Osimertinib after Chemoradiotherapy in Stage III EGFR -Mutated NSCLC

作者：Shun Lu, Terufumi Kato, Xiaorong Dong, Myung‐Ju Ahn, Le-Van Quang, Nopadol Soparattanapaisarn, Takako Inoue, Chih-Liang Wang, Meijuan Huang, James Chih‐Hsin Yang, Manuel Cobo, Mustafa Özgüroğlu, Ignacio Casarini, Dang-Van Khiem, Virote Sriuranpong, Eduardo Cronemberger, Toshiaki Takahashi, Y. Runglodvatana, Ming Chen, Xiangning Huang, Ellie Grainger, Dana Ghiorghiu, Toon van der Gronde, Suresh S. Ramalingam · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2402614 · 被引用次数：325 · 研究领域：Lung Cancer Treatments and Mutations、Colorectal Cancer Treatments and Studies、Lung Cancer Diagnosis and Treatment

Background Osimertinib is a recommended treatment for advanced non–small-cell lung cancer (NSCLC) with an epidermal growth factor receptor ( EGFR ) mutation and as adjuvant treatment for resected EGFR -mutated NSCLC. EGFR-tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR -mutated NSCLC. Methods In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR -mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review. Results A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 8...