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Open-Label, Multicenter, Phase II Study of Ceritinib in Patients With Non-Small-Cell Lung Cancer Harboring ROS1 Rearrangement.

Authors
 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  ;  Byoung Chul Cho 
Citation
 Journal of Clinical Oncology, Vol.35(23) : 2613-2618, 2017 
Journal Title
 Journal of Clinical Oncology 
ISSN
 0732-183X 
Issue Date
2017
MeSH
Adult ; Aged ; Anorexia/chemically induced ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use* ; Brain Neoplasms/drug therapy* ; Brain Neoplasms/secondary ; Carcinoma, Non-Small-Cell Lung/chemistry ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/secondary ; DNA, Neoplasm/analysis* ; Diarrhea/chemically induced ; Disease-Free Survival ; Female ; Gene Rearrangement ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Lung Neoplasms/chemistry ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Nausea/chemically induced ; Protein-Tyrosine Kinases/analysis ; Protein-Tyrosine Kinases/genetics* ; Proto-Oncogene Proteins/analysis ; Proto-Oncogene Proteins/genetics* ; Pyrimidines/adverse effects ; Pyrimidines/therapeutic use* ; Sequence Analysis, DNA ; Sulfones/adverse effects ; Sulfones/therapeutic use* ; Survival Rate
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-naïve. 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-naïve 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.
Full Text
http://ascopubs.org/doi/abs/10.1200/JCO.2016.71.3701
DOI
10.1200/JCO.2016.71.3701
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
김주항(Kim, Joo Hang)
김혜련(Kim, Hye Ryun) ORCID logo https://orcid.org/0000-0002-1842-9070
심효섭(Shim, Hyo Sup) ORCID logo https://orcid.org/0000-0002-5718-3624
임선민(Lim, Sun Min)
조병철(Cho, Byoung Chul) ORCID logo https://orcid.org/0000-0002-5562-270X
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/154232
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