Real-world evidence of osimertinib in Chinese patients with EGFR T790M-positive non-small cell lung cancer: a subgroup analysis from ASTRIS study

作者：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; Wang, Chang-Li; Zhou, Jian-Ying; Liu, Yun-Peng; He, Jian-Xing; Wang, Jie; Wu, Yi-Long^*

来源：Journal of Cancer Research and Clinical Oncology, 2023, 149(12): 10771-10780.

DOI：10.1007/s00432-023-04923-8

• Epidermal growth factor receptor
• T790M
• Non-small cell lung cancer
• Osimertinib
• Real-world

PurposeASTRIS 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.MethodsAdults 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.ResultsA 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.ConclusionOsimertinib 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.

• 单位
  华中科技大学; 同济大学; 安徽医科大学; 浙江大学; 中国医学科学院; 广州医学院; 中国医学科学院北京协和医院; 中国医科大学; 广东省人民医院; 山东省医学科学院; 山东大学; 上海交通大学; 哈尔滨医科大学; 四川大学; 中国人民解放军第四军医大学