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Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Huang Jing[1] * ; Xu Jianming[2,*1] * ; Chen Yun[3] * ; Zhuang Wu[4] ; Zhang Yiping[5] ; Chen Zhendong[6] ; Chen Jia[7] ; Zhang Helong[8] ; Niu Zuoxing[9] ; Fan Qingxia[10] ; Lin Lizhu[11] ; Gu Kangsheng[12] ; Liu Ying[13] ; Ba Yi[14] ; Miao Zhanhui[15] ; Jiang Xiaodong[16] ; Zeng Ming[17] ; Chen Jianhua[18] ; Fu Zhichao[19] ; Gan Lu[20] ; Wang Jun[21] ; Zhan Xianbao[22] ; Liu Tianshu[23] ; Li Zhiping[24] ; Shen Lin[25] ; Shu Yongqian[26] ; Zhang Tao[27] ; Yang Qing[27] ; Zou Jianjun[27] ; the ESCORT Study Group[1] ;
机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [2]Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com. [3]Department of Radiation Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China. [4]Department of Thoracic Medical Oncology, Fujian Province Cancer Hospital, Fuzhou, China. [5]Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [6]Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China. [7]Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China. [8]Oncology Department, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China. [9]Internal Medicine Ward 4, Shandong Cancer Hospital, Jinan, China. [10]Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [11]Oncology Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [12]Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China. [13]Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [14]Medical Oncology, Tianjin Cancer Hospital, Tianjin, China. [15]Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China. [16]Oncology Department, The First People's Hospital of Lianyungang, Lianyungang, China. [17]Oncology Center, Sichuan Academy of Medical Sciences &amp [18]Sichuan Provincial People's Hospital, Chengdu, China. [18]Department of Medical Oncology, Cancer Hospital of Central South University, Changsha, China. [19]Department of Radiotherapy, 900 Hospital of the Joint Logistics Team, Fuzhou, China. [20]The Oncology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [21]Department of Radiotherapy, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [22]Department of Medical Oncology, Changhai Hospital, Second Military Medical University, Shanghai, China. [23]Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. [24]Integrated Chinese and Western Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China. [25]Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China. [26]Medical Oncology, Jiangsu Province Hospital, Nanjing, China. [27]Jiangsu Hengrui Medicine, Shanghai, China.
出处：
DOI： 10.1016/S1470-2045(20)30110-8
ISSN：

摘要：
Patients with advanced or metastatic oesophageal squamous cell carcinoma have poor prognosis and few treatment options after first-line therapy. We aimed to assess efficacy and safety of the anti-PD-1 antibody camrelizumab versus investigator's choice of chemotherapy in previously treated patients. ESCORT is a randomised, open-label, phase 3 study of patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy. Patients were randomly assigned (1:1) to camrelizumab (200 mg every 2 weeks) or chemotherapy with docetaxel (75 mg/m2 every 3 weeks) or irinotecan (180 mg/m2 every 2 weeks), all given intravenously. Central randomisation was done using the Randomization and Trial Supply Management system with block size randomly generated as four or six and stratified by disease and ECOG performance status. The primary endpoint was overall survival, assessed in randomised patients who had received at least one dose of treatment. Safety was assessed in all treated patients. The trial is registered with ClinicalTrials.gov, NCT03099382, and is closed to new participants. From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients were randomly assigned to treatment, of whom 228 received camrelizumab treatment and 220 received chemotherapy. As of data cutoff on May 6, 2019, with a median follow-up time of 8·3 months (IQR 4·1-12·8) in the camrelizumab group and 6·2 months (3·6-10·1) in the chemotherapy group, median overall survival was 8·3 months (95% CI 6·8-9·7) in the camrelizumab group and 6·2 months (5·7-6·9) in the chemotherapy group (hazard ratio 0·71 [95% CI 0·57-0·87]; two-sided p=0·0010). The most common treatment-related adverse events of grade 3 or worse were anaemia (camrelizumab vs chemotherapy: six [3%] vs 11 [5%]), abnormal hepatic function (four [2%] vs one [<1%]), and diarrhoea (three [1%] vs nine [4%]). Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group. Ten treatment-related deaths occurred, seven (3%) in the camrelizumab group (three deaths from unknown causes, one enterocolitis, one hepatic function abnormal, one pneumonitis, and one myocarditis) and three (1%) in the chemotherapy group (two deaths from unknown causes, and one gastrointestinal haemorrhage). Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy, with a manageable safety profile. It might represent a potential option of standard second-line treatment for patients with oesophageal squamous cell carcinoma in China. Jiangsu Hengrui Medicine. Copyright © 2020 Elsevier Ltd. All rights reserved.

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中科院分区：
出版当年[2020]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2020]版：
Q1 ONCOLOGY
最新[2024]版：
Q1 ONCOLOGY

影响因子： 最新[2024版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
共同第一作者：
通讯作者：
通讯机构： [2]Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com. [*1]Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Fengtai District, Beijing 100071, China
推荐引用方式(GB/T 7714)：
Huang Jing,Xu Jianming,Chen Yun,et al.Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.[J].LANCET ONCOLOGY.2020,21(6):832-842.doi:10.1016/S1470-2045(20)30110-8.
APA：
Huang Jing,Xu Jianming,Chen Yun,Zhuang Wu,Zhang Yiping...&the ESCORT Study Group.(2020).Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study..LANCET ONCOLOGY,21,(6)
MLA：
Huang Jing,et al."Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.".LANCET ONCOLOGY 21..6(2020):832-842

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