Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer
Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer
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DOI：
10.1056/nejmoa2027071
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发表时间：
2020-10-29
影响因子：
158.5
通讯作者：
Herbst, Roy S.
中科院分区：
文献类型：
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作者：
Wu, Yi-Long;Tsuboi, Masahiro;Herbst, Roy S.
研究背景奥希替尼是治疗表皮生长因子受体（EGFR）突变阳性的晚期非小细胞肺癌（NSCLC）的标准治疗药物。奥希替尼作为辅助治疗的疗效和安全性是unknow.MethodsIn这个双盲，3期试验，我们随机分配患者完全切除EGFR突变阳性的非小细胞肺癌在1：1的比例接受奥希替尼（80毫克，每天一次）或安慰剂3年。主要终点是II至IIIA期疾病患者的无病生存期（根据研究者评估）。次要终点包括IB期至IIIA期疾病患者总体人群的无病生存率、总生存率和safety.ResultsA共682例患者接受随机分组（339例为奥希替尼组，343例为安慰剂组）。24个月时，奥希替尼组90%的II至IIIA期患者（95%置信区间[CI]，84至93）和安慰剂组44%的患者（95% CI，37至51）存活且无疾病（疾病复发或死亡的总体风险比，0.17; 99.06% CI，0.11至0.26; P
BackgroundOsimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.MethodsIn this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety.ResultsA total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P