한빛사 논문
Sun Min Lim, Hye Ryun Kim, Jong-Seok Lee, Ki Hyeong Lee, Yun-Gyoo Lee, Young Joo Min, Eun Kyung Cho, Sung Sook Lee, Bong-Seog Kim, Moon Young Choi, Hyo Sup Shim, Jin-Haeng Chung, Yoon La Choi, Min Jeong Lee, Maria Kim, Joo-Hang Kim, Siraj M. Ali, Myung-Ju Ahn, and Byoung Chul Cho
Sun Min Lim, Hye Ryun Kim, Hyo Sup Shim, Joo-Hang Kim, and Byoung Chul Cho, Yonsei University College of Medicine; Yun-Gyoo Lee, Yoon La Choi, and Myung-Ju Ahn, Sungkyunkwan University School of Medicine; Bong-Seog Kim, VHS Medical Center; Min Jeong Lee and Maria Kim, Yonsei University Health System, Seoul; Jong-Seok Lee and Jin-Haeng Chung, Seoul National University Bundang Hospital, Bundang; Ki Hyeong Lee, Chungbuk National University, Cheongju; Young Joo Min, University of Ulsan College of Medicine, Ulsan; Eun Kyung Cho, Gachon Medical School, Inchon; Sung Sook Lee, Inje University College of Medicine; Moon Young Choi, Inje University, Busan; Jin-Haeng Chung, Seoul National University College of Medicine, Seongnam, Republic of Korea; and Siraj M. Ali, Foundation Medicine, Cambridge, MA.
S.M.L. and H.R.K. contributed equally to this work.
M.J.A. and B.C.C. contributed equally to this work.
Corresponding author: Byoung Chul Cho, MD, PhD, Yonsei Cancer Center, Division of Medical Oncology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea;
Abstract
Purpose
ROS1 rearrangement is a distinct molecular subset of non?small-cell lung cancer (NSCLC). We investigated the efficacy and safety of ceritinib in patients with ROS1-rearranged NSCLC.
Patients and Methods
We enrolled 32 patients with advanced NSCLC who tested positive for ROS1 rearrangement by fluorescent in situ hybridization. Ceritinib 750 mg was administered once daily. The primary end point was objective response rate. The secondary end points were disease control rate; duration of response; progression-free survival; overall survival; toxicity; and concordance among fluorescent in situ hybridization, immunohistochemistry, and next-generation sequencing.
Results
Between June 7, 2013, and February 1, 2016, 404 patients underwent ROS1 prescreening, and 32 patients with ROS1 rearrangement were enrolled. All patients except two were crizotinib-naive. At the time of data cutoff, the median follow-up was 14.0 months, and 18 patients (56%) had discontinued treatment. Of the 32 patients enrolled, 28 were evaluable for response by independent radiologic review. Objective response rate was 62% (95% CI, 45% to 77%), with one complete response and 19 partial responses; duration of response was 21.0 months (95% CI, 17 to 25 months); and disease control rate was 81% (95% CI, 65% to 91%). The median progression-free survival was 9.3 months (95% CI, 0 to 22 months) for all patients and 19.3 months (95% CI, 1 to 37 months) for crizotinib-naive patients. The median overall survival was 24 months (95% CI, 5 to 43 months). Of the eight patients with brain metastases, intracranial disease control was reported in five (63%; 95% CI, 31% to 86%). The most common adverse events (majority, grade 1 or 2) for all treated patients were diarrhea (78%), nausea (59%), and anorexia (56%).
Conclusion
Ceritinib demonstrated potent clinical activity in patients with ROS1-rearranged NSCLC who were heavily treated previously with multiple lines of chemotherapy.
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