杜瓦卢马布
医学
内科学
肿瘤科
临床终点
肺癌
放化疗
阶段(地层学)
护理标准
外科
疾病
癌症
疾病控制
总体生存率
临床试验
肿瘤分期
肺病
作者
David R. Spigel,Corinne Faivre-Finn,Jhanelle E. Gray,David Vicente,David Planchard,Luis Paz-Ares,Johan F. Vansteenkiste,Marina C. Garassino,Rina Hui,Xavier Quantin,Andreas Rimner,Yi-Long Wu,Mustafa Özgüroğlu,Ki H. Lee,Terufumi Kato,Maike de Wit,Takayasu Kurata,Martin Reck,Byoung C. Cho,Suresh Senan
摘要
PURPOSE: < .0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned. METHODS: Patients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method. RESULTS: 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS. CONCLUSION: These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.
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