A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer
Gynecologic Oncology Mar 10, 2020
Monk BJ, Herzog TJ, Wang G, et al. - In this phase 3 study, researchers contrasted overall survival (OS) of women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with third-line trabectedin (T) + pegylated liposomal doxorubicin (PLD) vs PLD monotherapy. Five hundred seventy-six patients with advanced-relapsed epithelial ovarian cancer were randomly assigned 1: 1 to intravenous infusions of either T + PLD (trabectedin 1.1 mg/m2 for 3 h; PLD 30 mg/m2 for 1.5 h, every 3 weeks) or PLD (50 mg/m2 for 1.5 h, every 4 weeks). The combination of T and PLD demonstrated no beneficial OS advantage or safety, however, patients with germline BRCA1/2 mutations and/or a PFI of 6–12 months seem to have clinically relevant survival benefit with T + PLD. No new safety signals have been identified.
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