TY - JOUR
T1 - Disparities in older adult accrual to cancer trials
T2 - Analysis from the alliance for clinical trials in oncology (A151736)
AU - VanderWalde, Noam A.
AU - Dockter, Travis
AU - Wakefield, Daniel V.
AU - Satele, Daniel
AU - Sloan, Jeff
AU - Jagsi, Reshma
AU - Lichtman, Stuart M.
AU - Freedman, Rachel A.
AU - Lafky, Jacqueline M.
AU - Muss, Hyman
AU - Cohen, Harvey Jay
AU - Le-Rademacher, Jennifer
AU - Jatoi, Aminah
N1 - Funding Information:
Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under the Award Number UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant), U10CA180821 , U10CA180882 , UG1CA233160 , UG1CA233180 , UG1CA233253 , UG1CA233290 , UG1CA233373 , P30CA033572 ; SML is supported by the NCI Cancer Center Support Grant ( P30CA008748 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. https://acknowledgments.alliancefound.org .
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2022/1
Y1 - 2022/1
N2 - Background: Older adults are under-represented in cancer clinical trials. However, it remains unclear which types of trials under-enroll aging patients. We aimed to identify associations between trial characteristics and disparate enrollment of older adults onto trials sponsored by the Alliance for Clinical Trials in Oncology (Alliance). Methods: Actual age ≥ 65 percentage and trial data were extracted from the Alliance closed study list. Each trial, based on its cancer type and years of enrollment, was assigned an expected age ≥ 65 percentage extracted from the Surveillance, Epidemiology, and End Results (SEER) US population-based database. Enrollment disparity difference (EDD), the difference between the expected age ≥ 65 percentage and the actual age ≥ 65 percentage, was calculated for each trial. Linear regression determined trial variables associated with larger EDDs and variables with an overall association p-value <0.20 were included in a multivariable fixed-effects linear model. Results: The median age of 66,708 patients across 237 trials was 60 years (range 18–102). The average actual age ≥ 65 percentage enrolled per trial was lower than each trial's expected age ≥ 65 percentage average (39% vs. 58%; EDD 19, 95% CI 17.1–21.3%, p < 0.0001). In multivariable analyses, non-genitourinary (GU) cancer types (p < 0.001), trimodality+ trials (estimate 8.78, 95%CI 2.21–15.34, p = 0.009), and phase 2 trials (estimate 4.43 95% CI -0.06-8.91; p = 0.05) were all associated with larger EDDs. Conclusions: Disparate enrollment of older adults is not equal across cancer trials. Future strategies to improve older adult inclusion should focus on trial types associated with the highest disparate enrollment.
AB - Background: Older adults are under-represented in cancer clinical trials. However, it remains unclear which types of trials under-enroll aging patients. We aimed to identify associations between trial characteristics and disparate enrollment of older adults onto trials sponsored by the Alliance for Clinical Trials in Oncology (Alliance). Methods: Actual age ≥ 65 percentage and trial data were extracted from the Alliance closed study list. Each trial, based on its cancer type and years of enrollment, was assigned an expected age ≥ 65 percentage extracted from the Surveillance, Epidemiology, and End Results (SEER) US population-based database. Enrollment disparity difference (EDD), the difference between the expected age ≥ 65 percentage and the actual age ≥ 65 percentage, was calculated for each trial. Linear regression determined trial variables associated with larger EDDs and variables with an overall association p-value <0.20 were included in a multivariable fixed-effects linear model. Results: The median age of 66,708 patients across 237 trials was 60 years (range 18–102). The average actual age ≥ 65 percentage enrolled per trial was lower than each trial's expected age ≥ 65 percentage average (39% vs. 58%; EDD 19, 95% CI 17.1–21.3%, p < 0.0001). In multivariable analyses, non-genitourinary (GU) cancer types (p < 0.001), trimodality+ trials (estimate 8.78, 95%CI 2.21–15.34, p = 0.009), and phase 2 trials (estimate 4.43 95% CI -0.06-8.91; p = 0.05) were all associated with larger EDDs. Conclusions: Disparate enrollment of older adults is not equal across cancer trials. Future strategies to improve older adult inclusion should focus on trial types associated with the highest disparate enrollment.
KW - Cancer
KW - Clinical trials
KW - Enrollment
KW - Older adults
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U2 - 10.1016/j.jgo.2021.07.008
DO - 10.1016/j.jgo.2021.07.008
M3 - Article
C2 - 34364834
AN - SCOPUS:85112003146
VL - 13
SP - 20
EP - 26
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
SN - 1879-4068
IS - 1
ER -