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. 2024 Mar 1;130(5):750-769.
doi: 10.1002/cncr.35078. Epub 2023 Nov 2.

Alliance A151945: Accrual and characteristics of adolescent and young adult patients in Alliance trials from 2000 to 2017

Shoshana M Rosenberg  1 , Shaylene McCue  2 , Jun He  2 , Jacqueline M Lafky  3 , Lisa A Carey  4 , Evanthia Galanis  3 , John P Leonard  1 , Jeffrey Meyerhardt  5 , Kimmie Ng  5 , Gary K Schwartz  6 , Wendy Stock  7 , Electra D Paskett  8 , Ann H Partridge  5 , Suzanne George  5
Affiliations

Alliance A151945: Accrual and characteristics of adolescent and young adult patients in Alliance trials from 2000 to 2017

Shoshana M Rosenberg et al. Cancer. .

Abstract

Background: Identifying patient- and disease-specific characteristics associated with clinical trial enrollment of adolescents and young adults (AYAs) with cancer may target efforts to improve accrual.

Methods: Alliance for Clinical Trials in Oncology (Alliance) trials opened from January 1, 2000, and closed before January 1, 2018, for common AYA cancers were identified. Proportions of AYAs (aged 18-39 years old) versus non-AYAs (aged ≥40 years old) enrolled by cancer type were summarized by descriptive statistics. Among studies with ≥20 AYAs enrolled, demographic and disease characteristics of AYAs versus non-AYAs were compared with χ2 and Kruskal-Wallis tests. A qualitative review was also conducted of therapeutic trials included in analysis in PubMed through December 31, 2021, that reported AYA-specific survival.

Results: Among 188 trials enrolling 40,396 patients, AYAs represented 11% (4468 of 40,396) of accrual. AYA accrual varied by cancer type (leukemia, 23.6%; breast, 9.9%; lymphoma, 14.8%; colorectal, 6.2%; central nervous system, 8.1%; melanoma, 11.8%; sarcoma, 12%). Across ages, the proportion of Black and Hispanic patients enrolled was 1%-10%. Compared to non-AYAs, AYAs in breast and colorectal cancer trials were less likely to be White and more likely to be Hispanic. Disease characteristics differed by age for selected trials. Two trials reported AYA-specific survival, with no significant differences observed by age.

Conclusions: AYA accrual to Alliance trials was comparable to or exceeded population-based, age-specific prevalence estimates for most cancer types. Greater proportional representation of Hispanic and non-White patients among AYAs reflects US demographic trends. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs.

Keywords: adolescent and young adult (AYA); cancer clinical trials; clinical trial accrual; clinical trial enrollment disparities.

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Conflict of interest statement

Conflicts of Interest: Dr. Galanis reports serving on the advisory board for Kaypopharm Therapeutics, Inc and Kiyatec, Inc and research funding (institutional) from Celgene, Denovo Biopharma, Medimmune, Inc. and Servier Pharmaceuticals LLC. Dr. Leonard has served as an advisor/consultant to Abbvie, Astellas, AstraZeneca, Bayer, Beigene, BMS, Calithera, Constellation, Caribou Biosciences, Eisai, Lilly, Epizyme, Genmab, Grail, Incyte, Jansssen, MEI Pharma, Merck, Mustang Bio, Novartis, Pfizer, Roche/Genentech, Seagen, Second Genome, Sutro. Dr. Meyerhardt has served as an advisor/consultant to Merck Pharmaceutical and COTA Healthcare. Dr. Ng reports institutional research funding from Pharmavite, Evergrande Group, Revolution Medicines, and Janssen; and has served on advisory boards and/or as a consultant for Bayer, GlaxoSmithKline, and Pfizer. Dr. Paskett reports research funding from Pfizer, Merck Foundation, Genentech and Guardant Health not related to this work and is an Advisory Board member for GSK. Dr. Partridge receives royalties from Elsevier for UpToDate authorship. Dr. George research funding from Tracon, Springworks, Blueprint Medicines, Theseus Pharmaceuticals, IDRX, BioAtla, Equity Abbot Laboratories, royalties from Elsevier for UpToDate authorship.

Figures

Figure 1.
Figure 1.
Overall AYA accrual changes by age 2000–2017 in Alliance trials
See this image and copyright information in PMC

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