医学
阿替唑单抗
内科学
危险系数
人口
肺癌
化疗
胃肠病学
阶段(地层学)
肿瘤科
癌症
外科
置信区间
彭布罗利珠单抗
免疫疗法
古生物学
生物
环境卫生
作者
Enriqueta Felip,Nasser K. Altorki,Caicun Zhou,Eric Vallières,Tibor Csőszi,Ihor Vynnychenko,Oleksandr Goloborodko,Achim Rittmeyer,Martin Reck,Alex Martínez‐Martí,Hirotsugu Kenmotsu,Yuh-Min Chen,Antonio Chella,Shunichi Sugawara,Chenqi Fu,Marcus Ballinger,Yu Deng,Minu K. Srivastava,Elizabeth L. Bennett,Barbara J. Gitlitz
摘要
IMpower010 (ClinicalTrials.gov identifier: NCT02486718 ) previously showed that atezolizumab improved disease-free survival (DFS) versus best supportive care (BSC) after adjuvant chemotherapy in patients with resected non–small cell lung cancer (NSCLC). We report DFS final analysis, second overall survival (OS) interim analysis, and safety with a ≥5-year follow-up. Patients with completely resected stage IB-IIIA NSCLC were randomly assigned to atezolizumab (1,200 mg once every 3 weeks, 16 cycles) or BSC after platinum-based chemotherapy. At clinical cutoff (January 26, 2024), stratified hazard ratios (HRs; 95% CI) for DFS were 0.85 (95% CI, 0.71 to 1.01; P = .07) in the intention-to-treat (n = 1,005), 0.83 (95% CI, 0.69 to 1.00) in the all-randomized stage II-IIIA (n = 882), and 0.70 (95% CI, 0.55 to 0.91) in stage II-IIIA PD-L1 tumor cell (TC) ≥1% (n = 476) populations. Stratified HRs (95% CI) for OS were 0.97 (95% CI, 0.78 to 1.22), 0.94 (95% CI, 0.75 to 1.19), and 0.77 (95% CI, 0.56 to 1.06), respectively. The unstratified HRs (95% CI) in the stage II-IIIA PD-L1 TC ≥50% population (n = 229) were 0.48 (95% CI, 0.32 to 0.72) for DFS and 0.47 (95% CI, 0.28 to 0.77) for OS, and the unstratified HRs in the stage II-IIIA PD-L1 TC ≥50% without EGFR / ALK alterations (n = 209) population were 0.49 (95% CI, 0.32 to 0.75) and 0.44 (95% CI, 0.26 to 0.74). No new safety signals were reported. IMpower010 is the first study to report survival outcomes with a ≥5-year follow-up and continued to show benefit with atezolizumab versus BSC after adjuvant chemotherapy in patients with resected stage II-IIIA PD-L1–selected NSCLC.