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Real-world Use of Osimertinib in Non-Small Cell Lung Cancer: ASTRIS Study Korean Subgroup Analysis

Authors
 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 
Citation
 CURRENT MEDICAL RESEARCH AND OPINION, Vol.36(3) : 477-482, 2020-03 
Journal Title
 CURRENT MEDICAL RESEARCH AND OPINION 
ISSN
 0300-7995 
Issue Date
2020-03
Keywords
EGFR T790M mutation ; EGFR-TKI therapy ; NSCLC ; Osimertinib ; non–small cell lung cancer
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.
Full Text
https://www.tandfonline.com/doi/full/10.1080/03007995.2019.1676708
DOI
10.1080/03007995.2019.1676708
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/176005
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