卡瑞利珠单抗治疗复发或晚期转移性食管鳞癌临床疗效及免疫相关不良反应观察

目的:探讨卡瑞利珠单抗治疗复发或晚期转移性食管鳞癌的临床疗效以及免疫相关不良反应。方法:回顾性分析88例复发或晚期转移性食管鳞癌患者的治疗经过和疗效，将患者随机分为免疫联合化疗组、化疗组各44例，统计客观缓解率（objective remission rate，ORR)、疾病控制率(disease control rate,DCR)、无进展生存期(progress free survival,PFS)、总生存期（overall survival，OS），用Kaplan-Meier法绘制生存曲线，用log-rank检验进行影响PFS和OS的单因素分析、COX风险回归模型进行多因素分析，并观察免疫相关不良反应。结果:免疫联合化疗组和化疗组的ORR分别为8例（18%）和4例（9%），DCR分别为31例（70%）和20例（45%），免疫联合化疗较单纯化疗可延长患者mPFS（5.5个月vs 3.5个月，P=0.007）和mOS（11.25个月vs 7.75个月，P＜0.001）。ECOG评分、肿瘤分化程度和转移部位数量是PFS和OS的影响因素。免疫相关不良反应主要有毛细血管增生症、甲状腺功能减低、乏力、食欲减退等，但多为1-2级，经对症处理后均可缓解。结论:卡瑞利珠单抗联合化疗较单纯化疗在复发或晚期转移性食管鳞癌中可明显延长PFS和OS，临床疗效显著，且安全性良好。

Clinical efficacy and immune-related adverse events of Camrelizumab in patients with recurrent and advanced metastatic esophageal squamous cell cancer

Objective:To explore the clinical efficacy and immune-related adverse events of PD-1 inhibitor,Camrelizumab,in recurrent and advanced metastatic esophageal squamous cell cancer（ESCC).Methods:Retrospective study of 88 cases of patients with recurrent and advanced metastatic esophageal squamous cell cancer were admitted.Patients were divided into combination of immunotherapy and chemotherapy group(n=44) or chemotherapy alone group(n=44) randomly.Objective remission rate（ORR),disease control rate（DCR),progress free survival（PFS),overall survival（OS) were calculated,survival analysis was analyzed by Kaplan-Meier method.Log-rank test was used for univariate analysis,and COX regression model was used for multivariate analysis.Immune-related adverse events were also observed.Results:The ORR and DCR in combination group and chemotherapy alone group were 8（18%) and 4（9%),31（70%) and 20（45%),respectively.Combination of immunotherapy and chemotherapy significantly prolonged median PFS（5.5 months vs 3.5 months，P=0.007),as well as median OS（11.25 months vs 7.75 months，P＜0.001).ECOG score,tumor differentiation degree and number of metastasis area were the influential factors for PFS and OS.Immune-related adverse events mainly include capillary hyperplasia,hypothyroidism,fatigue,anorexia,etc.,but most of them are in grade 1-2.Conclusion:Compared with chemotherapy alone,Camrelizumab with chemotherapy significantly prolong median PFS and OS in patients with recurrent and advanced metastatic esophageal squamous cell carcinoma,which showed significant clinical efficacy and good safety.