【收藏】CSCO食管癌指南（2020版）将卡瑞利珠单抗列为晚期食管癌二线治疗I级专家推荐方案

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2020年5月13日，国际顶级学术期刊《柳叶刀·肿瘤学》(The Lancet Oncology)在线发表了一篇食管鳞癌的临床研究。

Abstract

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.

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.

• 截至2019年5月6日，卡瑞利珠单抗组和化疗组的中位随访时间分别为8.3个月和6.2个月，卡瑞利珠单抗组和化疗组的中位总生存期分别为8.3个月和6.2个月（危险比0.71，[95%CI 0.57–0.87]；双侧p=0.0010）。
  
  
• 与化疗相比，卡瑞利珠单抗可显著延长患者的中位总生存时间（mOS，8.3个月对6.2个月，HR=0.71，95%CI为0.57~0.87，P=0.001），降低死亡风险近30%。

• 卡瑞利珠单抗组患者的客观缓解率更高（ORR，20.2%对6.4%），持续缓解时间更长（DoR，7.4个月对3.4个月，HR=0.34，95%CI为0.14~0.92）。

   

• 最常见的3级或更严重的治疗相关不良事件是贫血（卡瑞利珠单抗与化疗：6例[3%]vs 11例[5%]）、肝功能异常（4例[2%]vs 1例[<1%]）和腹泻（3例[1%]vs 9例[4%]）。

• 与治疗相关的严重不良事件发生在卡瑞利珠单抗组228例患者中的37例（16%）和化疗组220例患者中的32例（15%）。

• 发生10例治疗相关死亡，卡瑞利珠单抗组7例（3%）：3例死于不明原因，1例死于小肠结肠炎，1例死于肝功能异常，1例死于肺炎，1例死于心肌炎；化疗组3例（1%）：2例死于不明原因，1例死于胃肠道出血。

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).