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Perioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer

医学 彭布罗利珠单抗 围手术期 安慰剂 肺癌 危险系数 中期分析 内科学 外科 肿瘤科 癌症 随机对照试验 置信区间 免疫疗法 病理 替代医学
作者
Heather A. Wakelee,Moïshe Liberman,Terufumi Kato,Masahiro Tsuboi,Se‐Hoon Lee,Shugeng Gao,Ke‐Neng Chen,Christophe Dooms,Margarita Majem,E. Eigendorff,Gastón L. Martinengo,Olivier Bylicki,Delvys Rodríguez‐Abreu,Jamie E. Chaft,Silvia Novello,Jing Yang,Steven M. Keller,Ayman Samkari,Jonathan Spicer
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:389 (6): 491-503 被引量:597
标识
DOI:10.1056/nejmoa2302983
摘要

Among patients with resectable early-stage non–small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. Download a PDF of the Research Summary. We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P=0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P=0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points; 95% CI, 10.1 to 18.7; P<0.0001; threshold, P=0.0001). Across all treatment phases, 44.9% of the participants in the pembrolizumab group and 37.3% of those in the placebo group had treatment-related adverse events of grade 3 or higher, including 1.0% and 0.8%, respectively, who had grade 5 events. Among patients with resectable, early-stage NSCLC, neoadjuvant pembrolizumab plus chemotherapy followed by resection and adjuvant pembrolizumab significantly improved event-free survival, major pathological response, and pathological complete response as compared with neoadjuvant chemotherapy alone followed by surgery. Overall survival did not differ significantly between the groups in this analysis. (Funded by Merck Sharp and Dohme; KEYNOTE-671 ClinicalTrials.gov number, NCT03425643.) QUICK TAKE VIDEO SUMMARYNeoadjuvant Pembrolizumab for Lung Cancer 02:12
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