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Multicenter randomized double-blind phase III trial of donafenib in progressive radioactive iodine-refractory differentiated thyroid cancer

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作者：
Lin Yansong[1] ; Qin Shukui[2] ; Yang Hui[3] ; Shi Feng[4] ; Yang Aimin[5] ; Han Xingmin[6] ; Liu Bin[7] ; Li Zhiyong[8] ; Ji Qinghai[9] ; Tang Lijun[10] ; Deng Zhiyong[11] ; Ding Yong[12] ; Fu Wei[13] ; Xie Xianhe[14] ; Li Linfa[15] ; He Xiaohui[16] ; Lv Zhongwei[17] ; Ma Qingjie[18] ; Shen Zan[19] ; Guo Zhuming[20] ; Chen Zhendong[21] ; Cui Yali[22] ; Tan Jian[23] ; Gao Zairong[24] ; Jing Shanghua[25] ; Lu Keyi[26] ; Luo Xianyang[27] ; Zhang Yuan[28] ; Fang Yong[29] ; Li Zhendong[30] ; Cheng Yizhuang[31] ; Lei Shangtong[32] ; Luan Sha[33] ; Chen Guang[34] ; Wang Guihua[35] ; Wu Liqing[36] ; Liu Lingling[36] ;
机构： [1]Peking Union Medical College Hospital, Beijing, China. [2]Nanjing Jinling Hospital, Nanjing, Jiangsu, China. [3]The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [4]Hunan Cancer Hospital, Changsha, China. [5]First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [6]First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [7]West China Hospital of Sichuan University, Chengdu, China. [8]The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. [9]Fudan University Shanghai Cancer Center, Shanghai, China. [10]The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. [11]Yunnan Cancer Hospital, Kunming, China. [12]The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. [13]Affiliated Hospital of Guilin Medical University, Guilin, China. [14]First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China. [15]Zhejiang Cancer Hospital, Hangzhou, China. [16]Cancer Institute and Hospital of CAMS, Beijing, China. [17]Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China. [18]China-Japan Union Hospital of Jilin University, Changchun, China. [19]Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, Shanghai, China. [20]Sun Yat-sen University Cancer Center, Guangzhou, China. [21]Dept. of Oncology, Hefei, China. [22]Harbin Medical University Cancer Hospital, Harbin, China. [23]Tianjin Medical University General Hospital, Tianjin, China. [24]Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. [25]Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [26]First Hospital of Shanxi Medical University, Taiyuan, China. [27]First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China. [28]Jiangsu Cancer Hospital, Nanjing, China. [29]Sir Run Run Shaw Hospital, ZheJiang University School of Medicine, Hangzhou, Zhejiang, China. [30]Liaoning Cancer Hospital and Institute, China. [31]The First Affiliated Hospital of University of Science and Technology of China, Hefei, China. [32]Nanfang Hospital, Southern Medical University, Guangzhou, China. [33]Fourth Affiliated Hospital of Harbin Medical University, Harbin, China. [34]First Hospital of Jilin University, changchun, China. [35]Changsha Central Hospital, Changsha, China. [36]Suzhou Zelgen Biopharmaceuticals Co., Ltd, Suzhou, China.
出处：
DOI： 10.1158/1078-0432.CCR-22-3613
ISSN：

摘要：
The phase II/III study of donafenib was initiated when there was no available treatment indicated for Chinese patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). Donafenib, an oral tyrosine kinase inhibitor (TKI), showed good efficacy and tolerability in the phase II study. We aimed to further evaluate the antitumour activity and safety of donafenib in Chinese RAIR-DTC patients.This multicenter, double-blind, placebo-controlled, phase III study enrolled 191 patients with progressive RAIR-DTC and randomized in a ratio of 2:1 to donafenib (300 mg twice daily, n=128) or matched placebo (n=63). An open-label donafenib treatment period was allowed upon disease progression. The primary endpoint was progression-free survival (PFS) assessed by the independent review committee. The second endpoints include objective response rate (ORR), disease control rate (DCR), safety, etc. Results: Donafenib demonstrated prolonged median PFS over placebo (12.9 vs. 6.4 months, HR 0.39, 95% CI 0.25-0.61, p<0.0001) in Chinese RAIR-DTC patients. Improved ORR (23.3% vs. 1.7%, p=0.0002) and DCR (93.3% vs. 79.3%,p=0.0044) were observed in the donafenib group over placebo. For donafenib, the most common grade ≥3 treatment-related adverse events included hypertension (13.3%) and hand-foot syndrome (12.5%), 42.2% underwent dose reduction or interruption and 6.3% experienced discontinuation.Donafenib was well-tolerated, and demonstrated clinical benefit in terms of improved PFS, ORR and DCRin patients with RAIR-DTC. The results suggest that donafenib could be a new treatment option for RAIR-DTC patients.

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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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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]Peking Union Medical College Hospital, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Lin Yansong,Qin Shukui,Yang Hui,et al.Multicenter randomized double-blind phase III trial of donafenib in progressive radioactive iodine-refractory differentiated thyroid cancer[J].CLINICAL CANCER RESEARCH.2023,29(15):2791-2799.doi:10.1158/1078-0432.CCR-22-3613.
APA：
Lin Yansong,Qin Shukui,Yang Hui,Shi Feng,Yang Aimin...&Liu Lingling.(2023).Multicenter randomized double-blind phase III trial of donafenib in progressive radioactive iodine-refractory differentiated thyroid cancer.CLINICAL CANCER RESEARCH,29,(15)
MLA：
Lin Yansong,et al."Multicenter randomized double-blind phase III trial of donafenib in progressive radioactive iodine-refractory differentiated thyroid cancer".CLINICAL CANCER RESEARCH 29..15(2023):2791-2799

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