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作者：SCI天天读
SCI
14 June 2023
Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
(The New England Journal of Medicine, IF: 176.079)
Masahiro Tsuboi, Roy S. Herbst, Thomas John, Terufumi Kato, Margarita Majem, Christian Grohé, M.D., Jie Wang, Jonathan W. Goldman, Shun Lu, Wu‑Chou Su, Filippo de Marinis, Frances A. Shepherd, Ki Hyeong Lee, Nhieu Thi Le, Arunee Dechaphunkul, Dariusz Kowalski, Lynne Poole, Ana Bolanos, Yuri Rukazenkov, and Yi‑Long Wu, for the ADAURA Investigators
CORRESPONDENCE TO: mtsuboi@east.ncc.go.jp, roy.herbst@yale.edu, syylwu@live.cn
BACKGROUND 背景
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.
在ADAURA试验中，在可切除的、表皮生长因子受体基因（EGFR）突变的IB至IIIA期非小细胞肺癌（NSCLC）患者中，在辅助治疗中应用奥西替尼治疗，无论是否进行先前的辅助化疗，都比安慰剂显著延长了患者的无病生存期。我们报告了总体生存率的最终分析结果。
METHODS 方法
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.
在这项3期双盲试验中，我们以1:1的比例随机分配符合条件的患者接受奥西替尼（每天一次，80 mg）或安慰剂治疗，直到观察到疾病复发、试验方案完成（3年）或达到停药标准。主要终点是研究者评估的II至IIIA期疾病患者的无病生存率。次要终点包括IB至IIIA期患者的无病生存率、总生存率和安全性。
RESULTS 结果
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<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis.
在682名接受随机分组的患者中，339人接受奥西替尼治疗，343人接受安慰剂治疗。在II至IIIA期疾病患者中，奥西替尼组和安慰剂组的5年总生存率分别为85%和73%（总死亡风险比为0.49；95.03%置信区间[CI]为0.33至0.73；P<0.001）。在总体人群中，即IB至IIIA期疾病患者中，奥西替尼组的5年总生存率为88%，安慰剂组为78%（死亡的总危险比为0.49；95.03%CI为0.34至0.70；P<0.001）。在之前公布数据的截止日期之后报告了一例新的严重不良事件，即2019冠状病毒病相关肺炎（研究人员认为该事件与试验方案无关，并且患者已完全康复）。辅助奥西替尼的安全性与初步分析一致。
CONCLUSIONS 结论
Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC. (Funded by Astra-Zeneca; ADAURA ClinicalTrials.gov number, NCT02511106.)
辅助奥西替尼在完全切除的EGFR突变的IB至IIIA期NSCLC患者中提供了显著的总体生存益处。（由阿斯利康资助；ADAURA ClinicalTrials.gov编号，NCT02511106。）
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原文地址：http://mp.weixin.qq.com/s?src=11×tamp=1686761303&ver=4590&signature=otw-PLx0T*JFx3mUZ9ZYHXXkvuZKFum36xX0rgUdIrbD-8Cn7mqL6q5EDMdax4uS-6i4W41QFxNnEBhqng*YlBcsatAO2hyANmWTvQEfcFbkIetWCbGAxdrO14rgqZWX&new=1 |
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