Author:
Lee Jang Ho,Kim Eun Young,Park Cheol-Kyu,Lee Shin Yup,Lee Min ki,Yoon Seong-Hoon,Lee Jeong Eun,Lee Sang Hoon,Kim Seung Joon,Lee Sung Yong,Lim Jun Hyeok,Jang Tae-Won,Jang Seung Hun,Lee Kye Young,Lee Seung Hyeun,Yang Sei Hoon,Park Dong Won,Park Chan Kwon,Kang Hye Seon,Yeo Chang Dong,Choi Chang-Min,Lee Jae Cheol
Abstract
Purpose Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (<i>EGFR</i>) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with <i>EGFR</i> T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.Materials and Methods Patients with confirmed <i>EGFR</i> T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.Results A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary <i>EGFR</i> mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma <i>EGFR</i> T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.Conclusion Osimertinib demonstrated its clinical effectiveness and survival benefit for <i>EGFR</i> T790M mutation–positive in Korean patients with no new safety signals.
Funder
AstraZeneca Korea
Korea Medical Device Development Fund
Publisher
Korean Cancer Association
Cited by
9 articles.
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