抗PD-1抗体联合治疗晚期肝细胞癌的真实世界研究  

A Real-world Study of Anti-PD-1 Antibody Combination Therapy in Advanced Hepatocellular Carcinoma

作　　者：乔师师[1] 孔天东[2] 于丹 杨振[1] 潘延凤[1] 赵玲娣[4] QIAO Shishi;KONG Tiandong;YU Dan;YANG Zhen;PAN Yanfeng;ZHAO Lingdi(Department of HBP,The First Affiliated Hospital of Zhengzhou University,Zhengzhou450052,China;Department of Oncology,Affiliated Cancer Hospital of Henan University,Zhengzhou 450052,China;Department of Oncology,Zhengzhou Yihe Hospital,Zhengzhou450052,China;Department of Oncology,Henan Cancer Hospital,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院肝胆胰外科,郑州450052 [2]河南大学肿瘤医院肿瘤科,郑州450052 [3]郑州市颐和医院肿瘤科,郑州450052 [4]河南省肿瘤医院肿瘤科,郑州450052

出　　处：《肿瘤防治研究》2023年第3期293-297,共5页Cancer Research on Prevention and Treatment

基　　金：河南省医学科技攻关项目(SB201901026)。

摘　　要：目的探讨真实世界中以抗PD-1抗体为基础的疗法在晚期肝细胞癌治疗中的疗效、不良反应及可能影响疗效的因素。方法收集55例接受以PD-1抗体为基础治疗的晚期肝细胞癌患者,回顾性分析其临床特点、疗效及不良反应,并进行随访。结果客观有效率为21.8%,疾病控制率为76.4%。治疗过程中不良反应整体发生率为81.8%,其中3~4级不良反应发生率为14.5%,免疫相关不良反应发生率为58.2%,其中3~4级免疫相关不良反应发生率为3.6%,无治疗相关死亡。55例患者中位无进展生存期为5.0月(95%CI:3.9~6.1),中位生存期11.4月(95%CI:6.5~16.3)。应用抗PD-1抗体前患者肝功能Child-Pugh评分和体能状态ECOG评分是影响治疗有效率和生存时间的主要因素;多因素分析也表明治疗前患者的体能状态ECOG评分和肝功能Child-Pugh评分是影响患者生存的独立预后因素(P<0.001,P=0.034)。结论真实世界中以PD-1抗体为基础的治疗在晚期肝细胞肝癌患者中是安全有效的,其中治疗前患者的体能状态ECOG评分和肝功能Child-Pugh评分是影响患者生存期的独立预后因素。Objective To explore the efficacy,safety,and factors that might influence the efficacy of antiPD-1 antibody-based therapy in advanced hepatocellular carcinoma in the real world.Methods The clinical features,efficacy,and safety in patients with advanced hepatocellular carcinoma who received anti-PD-1 antibody-based therapy were retrospectively analyzed.The survival status was followed-up.Results The objective response and the disease control rate were 21.8%and 76.4%,respectively.The overall incidence of adverse events during treatment was 81.8%,of which the incidence of grade 3/4 adverse events was 14.5%.The incidence of immune-related adverse events was 58.2%and the incidence of grade 3/4 immune-related adverse events was 3.6%,and no treatment-related death was observed.The median PFS of the 55 patients was 5.0(95%CI:3.9-6.1)months,and the median OS was 11.4(95%CI:6.5-16.3)months.Univariate and multivariate analyses showed that liver function Child-Pugh scores and performance status ECOG score were the influencing factors of the objective response rate and survival.Conclusion In the real world anti-PD-1 antibody-based therapy is safe and effective in patients with advanced hepatocellular carcinoma,in which the performance status ECOG score and liver function Child-Pugh score before treatment are independent prognostic factors influencing survival.

关 键 词：肝细胞肝癌 抗PD-1抗体 肝功能 体能评分 真实世界 

分 类 号：R735.7[医药卫生—肿瘤]