Cancer biology & medicine · 2026
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).
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Shen Lisha, Lv Dongqing, Tang Ke-Jing, Zhao Jun, Zhu Dan, Zhao Yanqiu, Wang Ke, Wang Yan, Cai Zhigang, Xing Ligang, Xie Ke, Cui Jiuwei, Mu Lin, Cao Chao, Ding Liren, Chen Peifeng, Liang Jun, Ding Yongmin, Lu Liqin, Zhang Jiliang, Yu Xinmin, Chen Li, Zheng Jing, Zhou Jianya, Zhou Jianying
Аннотация
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.
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.