Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial
Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial
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DOI：
10.1016/j.jtho.2020.12.015
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发表时间：
2021-04-22
影响因子：
20.4
通讯作者：
Antonia, Scott J.
中科院分区：
文献类型：
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作者：
Faivre-Finn, Corinne;Vicente, David;Antonia, Scott J.
简介：在同步放化疗后无疾病进展的不可切除的III期NSCLC患者的III期安慰剂对照PACIFIC试验中，巩固性durvalumab与总生存期（OS）的主要终点显著改善相关（风险比[HR] = 0.68; 95%置信区间[CI]：0.53-0.87; p = 0.00251;数据截止日期：2018年3月22日）和无进展生存期（PFS）（设盲独立中心审查;实体瘤疗效评价标准第1.1版）（HR = 0.52; 95% CI：0.42-65; p < 0.0001; 2017年2月13日），安全性可控。方法：WHO体能状态为0或1（以及任何肿瘤程序性死亡配体1状态）的患者随机（2：1）接受静脉内durvalumab（10 mg/kg）或安慰剂，每2周给药一次（
Introduction: In the Phase 3, placebo-controlled PACIFIC trial of patients with unresectable, stage III NSCLC without disease progression after concurrent chemoradiotherapy, consolidative durvalumab was associated with significant improvements in the primary end points of overall survival (OS) (hazard ratio [HR] = 0.68; 95% confidence interval [CI]: 0.53-0.87; p = 0.00251; data cutoff, March 22, 2018) and progression-free survival (PFS) (blinded independent central review; Response Evaluation Criteria in Solid Tumors version 1.1) (HR = 0.52; 95% CI: 0.42-65; p < 0.0001; February 13, 2017) with manageable safety. Here, we report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.Methods: Patients with WHO performance status of 0 or 1 (and any tumor programmed death-ligand 1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg) or placebo, administered every 2 weeks (