免疫检查点抑制剂联合抗血管生成药治疗乙型肝炎相关不可切除肝细胞癌的疗效及安全性  

Efficacy and safety of immune checkpoint inhibitors plus antiangiogenic agents for chronic hepat itis B-associated unresectable hepatocellular carcinoma

作　　者：刘丹[1] 王莉琳[1] 任姗[1] 侯维[1] 马丽娜[1] 郑素军[1] 鲁俊锋[1] LIU Dan;WANG Lilin;REN Shan;MA Lina;HOU Wei;ZHENG Sujun;LU Junfeng(Hepatology Center Department 1,Beijing You’an Hospital,Capital Medical University,100069,China)

机构地区：[1]首都医科大学附属北京佑安医院肝病中心一科,100069

出　　处：《传染病信息》2024年第4期323-328,共6页Infectious Disease Information

基　　金：北京市自然科学基金面上项目(7232080);首都临床特色诊疗技术研究及转化应用(Z221100007422063)。

摘　　要：目的探讨免疫检查点抑制剂联合抗血管生成药治疗乙型肝炎相关不可切除肝细胞癌(unresectable hepatocellularcarcinoma,uHCC)的疗效及安全性。方法将2019年7月至2023年7月期间在首都医科大学附属北京佑安医院住院并接受免疫检查点抑制剂联合抗血管生成药治疗的85例乙型肝炎相关uHCC患者纳入研究,收集其临床资料,对疗效和安全性进行回顾性分析。结果85例uHCC患者中男性65例,女性20例,中位年龄60.0岁,中国肝癌分期方案(China Liver Cancer Staging,CNLC)Ⅲ期者54例(63.5%),血管侵犯者37例(43.5%),远处转移者37例(43.5%),肝功能Child-Pugh B~C级者共28例(32.9%)。经治疗6例(7.1%)完全缓解,28例(32.9%)部分缓解,客观应答率可达40.0%,中位无进展生存期为5.8个月(95%CI:4.0~7.7),中位总生存期为25.8个月(95%CI:16.4~35.2)。单因素分析显示年龄<55岁、Child-Pugh B~C级、有血管侵犯、CNLC分期Ⅲ~Ⅳ期患者的中位总生存期明显低于年龄≥55岁、Child-Pugh A级、无血管侵犯、CNLC分期Ⅰ~Ⅱ期的患者(P<0.05)。总体安全性良好,≥3级不良事件发生率为32.9%。结论免疫检查点抑制剂联合抗血管生成药治疗uHCC可延长患者的生存期,安全性良好。Objective This study aimed to investigate the efficacy and safety of immune checkpoint inhibitors combined with antiangiogenic agents for patients with chronic hepatitis B associated-unresectable hepatocellular carcinoma(uHCC).Methods Eighty-five patients with uHCC who were hospitalized in Beijing You’an Hospital,Capital Medical University from July 2019 to July 2023 and treated with immune checkpoint inhibitors plus antiangiogenic agents were enrolled.A retrospective study was conducted to analysis the efficacy and safety with clinical data.Results Eighty-five patients with chronic hepatitis B associateduHCC included 65 males and 20 females,with a median age of 60.0 years old.54 cases(63.5%)were China Liver Cancer Staging(CNLC)Ⅲ,37(43.5%)were vascular invasion,37(43.5%)were distant metastases and 28(32.9%)were Child-Pugh B and C diseases.After treatment,6 cases(7.1%)had complete responses,28(32.9%)had partial responses,and the objective response rate reached 40.0%.The median progression-free survival was 5.8 months(95%CI:4.0-7.7),and the median overall survival was 25.8 months(95%CI:16.4-35.2).Univariate analysis showed that the median OS of the subgroups of patients who were under 55 years old,Child-Pugh BC diseases,vascular invasion and CNLCⅢ-Ⅳwere significantly lower than that of patients who were over 55 years old,Child-Pugh A disease,no vascular invasion and CNLC I-II(P<0.05).The overall safety profile was good,with a grade≥3 adverse event rate of 32.9%.Conclusions The combination of immune checkpoint inhibitor and antiangiogenic agents can prolong the survival of the patients with chronic hepatitis B associated-uHCC and show a good safety.

关 键 词：免疫检查点抑制剂 抗血管生成药物 乙肝肝炎病毒 肝癌 

分 类 号：R512.62[医药卫生—内科学]