Retrospective trial on trabectedin (ET-743) monotherapy in very heavily pretreated advanced ovarian cancer

Abstract

Background: Trabectedin, is a natural product derived from the marine tunicate Ecteinascidia turbinata binding the minor groove of DNA. The present phase II prospective trial was designed to address the activity and toxicity profile of trabectedin in a population of very heavily pretreated recurrent ovarian cancer patients. Patients and methods: Sixty recurrent ovarian cancer patients were treated with trabectedin 1.1–1.3 mg/m2 i.v. over 3 hours every 3 weeks; 37 (62%) were platinum-sensitive and 23 (38%) platinum-resistant. Median number of previous chemotherapy lines was four. The primary study objective was overall response rate (ORR) according to RECIST version 1.1 criteria. Results: ORR was 25%; 13 responses were registered among 37 platinum-sensitive patients (35%) and two responses were reported among the 23 platinum-resistant patients (9%). Disease stabilization was registered in 20/60 (33%) patients. The most common trabectedin-related grade 3–4 non-haematological adverse events per patient were asthenia (50%), transaminitis (31%) and nausea (14%). The most common grade 3–4 haematological toxicities per patient were neutropenia (32%), leukopenia (32%), anaemia (18%) and thrombocytopenia (14%). Conclusions: Trabectedin plays a definite therapeutic role as single agent in the ovarian cancer recurrent setting, with activity maintained even after several previous chemotherapy lines.