한빛사 논문
Jang Ho Cho, MD1; Sung Hee Lim, MD2; Ho Jung An, MD, PhD3; Ki Hwan Kim, MD4; Keon Uk Park, MD, PhD5; Eun Joo Kang, MD, PhD6; Yoon Hee Choi, MD7; Mi Sun Ahn, MD8; Myung Hee Lee, PhD9; Jong-Mu Sun, MD, PhD1; Se-Hoon Lee, MD, PhD1; Jin Seok Ahn, MD, PhD1; Keunchil Park, MD, PhD1; and Myung-Ju Ahn, MD, PhD1,*
1 Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
2 Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea
3 St Vincent’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea
4 Boramae Medical Center, Seoul National University Hospital, Seoul, Republic of Korea
5 Dongsan Hospital, Keimyung University, Daegu, Republic of Korea
6 Guro Hospital, Korea University Medical Center, Seoul, Republic of Korea
7 Dongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea
8 Ajou University Medical Center, Suwon, Republic of Korea
9 Samsung Medical Center, Seoul, Republic of Korea
*Address Correspondence and Reprint Requests to Myung-Ju Ahn, MD, PhD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Republic of Korea
Abstract
PURPOSE
Approximately 10% of patients with epidermal growth factor receptor (EGFR) mutation–positive non–small-cell lung cancer (NSCLC) harbor uncommon mutations. Here, we report the efficacy and safety of osimertinib in patients with NSCLC harboring uncommon EGFR mutations.
PATIENT AND METHODS
This was a multicenter, single-arm, open-label, phase II study in Korea. Patients with histologically confirmed metastatic or recurrent NSCLC harboring EGFR mutations other than the exon 19 deletion, L858R and T790M mutations, and exon 20 insertion were eligible for the study. The primary end point of objective response rate was assessed every 6 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary end points were progression-free survival, overall survival, duration of response, and safety.
RESULTS
Between March 2016 and October 2017, 37 patients were enrolled. All were evaluable except one patient who withdrew consent after starting treatment. Median age was 60 years, and 22 (61%) were male. Among patients, 61% received osimertinib as first-line therapy. The mutations identified were G719X (n = 19; 53%), followed by L861Q (n = 9; 25%), S768I (n = 8; 22%), and others (n = 4; 11%). Objective response rate was 50% (18 of 36 patients; 95% CI, 33% to 67%). Median progression-free survival was 8.2 months (95% CI, 5.9 to 10.5 months), and median overall survival was not reached. Median duration of response was 11.2 months (95% CI, 7.7 to 14.7 months). Adverse events of any grade were rash (n = 11; 31%), pruritus (n = 9; 25%), decreased appetite (n = 9; 25%), diarrhea (n = 8; 22%), and dyspnea (n = 8; 22%), but all adverse events were manageable.
CONCLUSION
Osimertinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations.
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