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The aim of this multicenter, retrospective study was to evaluate the efficacy and the safety of single agent Trabectedin (ET-743, Yondelis®) in very heavily treated, relapsed ovarian cancer (ROC) patients. Response to treatment was classified according to RECIST criteria. Progression-free (PFS), and overall survival (OS) were also assessed. 98 patients were analyzed (originally 67 platinum sensitive, and 31 platinum refractory/resistant).
Median number of previous regimens was 4 (range: 1–6). In the whole population, overall response rate (ORR) was 27.5%; stable disease (SD) was observed in 33 patients (33.6%), and clinical benefit was achieved in 60 cases (61.2%). ORR was 38.6% in fully platinum sensitive population, and 26.1% in partially platinum sensitive patients.
In platinum refractory/resistant disease, ORR was 12.9%. Overall, median PFS and OS were 5, and 13months, respectively. Patients responding to Trabectedin showed a more favorable PFS (median=9months) than patients with SD (median=6months), or progression (median=2months).
Median OS of responding patients was 18months compared to 14months in SD patients, and 9months in progressing patients. Grade 3–4 neutropenia was observed in 17 (17.3%) patients.
Transient and non-cumulative Grade 3–4 AST and ALT level elevation was found in 7 (7.1%), and 13 (13.3%) cases, respectively. There was 1 case of Grade 3, and 1 case of Grade 4 cardiac toxicity.
Trabectedin, as a single agent, retains its efficacy in terms of rate of ORR and clinical benefit in heavily treated ROC patients, especially in the group of platinum sensitive disease.