当前位置:科学网首页 > 小柯机器人 >详情
奥希替尼治疗切除后EGFR突变非小细胞肺癌可显著改善预后
作者:小柯机器人 发布时间:2020/9/22 14:28:16

广东省人民医院吴一龙课题组联合美国耶鲁大学医学院Roy S. Herbst和日本国立癌症研究中心东医院Masahiro Tsuboi团队研究了奥希替尼治疗切除后EGFR突变的非小细胞肺癌的疗效。2020年9月19日,该研究发表在《新英格兰医学杂志》上。

奥希替尼是初治的表皮生长因子受体(EGFR)突变阳性的晚期非小细胞肺癌(NSCLC)的标准治疗方法。但奥希替尼作为辅助治疗的疗效和安全性尚不清楚。

在这项双盲、3期临床试验中,研究组招募了682例完全切除的EGFR突变阳性NSCLC患者,将其按1:1随机分组,其中339例接受奥希替尼治疗,343例接受安慰剂治疗,为期3年。主要终点是II至IIIA期疾病患者的无病生存率。

第24个月时,奥希替尼组II至IIIA期患者中有90%无病生存,显著高于安慰剂组(44%),疾病复发或死亡的总风险比为0.17。在总人群中,奥希替尼组有89%的患者无病生存,显著高于安慰剂组(52%),疾病复发或死亡的总风险比为0.20。第24个月时,奥希替尼组中98%的患者存活,且没有中枢神经系统疾病,安慰剂组为85%。总体生存数据尚不成熟,共有29例患者死亡,其中奥希替尼组9例,安慰剂组20例,未发现新的安全隐患。

总之,对于IB期至IIIA期EGFR突变阳性的NSCLC患者,与安慰剂相比,接受奥希替尼治疗可显著延长无病生存期。

附:英文原文

Title: Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer | NEJM

Author: Yi-Long Wu, M.D.,, Masahiro Tsuboi, M.D.,, Jie He, M.D.,, Thomas John, Ph.D.,, Christian Grohe, M.D.,, Margarita Majem, M.D.,, Jonathan W. Goldman, M.D.,, Konstantin Laktionov, Ph.D.,, Sang-We Kim, M.D., Ph.D.,, Terufumi Kato, M.D.,, Huu-Vinh Vu, M.D., Ph.D.,, Shun Lu, M.D.,, Kye-Young Lee, M.D., Ph.D.,, Charuwan Akewanlop, M.D.,, Chong-Jen Yu, M.D., Ph.D.,, Filippo de Marinis, M.D.,, Laura Bonanno, M.D.,, Manuel Domine, M.D., Ph.D.,, Frances A. Shepherd, M.D.,, Lingmin Zeng, Ph.D.,, Rachel Hodge, M.Sc.,, Ajlan Atasoy, M.D.,, Yuri Rukazenkov, M.D., Ph.D.,, and Roy S. Herbst, M.D., Ph.D.

Issue&Volume: 2020-09-19

Abstract:

Background

Osimertinib 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.

Methods

In 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.

Results

A 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<0.001). In the overall population, 89% of the patients in the osimertinib group (95% CI, 85 to 92) and 52% of those in the placebo group (95% CI, 46 to 58) were alive and disease-free at 24 months (overall hazard ratio for disease recurrence or death, 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). At 24 months, 98% of the patients in the osimertinib group (95% CI, 95 to 99) and 85% of those in the placebo group (95% CI, 80 to 89) were alive and did not have central nervous system disease (overall hazard ratio for disease recurrence or death, 0.18; 95% CI, 0.10 to 0.33). Overall survival data were immature; 29 patients died (9 in the osimertinib group and 20 in the placebo group). No new safety concerns were noted.

Conclusions

In patients with stage IB to IIIA EGFR mutation–positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo.

DOI: 10.1056/NEJMoa2027071

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2027071

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home