基于CalliSpheres■新型载药微球的化疗栓塞治疗肝细胞癌患者疗效及安全性分析  

Efficacy and safety of CalliSpheres■microspheres-based drug-eluting beads transaterial chemoembolization in the treatment of hepatocellular carcinoma

作　　者：郑亚璐 熊恺[1] 石青 杨慧 郑雄 ZHENG Ya-lu;XIONG Kai;SHI Qing;YANG Hui;ZHENG Xiong(Department of Gastroenterology,the Second Affiliated Hospital of Nanchang University,Jiangxi 330006,China;Department of Gastroenterology,Jiu Jiang No.1 People’s Hospital,Jiangxi 332000,China;Jiangxi Health Vocational College,Nanchang 330052,China)

机构地区：[1]南昌大学第二附属医院消化内科,江西330006 [2]九江市第一人民医院消化三科,332000 [3]江西卫生职业学院药学系,330052

出　　处：《肝脏》2024年第10期1194-1199,共6页Chinese Hepatology

基　　金：江西省卫生健康委科技计划(202210566)。

摘　　要：目的评估基于CalliSpheres■(CSM)载药微球的经动脉化疗栓塞(DEB-TACE)治疗中国肝细胞癌(HCC)患者的治疗应答、生存获益、肝功能变化以及不良反应。方法回顾性纳入南昌大学第二附属医院接受基于CSM的DEB-TACE治疗的HCC患者66例。收集患者基线期信息,记录患者术后1个月的治疗应答、术后的不良反应和肝功能指标,评估患者的无病生存期(DFS)和总体生存期(OS)。结果DEB-TACE术后1个月,患者完全缓解率、总体应答率(ORR)和疾病控制率分别为18.2%,75.8%和93.9%。亚组分析显示,Child-Pugh分级较高(B级50.0%vs.A级80.4%,P=0.039)和BCLC分期较高(C期40.0%vs.B期82.4%vs.A期94.1%,P=0.001)的患者ORR更低。中位DFS和OS分别为6.0个月和20.0个月,亚组分析显示Child-Pugh B级以及BCLC分期较高的患者DFS较差(P=0.015和P=0.009),OS也较差(P=0.018和P=0.002);此外,多病灶的患者DFS较差(P=0.007)。术后1个月患者的Alb(中位值34.7 g/L比37.7 g/L,P<0.001)和Scr水平(中位值66.7μmol/L比70.7μmol/L,P=0.016)与基线期相比降低,TBil水平与基线期相比升高(中位值20.4μmol/L比16.8μmol/L,P=0.025),而其他生化指标无差异。术后最常见的不良反应为疼痛(47.0%发生率)。结论综上所述,基于CSM的DEB-TACE治疗中国HCC患者实现了较好的治疗应答、较长的生存获益以及较好的安全性,且病灶数、Child-Pugh分级以及BCLC分期可作为DEB-TACE治疗HCC患者的预后因素。Objective To evaluate the treatment response,survival benefit,change of liver function and adverse events(AEs)of CalliSpheres■(CSM)based drug-eluting beads transarterial chemoembolization(DEB-TACE)in treating hepatocellular carcinoma(HCC).Methods Sixty-six HCC patients who underwent CSM-based DEB-TACE in the Second Affiliated Hospital of Nanchang University were consecutively enrolled in this retrospective cohort study.The baseline characteristics of HCC patients were recorded.Treatment responses at 1 month after treatment,liver function related laboratory indexes pre and post-treatment,and the post-treatment AEs were recorded.Disease-free survival(DFS)and overall survival(OS)were documented and evaluated.Results Complete response(CR),Overall Response Rate(ORR)and Disease Control Rate(DCR)within 1 month post treatment were 18.2%,75.8%,and 93.9%,respectively.Subgroup analysis revealed that patient with higher Child-Pugh stage(B stage 50.0%vs A stage 80.4%,P=0.039)and higher BCLC stage(C stage 40.0%vs B stage 82.4%vs A stage 94.1%,P=0.001)had worse ORR.The median PFS and OS were 6.0 months and 20.0 months,respectively.Subgroup analysis disclosed that patients with Child-Pugh B and higher BCLC C had both shorter DFS(P=0.015 and P=0.009),as well as worse OS(P=0.018 and P=0.002);additionally,the patients with multifocal disease had worse DFS(P=0.007).The Alb(median 34.7 g/L vs 37.7 g/L,P<0.001)and Scr(median 66.7μmol/L vs 70.7μmol/L,P=0.016)level decreased,while TBil(median 20.4μmol/L vs.16.8μmol/L,P=0.025)increased after treatment.Other liver function-related indexes did not change after treatment.The most common AEs post treatment was pain(incidence rate of 47.0%).Conclusion CSM based DEB-TACE achieves favorable treatment response and survival benefit in Chinese HCC patients,also with good tolerance.Several clinical features might have the potentials to serve as prognostic markers.

关 键 词：肝细胞癌 经动脉化疗栓塞术 载药微球 疗效 安全性 

分 类 号：R735.7[医药卫生—肿瘤]