Efficacy and safety outcomes in heavily pretreated patients (pts) with relapsed ovarian cancer (ROC) after single-agent trabectedin.

e16538 Background: Trabectedin is a marine-derived antineoplastic agent, initially isolated from the tunicate Ecteinascidia turbinata and currently produced synthetically. In combination with pegylated liposomal doxorubicin, trabectedin is approved in Europe for the treatment of pts with platinum-sensitive (PS) ROC. The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of single agent trabectedin in the palliative treatment of heavily pretreated patients with ROC. Methods: Patients with measurable ROC and at least 2 prior treatments were eligible. Patients received single agent trabectedin (1.3 mg/m2, n = 56; 1.1 mg/m2, n=42) as a 3-hour i.v. infusion every 3 weeks. An analysis of the overall response rate (ORR; primary end point) as per RECIST, time to progression (TTP) and overall survival (OS) were performed. Results: Overall, 98 pts were enrolled: median age at diagnosis of recurrence was 53 years (range: 29-79). Forty-four pts (44.9%) were fully PS, while 23 (23.5%)...