Inclusion, characteristics, and reporting of older patients in recent registration trials for DLBCL.

abstractThe incidence of diffuse large B-cell lymphoma (DLBCL) increases with older age. Thus, subgroup reporting for older adults in clinical trials is necessary to determine the relevance of novel therapy outcomes to this vulnerable population. This study assessed subgroup reporting of older adults (aged ≥65 years) enrolled in US Food and Drug Administration and European Medicines Agency registration trials for DLBCL between 2017 and 2023. Clinical efficacy end points for each trial were extracted from ClinicalTrials.gov registry data and study protocols. Primary and secondary publications reporting on included studies were identified through a systematic review process within Covidence. Ten therapies with 12 indications were approved between 2017 and 2023. Ninety-two publications were included for data extraction. The availability and completeness of older adult subgroup data relating to protocol-defined efficacy end points, as well as data relating to baseline patient characteristics, health-related quality-of-life outcomes, and toxicity outcomes, were assessed according to predefined criteria. Of 12 primary end points, 10 (83.4%) were reported completely, 1 (8.3%) was reported partially, and 1 (8.3%) was not reported among older subgroups. Of 66 secondary end points, 25 (37.9%) were completely reported, 6 (9.1%) were partially reported, and 35 (53.1%) were unreported. Baseline characteristics, health-related quality-of-life outcomes, and toxicities outcomes among older adults were mostly unreported. This analysis highlights a need for improvement in older adult subgroup reporting in DLBCL trials, particularly among secondary end points.