Randomized phase II trial of bevacizumab plus everolimus vs bevacizumab alone for recurrent or persistent ovarian, fallopian tube or peritoneal carcinoma: An NRG Oncology/Gynecologic Oncology Group study
Gynecologic Oncology Sep 08, 2018
Tew WP, et al. - In women with recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer (OC), combining bevacizumab (BV) and everolimus (EV), an mTOR kinase inhibitor, was assessed as a strategy to get around BV-resistance. Subjects with OC and having measurable (RECIST1.1) or detectable disease, 1-3 prior regimens, performance status 0-2, and no prior m-TOR inhibitor were eligible to be included in this study. Every 2 weeks, BV 10?mg/kg IV was administered to all patients, with patients randomly allocated (1:1) to oral EV (10?mg daily) or placebo stratified by platinum-free interval (PFI), measurable disease and prior BV. Compared with BV alone, the use of combination regimen (BV?+?EV) resulted in no significantly attenuated hazard of progression or death and was related to increased rates of adverse events and study discontinuation. For BV?+?EV vs BV, the estimated median progression-free survival was 5.9 vs 4.5?months and the median OS was 16.6 vs 17.3?months, respectively.
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