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
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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 |
ISSN | 0169-5002 |
EISSN | 1872-8332 |
卷号 | 180 |
DOI | 10.1016/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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