Quality of Outcome Reporting for Older Subgroups in FDA Registration Gastroesophageal Cancer Trials (2010-2024): A...

Background: Gastroesophageal adenocarcinoma is predominantly a disease of older adults. However, older adults are underrepresented in randomised controlled trials (RCTs), and outcomes specific to this subgroup are underreported. Clinicians therefore extrapolate data from younger, fitter trial populations, which can lead to over- and undertreatment of older cancer patients. This study examines the inclusion and completeness of outcome reporting for older patients in practice-changing trials in gastroesophageal cancer. Methods: RCTs were identified from United States Food and Drug Administration (accelerated) approvals between 2010 and 2024. The primary study report, clinicaltrial.gov repository and all relevant secondary publications were assessed for the level of reporting of outcomes. Efficacy outcomes were reported as complete, partial, qualitative or quantitative based on availability of sample size, effect size and measures of precision. Baseline characteristics, toxicity outcomes and health-related quality of life (HRQOL) outcomes were assessed using minimum data thresholds. Results: In total, 13 trials, 53 publications and 13 repository webpages were assessed. A total of 9320 patients were included, of which 40.1% were classified as older adults. Among the patients, 42.2% had an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, with all but one trial excluding patients with an ECOG PS of 2 (n = 63). Baseline characteristics and toxicity outcomes for older adults were fully reported in only two trials (15.4%). Reporting of HRQOL outcomes (25.0%), secondary (20.0%) and primary endpoints (66.7%) was more complete. Overall survival (76.9%) and progression-free survival (67.0%) were the most commonly reported primary or secondary endpoints. Conclusions: This study highlights deficits in the outcome reporting of older cancer patients in GOA trials. Simultaneously, this subgroup also remains heavily underrepresented in GOA trials compared to the real-world patient population. These findings highlight the need for improvements in both trial design and outcome reporting standards for older adults.