TACE联合仑伐替尼及PD-1单抗治疗中晚期肝细胞癌的疗效及安全性分析

Clinical efficacy and safety of TACE combined with lenvatinib and PD-1 antibody in treatment of intermediate-advanced hepatocellular carcinoma

目的分析经肝动脉化疗栓塞(transcatheter arterial chemoembolization,TACE)联合仑伐替尼及PD-1单抗的三联疗法治疗中晚期肝细胞癌(hepatocellular carcinoma,HCC)的疗效和安全性。方法本项目是一项回顾性队列研究。收集2021年1月至2023年6月陆军军医大学第一附属医院肝胆外科收治的105例行TACE联合仑伐替尼及PD-1单抗治疗的中晚期HCC患者的临床资料,收集患者TACE术前和术后随访的血生化指标及影像学特征,统计客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、转化切除率、总生存期(overall survival,OS)和无进展生存期(progression-free survival,PFS)等指标评价三联疗法的临床疗效,记录治疗过程中出现的所有不良反应的频率及严重程度以评估三联疗法的安全性。结果105例接受三联治疗的中晚期HCC患者有33例死亡,72例仍存活。ORR为62.8%,DCR为72.3%,转化切除率为11.4%。中位总生存期(median overall survival,mOS)未达到。中位无进展生存期(median progression-free survival,mPFS)为(10.3±0.8)个月。所有等级不良反应发生率为97.1%,3~4级不良反应发生率为33.3%,无治疗相关的死亡病例发生。结论TACE联合仑伐替尼及PD-1单抗的三联疗法是一种安全、有效的综合治疗方案,为改善中晚期肝细胞癌的预后提供了新的治疗策略。

Objective To analyze the clinical efficacy and safety of transcatheter arterial chemoembolization(TACE)combined with lenvatinib and PD-1 antibody in the treatment of intermediate-advanced hepatocellular carcinoma(HCC).Methods A retrospective cohort trial was conducted on 105 patients with intermediate-advanced HCC(BCLC B or C stage)treated with TACE combined with lenvatinib and PD-1 antibody in our institute from January 2021 to June 2023.The blood biochemical indicators and imaging characteristics of the patients were collected before and after TACE.Objective response rate(ORR),disease control rate(DCR),conversion resection rate,overall survival(OS)and progression-free survival(PFS)were analyzed to evaluate the clinical efficacy of the triple therapy,and the frequency and severity of all adverse reactions during treatment were recorded to evaluate the safety of the therapy.Results Among the 105 patients with intermediate-advanced HCC who received triple therapy,33 died and 72 survived.The ORR was 62.8%and the DCR was 72.3%.The conversion resection rate was 11.4%.The median OS(mOS)was not reached.The median PFS(mPFS)was(10.3±0.8)months.The incidence of adverse reactions of all grades was 97.1%,and the incidence of those of grade 3~4 was 33.3%.No treatment-related death occurred.Conclusion The triple therapy of TACE combined with lenvatinib and PD-1 antibody is a safe and effective comprehensive treatment regimen,which provides a new treatment strategy for improving the prognosis of intermediate-advanced HCC.