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 Jan 16, 2020
Monk BJ, Herzog TJ, Wang G, et al. - Among women who received treatment for platinum-sensitive, recurrent ovarian cancer, researchers compared overall survival (OS) between those managed with third-line trabectedin (T) + pegylated liposomal doxorubicin (PLD) vs PLD monotherapy, in this phase 3 study. Random allocation (1: 1) of women with advanced-relapsed epithelial ovarian cancer (n = 576) 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) (n = 289) or PLD (50 mg/m2 for 1.5 h, every 4 weeks) (n = 287) was done. Findings revealed that neither favorable OS benefit nor safety was shown by the combination of T and PLD; however, T + PLD seemed to provide a clinically relevant survival benefit in patients with germline BRCA1/2 mutations and/or a platinum-free interval of 6–12 months. No new safety signals were reported.
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