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Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Shi Yuankai[1] * ; Guo Wei[2] * ; Wang Wei[3] * ; Wu Yunteng[2] ; Fang Meiyu[4] ; Huang Xiaoming[5] ; Han Ping[5] ; Zhang Qingyuan[6] ; Dong Pin[7] ; Zhou Xiaohong[8] ; Peng Hanwei[9] ; Hu Chunhong[10] ; Chen Xiaopin[11] ; Zhang Shurong[12] ; Chang Zhiwei[13] ; Li Xiaojiang[14] ; Ding Yuhai[15] ; Qu Song[16] ; Jing Shanghua[17] ; Zhang Songnan[18] ; Gui Lin[19] ; Sun Yan[20] ; Wang Lin[21] ; Liu Yanyan[22] ; Wu Hui[22] ; Li Guoqing[23] ; Fu Zhichao[24] ; Shi Jianhua[25] ; Jiang Hao[26] ; Bai Yuansong[27] ; Cui Jiuwei[28] ; Zheng Yulong[29] ; Cui Wei[30] ; Jia Xiaojing[31] ; Zhai Limin[32] ; Cai Qingqing[33] ; Xiong Deming[34] ; Wu Yunong[35] ; Cao Junning[36] ; Wu Rong[37] ; Hu Guangyuan[38] ; Peng Liang[39] ; Xie Liangzhi[40] ; Gai Wenlin[40] ; Wang Yan[40] ; Su Yuehua[40] ;
机构： [1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. [2]Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China. [3]Hunan Cancer Hospital, Changsha, China. [4]Zhejiang Cancer Hospital, Hangzhou, China. [5]Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. [6]Harbin Medical University Cancer Hospital, Harbin, China. [7]Shanghai General Hospital, Shanghai, China. [8]Chongqing University Cancer Hospital, Chongqing, China. [9]Cancer Hospital of Shantou University Medical College, Shantou, China. [10]The Second Xiangya Hospital of Central South University, Changsha, China. [11]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [12]Beijing Tongren Hospital, Capital Medical University, Beijing, China. [13]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [14]Yunnan Cancer Hospital, Kunming, China. [15]Ganzhou People's Hospital, Ganzhou, China. [16]Guangxi Medical University Cancer Hospital, Nanning, China. [17]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [18]Yanbian University Hospital, Yanji, China. [19]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. [20]Peking University Cancer Hospital, Beijing, China. [21]Hainan General Hospital, Haikou, China. [22]Henan Cancer Hospital, Zhengzhou, China. [23]Jiangxi Cancer Hospital, Nanchang, China. [24]The 900 Hospital of Joint Logistics Support Force of PLA, Fuzhou, China. [25]LinYi Cancer Hospital, Linyi, China. [26]Department of Radiation Oncology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China. [27]The Third Bethune Hospital of Jilin University, Changchun, China. [28]The First Hospital of Jilin University, Changchun, China. [29]The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. [30]Affiliated Hospital of Jining Medical University, Jining, China. [31]The Second Norman Bethune Hospital of Jilin University, Changchun, China. [32]Shandong First Medical University Affiliated Cancer Hospital, Jinan, China. [33]Sun Yat-sen University Cancer Center, Guangzhou, China. [34]Chongqing University Three Gorges Hospital, Chongqing, China. [35]Stomatological College of Nanjing Medical University, Nanjing, China. [36]Fudan University Shanghai Cancer Center, Shanghai, China. [37]Shengjing Hospital of China Medical University, Shenyang, China. [38]Tongji Medical College of HUST, Wuhan, China. [39]Chinese PLA General Hospital, Beijing, China. [40]Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.
出处：
DOI： 10.1038/s41591-024-03110-7
ISSN：

摘要：
Immunotherapy combined with chemotherapy regimen has been shown to be effective in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). However, due to the small number of patients, its efficacy remains controversial in Asian populations, particularly in mainland China. Here a randomized, double-blind phase 3 trial evaluated the efficacy and safety of finotonlimab (SCT-I10A), a programmed cell death 1 (PD-1) monoclonal antibody, combined with cisplatin plus 5-fluorouracil (C5F) for the first-line treatment of R/M HNSCC. Eligible patients (n = 370) were randomly 2:1 assigned to receive finotonlimab plus C5F (n = 247) or placebo plus C5F (n = 123). The primary endpoint was overall survival (OS). In the finotonlimab plus C5F group, OS was 14.1 months (95% confidence interval (CI) 11.1-16.4), compared with 10.5 months (95% CI 8.1-11.8) in the placebo plus C5F group. The hazard ratio was 0.73 (95% CI 0.57-0.95, P = 0.0165), meeting the predefined superiority criteria for the primary endpoint. Finotonlimab plus C5F showed significant OS superiority compared with C5F alone and acceptable safety profile with R/M HNSCC, supporting its use as a first-line treatment option for R/M HNSCC. These results validate the efficacy and safety of the combination of finotonlimab and C5F in Asian patients with R/M HNSCC. ClinicalTrials.gov identifier: NCT04146402 .© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.

基金：
This study was sponsored by Sinocelltech Ltd., Beijing, China, who contributed to trial design, data analyses and preparation of the manuscript. This study was funded by the National Key Research and Development Program of China (2023YFC3042100) and the National Science and Technology Major Projects for Key New Drug Development of China (2019ZX09732-001 and 2017ZX09304015).
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外文
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中科院分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学 1 区 医学：研究与实验
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学 1 区 医学：研究与实验
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出版当年[2024]版：
无
最新[2023]版：
Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 CELL BIOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Shi Yuankai,Guo Wei,Wang Wei,et al.Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial[J].Nature Medicine.2024,30(9):doi:10.1038/s41591-024-03110-7.
APA：
Shi Yuankai,Guo Wei,Wang Wei,Wu Yunteng,Fang Meiyu...&Su Yuehua.(2024).Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial.Nature Medicine,30,(9)
MLA：
Shi Yuankai,et al."Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial".Nature Medicine 30..9(2024)

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