肿瘤完全切除术后 IB 至 IIIA 期表皮生长因子受体（EGFR）突变阳性非小细胞肺癌（NSCLC）患者的奥希替尼辅助治疗：ADAURA 研究中国亚组分析
Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis.
作者信息
Wang Jie, Wu Yi-Long, Lu Shun, Wang Qun, Li Shanqing, Zhong Wen-Zhao, Wang Qiming, Li Wei, Wang Buhai, Chen Jun, Cheng Ying, Duan Hongbing, Li Gaofeng, Shan Li, Liu Yangbo, Liu Jing, Huang Xiangning, Bolanos Ana, He Jie
机构信息
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, People's Republic of China.
出版信息
JTO Clin Res Rep. 2023 Dec 17;5(2):100621. doi: 10.1016/j.jtocrr.2023.100621. eCollection 2024 Feb.
INTRODUCTION
In Chinese patients with NSCLC, prevalence of EGFR-mutated (EGFRm) disease is high. In the global phase 3 ADAURA study (NCT02511106), adjuvant osimertinib was found to have a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus placebo in resected stage IB to IIIA EGFRm NSCLC. We present efficacy and safety data from a subgroup analysis of 159 Chinese patients enrolled in the People's Republic of China from ADAURA.
METHODS
In ADAURA, patients with completely resected stage IB to IIIA EGFRm (exon 19 deletion/exon 21 L858R) NSCLC were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo for 3 years or until disease recurrence/discontinuation. Adjuvant chemotherapy was permitted before randomization, per physician/patient choice. Primary end point was investigator-assessed DFS in stage II to IIIA disease; secondary end points included DFS in stage IB to IIIA (overall population), overall survival, health-related quality of life (HRQoL), and safety.
RESULTS
Of 682 patients enrolled globally, 159 patients in the People's Republic of China were included in this subgroup analysis (osimertinib n = 77; placebo n = 82). Baseline characteristics were balanced across the treatment arms. At data cutoff, stage II to IIIA DFS hazard ratio (HR) was 0.23 (95% confidence interval [CI]: 0.13-0.42; maturity 59%); stage IB to IIIA DFS HR was 0.29 (95% CI: 0.17-0.48; maturity 42%). At 13% maturity (21 deaths), HR for overall survival in the stage IB to IIIA population was 0.51 (95% CI: 0.21-1.20). HRQoL was maintained from baseline, and safety was consistent with the global population.
CONCLUSIONS
In this population of Chinese patients from ADAURA, adjuvant osimertinib was found to have a clinically meaningful improvement in DFS versus placebo, with maintained HRQoL and a safety profile consistent with the global study population.
简介
在中国非小细胞肺癌（NSCLC）患者中，表皮生长因子受体突变（EGFRm）疾病的患病率很高。在全球3期ADAURA研究（NCT02511106）中，发现对于IB至IIIA期EGFRm NSCLC患者，辅助使用奥希替尼相对于安慰剂在无病生存期（DFS）方面有统计学上显著且具有临床意义的改善。我们展示了ADAURA研究中159名来自中华人民共和国的患者亚组分析的疗效和安全性数据。
方法
在ADAURA研究中，将完全切除的IB至IIIA期EGFRm（外显子19缺失/外显子21 L858R）NSCLC患者按1:1随机分组，接受奥希替尼（每日一次，80毫克）或安慰剂治疗3年，或直至疾病复发/停药。根据医生/患者的选择，允许在随机分组前进行辅助化疗。主要终点是研究者评估的II至IIIA期疾病的DFS；次要终点包括IB至IIIA期（总体人群）的DFS、总生存期、健康相关生活质量（HRQoL）和安全性。
结果
在全球入组的682例患者中，159例来自中华人民共和国的患者纳入了该亚组分析（奥希替尼组n = 77；安慰剂组n = 82）。各治疗组的基线特征均衡。在数据截止时，II至IIIA期DFS风险比（HR）为0.23（95%置信区间[CI]：0.13 - 0.42；成熟度59%）；IB至IIIA期DFS HR为0.29（95%CI：0.17 - 0.48；成熟度42%）。在成熟度为13%（21例死亡）时，IB至IIIA期人群的总生存期HR为0.51（95%CI：0.21 - 1.20）。HRQoL从基线水平得以维持，安全性与全球人群一致。
结论
在ADAURA研究的这一中国患者群体中，发现辅助使用奥希替尼相对于安慰剂在DFS方面有临床意义的改善，HRQoL得以维持，且安全性与全球研究人群一致。
Zotero 插件