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- Title
Real-world evidence of osimertinib in Chinese patients with EGFR T790M-positive non-small cell lung cancer: a subgroup analysis from ASTRIS study.
- Authors
Zhou, Qing; Zhang, He-Long; Jiang, Li-Yan; Shi, Yuan-Kai; Chen, Yuan; Yu, Jin-Ming; Zhou, Cai-Cun; He, Yong; Hu, Yan-Ping; Liang, Zong-An; Pan, Yue-Yin; Zhuo, Wen-Lei; Song, Yong; Wu, Gang; Chen, Gong-Yan; Lu, You; Zhang, Cui-Ying; Zhang, Yi-Ping; Cheng, Ying; Lu, Shun
- Abstract
Purpose: ASTRIS study aimed the largest to evaluate the effectiveness and safety of second- or higher-line osimertinib in patients with advanced/metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non–small cell lung cancer (NSCLC) in the real-world setting. Here we report the results of Chinese patients in ASTRIS study. Methods: Adults with EGFR T790M-positive advanced NSCLC pretreated with EGFR-tyrosine kinase inhibitor (EGFR-TKI), having a WHO performance status score of 0–2 and asymptomatic, stable central nervous system (CNS) metastases were included. All patients received once-daily osimertinib 80 mg orally. The outcomes included investigator-assessed clinical response, progression-free survival (PFS), time-to-treatment discontinuation (TTD), and safety. Results: A total of 1350 patients were included. Response rate was 55.7% (95% confidence interval [CI] 0.53–0.58). The median PFS and the median TTD were 11.7 months (95% CI 11.1–12.5) and 13.9 months (95% CI 13.1–15.2), respectively. Overall, 389 patients (28.8%) had at least one protocol-specified adverse event (AE); AEs of interstitial lung diseases/pneumonitis-like events and QT prolongation were reported in 3 (0.2%) and 59 (4.4%) patients, respectively. Conclusion: Osimertinib was effective in Chinese patients with T790M-positive NSCLC who had progressed after first- or second-generation EGFR-TKI in real-word setting and the results were consistent with ASTRIS study overall population and AURA studies. No new safety signals or events were identified. Clinical trial number: NCT02474355.
- Subjects
NON-small-cell lung carcinoma; CHINESE people; EPIDERMAL growth factor receptors; MIGRAINE aura; OSIMERTINIB; INTERSTITIAL lung diseases; SUBGROUP analysis (Experimental design)
- Publication
Journal of Cancer Research & Clinical Oncology, 2023, Vol 149, Issue 12, p10771
- ISSN
0171-5216
- Publication type
Article
- DOI
10.1007/s00432-023-04923-8