Treatment of elderly ovarian cancer patients in the context of controlled clinical trials: a joint analysis of the AGO Germany experience

Abstract

Background: Age remains a negative prognostic factor in ovarian cancer (OC). 3 separate analyses by the AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) give insight into the treatment of elderly patients (EPs) in the context of controlled clinical trials (CCTs).

Methods: 1 retrospective study evaluated the reasons for non-enrolment into CCTs of patients with advanced OC in AGO centers. 2 other exploratory age-specific analyses of a phase III trial in advanced OC treated with platinum/ paclitaxel evaluated (1) feasibility, toxicity and quality of life (QoL) and (2) the clinical outcome.

Results: Non-study patients were significantly older (66.7 vs. 57.2 years). Reasons for non-enrolment were predominantly predefined exclusion criteria, numeric age, and the patient's decision. The phase III trial confirmed an under-representation of EPs. Cycle delivery was significantly lower and discontinuation more frequent in EPs than in younger patients (YPs), although QoL, toxicity, cycle delays, and dose reductions were comparable. Delivery of cycles was prognostically significant in EPs but not YPs. The survival advantage of YPs remained significant even in completely debulked patients.

Conclusion: There is some kind of investigator reservation for the treatment of EPs, which not only applies for the enrolment into clinical trials but also for the treatment, even under CCT conditions, with impact on outcome.