Do elderly and young patients derive similar relative survival benefits from novel oncology drugs? A systematic review and meta-analysis.

Abstract

10029 Background: Elderly patients are commonly believed to derive less benefit from cancer drugs, even if they fulfil clinical trial eligibility. We aim to examine if novel oncology drugs provide differential treatment outcomes for elderly and young patients on clinical trials. Methods: A systematic review of randomized control trials (RCTs) cited for clinical efficacy evidence in novel oncology drug approvals by the Food and Drug Administration, European Medicines Agency, and Health Canada between 2006 and 2015 was conducted. Studies reporting age-based subgroup analyses for overall or progression free survival (OS/PFS), were considered. Independent reviewers extracted survival hazard ratios (HRs) and confidence intervals (CIs) for age-based subgroups. Meta-analyses based on an inverse variance random effects model were performed to examine patient subgroups < 65 and ≥ 65 years separately, and pooled HRs were compared to examine if differences in relative survival benefits existed between patient subgroups. Sensitivity analyses were conducted specific to cancer type, primary endpoint, and the type of systemic treatment. Results: Eighty-five RCTs, including 55,512 patients, reported age-based survival outcomes and were included. One study reported age-based toxicity and no studies age-based quality of life results. Pooled HRs [95% CIs] for patients < 65 and ≥ 65 years were 0.60 [0.56-0.65] and 0.66 [0.61-0.72], respectively with no difference between the two subgroups ( P= 0.08). All sensitivity analyses revealed similar results. Conclusions: Our results suggest that elderly and young patients derive similar relative survival benefits from novel oncology drugs. In settings where there is no other direct high-level evidence of elderly patients deriving less benefit than younger patients, it is reasonable to consider offering novel oncology drugs to elderly patients who fulfil trial eligibility. There is, however, a need to report age-based toxicity and quality of life results to support patient discussions regarding the balance of treatment benefit and harm, to encourage informed individualized decision-making.