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SCI 10 October 2018
BACKGROUND 背景 An earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non–small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. 这个3期临床试验的早期分析显示，与安慰剂相比，durvalumab显着延长了III期不可切除的在同步放化疗后没有疾病进展NSCLC无进展生存期。在这里，我们报告了总生存的第二个主要终点的结果。 METHODS 方法 We randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. 我们以2：1的比例随机分配患者静脉注射durvalumab，剂量为每公斤体重10毫克，或每2周一次匹配安慰剂，最多12个月。 在患者接受化放疗后1至42天进行随机化，并根据年龄，性别和吸烟史进行分层。主要终点是无进展生存期（通过盲法独立中心评估评估）和总体生存期。 次要终点包括死亡或远处转移的时间，第二次进展的时间和安全性。 Of the 713 patients who underwent randomization, 709 received the assigned intervention (473 patients received durvalumab and 236 received placebo).As of March 22, 2018, the median follow-up was 25.2 months. The 24-month overall survival rate was 66.3% in the durvalumab group, as compared with 55.6% in the placebo group. Durvalumab significantly prolonged overall survival, as compared with placebo. Updated analyses regarding progression-free survival were similar to those previously reported, with a median duration of 17.2 months in the durvalumab group and 5.6 months in the placebo group. The median time to death or distant metastasis was 28.3 months in the durvalumab group and 16.2 months in the placebo group. A total of 30.5% of the patients in the durvalumab group and 26.1% of those in the placebo group had grade 3 or 4 adverse events of any cause; 15.4% and 9.8% of the patients, respectively, discontinued the trial regimen because of adverse events. 在接受随机分组的713名患者中，709名接受了指定的干预（473名患者接受了durvalumab，236名接受了安慰剂）。截至2018年3月22日，中位随访时间为25.2个月。durvalumab组的24个月总生存率为66.3％，而安慰剂组为55.6％。与安慰剂相比，Durvalumab显着延长了总体生存期。 关于无进展生存的最新分析与之前报道的相似，durvalumab组的中位持续时间为17.2个月，安慰剂组为5.6个月。durvalumab组的中位死亡时间或远处转移时间为28.3个月，安慰剂组为16.2个月。durvalumab组中总共30.5％的患者和安慰剂组中26.1％的患者发生任何原因的3级或4级不良事件; 由于不良事件，15.4％和9.8％的患者分别停止了试验方案。 Durvalumab therapy resulted in significantly longer overall survival than placebo. No new safety signals were identified. Durvalumab治疗导致总生存期明显长于安慰剂。没有发现新的安全信号。 喜欢SCI天天读的理由 陪您一起学习SCI医学论文 每天5分钟，让自己的英语牛逼起来 特殊福利让您惊喜连连 |
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来自： rodneyzhang > 《肿瘤》
