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Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies

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作者：
Yang Sheng[1] * ; Wu Shiman[2] ; Zhao Yanqiu[3] ; Chen Gongyan[4] ; Zhu Bo[5] ; Li Xingya[6] ; Wang Ke[7] ; Shi Jianhua[8] ; Cang Shundong[9] ; Yao Wenxiu[10] ; Fan Yun[11] ; Fang Jian[12] ; Zhang Liangming[13] ; Zhou Jianying[14] ; Wu Lin[15] ; Zheng Rongsheng[16] ; Huang Meijuan[17] ; Pan Yueyin[18] ; Yang Zhixiong[19] ; Sun Meili[20] ; Yu Huiqing[21] ; Wang Donglin[21] ; Huang Jianan[22] ; Wang Lijun[23] ; Shu Yongqian[24] ; Chen Zhaohong[25] ; Liu Chunling[26] ; Li Jingzhang[27] ; Liu Jiwei[28] ; Sun Shenghua[29] ; Guo Yanzhen[30] ; Meng Zili[31] ; Liu Zhefeng[32] ; Han Zhigang[33] ; Wu Gang[34] ; Lu Hong[35] ; Ma Rui[36] ; Hu Sheng[37] ; Zhao Guofang[38] ; Zhang Longzhen[39] ; Liu Zheng[40] ; Xie Congying[41] ; Zhong Diansheng[42] ; Zhao Hui[43] ; Bi Minghong[44] ; Yi Shanyong[45] ; Guo Shuliang[46] ; Yi Tienan[47] ; Li Wen[48] ; Lin Yingcheng[49] ; Chen Zhendong[50] ; Zhuang Zhixiang[51] ; Guo Zhongliang[52] ; Greco Michael[53] ; Wang Tingting[54] ; Zhou Anqi[54] ; Shi Yuankai[1,*1] ;
机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People’s Republic of China [2]Department of Respiratory Medicine, The First Hospital of Shanxi Medical University, Taiyuan, People’s Republic of China [3]Department of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China [4]Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, People’s Republic of China [5]Department of Oncology, Institute of Cancer, Xinqiao Hospital, Third Military Medical University, Chongqing, People’s Republic of China [6]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China [7]Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, People’s Republic of China [8]Department of Medical Oncology, Linyi Cancer Hospital, Linyi, People’s Republic of China [9]Department of Medical Oncology, Henan Provincial People’s Hospital, Zhengzhou, People’s Republic of China [10]Department of Medical Oncology, Sichuan Cancer Hospital, Chengdu, People’s Republic of China [11]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China [12]Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, People’s Republic of China [13]Department of Medical Oncology, Yantai Yuhuangding Hospital, Yantai, People’s Republic of China [14]Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, People’s Republic of China [15]Department of Thoracic Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, People’s Republic of China [16]Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China [17]Thoracic Oncology Ward, Division of Medical Oncology, West China Hospital, Sichuan University, Chengdu, People’s Republic of China [18]Department of Thoracic Cancer Chemotherapy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, People’s Republic of China [19]Cancer Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, People’s Republic of China [20]Department of Oncology, Jinan Central Hospital Shandong University, Jinan, People’s Republic of China [21]Department of Palliative Care, Department of Geriatric Oncology, Chongqing University Cancer Hospital, Chongqing, People’s Republic of China [22]Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China [23]Cancer Center, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, People’s Republic of China [24]Department of Oncology, Jiangsu Province Hospital, Nanjing, People’s Republic of China [25]Department of Oncology, People’s Hospital of Deyang City, Deyang, People’s Republic of China [26]Pulmonary Cancer Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, People’s Republic of China [27]Department of Oncology, Liuzhou People’s Hospital, Liuzhou, People’s Republic of China [28]Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, People’s Republic of China [29]Department of Respiratory Medicine, Third Xiangya Hospital of Central South University, Changsha, People’s Republic of China [30]Department of Medical Oncology, The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, People’s Republic of China [31]Department of Respiratory Medicine, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, People’s Republic of China [32]Department of Oncology, Chinese PLA General Hospital, Beijing, People’s Republic of China [33]Pulmonary Cancer Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, People’s Republic of China [34]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China [35]Department of Oncology, Huaihe Hospital of Henan University, Kaifeng, People’s Republic of China [36]Department of Thoracic Oncology, Liaoning Cancer Hospital & Institute, Shenyang, People’s Republic of China [37]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, People’s Republic of China [38]Department of Thoracic Surgery, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, People’s Republic of China [39]Department of Radiotherapy, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, People’s Republic of China [40]Department of Oncology, HanDan Central Hospital, Handan, People’s Republic of China [41]Department of Radiotherapy, The 1st Affiliated Hospital of Wenzhou Medical University, Wenzhou, People’s Republic of China [42]Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China [43]Department of Respiratory Medicine, The Second Hospital of Anhui Medical University, Hefei, People’s Republic of China [44]Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China [45]Department of Medical Oncology, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, People’s Republic of China [46]Department of Respiratory Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People’s Republic of China [47]Department of Oncology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Sciences, Xiangyang, People’s Republic of China [48]Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital Zhejiang University School of Medicine. Hangzhou, People’s Republic of China [49]Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou, People’s Republic of China [50]Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, People’s Republic of China [51]Department of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, People’s Republic of China [52]Department of Respiratory Medicine, Shanghai East Hospital, Shanghai, People’s Republic of China [53]Department of Drug Discovery, Beta Pharma Inc., Princeton, NJ, USA [54]Department of Clinical Development, Beta Pharma (Shanghai) Co., Ltd., Shanghai, People’s Republic of China
出处：
DOI： 10.1016/j.lungcan.2023.107194
ISSN：

摘要：
Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) which revealed the systematic and central nervous system (CNS) antitumor activities for EGFR T790M-mutated advanced NSCLC in previous clinical studies and is further analyzed here.Eligible patients from the previous phase I and phase IIb studies of rezivertinib were included for pooled analysis. Post-progressive patients who received a prescribed dosage (≥180 mg) of rezivertinib orally once daily were included in full analysis set (FAS), while those with stable, asymptomatic CNS lesions, including measurable and non-measurable ones at baseline were included in CNS full analysis set (cFAS). Patients with measurable CNS lesions were included in CNS evaluable for response set (cEFR). BICR-assessed CNS objective response rate (CNS-ORR), CNS disease control rate (CNS-DCR), CNS duration of response (CNS-DoR), CNS progression-free survival (CNS-PFS), and CNS depth of response (CNS-DepOR) were evaluated.355 patients were included in FAS, among whom 150 and 45 patients were included in cFAS and cEFR. This pooled analysis showed the CNS-ORR was 32.0% (48/150; 95% CI: 24.6-40.1%) and the CNS-DCR was 42.0% (63/150; 95% CI: 34.0-50.3%) in cFAS, while that in cEFR were 68.9% (31/45; 95% CI: 53.4-81.8%) and 100% (45/45; 95% CI: 92.1-100.0%). In cEFR, the median CNS-DepOR and the mean of CNS-DepOR were -52.0% (range: -100.0 to 16.1%) and -46.8% (95% CI: -55.5 to -38.1%). In cFAS, the median CNS-DoR and CNS-PFS were 13.8 (95% CI: 9.6-not calculable [NC]) and 16.5 (95% CI: 13.7-NC) months.Rezivertinib demonstrated encouraging clinical CNS efficacy among advanced NSCLC patients with EGFR T790M mutation and CNS metastases.Copyright © 2023 Elsevier B.V. All rights reserved.

基金：
In this pooled analysis, both previous clinical studies (NCT03386955; NCT03812809) were funded by Beta Pharma (Shanghai) Co., Ltd. Shanghai, People’s Republic of China, and partly supported by the China National Major Project for New Drug Innovation (2017ZX09304015) and the New National Natural Science Foundation of China (81972805; 82172856).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2023]版：
Q1 RESPIRATORY SYSTEM Q1 ONCOLOGY
最新[2023]版：
Q1 RESPIRATORY SYSTEM Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People’s Republic of China
通讯作者：
通讯机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People’s Republic of China [*1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs. No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, People’s Republic of China.
推荐引用方式(GB/T 7714)：
Yang Sheng,Wu Shiman,Zhao Yanqiu,et al.Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies[J].LUNG CANCER.2023,180:doi:10.1016/j.lungcan.2023.107194.
APA：
Yang Sheng,Wu Shiman,Zhao Yanqiu,Chen Gongyan,Zhu Bo...&Shi Yuankai.(2023).Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies.LUNG CANCER,180,
MLA：
Yang Sheng,et al."Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies".LUNG CANCER 180.(2023)

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