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. 2022 Jan;13(1):20-26.
doi: 10.1016/j.jgo.2021.07.008. Epub 2021 Aug 4.

Disparities in older adult accrual to cancer trials: Analysis from the alliance for clinical trials in oncology (A151736)

Noam A VanderWalde  1 , Travis Dockter  2 , Daniel V Wakefield  3 , Daniel Satele  2 , Jeff Sloan  2 , Reshma Jagsi  4 , Stuart M Lichtman  5 , Rachel A Freedman  6 , Jacqueline M Lafky  2 , Hyman Muss  7 , Harvey Jay Cohen  8 , Jennifer Le-Rademacher  2 , Aminah Jatoi  9
Affiliations

Disparities in older adult accrual to cancer trials: Analysis from the alliance for clinical trials in oncology (A151736)

Noam A VanderWalde et al. J Geriatr Oncol. 2022 Jan.

Abstract

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.

Keywords: Cancer; Clinical trials; Enrollment; Older adults.

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Conflict of interest statement

Declaration of Competing Interest NV reports advisory board member for Concerto Health AI. RJ has stock options as compensation for her advisory board role in Equity Quotient, a company that evaluates culture in health care companies; she has received personal fees from Amgen and Vizient and grants for unrelated work from the National Institutes of Health, the Doris Duke Foundation, the Greenwall Foundation, the Komen Foundation, and Blue Cross Blue Shield of Michigan for the Michigan Radiation Oncology Quality Consortium. She has a contract to conduct an investigator initiated study with Genentech. She has served as an expert witness for Sherinian and Hasso and Dressman Benzinger LaVelle. She is an uncompensated founding member of TIME'S UP Healthcare and a member of the Board of Directors of ASCO.

Figures

Figure 1:
Figure 1:
Consort Diagram of included and excluded trials.
Figure 2:
Figure 2:
2A: Actual Older Adult Accrual Percentage versus Expected Percentage by Cancer Type. 2B: Actual Older Adult Accrual Percentage versus Expected Percentage by Number of Treatment Modalities.
Figure 3:
Figure 3:
Forest Plot: Lease Square Means of Enrollment Disparity Difference
See this image and copyright information in PMC

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