Engot-Ov24-Nsgo/Avanova: Niraparib Versus Bevacizumab-Niraparib Combination Versus Bevacizumab And Niraparib As Sequential Therapy In Women With Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, Or Peritoneal Cancer.

JOURNAL OF CLINICAL ONCOLOGY(2015)

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摘要
TPS5607 Background: Multiple Phase 1 and 2 clinical studies of PARP inhibitors used as monotherapy to treat patients with recurrent ovarian cancer (ROC) suggest that the agents are active in this population and there is level one evidence that bevacizumab is beneficial In the same population. A phase two randomized study demonstrated that the addition of a PARP inhibitor to an anti-angiogenic drug cediranib improves Progression-free survival (PFS). Our aim is to compare tolerability and efficacy of niraparib alone versus niraparib-bevacizumab combination versus sequential bevacizumab and niraparib. Methods: The ENGOT-OV24-NSGO/AVANOVA study comprises of two parts. Part 1 is a classic phase 1 trial of niraparib and bevacizumab combination. Part 2 is a three-arm, open-label, phase II, 1:1:1 randomized study of niraparib and/or Niraparib-bevacizumab combination against bevacizumab followed by niraparib in women with platinum-sensitive ROC. BRCAmut and or high-grade serous/endometrioid carcinoma patients with...
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