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Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT)

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收录情况： ◇ SCIE

作者：
Sheng Xinan[1] ; Ye Dingwei[2] ; Zhou Aiping[3] ; Yao Xin[4] ; Luo Hong[5] ; He Zhisong[6] ; Wang Zengjun[7] ; Zhao Yingchao[8] ; Ji Zhigang[9] ; Zou Qing[10] ; He Chaohong[11] ; Guo Jianming[12] ; Tu Xinhua[13] ; Liu Ziling[14] ; Shi Benkang[15] ; Liu Ben[16] ; Chen Peng[17] ; Wei Qiang[18] ; Hu Zhiquan[19] ; Zhang Yanqiao[20] ; Jiang Kui[21] ; Zhou Fangjian[22] ; Wu Dapeng[23] ; Fu Cheng[24] ; Li Xingya[25] ; Wu Bin[26] ; Wang Lijie[27] ; Qin Shukui[28] ; Li Gang[29] ; Liu Yunpeng[30] ; Guo Hongqian[31] ; Chen Kehe[32] ; Zhang Dahong[33] ; Wang Gongxian[34] ; Ding Lieming[35] ; Wang Yang[35] ; Yuan Xiaobin[35] ; Guo Jun[1] ;
机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, China. [2]Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China. [3]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. [4]Department of Genitourinary Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [5]Department of Urologic Oncology, Chongqing University Cancer Hospital, Chongqing, China. [6]Department of Urology, Peking University First Hospital, Beijing, China. [7]Department of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China. [8]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [9]Urology Department, Peking Union Medical College Hospital, Beijing, China. [10]Department of Urology, Jiangsu Cancer Hospital, Nanjing, China. [11]Department of Urology, Cancer Hospital of Henan Province, Zhengzhou, China. [12]Urology, Zhongshan Hospital, Fudan University, Shanghai, China. [13]Department of Urology, Jiangxi Province Tumor Hospital, Nanchang, China. [14]Department of Oncology, The First Hospital of Jilin University, Changchun, China. [15]Department of Urology, Qilu Hospital of Shandong University, Jinan, China. [16]Department of Urology, The First Affiliated Hospital, School of Medical, Zhejiang University, Hangzhou, China. [17]Department of Urology, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China. [18]Department of Urology, West China Hospital Sichuan University, Chengdu, China. [19]Department of Urology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. [20]Gastroenterology Department II, Harbin Medical University Cancer Hospital, Harbin, China. [21]Department of Gynecological and Genitourinary Medical Oncology, The Second Hospital of Dalian Medical University, Dalian, China. [22]Urology, Cancer Center, Sun Yat-sen University, Guangzhou, China. [23]Department of Urology, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China. [24]Department of Urology, Liaoning Cancer Hospital & Institute, Shenyang, China. [25]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [26]Department of Urology, Shengjing Hospital of China Medical University, Shenyang, China. [27]Department of Oncology, Chinese PLA General Hospital, Beijing, China. [28]Department of Oncology, Qinhuai Medical Area, Theater General Hospital of PLA, Nanjing, China. [29]Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China. [30]Department of Oncology, The First Hospital of China Medical University, Shenyang, China. [31]Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [32]Department of Medical Oncology II, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China. [33]Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, China. [34]Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China. [35]Betta Pharmaceuticals Co., Ltd., Hangzhou, China.
出处：
DOI： 10.1016/j.ejca.2022.10.025
ISSN：

关键词： Vorolanib Everolimus Renal cell carcinoma VEGFR mTOR

摘要：
Vorolanib is a highly potent tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor. This three-arm, randomised, registered study aimed to assess the combination of vorolanib and everolimus or vorolanib alone versus a control arm of everolimus as second-line treatment in patients with metastatic renal cell carcinoma (RCC).Patients with advanced or metastatic RCC who had received one prior VEGFR-TKI were randomised (1:1:1) to receive the combination of vorolanib and everolimus or either monotherapy. Patients with brain metastases were excluded. The primary end-point was progression-free survival (PFS) assessed by the independent review committee per Response Evaluation Criteria in Solid Tumours v1.1.Between 10th March 2017 and 30th May 2019, 399 patients (133 in each group) were enrolled. By the cutoff date (30th April 2020), a significant improvement in PFS was detected in the combination group compared with the everolimus group (10.0 versus 6.4 months; hazard ratio, 0.70; P = 0.0171). PFS was similar between the vorolanib group and the everolimus group (median: 6.4 versus 6.4 months; hazard ratio, 0.94; P = 0.6856). A significantly higher objective response rate was observed in the combination group than in the everolimus group (24.8% versus 8.3%; P = 0.0003), whereas there was no significant difference between the vorolanib group and the everolimus group (10.5% versus 8.3%; P = 0.5278). The overall survival data were immature. A total of 96 (72.2%), 52 (39.1%) and 71 (53.4%) grade 3 or higher treatment-related adverse events occurred in the combination group, vorolanib group and everolimus group, respectively.The addition of vorolanib to everolimus as 2nd-line treatment for patients with advanced or metastatic RCC who have experienced cancer progression after VEGFR-TKI therapy provided a better objective response rate and PFS than everolimus alone with a manageable safety profile.ClinicalTrials.gov, NCT03095040; Chinadrugtrials, CTR20160987.Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2023]版：
Q1 ONCOLOGY
最新[2023]版：
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]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Sheng Xinan,Ye Dingwei,Zhou Aiping,et al.Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT)[J].EUROPEAN JOURNAL OF CANCER.2023,178:205-215.doi:10.1016/j.ejca.2022.10.025.
APA：
Sheng Xinan,Ye Dingwei,Zhou Aiping,Yao Xin,Luo Hong...&Guo Jun.(2023).Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT).EUROPEAN JOURNAL OF CANCER,178,
MLA：
Sheng Xinan,et al."Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT)".EUROPEAN JOURNAL OF CANCER 178.(2023):205-215

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