis, it may be useful to obtain an electrocardiogram to rule out conduction abnormalities from myocardial involvement, along with esophageal manometry to evaluate for esophageal dysmotility.1,5
In the management of paraneoplastic CADM, the underlying malignancy should be treated first.6 If symptoms persist after the cancer is in remission, then CADM is treated with immunosuppressive medications such as methotrexate, mycophenolate mofetil, or azathioprine. Physical therapy can also provide further symptom relief for those suffering from proximal weakness.
CONCLUSIONS
Presumed mastitis, angioedema, and eczematous lesions for this patient were dermatologic manifestations of an underlying inflammatory breast cancer. This case highlights the importance of early recognition, the diagnosis of CADM and awareness of its association with underlying malignancy, especially within the primary care setting where most skin concerns are addressed. Early clinical suspicion and a swift diagnostic workup can further optimize multidisciplinary management, which is often required to treat malignancies.
- Cao H, Xia Q, Pan M, et al. Gottron papules and gottron sign with ulceration: a distinctive cutaneous feature in a subset of patients with classic dermatomyositis and clinically amyopathic dermatomyositis. J Rheumatol. 2016;43(9):1735-1742. doi:10.3899/jrheum.160024
- Satoh M, Tanaka S, Ceribelli A, Calise SJ, Chan EK. A comprehensive overview on myositis-specific antibodies: new and old biomarkers in idiopathic inflammatory myopathy. Clin Rev Allergy Immunol. 2017;52(1):1-19. doi:10.1007/s12016-015-8510-y
- Zahr ZA, Baer AN. Malignancy in myositis. Curr Rheumatol Rep. 2011;13(3):208-215. doi:10.1007/s11926-011-0169-7
- Udkoff J, Cohen PR. Amyopathic dermatomyositis: a concise review of clinical manifestations and associated malignancies. Am J Clin Dermatol. 2016;17(5): 509-518. doi:10.1007/s40257-016-0199-z
- Fathi M, Lundberg IE, Tornling G. Pulmonary complications of polymyositis and dermatomyositis. Semin Respir Crit Care Med. 2007;28(4):451-458. doi:10.1055/s-2007-985666
- Hendren E, Vinik O, Faragalla H, Haq R. Breast cancer and dermatomyositis: a case study and literature review. Curr Oncol. 2017;24(5):e429-e433. doi:10.3747/co.24.3696
A previously healthy 31-year-old female active-duty Navy sailor working as a calibration technician developed a painful, erythematous, pruritic, indurated plaque on her left breast. The sailor was not lactating and had no known family history of malignancy. Initially, she was treated by her primary care practitioner for presumed mastitis with oral cephalexin and then with oral clindamycin with no symptom improvement. About 2 weeks after the completion of both antibiotic courses, she developed angioedema and periorbital edema (Figure 1), requiring highdose corticosteroids and antihistamines with a corticosteroid course of prednisone 40 mg daily tapered to 10 mg daily over 12 days and diphenhydramine 25 mg to use up to 4 times daily. Workup for both was acquired and hereditary angioedema was unremarkable. Two months later, the patient developed patches of alopecia, oral ulcerations, and hypopigmented plaques with a peripheral hyperpigmented rim on the central face and bilateral conchal bowls (Figure 2). She also developed hypopigmented papules with peripheral hyperpigmentation on the bilateral dorsal hands overlying the metacarpal and proximal interphalangeal joints, which eventually ulcerated (Figure 3). Laboratory evaluation, including tests for creatine kinase, aldolase, transaminases, lactate dehydrogenase, and autoantibodies (antiJo-1, anti-Mi-2, anti-MDA-5, anti-TIF-1, anti-NXP-2, and anti-SAEP), were unremarkable. A punch biopsy from a papule on the right dorsal hand showed superficial perivascular lymphohistiocytic inflammation with a subtle focal increase in dermal mucin, highlighted by the colloidal iron stain. Further evaluation of the left breast plaque revealed ER/PR+ HER2- stage IIIB inflammatory breast cancer.
DISCUSSION
Based on the clinical presentation and diagnosis of inflammatory breast cancer, the patient was diagnosed with paraneoplastic clinically amyopathic dermatomyositis (CADM). She was treated for her breast cancer with an initial chemotherapy regimen consisting of dose-dense cyclophosphamide and doxorubicin followed by paclitaxel. The patient underwent a mastectomy, axillary lymph node dissection, and 25 sessions of radiation therapy, and is currently continuing therapy with anastrozole 1 mg daily and ovarian suppression with leuprorelin 11.25 mg every 3 months. For the severe angioedema and dermatomyositis-like cutaneous findings, the patient was continued on high-dose corticosteroids at prednisone 60 mg daily with a prolonged taper to prednisone 10 mg daily. After about 10 months, she transitioned from prednisone 10 mg daily to hydrocortisone 30 mg daily and is currently tapering her hydrocortisone dosing. She was additionally started on monthly intravenous immunoglobulin, hydroxychloroquine 300 mg daily, and amlodipine 5 mg daily. The ulcerated papules on her hands were treated with topical clobetasol 0.05% ointment applied daily, topical tacrolimus 0.1% ointment applied daily, and multiple intralesional triamcinolone 5 mg/mL injections. With this regimen, the patient experienced significant improvement in her cutaneous symptoms.
CADM is a rare autoimmune inflammatory disease featuring classic dermatomyositis-like cutaneous findings such as a heliotrope rash and Gottron papules. Ulcerative Gottron papules are less common than the typical erythematous papules and are associated more strongly with amyopathic disease.1 Paraneoplastic myositis poses a diagnostic challenge because it presents like an idiopathic dermatomyositis and often has a heterogeneous clinical presentation with additional manifestations, including periorbital edema, myalgias, dysphagia, and shortness of breath. If clinically suspected, laboratory tests (eg, creatine kinase, aldolase, transaminases, and lactate dehydrogenase) can assist in diagnosing paraneoplastic myositis. Additionally, serologic testing for autoantibodies such as anti-CADM-140, anti-Jo-1, anti-Mi-2, antiMDA-5, anti-TIF-1, anti-NXP-2, and antiSAE can assist the diagnosis and predict disease phenotype.1,2
Malignancy can precede, occur during, or develop after the diagnosis of CADM.3 Malignancies most often associated with CADM include ovarian, breast, and lung cancers.4 Despite the strong correlation with malignancy, there are currently no screening guidelines for malignancy upon inflammatory myositis diagnosis. Therefore, it is important to consider the entirety of a patient’s clinical presentation in establishing further evaluation in the initial diagnostic workup.
There are numerous systemic complications associated with inflammatory myositis and imaging modalities can help to rule out some of these conditions. CADM is strongly associated with the development of interstitial lung disease, so chest radiography and pulmonary function testing are often checked.1 Though cardiac and esophageal involvement are more commonly associated with classic dermatomyositis, it may be useful to obtain an electrocardiogram to rule out conduction abnormalities from myocardial involvement, along with esophageal manometry to evaluate for esophageal dysmotility.1,5
In the management of paraneoplastic CADM, the underlying malignancy should be treated first.6 If symptoms persist after the cancer is in remission, then CADM is treated with immunosuppressive medications such as methotrexate, mycophenolate mofetil, or azathioprine. Physical therapy can also provide further symptom relief for those suffering from proximal weakness.
CONCLUSIONS
Presumed mastitis, angioedema, and eczematous lesions for this patient were dermatologic manifestations of an underlying inflammatory breast cancer. This case highlights the importance of early recognition, the diagnosis of CADM and awareness of its association with underlying malignancy, especially within the primary care setting where most skin concerns are addressed. Early clinical suspicion and a swift diagnostic workup can further optimize multidisciplinary management, which is often required to treat malignancies.
A previously healthy 31-year-old female active-duty Navy sailor working as a calibration technician developed a painful, erythematous, pruritic, indurated plaque on her left breast. The sailor was not lactating and had no known family history of malignancy. Initially, she was treated by her primary care practitioner for presumed mastitis with oral cephalexin and then with oral clindamycin with no symptom improvement. About 2 weeks after the completion of both antibiotic courses, she developed angioedema and periorbital edema (Figure 1), requiring highdose corticosteroids and antihistamines with a corticosteroid course of prednisone 40 mg daily tapered to 10 mg daily over 12 days and diphenhydramine 25 mg to use up to 4 times daily. Workup for both was acquired and hereditary angioedema was unremarkable. Two months later, the patient developed patches of alopecia, oral ulcerations, and hypopigmented plaques with a peripheral hyperpigmented rim on the central face and bilateral conchal bowls (Figure 2). She also developed hypopigmented papules with peripheral hyperpigmentation on the bilateral dorsal hands overlying the metacarpal and proximal interphalangeal joints, which eventually ulcerated (Figure 3). Laboratory evaluation, including tests for creatine kinase, aldolase, transaminases, lactate dehydrogenase, and autoantibodies (antiJo-1, anti-Mi-2, anti-MDA-5, anti-TIF-1, anti-NXP-2, and anti-SAEP), were unremarkable. A punch biopsy from a papule on the right dorsal hand showed superficial perivascular lymphohistiocytic inflammation with a subtle focal increase in dermal mucin, highlighted by the colloidal iron stain. Further evaluation of the left breast plaque revealed ER/PR+ HER2- stage IIIB inflammatory breast cancer.
DISCUSSION
Based on the clinical presentation and diagnosis of inflammatory breast cancer, the patient was diagnosed with paraneoplastic clinically amyopathic dermatomyositis (CADM). She was treated for her breast cancer with an initial chemotherapy regimen consisting of dose-dense cyclophosphamide and doxorubicin followed by paclitaxel. The patient underwent a mastectomy, axillary lymph node dissection, and 25 sessions of radiation therapy, and is currently continuing therapy with anastrozole 1 mg daily and ovarian suppression with leuprorelin 11.25 mg every 3 months. For the severe angioedema and dermatomyositis-like cutaneous findings, the patient was continued on high-dose corticosteroids at prednisone 60 mg daily with a prolonged taper to prednisone 10 mg daily. After about 10 months, she transitioned from prednisone 10 mg daily to hydrocortisone 30 mg daily and is currently tapering her hydrocortisone dosing. She was additionally started on monthly intravenous immunoglobulin, hydroxychloroquine 300 mg daily, and amlodipine 5 mg daily. The ulcerated papules on her hands were treated with topical clobetasol 0.05% ointment applied daily, topical tacrolimus 0.1% ointment applied daily, and multiple intralesional triamcinolone 5 mg/mL injections. With this regimen, the patient experienced significant improvement in her cutaneous symptoms.
CADM is a rare autoimmune inflammatory disease featuring classic dermatomyositis-like cutaneous findings such as a heliotrope rash and Gottron papules. Ulcerative Gottron papules are less common than the typical erythematous papules and are associated more strongly with amyopathic disease.1 Paraneoplastic myositis poses a diagnostic challenge because it presents like an idiopathic dermatomyositis and often has a heterogeneous clinical presentation with additional manifestations, including periorbital edema, myalgias, dysphagia, and shortness of breath. If clinically suspected, laboratory tests (eg, creatine kinase, aldolase, transaminases, and lactate dehydrogenase) can assist in diagnosing paraneoplastic myositis. Additionally, serologic testing for autoantibodies such as anti-CADM-140, anti-Jo-1, anti-Mi-2, antiMDA-5, anti-TIF-1, anti-NXP-2, and antiSAE can assist the diagnosis and predict disease phenotype.1,2
Malignancy can precede, occur during, or develop after the diagnosis of CADM.3 Malignancies most often associated with CADM include ovarian, breast, and lung cancers.4 Despite the strong correlation with malignancy, there are currently no screening guidelines for malignancy upon inflammatory myositis diagnosis. Therefore, it is important to consider the entirety of a patient’s clinical presentation in establishing further evaluation in the initial diagnostic workup.
There are numerous systemic complications associated with inflammatory myositis and imaging modalities can help to rule out some of these conditions. CADM is strongly associated with the development of interstitial lung disease, so chest radiography and pulmonary function testing are often checked.1 Though cardiac and esophageal involvement are more commonly associated with classic dermatomyositis, it may be useful to obtain an electrocardiogram to rule out conduction abnormalities from myocardial involvement, along with esophageal manometry to evaluate for esophageal dysmotility.1,5
In the management of paraneoplastic CADM, the underlying malignancy should be treated first.6 If symptoms persist after the cancer is in remission, then CADM is treated with immunosuppressive medications such as methotrexate, mycophenolate mofetil, or azathioprine. Physical therapy can also provide further symptom relief for those suffering from proximal weakness.
CONCLUSIONS
Presumed mastitis, angioedema, and eczematous lesions for this patient were dermatologic manifestations of an underlying inflammatory breast cancer. This case highlights the importance of early recognition, the diagnosis of CADM and awareness of its association with underlying malignancy, especially within the primary care setting where most skin concerns are addressed. Early clinical suspicion and a swift diagnostic workup can further optimize multidisciplinary management, which is often required to treat malignancies.
- Cao H, Xia Q, Pan M, et al. Gottron papules and gottron sign with ulceration: a distinctive cutaneous feature in a subset of patients with classic dermatomyositis and clinically amyopathic dermatomyositis. J Rheumatol. 2016;43(9):1735-1742. doi:10.3899/jrheum.160024
- Satoh M, Tanaka S, Ceribelli A, Calise SJ, Chan EK. A comprehensive overview on myositis-specific antibodies: new and old biomarkers in idiopathic inflammatory myopathy. Clin Rev Allergy Immunol. 2017;52(1):1-19. doi:10.1007/s12016-015-8510-y
- Zahr ZA, Baer AN. Malignancy in myositis. Curr Rheumatol Rep. 2011;13(3):208-215. doi:10.1007/s11926-011-0169-7
- Udkoff J, Cohen PR. Amyopathic dermatomyositis: a concise review of clinical manifestations and associated malignancies. Am J Clin Dermatol. 2016;17(5): 509-518. doi:10.1007/s40257-016-0199-z
- Fathi M, Lundberg IE, Tornling G. Pulmonary complications of polymyositis and dermatomyositis. Semin Respir Crit Care Med. 2007;28(4):451-458. doi:10.1055/s-2007-985666
- Hendren E, Vinik O, Faragalla H, Haq R. Breast cancer and dermatomyositis: a case study and literature review. Curr Oncol. 2017;24(5):e429-e433. doi:10.3747/co.24.3696
- Cao H, Xia Q, Pan M, et al. Gottron papules and gottron sign with ulceration: a distinctive cutaneous feature in a subset of patients with classic dermatomyositis and clinically amyopathic dermatomyositis. J Rheumatol. 2016;43(9):1735-1742. doi:10.3899/jrheum.160024
- Satoh M, Tanaka S, Ceribelli A, Calise SJ, Chan EK. A comprehensive overview on myositis-specific antibodies: new and old biomarkers in idiopathic inflammatory myopathy. Clin Rev Allergy Immunol. 2017;52(1):1-19. doi:10.1007/s12016-015-8510-y
- Zahr ZA, Baer AN. Malignancy in myositis. Curr Rheumatol Rep. 2011;13(3):208-215. doi:10.1007/s11926-011-0169-7
- Udkoff J, Cohen PR. Amyopathic dermatomyositis: a concise review of clinical manifestations and associated malignancies. Am J Clin Dermatol. 2016;17(5): 509-518. doi:10.1007/s40257-016-0199-z
- Fathi M, Lundberg IE, Tornling G. Pulmonary complications of polymyositis and dermatomyositis. Semin Respir Crit Care Med. 2007;28(4):451-458. doi:10.1055/s-2007-985666
- Hendren E, Vinik O, Faragalla H, Haq R. Breast cancer and dermatomyositis: a case study and literature review. Curr Oncol. 2017;24(5):e429-e433. doi:10.3747/co.24.3696
Implementation of a Prior Authorization Drug Review Process for Care in the Community Oncology Prescriptions
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
The OCTAGON Project: A Novel VA-Based Telehealth Intervention for Oral Chemotherapy Monitoring
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
How to Make Keeping Up With the Drugs as Easy as Keeping Up With the Kardashians: Implementing a Local Oncology Drug Review Committee
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.