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Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Wu Xiaohua[1,*1] * ; Sun Yang[2] ; Yang Hongying[3] ; Wang Jing[4] ; Lou Hanmei[5] ; Li Dan[6] ; Wang Ke[7] ; Zhang Hui[8] ; Wu Tao[9] ; Li Yuzhi[10] ; Wang Chunyan[11] ; Li Guiling[12] ; Wang Yifeng[13] ; Li Dapeng[14] ; Tang Ying[15] ; Pan Mei[16] ; Cai Hongyi[17] ; Wang Weihu[18] ; Yang Bing[19] ; Qian Hua[20] ; Tian Qiuhong[21] ; Yao Desheng[22] ; Cheng Ying[23] ; Wei Bing[24] ; Li Xiumin[25] ; Wang Tao[26] ; Hao Min[27] ; Wang Xiaohong[28] ; Wang Tiejun[29] ; Ran Juntao[30] ; Zhu Hong[31] ; Zhu Lijing[32] ; Liu Xianling[33] ; Li Yunxia[34] ; Chen Lihong[35] ; Li Qingshan[36] ; Yan Xiaojian[37] ; Wang Fei[38] ; Cai Hongbing[39] ; Zhang Yunyan[40] ; Liang Zhiqing[41] ; Liu Funan[42] ; Huang Yi[43] ; Xia Bairong[44] ; Qu Pengpeng[45] ; Zhu Genhai[46] ; Chen Youguo[47] ; Song Kun[48] ; Sun Meili[49] ; Chen Zhengzheng[50] ; Zhou Qiang[51] ; Hu Lina[52] ; Abulizi Guzhalinuer[53] ; Guo Hongyan[54] ; Liao Sihai[55] ; Ye Yijing[56] ; Yan Ping[57] ; Tang Qiu[58] ; Sun Guoping[59] ; Liu Ting[60] ; Lu Dongmei[60] ; Hu Mingxiu[60] ; Wang Zhongmin M[60] ; Li Baiyong[60] ; Xia Michelle[60] ;
机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wu.xh@fudan.edu.cn. [2]Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China. [3]Yunnan Cancer Hospital, Kunming, China. [4]Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [5]Zhejiang Cancer Hospital, Hangzhou, China. [6]The Affiliated Hospital of Southwest Medical University, Luzhou, China. [7]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [8]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [9]Changde First People's Hospital, Changde, China. [10]The First Affiliated Hospital of Bengbu Medical University, Bengbu, China. [11]Liaoning Cancer Hospital and Institute, Shenyang, China. [12]Union Hospital Affiliated to Tongji Medical College, Wuhan, China. [13]Zhujiang Hospital of Southern Medical University, Guangzhou, China. [14]Cancer Hospital of Shandong First Medical University, Jinan, China. [15]Affiliated Cancer Hospital of Chongqing University, Chongqing, China. [16]Jiangxi Maternal and Child Health Hospital, Nanchang, China. [17]Gansu Provincial Hospital, Lanzhou, China. [18]Beijing Cancer Hospital, Beijing, China. [19]Affiliated Hospital of Zunyi Medical University, Zunyi, China. [20]Taizhou People's Hospital Affiliated to Nanjing Medical University, Taizhou, China. [21]The First Affiliated Hospital of Nanchang University, Nanchang, China. [22]Guangxi Medical University Cancer Hospital and Guangxi Cancer Institute, Nanning, China. [23]Jilin Cancer Hospital, Changchun, China. [24]The Second Hospital of Anhui Medical University, Hefei, China. [25]Linyi Cancer Hospital, Linyi, China. [26]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [27]The Second Hospital of Shanxi Medical University, Taiyuan, China. [28]The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China. [29]The Second Hospital of Jilin University, Changchun, China. [30]The First Hospital of Lanzhou University, Lanzhou, China. [31]Xiangya Hospital Central South University, Changsha, China. [32]The Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [33]The Second Xiangya Hospital, Central South University, Changsha, China. [34]General Hospital of Ningxia Medical University, Yinchuan, China. [35]Shaanxi Provincial People's Hospital, Xi'an, China. [36]Affiliated Hospital of Chengde Medical University, Chengde, China. [37]The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [38]Shandong Provincial Hospital, Jinan, China. [39]Zhongnan Hospital Affiliated to Wuhan University, Wuhan, China. [40]Affiliated Cancer Hospital of Harbin Medical University, Harbin, China. [41]The First Affiliated Hospital of Army Military Medical University, Chongqing, China. [42]The First Hospital of China Medical University, Shenyang, China. [43]Hubei Cancer Hospital, Wuhan, China. [44]Anhui Provincial Cancer Hospital, Hefei, China. [45]Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China. [46]Hainan General Hospital, Haikou, China. [47]The First Affiliated Hospital of Soochow University, Suzhou, China. [48]Qilu Hospital of Shandong University, Jinan, China. [49]Jinan Central Hospital, Jinan, China. [50]The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China. [51]Suining Central Hospital, Suining, China. [52]The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. [53]Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, China. [54]Peking University Third Hospital, Beijing, China. [55]Affiliated Hospital of Guangdong Medical University, Zhanjiang, China. [56]Zhongshan City People's Hospital, Zhongshan, China. [57]Hebei General Hospital, Shijiazhuang, China. [58]Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China. [59]The First Affiliated Hospital of Anhui Medical University, Hefei, China. [60]Akeso Biopharma, Zhongshan, China.
出处：
DOI： 10.1016/S0140-6736(24)02135-4
ISSN：

摘要：
Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4, which has shown substantial clinical benefits in advanced cervical cancer. In the COMPASSION-16 trial, we aimed to evaluate the addition of cadonilimab to first-line standard chemotherapy in persistent, recurrent, or metastatic cervical cancer.In this randomised, double-blind, multicentre, placebo-controlled phase 3 trial, women aged 18-75 years across 59 clinical sites in China with previously untreated persistent, recurrent, or metastatic cervical cancer were randomly assigned (1:1) to receive cadonilimab (10 mg/kg) or placebo plus platinum-based chemotherapy with or without bevacizumab every 3 weeks for six cycles, followed by maintenance therapy every 3 weeks for up to 2 years. Randomisation was performed centrally through an interactive web-response system. Stratification factors were the use of bevacizumab (yes or no) and previous concurrent chemoradiotherapy (yes or no). The dual primary outcomes were progression-free survival as assessed by blinded independent central review and overall survival in the full analysis set. This study is registered with ClinicalTrials.gov, NCT04982237; the study has completed enrolment and is ongoing for treatment and follow-up.445 eligible women were enrolled between Sept 11, 2021, and June 23, 2022. Median progression-free survival was 12·7 months (95% CI 11·6-16·1) in the cadonilimab group and 8·1 months (7·7-9·6) in the placebo group (hazard ratio 0·62 [95% CI 0·49-0·80], p<0·0001); median overall survival was not reached (27·0 months to not estimable) versus 22·8 months (17·6-29·0), respectively (hazard ratio 0·64 [0·48-0·86], p=0·0011). The most common grade 3 or higher adverse events were decreased neutrophil count, decreased white blood cell count, and anaemia.The addition of cadonilimab to first-line standard chemotherapy significantly improved progression-free survival and overall survival with a manageable safety profile in participants with persistent, recurrent, or metastatic cervical cancer. The data support the use of cadonilimab plus chemotherapy as an efficacious first-line therapy in persistent, recurrent, or metastatic cervical cancer.Akeso Biopharma.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

基金：
This study was supported by Akeso Biopharma
语种：
外文
被引次数：
WOS：
PubmedID：
中科院分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2024]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2024]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2024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 Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wu.xh@fudan.edu.cn. [*1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China
通讯作者：
通讯机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wu.xh@fudan.edu.cn. [*1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China
推荐引用方式(GB/T 7714)：
Wu Xiaohua,Sun Yang,Yang Hongying,et al.Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China[J].Lancet (London, England).2024,404(10463):1668-1676.doi:10.1016/S0140-6736(24)02135-4.
APA：
Wu Xiaohua,Sun Yang,Yang Hongying,Wang Jing,Lou Hanmei...&Xia Michelle.(2024).Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China.Lancet (London, England),404,(10463)
MLA：
Wu Xiaohua,et al."Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China".Lancet (London, England) 404..10463(2024):1668-1676

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