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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2022.381    [Accepted]
Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation-Positive Non-Small Cell Lung Cancer
Jang Ho Lee1 , Eun Young Kim2, Cheol-Kyu Park3, Shin Yup Lee4, Min ki Lee5, Seong‐Hoon Yoon6, Jeong Eun Lee7, Sang Hoon Lee2, Seung Joon Kim8, Sung Yong Lee9, Jun Hyeok Lim10, Tae-Won Jang11, Seung Hun Jang12, Kye Young Lee13, Seung Hyeun Lee14, Sei Hoon Yang15, Dong Won Park16, Chan Kwon Park17, Hye Seon Kang18, Chang Dong Yeo19, Chang-Min Choi1,20, Jae Cheol Lee20
1Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
3Department of Internal Medicine, Lung and Esophageal Cancer Clinic, Chonnam National University Medical School, Hwasun Hospital, Hwasun, Korea
4Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
5Division of Pulmonology, Allergy and Critical care medicine, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
6Department of Pulmonology and Critical care medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
7Division of Pulmonology, Department of Internal Medicine, Chungnam National University, Daejeon, Korea
8Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
9Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
10Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Inha University Hospital, College of Medicine, Incheon, Korea
11Department of Pulmonology, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea
12Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea
13Department of Pulmonary Medicine, Konkuk University School of Medicine, Seoul, Korea
14Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
15Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea
16Division of Pulmonology, Allergy and Critical care medicine, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Korea
17Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
18Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea
19Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
20Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence  Jae Cheol Lee ,Tel: 82-2-3010-3208, Fax: 82-2-3010-6968, Email: jclee@amc.seoul.kr
Received: June 14, 2022;  Accepted: August 30, 2022.  Published online: August 31, 2022.
*Jang Ho Lee and Eun Young Kim contributed equally to this work.
ABSTRACT
Purpose
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) 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 EGFR 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 EGFR 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), 13.0–16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1–15.9). The median overall survival was 36.7 months (95% CI, 30.9–not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten (1.8%) patients, including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.
Conclusion
Osimertinib demonstrated its clinical effectiveness and survival benefit for EGFR T790M mutation-positive in Korean patients with no new safety signals.
Key words: Osimertinib, EGFR T790M, Non-small cell lung cancer, Real-world efficacy
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