TACE-HAIC-靶向-免疫四联治疗中晚期肝细胞癌的回顾性对照研究

A retrospective controlled study of TACE-HAIC-targeted-immune quadruple therapy for intermediate and advanced-stage hepatocellular carcinoma

目的评价经导管动脉化疗栓塞术(TACE)-肝动脉灌注化疗(HAIC)-靶向-免疫四联治疗中晚期肝细胞癌(HCC)患者的疗效和安全性。方法根据入排标准入组101例中晚期HCC患者,分为联合组和对照组。联合组患者行TACE-HAIC-靶向-免疫四联治疗,对照组患者仅接受TACE治疗。对2组患者的总生存期(OS)、无疾病进展生存期(PFS)、治疗相关的不良反应进行统计分析。据资料不同采用t检验、χ2检验、秩和检验、Kaplan-Meier曲线、对数秩检验、Cox回归分析或Cox比例风险模型分析进行统计学分析。结果以mRECIST 1.1标准评估联合组肿瘤客观缓解率和疾病控制率分别为80%和94%,明显高于对照组的41.2%(P<0.001)和74.5%(P=0.007)。联合组的OS和PFS为15.6(95%CI 11.3~NA)个月和8.8(95%CI 6.9~12.0)个月,明显优于对照组的6.1(95%CI 5.3~6.6)个月(P<0.001)和3.2(95%CI 3.0~3.6)个月(P<0.001)。联合组胃溃疡发生率(9/50,18%)比对照组(2/51,3.9%)明显增加(P=0.023)。结论TACE-HAIC-靶向-免疫四联治疗对比单纯TACE治疗是一种更有效的中晚期HCC治疗方式,需注意对靶免治疗相关不良反应的监测。

Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization(TACE)-hepatic arterial infusion chemotherapy(HAIC)-targeted-immune quadruple therapy in patients with intermediate and advanced-stage hepatocellular carcinoma(HCC).Methods 101 patients with intermediate and advanced stage HCC were enrolled according to the inclusion and exclusion criteria,and then they were divided into a combination group and a control group.Patients in the combination group was treated with TACE-HAIC-targeted-immune quadruple therapy,while the control group was only treated with TACE therapy.The overall survival(OS),progression-free survival(PFS),and treatment-related adverse reactions were statistically analyzed in the two groups of patients.Statistical analysis was carried out by t-test,χ2 test,rank sum test,Kaplan-Meier curve,log-rank test,Cox regression(or proportional hazards model)analysis according to different data.Results The tumor objective response rate and disease control rate as evaluated by mRECIST 1.1 criteria in the combination group were 80%and 94%,respectively,which were significantly higher than those in the control group,41.2%(P<0.001)and 74.5%(P=0.007).The OS and PFS of the combination group were 15.6 months[95%CI 11.3-NA]and 8.8 months[95%CI 6.9-12.0],respectively,which were significantly better than the control group at 6.1 months[95%CI 5.3-6.6](P<0.001)and 3.2 months[95%CI 3.0-3.6](P<0.001).Gastric ulcer incidence was significantly higher in the combination group(9/50,18%)than that in the control group(2/51,3.9%)(P=0.023).Conclusion TACE-HAIC-targeted-immune quadruple therapy is a more effective treatment mode for intermediate and advanced-stage HCC than TACE alone,and attention should be paid to the monitoring of target immune-related adverse reactions.