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 - 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
SN - 1879-4068
VL - 13
SP - 20
EP - 26
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
IS - 1
ER -