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
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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DOI：
10.1016/s1470-2045(20)30110-8
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发表时间：
2020-06-01
期刊：
影响因子：
51.1
通讯作者：
Zou, Jianjun
中科院分区：
文献类型：
--
作者：
Huang, Jing;Xu, Jianming;Zou, Jianjun
背景晚期或转移性食管鳞状细胞癌患者一线治疗后预后差，治疗选择少。我们的目的是评估疗效和安全性的抗PD-1抗体camrelizumab与研究者的选择化疗在以前treated patients.Methods ESCORT是一个随机的，开放标签，3期研究的患者年龄在18至75岁的组织学或细胞学诊断的晚期或转移性食管鳞状细胞癌在43家医院在中国。符合条件的患者的东部肿瘤协作组（ECOG）体能状态评分为0或1，并且在一线标准治疗期间发生疾病进展或不耐受。患者被随机分配（1：1）接受camrelizumab（200 mg，每2周一次）或多西他赛化疗（75 mg/m2，每3周一次）或伊立替康（180 mg/m2，每2周一次），均静脉给药。使用随机化和试验供应管理系统进行中心随机化，随机生成的区组大小为4或6，并按疾病和ECOG体能状态分层。主要终点是总生存期，在接受至少一剂治疗的随机化患者中进行评估。在所有接受治疗的患者中评估安全性。该试验注册于ClinicalTrials.gov，NCT 03099382，并对新参与者关闭。结果从2017年5月10日至2018年7月24日，在607名筛选患者中，有457名（75%）被随机分配接受治疗，其中228名接受camrelizumab治疗，220名接受化疗。截至数据截止日期2019年5月6日，中位随访时间为8.3个月（IQR 4.1-12.8），Camrelizumab组为6.2个月（3.6-10.1）化疗组，中位总生存期为8.3个月Camrelizumab组为6.2个月（95% CI 6.8-9.7），化疗组为6.2个月（5.7-6.9）（风险比0.71 [95% CI 0.57-0.87];双侧p=0.0010）。最常见的3级或更严重的治疗相关不良事件是贫血（camrelizumab vs化疗：6例[3%] vs 11例[5%]），肝功能异常（4例[2%] vs 1例[5%]），
Background 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.Methods 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/m(2) every 3 weeks) or irinotecan (180 mg/m(2) 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.Findings 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 [