Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial
Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial
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DOI：
10.1016/s1470-2045(14)70244-x
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发表时间：
2014-07-01
期刊：
影响因子：
51.1
通讯作者：
Oza, Amit M.
中科院分区：
文献类型：
--
作者：
Monk, Bradley J.;Poveda, Andres;Oza, Amit M.
背景血管生成是上皮性卵巢癌治疗的有效靶点。Trebananib抑制血管生成素1和2与Tie 2受体的结合，从而抑制血管生成。我们的目的是评估是否除了trebananib单药每周紫杉醇复发性上皮性卵巢癌患者改善progression-free survival.Methods为这个随机，双盲3期研究进行了2010年11月10日和2012年11月19日之间，我们招募了来自32个国家的复发性上皮性卵巢癌的妇女。患者合格性标准包括既往接受过三种或更少的方案治疗，无铂间隔时间小于12个月。我们使用计算机交互式语音应答系统招募患者，并使用排列区组法（区组大小为4）以1：1的比例将患者随机分配至每周静脉注射紫杉醇（80 mg/m2）+每周静脉注射安慰剂或曲巴那尼（15 mg/kg）。患者根据无铂间隔（>= 0和6，
Background Angiogenesis is a valid target in the treatment of epithelial ovarian cancer. Trebananib inhibits the binding of angiopoietins 1 and 2 to the Tie2 receptor, and thereby inhibits angiogenesis. We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival.Methods For this randomised, double-blind phase 3 study undertaken between Nov 10, 2010, and Nov 19, 2012, we enrolled women with recurrent epithelial ovarian cancer from 32 countries. Patient eligibility criteria included having been treated with three or fewer previous regimens, and a platinum-free interval of less than 12 months. We enrolled patients with a computerised interactive voice response system, and patients were randomly assigned using a permuted block method (block size of four) in a 1:1 ratio to receive weekly intravenous paclitaxel (80 mg/m(2)) plus either weekly masked intravenous placebo or trebananib (15 mg/kg). Patients were stratified on the basis of platinum-free interval (>= 0 and 6 and