Treatment of elderly patients with advanced ovarian cancer in the context of controlled clinical trials – A joint analysis of 3 AGO-Ovar subprojects

Aims: Elderly are the fastest-growing segment of patients (pts) with ovarian cancer (OC). Despite optimization of OC treatment, age remains a negative prognostic factor. Methods: In three subprotocols of the AGO-OVAR the impact of age on quality of life (Qol), safety, feasibility and efficacy of platinum-paclitaxel-based treatment (Ovar–3 subprotocols) and participation in clinical trials (OVAR 7 subprotocol Ovar 14) has been investigated. Results: In the Ovar–3 only 103 of 787 pts were ≥ 70 years. The number of cycles was significantly lower and early discontinuation more frequent in elderly, although Qol, non-hematological and the vast majority of hematological toxicity were comparable between elderly and younger pts. There were no significant differences with regard to cycle delays, dose reductions or supportive therapy. Multivariate analysis showed that the number of cycles had significant impact on survival in elderly but not younger pts and that the survival disadvantage remained significant even in completely debulked pts. The Ovar–14 showed that non-participating pts were significantly older (median age 66.7 vs. 57.2; p=0.0001), had a decreased performance status and received less radical surgery. Conclusion: Reasons for non-enrolment were predominantly age-related, resulting in an underrepresentation of elderly in clinical trials. Although toxicity and Qol of platinum/paclitaxel-based treatment were comparable to younger pts there seems to be a different investigatorsrsquor; estimation of toxicity and less intention to maintain trial treatment in elderly which has significant impact on the outcome of elderly even under phase III trial conditions.

clinical trials - elderly patients - ovarian cancer