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Safety but Limited Efficacy of Ensartinib in ROS1-Positive Non-small Cell Lung Cancer: A Single-arm, Multicenter Phase II study.

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收录情况： ◇ SCIE

作者：
Ai Xinghao[1] * ; Wang Qiming[2] ; Cheng Ying[3] ; Liu Xiaoqing[4] ; Cao Lejie[5] ; Chen Jianhua[6] ; Dong Xiaorong[7] ; Zhou Jianying[8] ; Fan Yun[9] ; Huang Cheng[10] ; Cui Jiuwei[11] ; Wang Yan[12] ; Chen Gongyan[13] ; Ding Cuimin[14] ; Gao Beili[15] ; Li Xingya[16] ; Wang Ziping[17] ; Zhang Helong[18] ; Ding Lieming[19] ; Wang Yang[19] ; Yuan Xiaobin[19] ; Cheng Hongke[19] ; Wang Tao[20] ; Lu Shun[1,*1] ;
机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. [2]Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. [3]Medical Oncology, Jilin Cancer Hospital, Changchun, China. [4]Department of lung oncology, South Campus of the fifth medical center of PLA General Hospital, Beijing, China. [5]Respiratory Medicine, The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital), Hefei, China. [6]Department of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China. [7]Cancer Center, Union Hospital, Tongji Medical College , Huazhong University of Science and Technology, Wuhan, China. [8]Respiratory Medicine, The First Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China. [9]Thoracic Medical Oncology II, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China. [10]Department of Thoracic Medical Oncology, Fujian Cancer Hospiital, Fuzhou, China. [11]Cancer Center, The First Hospital of Jilin University, Changchun, China. [12]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [13]Respiratory Medicine Department, Harbin Medical University Cancer Hospital, Harbin, China. [14]Respiratory Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [15]Respiratory Medicine, Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School, Shanghai, China. [16]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [17]Department of Thoracic Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China [18]Department of Oncology, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China. [19]Betta Pharmaceuticals Co., Ltd., Hangzhou, China. [20]Hangzhou Repugene Technology Inc., Hangzhou, China.
出处：
DOI： 10.1016/j.jtho.2021.06.023
ISSN：

关键词： non-small cell lung cancer ensartinib ALK ROS1

摘要：
Some Anaplastic lymphoma kinase (ALK) inhibitors with good inhibition of ROS1 in preclinical studies has been reported possibly beneficial in ROS1-positive non-small cell lung cancer (NSCLC). In this work, we studied the efficacy and safety of ensartinib in the treatment of patients with ROS1-positive NSCLC.The exploratory study was a phase II single-arm, multicenter design (NCT03608007). ROS1-positive NSCLC patients with a prior chemotherapy line number of ≤1 who received ensartinib at the dose of 225 mg once daily were enrolled. The primary endpoint was objective response rate (ORR) evaluated by investigator per Response Evaluation Criteria in Solid Tumors version 1.1.From June 2018 to July 2019, 59 patients were enrolled at 23 centers in China. At the time of data cutoff, the median follow-up was 19.8 months (range 0.8-22.5). The median ORR was 27.0% (95 % CI 13.8, 44.1) with 10 partial responses. Median duration of response (DoR) was 4.8 months (95% CI 1.8-10.8). The median progression-free survival (PFS) was 4.6 months (95% CI 4.0-6.4). The median overall survival (OS) was not estimable (95% CI 14.9-not estimable). Of 4 patients with brain metastases, intracranial disease control was reported in 3 (75.0%; 95% CI 19.4-99.4). The most common treatment-related adverse events (TRAEs) were rash and liver enzyme abnormalities, with good prognosis after adjustment for dosage and concomitant medication. The most of TRAEs were grade 1-2, and incidence of grade ≥3 TRAEs was 25.4%.Ensartinib had a moderset efficacy in patients with ROS1-positive NSCLC with an acceptable safety profile.Copyright © 2021. Published by Elsevier Inc.

基金：
This study was sponsored by Betta Pharmaceuticals Co., Ltd.
语种：
外文
被引次数：
WOS：
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中科院分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
JCR分区：
出版当年[2021]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
最新[2024]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 最新[2024版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
通讯作者：
通讯机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
推荐引用方式(GB/T 7714)：
Ai Xinghao,Wang Qiming,Cheng Ying,et al.Safety but Limited Efficacy of Ensartinib in ROS1-Positive Non-small Cell Lung Cancer: A Single-arm, Multicenter Phase II study.[J].JOURNAL OF THORACIC ONCOLOGY.2021,16(11):1959-1963.doi:10.1016/j.jtho.2021.06.023.
APA：
Ai Xinghao,Wang Qiming,Cheng Ying,Liu Xiaoqing,Cao Lejie...&Lu Shun.(2021).Safety but Limited Efficacy of Ensartinib in ROS1-Positive Non-small Cell Lung Cancer: A Single-arm, Multicenter Phase II study..JOURNAL OF THORACIC ONCOLOGY,16,(11)
MLA：
Ai Xinghao,et al."Safety but Limited Efficacy of Ensartinib in ROS1-Positive Non-small Cell Lung Cancer: A Single-arm, Multicenter Phase II study.".JOURNAL OF THORACIC ONCOLOGY 16..11(2021):1959-1963

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