Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials

Abstract

Purpose: Survival for adolescents and young adults (AYAs) with cancer has improved over the past few decades, and targeted approaches are needed to further improve outcomes. Limited reports suggest that AYAs tolerate cancer treatment differently than older and younger patients. Lack of adverse event (AE) data prevents the optimization of treatment regimens for AYAs by maximizing drug delivery and minimizing treatment-related toxicity. The extent to which the frequency and severity of AEs are reported for AYAs in cancer trials is unknown.

Methods: Using a retrospective, observational design we reviewed all phase II/III clinical trials published in 2021 that included cancer-directed therapy and enrolled at least one patient age 15-39 years diagnosed with one of the five common AYA cancers: breast cancer, colorectal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, or melanoma. The primary outcome was to determine the proportion of phase II/III trials that report AEs for the AYA population.

Results: Of 2,540 publications identified, 182 were included in the final analysis. No studies reported AE data for AYAs separate from older adults. Given the lack of reporting of AEs by age, it was not possible to assess differences in AE frequency or severity or whether AEs were associated with differences in dose reductions, treatment delays, or discontinuation for AYAs.

Conclusion: Reporting of AEs for AYAs with cancer is absent in the public domain. Failure to account for differences in treatment tolerance between AYAs and older adults may lead to undertreatment or overtreatment and delay progress toward further improving outcomes for AYAs.

FIG 1.

Flow diagram.