肿瘤完全切除术后 IB-IIIA 期 EGFR 基因突变阳性非小细胞肺癌患者的奥希替尼辅助治疗：ADAURA中国亚组分析

IF 3 Q2 ONCOLOGY JTO Clinical and Research Reports Pub Date : 2024-02-01 DOI:10.1016/j.jtocrr.2023.100621

Jie Wang MD, PhD , Yi-Long Wu MD , Shun Lu MD, PhD , Qun Wang MD , Shanqing Li MD , Wen-Zhao Zhong MD, PhD , Qiming Wang MD , Wei Li MD, PhD , Buhai Wang MD , Jun Chen MD , Ying Cheng MD , Hongbing Duan MD , Gaofeng Li MD , Li Shan MD , Yangbo Liu MS , Jing Liu MD , Xiangning Huang PhD , Ana Bolanos MD , Jie He MD, PhD

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引用次数: 0

摘要

导言：在中国的NSCLC患者中，表皮生长因子受体突变（EGFRm）疾病的发病率较高。在全球3期ADAURA研究（NCT02511106）中，在切除的IB至IIIA期EGFRm NSCLC患者中，奥希替尼辅助治疗与安慰剂相比，无病生存期（DFS）有显著的统计学意义和临床意义。方法在ADAURA中，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随机分配接受奥希替尼（80毫克，每天一次）或安慰剂治疗3年或直到疾病复发/停药。根据医生/患者的选择，允许在随机化治疗前进行辅助化疗。主要终点是研究者评估的II期至IIIA期疾病的DFS；次要终点包括IB期至IIIA期疾病的DFS（总体人群）、总生存期、健康相关生活质量（HRQoL）和安全性。结果在全球招募的682名患者中，中华人民共和国的159名患者被纳入本亚组分析（奥西替尼n=77；安慰剂n=82）。各治疗组的基线特征均衡。数据截止时，II期至IIIA期DFS危险比（HR）为0.23（95%置信区间[CI]：0.13-0.42；成熟度59%）；IB期至IIIA期DFS HR为0.29（95% CI：0.17-0.48；成熟度42%）。在成熟度为13%时（21例死亡），IB期至IIIA期人群的总生存期HR为0.51（95% CI：0.21-1.20）。结论在来自 ADAURA 的中国患者中，奥希替尼辅助治疗与安慰剂相比，DFS 有临床意义的改善，HRQoL 保持不变，安全性与全球研究人群一致。

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Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis

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.

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