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)
Year: 2026
Type: article
Study design: Observational Study
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.
Source: Cancer Biology and Medicine
Institutions: First Affiliated Hospital Zhejiang University, Zhejiang University, Wenzhou Medical University, The First Affiliated Hospital, Sun Yat-sen University, Changzhi Medical College, Jinhua Central Hospital, Zhengzhou University, Henan Cancer Hospital, West China Hospital of Sichuan University, Harbin Medical University, Hebei Medical University, Second Hospital of Hebei Medical University, Shandong Tumor Hospital, Shandong First Medical University, First Hospital of Jilin University, Ningbo University, Second Affiliated Hospital of Zhejiang University, Peking University International Hospital, Zhejiang Provincial People's Hospital, Chengdu Medical College, Chengdu Seventh People's Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Nanchang University
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,500
Funder: AstraZeneca
OpenAlex ID: W7162068942
FWCI:
Cites:
Cited by:
Related to: