User login
VA Cancer Clinical Trials as a Strategy for Increasing Accrual of Racial and Ethnic Underrepresented Groups
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Immunotherapy Experience in Nonagenarian Veterans with Cancer
Background
Immune checkpoint inhibitors [cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed cell death 1 receptor/ programmed death ligand-1 (PD1/ PD-L1)] have received broad FDA approval in most cancers. As clinical use of these agents proliferates, data for their efficacy and safety in elderly populations, particularly nonagenarians, is sparse [1]. Nonagenarians are commonly excluded from or underrepresented in clinical trials. This occurs despite the fact that the elderly embody the fastest growing portion of the population worldwide [2]. The purpose of this project was to describe the experience of treating veterans >/= 90 years of age with immune checkpoint inhibitors (IPI) for cancer.
Methods
We reviewed drug exposure in Nonagenarians who received IPI within the VA system nationwide between 2016-2017 using CAPRI. We identified 48 veterans and reviewed each patient’s treatment, duration of immunotherapy exposure, response, and toxicity to generate a global review on how those nonagenarians tolerated treatment. Demographic data of study participants and all endpoints have been analyzed using descriptive statistics.
Results
We obtained the record data for 48 veterans who received CPI in the VA health system between 2016 and 2017. Baseline characteristics revealed that the majority of patients (N=26) were ECOG 0-1 at the time of treatment initiation. The most commonly treated malignancies included melanoma (N=19) and NSCLC (N=15) with the majority of cancers being stage IV (N=42). The primary outcome measures are duration of therapy (average 12.2 cycles) and overall survival (average 1.59 years). The secondary outcome is adverse events, with a total rate of 27.1% and grade III/IV events occurring at a rate of 6.3%
Implications
These cases and data points illustrate that immunotherapy is being used in nonagenarians. With close monitoring of toxicities, nonagenarians with acceptable performance status can be treated with immunotherapy with their consent. Future aims will focus on the addition of more data points by expanding to include 2018.
References
1. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R,Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383–9. 2. Sgambato S, Casaluce F, Gridelli C. The role of checkpoint inhibitors immunotherapy in advanced non-small cell lung cancer in the elderly. Expert Opin Biol Ther. 2017;17(5):565-571.
Background
Immune checkpoint inhibitors [cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed cell death 1 receptor/ programmed death ligand-1 (PD1/ PD-L1)] have received broad FDA approval in most cancers. As clinical use of these agents proliferates, data for their efficacy and safety in elderly populations, particularly nonagenarians, is sparse [1]. Nonagenarians are commonly excluded from or underrepresented in clinical trials. This occurs despite the fact that the elderly embody the fastest growing portion of the population worldwide [2]. The purpose of this project was to describe the experience of treating veterans >/= 90 years of age with immune checkpoint inhibitors (IPI) for cancer.
Methods
We reviewed drug exposure in Nonagenarians who received IPI within the VA system nationwide between 2016-2017 using CAPRI. We identified 48 veterans and reviewed each patient’s treatment, duration of immunotherapy exposure, response, and toxicity to generate a global review on how those nonagenarians tolerated treatment. Demographic data of study participants and all endpoints have been analyzed using descriptive statistics.
Results
We obtained the record data for 48 veterans who received CPI in the VA health system between 2016 and 2017. Baseline characteristics revealed that the majority of patients (N=26) were ECOG 0-1 at the time of treatment initiation. The most commonly treated malignancies included melanoma (N=19) and NSCLC (N=15) with the majority of cancers being stage IV (N=42). The primary outcome measures are duration of therapy (average 12.2 cycles) and overall survival (average 1.59 years). The secondary outcome is adverse events, with a total rate of 27.1% and grade III/IV events occurring at a rate of 6.3%
Implications
These cases and data points illustrate that immunotherapy is being used in nonagenarians. With close monitoring of toxicities, nonagenarians with acceptable performance status can be treated with immunotherapy with their consent. Future aims will focus on the addition of more data points by expanding to include 2018.
References
1. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R,Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383–9. 2. Sgambato S, Casaluce F, Gridelli C. The role of checkpoint inhibitors immunotherapy in advanced non-small cell lung cancer in the elderly. Expert Opin Biol Ther. 2017;17(5):565-571.
Background
Immune checkpoint inhibitors [cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed cell death 1 receptor/ programmed death ligand-1 (PD1/ PD-L1)] have received broad FDA approval in most cancers. As clinical use of these agents proliferates, data for their efficacy and safety in elderly populations, particularly nonagenarians, is sparse [1]. Nonagenarians are commonly excluded from or underrepresented in clinical trials. This occurs despite the fact that the elderly embody the fastest growing portion of the population worldwide [2]. The purpose of this project was to describe the experience of treating veterans >/= 90 years of age with immune checkpoint inhibitors (IPI) for cancer.
Methods
We reviewed drug exposure in Nonagenarians who received IPI within the VA system nationwide between 2016-2017 using CAPRI. We identified 48 veterans and reviewed each patient’s treatment, duration of immunotherapy exposure, response, and toxicity to generate a global review on how those nonagenarians tolerated treatment. Demographic data of study participants and all endpoints have been analyzed using descriptive statistics.
Results
We obtained the record data for 48 veterans who received CPI in the VA health system between 2016 and 2017. Baseline characteristics revealed that the majority of patients (N=26) were ECOG 0-1 at the time of treatment initiation. The most commonly treated malignancies included melanoma (N=19) and NSCLC (N=15) with the majority of cancers being stage IV (N=42). The primary outcome measures are duration of therapy (average 12.2 cycles) and overall survival (average 1.59 years). The secondary outcome is adverse events, with a total rate of 27.1% and grade III/IV events occurring at a rate of 6.3%
Implications
These cases and data points illustrate that immunotherapy is being used in nonagenarians. With close monitoring of toxicities, nonagenarians with acceptable performance status can be treated with immunotherapy with their consent. Future aims will focus on the addition of more data points by expanding to include 2018.
References
1. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R,Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383–9. 2. Sgambato S, Casaluce F, Gridelli C. The role of checkpoint inhibitors immunotherapy in advanced non-small cell lung cancer in the elderly. Expert Opin Biol Ther. 2017;17(5):565-571.