卡瑞利珠单抗联合化疗治疗晚期食管癌患者的临床研究

Clinical trial of camrelizumab combined with chemotherapy in the treatment of patients with advanced esophageal squamous cell carcinoma

目的观察卡瑞利珠单抗联合化疗治疗晚期食管癌(ESCC)的疗效和生存获益情况。方法将晚期ESCC患者分为对照组(第1天静脉滴注260 mg·m^(-2)白蛋白紫杉醇+第1~5天静脉滴注20 mg·m^(-2)顺铂)和试验组(在对照组基础上第1天静脉滴注卡瑞利珠单抗200 mg)。2组均治疗4个周期,1个周期21 d。比较2组患者治疗后疾病控制率、客观缓解率、免疫功能(CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))、肿瘤标志物[糖类抗原199、癌胚抗原、糖类抗原125]、安全性及生存获益情况。结果试验组和对照组分别纳入48和42例。治疗后,试验组疾病控制率和客观缓解率分别为79.17%(38例/48例)和62.50%(30例/48例),均显著高于对照组[57.14%(24例/42例)和40.48%(17例/42例)](均P<0.05)。治疗后,试验组和对照组外周血CD4^(+)/CD8^(+)分别为1.11±0.29和1.87±0.38,血清糖类抗原199分别为(50.03±6.21)和(36.41±4.87)ng·mL^(-1),血清癌胚抗原分别为(21.25±3.39)和(14.97±2.85)ng·mL^(-1),血清糖类抗原125分别为(29.82±4.16)和(20.63±3.34)ng·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组6个月生存率分别为95.83%(46例/48例)和80.95%(34例/42例),在统计学上差异有统计学意义(P<0.05)。2组患者药物不良反应均以蛋白尿、肝功能异常、骨髓抑制、甲状腺功能异常、胃肠道反应为主,各种药物不良反应发生率比较,在统计学上差异均无统计学意义(均P>0.05)。结论卡瑞利珠单抗联合化疗能改善晚期ESCC患者免疫功能,抑制肿瘤标志物表达,提高生存率。

Objective To observe the effect and survival benefits of camrelizumab combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma(ESCC).Methods Patients with advanced ESCC were divided into control group and treatment group.The control group was given albumin-paclitaxel(260 mg·m^(-2),qd,intravenous drip on the 1st day)and cisplatin(20 mg·m^(-2),once a day,intravenous drip on the 1 st-5 th day),while treatment group was given camrelizumab(200 mg,qd,intravenous drip on the 1st day)on basis of control group.All patients were treated for 4 cycles(21 d/cycle).The curative effect(disease control rate,objective response rate),immune function(CD4^(+),CD8^(+),CD4^(+)/CD8^(+)),tumor markers(carbohydrate antigen 199,carcinoembryonic antigen,carbohydrate antigen 125),safety and survival benefits in the two groups were compared after treatment.Results There were 48 cases in treatment group and 42 cases in control group.After treatment,disease control rates in treatment group and control group were 79.17%(38 cases/48 cases)and 57.14%(24 cases/42 cases),objective response rates were 62.50%(30 cases/48 cases)and 40.48%(17 cases/42 cases),the differences were statistically significant(all P<0.05).After treatment,levels of peripheral blood CD4^(+)/CD8^(+) levels were 1.11±0.29 and 1.87±0.38;levels of levels of serum carbohydrate antigen 199 were(50.03±6.21)and(36.41±4.87)ng·mL^(-1);levels of serum carcinoembryonic antigen were(21.25±3.39)and(14.97±2.85)ng·mL^(-1);levels of serum carbohydrate antigen125 were(29.82±4.16)and(20.63±3.34)ng·mL^(-1),the differences were statistically significant(all P<0.05).The differences in 6-month survival rate between treatment group and control group were statistically significant[95.83%(46 cases/48 cases)vs 80.95%(34 cases/42 cases),P<0.05].The adverse drug reactions of the two groups were mainly proteinuria,abnormal liver function,bone marrow suppression,abnormal thyroid function and gastrointestinal reaction,and there was no significant difference in the incidence of adverse drug reactions between the two groups(P>0.05).Conclusion Camrelizumab combined with chemotherapy can enhance immune function in patients with advanced ESCC,inhibit the expressions of tumor markers and increase survival rate.