Real-world use of osimertinib in non–small cell lung cancer: ASTRIS study Korean subgroup analysis

Byoung Chul Cho, Dong Wan Kim, Keunchil Park, Jong Seok Lee, Seung Soo Yoo, Jin Hyoung Kang, Sung Yong Lee, Cheol Hyeon Kim, Seung Hun Jang, Young Chul Kim, Hyoung Kyu Yoon, Ji Youn Han, Sang We Kim

Research output: Contribution to journalArticle

Abstract

Objective: ASTRIS is a large real-world, open-label, multinational clinical study of osimertinib in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive advanced non-small cell lung cancer (NSCLC) who have previously received a tyrosine kinase inhibitor (TKI). We report data from the Korean ASTRIS subgroup. Methods: Adult patients with locally advanced or metastatic NSCLC with a confirmed T790M mutation, WHO performance status of 0–2 and prior EGFR-TKI therapy, received osimertinib 80 mg once daily. Efficacy outcomes were overall survival (OS), investigator-assessed response rate (RR) and progression-free survival (PFS), and time to treatment discontinuation (TTD). Results: At data cut-off (20 October 2017), 466 Korean patients were enrolled. Baseline EGFR molecular testing was mainly performed on biopsied tissue (75.1%). Baseline mutations co-occurring with T790M included exon 19 deletions (60.7%) and L858R (32.8%). 1-year OS was 82.7% (OS data not matured at data cut-off). Overall, RR was 71.0%, median PFS was 12.4 months and median TTD was 15.0 months. In patients with/without CNS metastases, RR was 68.0% and 79.6%, respectively; median PFS, 10.8 and 11.0 months, respectively; and median TTD, 11.2 and 14.7 months, respectively. Overall, 31.1% of patients experienced ≥1 adverse event (AE), leading to dose modification (12.0%), discontinuation (5.2%) or death (2.8%). Serious AEs (24.9%) included pulmonary embolism (1.7%), pleural effusion (1.7%), and pneumonia (1.5%). Conclusion: In this real-world subgroup analysis of Korean patients in the ASTRIS study, osimertinib demonstrated comparable clinical efficacy to that attained in the global ASTRIS study and other clinical trials, with no new safety concerns.

Original languageEnglish
Pages (from-to)477-482
Number of pages6
JournalCurrent Medical Research and Opinion
Volume36
Issue number3
DOIs
StatePublished - 3 Mar 2020

Keywords

  • EGFR T790M mutation
  • EGFR-TKI therapy
  • non–small cell lung cancer
  • NSCLC
  • Osimertinib

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    Cho, B. C., Kim, D. W., Park, K., Lee, J. S., Yoo, S. S., Kang, J. H., Lee, S. Y., Kim, C. H., Jang, S. H., Kim, Y. C., Yoon, H. K., Han, J. Y., & Kim, S. W. (2020). Real-world use of osimertinib in non–small cell lung cancer: ASTRIS study Korean subgroup analysis. Current Medical Research and Opinion, 36(3), 477-482. https://doi.org/10.1080/03007995.2019.1676708