Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
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DOI：
10.1056/nejmoa2304594
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发表时间：
2023-06-04
影响因子：
158.5
通讯作者：
Wu, Yi-Long
中科院分区：
文献类型：
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作者：
Tsuboi, Masahiro;Herbst, Roy S.;Wu, Yi-Long
背景在ADAURA试验中，在切除的、表皮生长因子受体（EGFR）突变的、IB至IIIA期非小细胞肺癌（NSCLC）患者中，奥希替尼辅助治疗（伴或不伴既往辅助化疗）导致无病生存期显著长于安慰剂。我们报告了计划的总生存期最终分析的结果。在这项3期双盲试验中，我们将符合条件的患者以1：1的比例随机分配接受奥希替尼（80 mg，每日一次）或安慰剂，直至观察到疾病复发，完成试验方案（3年）或符合停药标准。主要终点是II期至IIIA期疾病患者的经评估的无病生存率。次要终点包括IB至IIIA期疾病患者的无病生存期、总生存期和安全性。结果：在682例接受随机分组的患者中，339例接受奥希替尼，343例接受安慰剂。在II至IIIA期疾病患者中，奥希替尼组的5年总生存率为85%，安慰剂组为73%（死亡的总风险比为0.49; 95.03%置信区间[CI]为0.33至0.73; P
BACKGROUND Among patients with resected, epidermal growth factor receptor (EGFR)-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival. METHODS In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety. RESULTS Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P