Efficacy and safety of first-line osimertinib in Chinese patients with EGFR-mutated advanced non-small cell lung cancer: a prospective, multicenter, non-interventional study (FLOURISH).

IF 12.4 2区医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

Cancer Biology & Medicine Pub Date : 2026-05-21 DOI:10.20892/j.issn.2095-3941.2025.0566

Lisha Shen, Dongqing Lv, Ke-Jing Tang, Jun Zhao, Dan Zhu, Yanqiu Zhao, Ke Wang, Yan Wang, Zhigang Cai, Ligang Xing, Ke Xie, Jiuwei Cui, Lin Mu, Chao Cao, Liren Ding, Peifeng Chen, Jun Liang, Yongmin Ding, Liqin Lu, Jiliang Zhang, Xinmin Yu, Li Chen, Jing Zheng, Jianya Zhou, Jianying Zhou

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引用次数: 0

Abstract

Objective: Osimertinib has demonstrated superior efficacy as a first-line treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) in clinical trials. This study was aimed at providing real-world evidence of osimertinib treatment in Chinese populations.

Methods: This prospective, multicenter, non-interventional study was conducted from July 27, 2020, to April 27, 2022. Treatment-naïve adults (≥18 years of age) with locally advanced or metastatic EGFR-mutated NSCLC scheduled to receive first-line osimertinib were included. Of 507 patients screened, 481 were eligible in the full analysis set. The primary endpoint was time to treatment discontinuation (TTD). Secondary endpoints included real-world progression-free survival (rwPFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

Results: Among 481 patients (median age 64.1 years; 62.2% women), the median follow-up was 31.3 months. The mTTD was 24.6 months (95% CI, 22.4-26.7), the median rwPFS was 19.4 months (95% CI, 16.2-20.4), and the mOS was 41.0 months [95% CI, 39.7 to not reached (NR)]. The mOS was 43.1 months (95% CI, 39.7 to NR) in FLAURA-eligible patients vs. 33.5 months (95% CI, 26.8 to NR) in FLAURA-ineligible patients. The mOS was 29.3 months (95% CI: 25.4 to NR) in patients with co-mutations vs. NR (95% CI: 32.9 to NR) in the cohort with EGFR-only mutations. Adverse events occurred in 71.7% of patients, and grade ≥3 events occurred in 11.4%. The safety profiles were similar between FLAURA-eligible and ineligible patients.

Conclusions: First-line osimertinib demonstrated robust effectiveness and manageable safety in real-world Chinese patients with EGFR-mutated advanced NSCLC, including those ineligible for clinical trials. Patients with co-mutations showed diminished clinical benefit, thus suggesting a potential need for intensified treatment strategies in this population.

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一线奥西替尼治疗egfr突变晚期非小细胞肺癌的疗效和安全性：一项前瞻性、多中心、非介入研究（FLOURISH）

目的：在临床试验中，奥西替尼作为表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）的一线治疗显示出优越的疗效。本研究旨在为中国人群提供奥西替尼治疗的真实证据。方法：这项前瞻性、多中心、非介入研究于2020年7月27日至2022年4月27日进行。Treatment-naïve成人（≥18岁）局部晚期或转移性egfr突变NSCLC计划接受一线奥西替尼。在筛选的507例患者中，481例符合完整分析集的要求。主要终点是治疗停止时间（TTD）。次要终点包括真实世界无进展生存期（rwPFS）、总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。结果：481例患者（中位年龄64.1岁，62.2%为女性），中位随访时间为31.3个月。mTTD为24.6个月（95% CI, 22.4-26.7），中位rwPFS为19.4个月（95% CI, 16.2-20.4）， mOS为41.0个月[95% CI， 39.7至未达到（NR）]。符合flaura条件的患者生存期为43.1个月（95% CI, 39.7 - NR），而不符合flaura条件的患者生存期为33.5个月（95% CI, 26.8 - NR）。共突变患者的生存期为29.3个月（95% CI: 25.4至NR），而纯egfr突变患者的生存期为NR （95% CI: 32.9至NR）。不良事件发生率为71.7%，≥3级事件发生率为11.4%。符合flura条件和不符合flura条件的患者的安全性相似。结论：一线奥西替尼在中国egfr突变晚期NSCLC患者中显示出强大的有效性和可管理的安全性，包括那些不符合临床试验资格的患者。共突变患者的临床获益减少，因此提示该人群可能需要加强治疗策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Biology & Medicine Medicine-Oncology

CiteScore

9.80

自引率

3.60%

发文量

1143

审稿时长

12 weeks

期刊介绍： Cancer Biology & Medicine (ISSN 2095-3941) is a peer-reviewed open-access journal of Chinese Anti-cancer Association (CACA), which is the leading professional society of oncology in China. The journal quarterly provides innovative and significant information on biological basis of cancer, cancer microenvironment, translational cancer research, and all aspects of clinical cancer research. The journal also publishes significant perspectives on indigenous cancer types in China.