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Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations

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收录情况： ◇ ESCI

作者：
Lu Shun[1,*1] * ; Fang Jian[2] ; Li Xingya[3] ; Cao Lejie[4] ; Zhou Jianying[5] ; Guo Qisen[6] ; Liang Zongan[7] ; Cheng Ying[8] ; Jiang Liyan[9] ; Yang Nong[10] ; Han Zhigang[11] ; Shi Jianhua[12] ; Chen Yuan[13] ; Xu Hua[14] ; Zhang Helong[15] ; Chen Gongyan[16] ; Ma Rui[17] ; Sun Sanyuan[18] ; Fan Yun[19] ; Fan Songhua[20] ; Yu Jie[20] ; Lu Puhan[20] ; Luo Xian[20] ; Su Weiguo[20] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People's Republic of China. [2]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China. [3]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China. [4]Department of Respiratory Diseases, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei, People's Republic of China. [5]Department of Respiratory Diseases, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China. [6]Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China. [7]Department of Respiratory and Critical Care Medicine, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, People's Republic of China. [8]Department of Medical Thoracic Oncology, Jilin Cancer Hospital, Changchun, People's Republic of China. [9]Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China. [10]Department of Lung Cancer and Gastroenterology, Hunan Cancer Hospital, The Affiliated Tumour Hospital of Xiangya Medical School of Central South University, Changsha, People's Republic of China. [11]First Department of Lung Cancer Chemotherapy, The Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, People's Republic of China. [12]Department of Oncology, Linyi Cancer Hospital, Linyi, People's Republic of China. [13]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China. [14]Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, People's Republic of China. [15]Department of Oncology, Tangdu Hospital, Fourth Military Medical University, Xi'An, People's Republic of China. [16]Department of Medical Oncology, The Affiliated Tumour Hospital of Harbin Medical University, Harbin, People's Republic of China. [17]Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital, Shenyang, People's Republic of China. [18]Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, People's Republic of China. [19]Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, People's Republic of China. [20]HUTCHMED Limited, Shanghai, People's Republic of China.
出处：
DOI： 10.1016/j.jtocrr.2022.100407

关键词： Savolitinib Non–small cell lung cancer METex14 skipping mutations Pulmonary sarcomatoid carcinoma MET tyrosine kinase inhibitors

摘要：
Savolitinib has been found to have encouraging antitumor activity and a favorable safety profile in Chinese patients with pulmonary sarcomatoid carcinoma and other NSCLCs with MET exon 14 skipping alterations (MET ex14 positive) at the primary analysis of a phase 2 study. Here, we present the long-term efficacy and safety data of savolitinib, including subgroup analyses.This multicenter, single-arm, open-label, phase 2 study in the People's Republic of China enrolled MET inhibitor-naive adults with locally advanced or metastatic METex14-positive NSCLC (NCT02897479). Oral savolitinib at a dose of 400 or 600 mg was administered once daily (body weight dependent). The primary objectives of the final analysis were long-term overall survival (OS) and subgroup analyses by previous systemic treatment, NSCLC subtypes, and brain metastases.At the final analysis cutoff date (June 28, 2021), a total of 70 patients were enrolled and receiving savolitinib, and median follow-up was 28.4 (interquartile range: 26.2-36.3) months. The median OS was 12.5 months (95% confidence interval [CI]: 10.5-21.4 [18- and 24-mo OS rates, 42.1% and 31.5%, respectively]). Median OS in pretreated or treatment-naive patients was 19.4 (95% CI: 10.5-31.3) and 10.9 (95% CI: 7.5-14.0) months, respectively; it was 10.6 months (95% CI: 4.6-14.0) in patients with pulmonary sarcomatoid carcinoma, 17.3 months (95% CI: 10.6-23.6) in other NSCLC subtypes, and 17.7 months (95% CI: 10.5-not evaluable) in patients with brain metastases. No new safety signals emerged with prolonged follow-up and exposure.The updated results further confirm the favorable benefit and acceptable safety of savolitinib in Chinese patients with METex14-positive NSCLC.© 2022 The Authors.

基金：
This study was supported by funds provided to Dr. Lu by the National Key R&D Program of the People’s Republic of China (2016YFC1303300), the National Natural Science Foundation of China (82030045), Shanghai Municipal Science & Technology Commission Research Project (17431906103; 19411950500), Shanghai Chest Hospital Project of Collaborative Innovation (YJXT20190105), and the Clinical Research Plan of SHDC (16CR3005A; SHDC2020CR5001), and it was sponsored by HUTCHMED Limited and AstraZeneca. Medical writing support was provided by Lefteris Teperikidis and Jacqi Pan of Parexel International Limited, in accordance with Good Publication Practice 3 guidelines.
语种：
外文
被引次数：
WOS：
PubmedID：
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出版当年[2022]版：
无
最新[2023]版：
Q2 RESPIRATORY SYSTEM Q2 ONCOLOGY

影响因子： 最新[2023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[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People's Republic of China. [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, People’s Republic of China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People's Republic of China. [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, People’s Republic of China.
推荐引用方式(GB/T 7714)：
Lu Shun,Fang Jian,Li Xingya,et al.Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations[J].JTO CLINICAL AND RESEARCH REPORTS.2022,3(10):doi:10.1016/j.jtocrr.2022.100407.
APA：
Lu Shun,Fang Jian,Li Xingya,Cao Lejie,Zhou Jianying...&Su Weiguo.(2022).Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations.JTO CLINICAL AND RESEARCH REPORTS,3,(10)
MLA：
Lu Shun,et al."Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations".JTO CLINICAL AND RESEARCH REPORTS 3..10(2022)

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