科研成果详情

题名Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies
作者
Yang, Sheng1; Wu, Shiman2; Zhao, Yanqiu3; Chen, Gongyan4; Zhu, Bo5; Li, Xingya6; Wang, Ke7; Shi, Jianhua8; Cang, Shundong9; Yao, Wenxiu10; Fan, Yun11; Fang, Jian12; Zhang, Liangming13; Zhou, Jianying14; Wu, Lin15; Zheng, Rongsheng16; Huang, Meijuan17; Pan, Yueyin18; Yang, Zhixiong19; Sun, Meili20; Yu, Huiqing21; Wang, Donglin21; Huang, Jianan22; Wang, Lijun23; Shu, Yongqian24; Chen, Zhaohong25; Liu, Chunling26; Li, Jingzhang27; Liu, Jiwei28; Sun, Shenghua29; Guo, Yanzhen30; Meng, Zili31; Liu, Zhefeng32; Han, Zhigang26; Wu, Gang33; Lu, Hong34; Ma, Rui35; Hu, Sheng36; Zhao, Guofang37; Zhang, Longzhen38; Liu, Zheng39; Xie, Congying40; Zhong, Diansheng41; Zhao, Hui42; Bi, Minghong16; Yi, Shanyong43; Guo, Shuliang44; Yi, Tienan45; Li, Wen46; Lin, Yingcheng47; Chen, Zhendong48; Zhuang, Zhixiang49; Guo, Zhongliang50; Greco, Michael51; Wang, Tingting52; Zhou, Anqi52; Shi, Yuankai1
发表日期2023-06
发表期刊LUNG CANCER   影响因子和分区
语种英语
原始文献类型Article
关键词Rezivertinib BPI-7711 EGFR T790M mutation CNS NSCLC
其他关键词OSIMERTINIB ; CRITERIA ; SAFETY ; TKIS
摘要Background: Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyro-sine 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.Methods: 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 (& GE;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.Results: 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.Conclusions: Rezivertinib demonstrated encouraging clinical CNS efficacy among advanced NSCLC patients with EGFR T790M mutation and CNS metastases.
资助项目Beta Pharma (Shanghai) Co., Ltd. Shanghai, People's Republic of China [NCT03812809, 81972805]; Shanghai, People's Republic of China; China National Major Project for New Drug Innovation [NCT03386955]; New National Natural Science Foundation of China [82172856]; [2017ZX09304015]
出版者ELSEVIER IRELAND LTD
ISSN0169-5002
EISSN1872-8332
卷号180
DOI10.1016/j.lungcan.2023.107194
页数11
WOS类目Oncology ; Respiratory System
WOS研究方向Oncology ; Respiratory System
WOS记录号WOS:001015396600001
收录类别SCIE ; SCOPUS ; PUBMED
在线发表日期2023-05
URL查看原文
Pubmed记录号37163774
Scopus记录号2-s2.0-85158912995
通讯作者地址[Shi, Yuankai]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,China
scopus学科分类Oncology;Pulmonary and Respiratory Medicine;Cancer Research
引用统计
文献类型期刊论文
条目标识符https://kms.wmu.edu.cn/handle/3ETUA0LF/184011
专题附属第一医院_放化疗科
通讯作者Shi, Yuankai
作者单位
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,China;
2.Department of Respiratory Medicine,The First Hospital of Shanxi Medical University,Taiyuan,China;
3.Department of Respiratory Medicine,The Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou,China;
4.Department of Respiratory Medicine,Harbin Medical University Cancer Hospital,Harbin,China;
5.Department of Oncology,Institute of Cancer,Xinqiao Hospital,Third Military Medical University,Chongqing,China;
6.Department of Oncology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China;
7.Department of Respiratory and Critical Care Medicine,West China Hospital of Sichuan University,Chengdu,China;
8.Department of Medical Oncology,Linyi Cancer Hospital,Linyi,China;
9.Department of Medical Oncology,Henan Provincial People's Hospital,Zhengzhou,China;
10.Department of Medical Oncology,Sichuan Cancer Hospital,Chengdu,China;
11.Department of Medical Oncology,Zhejiang Cancer Hospital,Hangzhou,China;
12.Department of Thoracic Oncology,Beijing Cancer Hospital,Beijing,China;
13.Department of Medical Oncology,Yantai Yuhuangding Hospital,Yantai,China;
14.Department of Respiratory Medicine,The First Affiliated Hospital,Zhejiang University,School of Medicine,Hangzhou,China;
15.Department of Thoracic Medical Oncology,Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University,Changsha,China;
16.Department of Medical Oncology,The First Affiliated Hospital of Bengbu Medical College,Bengbu,China;
17.Thoracic Oncology Ward,Division of Medical Oncology,West China Hospital,Sichuan University,Chengdu,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,China;
19.Cancer Center,Affiliated Hospital of Guangdong Medical University,Zhanjiang,China;
20.Department of Oncology,Jinan Central Hospital Shandong University,Jinan,China;
21.Department of Palliative Care,Department of Geriatric Oncology,Chongqing University Cancer Hospital,Chongqing,China;
22.Department of Respiratory and Critical Care Medicine,The First Affiliated Hospital of Soochow University,Suzhou,China;
23.Cancer Center,The Second Affiliated Hospital of Xingtai Medical College,Xingtai,China;
24.Department of Oncology,Jiangsu Province Hospital,Nanjing,China;
25.Department of Oncology,People's Hospital of Deyang City,Deyang,China;
26.Pulmonary Cancer Medicine,Affiliated Tumor Hospital of Xinjiang Medical University,Urumqi,China;
27.Department of Oncology,Liuzhou People's Hospital,Liuzhou,China;
28.Department of Oncology,The First Affiliated Hospital of Dalian Medical University,Dalian,China;
29.Department of Respiratory Medicine,Third Xiangya Hospital of Central South University,Changsha,China;
30.Department of Medical Oncology,The First Affiliated Hospital of Henan University of Science & Technology,Luoyang,China;
31.Department of Respiratory Medicine,The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University,Huaian,China;
32.Department of Oncology,Chinese PLA General Hospital,Beijing,China;
33.Cancer Center,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China;
34.Department of Oncology,Huaihe Hospital of Henan University,Kaifeng,China;
35.Department of Thoracic Oncology,Liaoning Cancer Hospital & Institute,Shenyang,China;
36.Department of Thoracic Oncology,Hubei Cancer Hospital,Wuhan,China;
37.Department of Thoracic Surgery,Hwa Mei Hospital,University of Chinese Academy of Sciences,Ningbo,China;
38.Department of Radiotherapy,The Affiliated Hospital of Xuzhou Medical University,Xuzhou,China;
39.Department of Oncology,HanDan Central Hospital,Handan,China;
40.Department of Radiotherapy,The 1st Affiliated Hospital of Wenzhou Medical University,Wenzhou,China;
41.Department of Medical Oncology,Tianjin Medical University General Hospital,Tianjin,China;
42.Department of Respiratory Medicine,The Second Hospital of Anhui Medical University,Hefei,China;
43.Department of Medical Oncology,Zhengzhou Central Hospital Affiliated to Zhengzhou University,Zhengzhou,China;
44.Department of Respiratory Medicine,The First Affiliated Hospital of Chongqing Medical University,Chongqing,China;
45.Department of Oncology,Xiangyang Central Hospital,Affiliated Hospital of Hubei University of Arts and Sciences,Xiangyang,China;
46.Department of Respiratory and Critical Care Medicine,The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,China;
47.Department of Medical Oncology,Cancer Hospital of Shantou University Medical College,Shantou,China;
48.Department of Oncology,The Second Hospital of Anhui Medical University,Hefei,China;
49.Department of Oncology,The Second Affiliated Hospital of Soochow University,Suzhou,China;
50.Department of Respiratory Medicine,Shanghai East Hospital,Shanghai,China;
51.Department of Drug Discovery,Beta Pharma Inc.,Princeton,United States;
52.Department of Clinical Development,Beta Pharma (Shanghai) Co.,Ltd.,Shanghai,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.
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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