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.河南省肿瘤医院[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.四川大学华西医院[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.江苏省人民医院[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.浙江省肿瘤医院[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.吉林大学中日联谊医院[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.华中科技大学同济医学院附属协和医院[25]Fourth Hospital of Hebei Medical University, Shijiazhuang, China.河北医科大学第四医院[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.
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.
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
医学