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Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study

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机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing. [2]Department of Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha. [3]Department of Urology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Affiliated Cancer Hospital of Nanjing Medical University, Nanjing. [4]Department of Urology, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi. [5]Department of Urology, First Hospital of Peking University, Beijing. [6]Department of Urology, Shengjing Hospital of China Medical University, Shenyang. [7]Department of Urology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an. [8]Department of Urology, Cancer Hospital of Henan Province, Zhengzhou. [9]Department of Urology, The First Affiliated Hospital, Fujian Medical University, Fuzhou. [10]Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing. [11]Department of Urology, Harbin Medical University Cancer Hospital, Harbin. [12]Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu. [13]Department of Oncology, The First Hospital of China Medical University, Shenyang. [14]Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing. [15]Department of Urology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang. [16]Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai. [17]Department of Urology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu. [18]Department of Urology, Provincial Hospital Affiliated to Shandong First Medical University, Jinan. [19]Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou. [20]Department of Immunology and Biotherapy, Cancer Institute & Hospital, Tianjin Medical University, Tianjin. [21]Department of Medical Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun. [22]Department of Urology, Xijing Hospital of Air Force Military Medical University, Xi'an. [23]Department of Urology, The Third Medical Center, Chinese PLA General Hospital, Beijing. [24]Department of Urology, Sun Yat-sen University Cancer Center, Guangzhou. [25]Department of Urology, Peking University Third Hospital, Beijing. [26]Department of Urology, Zhongshan Hospital, Fudan University, Shanghai. [27]Department of Urology, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou. [28]Department of Urology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan. [29]Department of Urology, The Affiliated Hospital of Jiaxing University, Jiaxing. [30]Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing. [31]Department of Urology, Qilu Hospital of Shandong University, Jinan. [32]Department of Urology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou. [33]Department of Urology, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan. [34]Department of Oncology, General Hospital of Ningxia Medical University, Yinchuan. [35]Department of Urology, The Second Hospital of Lanzhou University, Lanzhou. [36]Department of Urology, Fujian Medical University Union Hospital, Fuzhou. [37]Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming. [38]Department of Urology, The First Affiliated Hospital of Soochow University, Suzhou. [39]Department of Urology, Peking University People's Hospital, Beijing. [40]Department of Urology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou. [41]Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang. [42]Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing. [43]Department of Urology, Huashan Hospital, Fudan University, Shanghai. [44]Department of Urology, The Second Affiliated Hospital of Anhui Medical University, Hefei. [45]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. [46]Department of Urology, The PLA General Hospital Army Characteristic Medical Center, Chongqing. [47]Shanghai Junshi Biosciences Co., Ltd., Shanghai. [48]Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
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关键词: advanced renal cell carcinoma progression-free survival toripalimab axitinib sunitinib

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Immune checkpoint inhibitors in combination with tyrosine kinase inhibitors are standard treatments for advanced clear cell renal cell carcinoma (RCC). This phase III RENOTORCH study compared the efficacy and safety of toripalimab plus axitinib versus sunitinib for the first-line treatment of patients with intermediate-/poor-risk advanced RCC.Patients with intermediate-/poor-risk unresectable or metastatic RCC were randomized in a ratio of 1 : 1 to receive toripalimab (240 mg intravenously once every 3 weeks) plus axitinib (5 mg orally twice daily) or sunitinib [50 mg orally once daily for 4 weeks (6-week cycle) or 2 weeks (3-week cycle)]. The primary endpoint was progression-free survival (PFS) assessed by an independent review committee (IRC). The secondary endpoints were investigator-assessed PFS, overall response rate (ORR), overall survival (OS), and safety.A total of 421 patients were randomized to receive toripalimab plus axitinib (n = 210) or sunitinib (n = 211). With a median follow-up of 14.6 months, toripalimab plus axitinib significantly reduced the risk of disease progression or death by 35% compared with sunitinib as assessed by an IRC [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.86; P = 0.0028]. The median PFS was 18.0 months in the toripalimab-axitinib group, whereas it was 9.8 months in the sunitinib group. The IRC-assessed ORR was significantly higher in the toripalimab-axitinib group compared with the sunitinib group (56.7% versus 30.8%; P < 0.0001). An OS trend favoring toripalimab plus axitinib was also observed (HR 0.61, 95% CI 0.40-0.92). Treatment-related grade ≥3 adverse events occurred in 61.5% of patients in the toripalimab-axitinib group and 58.6% of patients in the sunitinib group.In patients with previously untreated intermediate-/poor-risk advanced RCC, toripalimab plus axitinib provided significantly longer PFS and higher ORR than sunitinib and had a manageable safety profile TRIAL REGISTRATION: ClinicalTrials.gov NCT04394975.Copyright © 2023 Shanghai Junshi Biosciences Co. LTD. Published by Elsevier Ltd.. All rights reserved.

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大类 | 1 区 医学
小类 | 1 区 肿瘤学
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大类 | 1 区 医学
小类 | 1 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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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.
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通讯机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing. [48]Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China. [*2]Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Number 1630 Dong Fang Road, Shanghai 200127, China
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