Quality of Outcome Reporting for Older Subgroups in FDA Registration Gastroesophageal Cancer Trials (2010–2024): A Systematic Review

Abstract

Simple Summary Older adults are commonly excluded from drug trials, causing physicians to make treatment decisions based on younger and fitter patients, which may lead to inadequate treatment of older patients. This study assesses publications from practice-changing drug trials in gastroesophageal adenocarcinoma from 2010 to 2024 for the inclusion of older adults and reporting of outcomes for this subgroup. Only 40.1% of patients included in the 13 trials assessed were classified as an older adult. All but one trial excluded patients with a poor functional baseline, as measured by an Eastern Cooperative Oncology Group performance status of ≥2. Apart from the primary aims of the trials, all other outcomes, including secondary aims, quality of life, toxicity and baseline patient characteristics, were poorly reported. No specific measurement tools for older patients were used in any of the trials. This study highlights deficits in both the inclusion and reporting of outcomes for older adults.