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Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC

奥西默替尼 医学 内科学 T790米 肿瘤科 危险系数 培美曲塞 卡铂 铈替尼 肺癌 化疗 无进展生存期 临床终点 长春瑞滨 吉非替尼 置信区间 表皮生长因子受体 顺铂 随机对照试验 癌症 埃罗替尼 克里唑蒂尼 恶性胸腔积液
作者
David Planchard,Pasi A. Jänne,Ying Cheng,J.C-H. Yang,Noriko Yanagitani,Sang‐We Kim,Shunichi Sugawara,Yan Yu,Yun Fan,Sarayut Lucien Geater,К. К. Лактионов,Chee Khoon Lee,Natalia Valdiviezo,Samreen Ahmed,Jean-Marc Maurel,Igor Andrašina,Jonathan W. Goldman,Dana Ghiorghiu,Yuri Rukazenkov,A. H. Todd,Kunihiko Kobayashi
出处
期刊:The New England Journal of Medicine [New England Journal of Medicine]
卷期号:389 (21): 1935-1948 被引量:36
标识
DOI:10.1056/nejmoa2306434
摘要

Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that is selective for EGFR-TKI-sensitizing and EGFR T790M resistance mutations. Evidence suggests that the addition of chemotherapy may extend the benefits of EGFR-TKI therapy.In this phase 3, international, open-label trial, we randomly assigned in a 1:1 ratio patients with EGFR-mutated (exon 19 deletion or L858R mutation) advanced non-small-cell lung cancer (NSCLC) who had not previously received treatment for advanced disease to receive osimertinib (80 mg once daily) with chemotherapy (pemetrexed [500 mg per square meter of body-surface area] plus either cisplatin [75 mg per square meter] or carboplatin [pharmacologically guided dose]) or to receive osimertinib monotherapy (80 mg once daily). The primary end point was investigator-assessed progression-free survival. Response and safety were also assessed.A total of 557 patients underwent randomization. Investigator-assessed progression-free survival was significantly longer in the osimertinib-chemotherapy group than in the osimertinib group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.49 to 0.79; P<0.001). At 24 months, 57% (95% CI, 50 to 63) of the patients in the osimertinib-chemotherapy group and 41% (95% CI, 35 to 47) of those in the osimertinib group were alive and progression-free. Progression-free survival as assessed according to blinded independent central review was consistent with the primary analysis (hazard ratio, 0.62; 95% CI, 0.48 to 0.80). An objective (complete or partial) response was observed in 83% of the patients in the osimertinib-chemotherapy group and in 76% of those in the osimertinib group; the median response duration was 24.0 months (95% CI, 20.9 to 27.8) and 15.3 months (95% CI, 12.7 to 19.4), respectively. The incidence of grade 3 or higher adverse events from any cause was higher with the combination than with monotherapy - a finding driven by known chemotherapy-related adverse events. The safety profile of osimertinib plus pemetrexed and a platinum-based agent was consistent with the established profiles of the individual agents.First-line treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR-mutated advanced NSCLC. (Funded by AstraZeneca; FLAURA2 ClinicalTrials.gov number, NCT04035486.).
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