1. Real-world evidence of osimertinib in Chinese patients with EGFR T790M-positive non-small cell lung cancer: a subgroup analysis from ASTRIS study.
- Author
-
Zhou Q, Zhang HL, Jiang LY, Shi YK, Chen Y, Yu JM, Zhou CC, He Y, Hu YP, Liang ZA, Pan YY, Zhuo WL, Song Y, Wu G, Chen GY, Lu Y, Zhang CY, Zhang YP, Cheng Y, Lu S, Wang CL, Zhou JY, Liu YP, He JX, Wang J, and Wu YL
- Subjects
- Adult, Humans, Aniline Compounds adverse effects, East Asian People, ErbB Receptors genetics, Mutation, Protein Kinase Inhibitors adverse effects, Antineoplastic Agents adverse effects, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics
- 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., (© 2023. The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF