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Niraparib plus bevacizumab vs niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): A randomised, phase II, superiority trial

The Lancet Oncology Sep 06, 2019

Mirza MR, Lundqvist EA, Birrer MJ, et al. - In this phase 2, open-label, randomized, superiority trial (AVANOVA2), researchers compared niraparib and bevacizumab with niraparib monotherapy as definitive therapy for platinum-sensitive recurrent ovarian cancer. This investigation was conducted across 15 university hospitals in Denmark, Sweden, Finland, Norway, and the United States, and included adult women with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer. A total of 97 participants were randomized to once-daily oral niraparib 300 mg alone (n = 49) or with intravenous bevacizumab 15 mg/kg (n = 48) once every 3 weeks until disease progression. Participants were followed-up for a median duration of 16.9 months. Progression-free survival was significantly improved in those who received niraparib plus bevacizumab vs those treated with niraparib monotherapy. In the niraparib plus bevacizumab group and in the niraparib monotherapy group, 31 (65%) and 22 (45%) patients experienced grade 3 or worse adverse events, respectively. Increased incidences of any-grade proteinuria and hypertension were reported in correlation with niraparib plus bevacizumab vs niraparib alone. No treatment-related deaths were documented. Findings revealed the efficacy of this chemotherapy-free combination of approved agents in this patient population; nonetheless, further evaluation of the efficacy is warranted.

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