NEJ009更新分析:吉非替尼单药与吉非替尼联合化疗治疗EGFR突变的非小细胞肺癌

SCI

25 August 2022

Updated Analysis of NEJ009: Gefitinib-Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated EGFR

Correspondence to: Eisaku Miyauchi, MD, PhD, Department of Respiratory Medicine, Tohoku，University Hospital, 1-1, Seiryo-machi, Aobaku, Sendai, Miyagi 980-8574, Japan; 

Miyauchi E, Morita S, Nakamura A et al. Updated Analysis of NEJ009: Gefitinib-Alone Versus Gefitinib Plus Chemotherapy for Non-Small-Cell Lung Cancer With Mutated EGFR. J Clin Oncol 2022; Jco2102911.

In a randomized, open-label, phase III NEJ009 study, gefitinib plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared with gefitinib-alone in patients with untreated non–small-cell lung cancer harboring mutations in epidermal growth factor receptor. Herein, we report the updated survival outcome and long-term tolerability. Patients were randomly assigned to gefitinib (gefitinib 250 mg orally, once daily) and gefitinib combined with carboplatin plus pemetrexed (GCP in a 3-week cycle for six cycles followed by concurrent gefitinib and pemetrexed maintenance) groups. At the data cutoff (May 22, 2020), GCP demonstrated significantly better PFS2 (hazard ratio, 0.77; 95% CI, 0.62 to 0.97; P = .027) than gefitinib. However, the updated median OS was 38.5 months (95% CI, 31.1 to 47.1) and 49.0 months (95% CI, 41.8 to 56.7) in the gefitinib and GCP groups, respectively (hazard ratio, 0.82; 95% CI, 0.64 to 1.06; P = .127). The OS in both groups was similar for the overall patient population. No severe adverse events occurred since the first report. This updated analysis revealed that the GCP regimen improved PFS and PFS2 with an acceptable safety profile compared with gefitinib-alone. GCP is more efficient than gefitinib monotherapy as a first-line treatment for non–small-cell lung cancer with epidermal growth factor receptor mutations.

在一项随机、开放标签、III期NEJ009期研究中，与单独使用吉非替尼相比，吉非替尼联合化疗显著改善表皮生长因子受体突变的非小细胞肺癌患者的无进展生存期(PFS)和总生存期(OS)。在此，我们报告最新的生存结局和长期耐受性。患者被随机分配到吉非替尼(吉非替尼250 mg口服，每日1次)和吉非替尼联合卡铂+培美曲塞(GCP为3周一个周期，共6个周期，随后吉非替尼和培美曲塞同时维持)组。在数据截止点(2020年5月22日)，GCP显著优于PFS2(风险比0.77;95% CI, 0.62 ~ 0.97;P = .027)优于吉非替尼。然而，吉非替尼组和GCP组的更新中位OS分别为38.5个月(95% CI, 31.1 - 47.1)和49.0个月(95% CI, 41.8 - 56.7)(风险比，0.82;95% CI, 0.64 ~ 1.06;P= .127)。两组总患者的OS相似。自第一次报告以来，未发生严重不良事件。这项更新的分析显示，与单独使用吉非替尼相比，GCP方案改善了PFS和PFS2，且安全性可接受。作为具有表皮生长因子受体突变的非小细胞肺癌的一线治疗，GCP比吉非替尼单药治疗更有效。