机构地区:[1]苏州大学附属第一医院介入科,江苏苏州215000
出 处:《临床肝胆病杂志》2024年第12期2450-2456,共7页Journal of Clinical Hepatology
基 金:江苏省自然科学基金面上项目(SBK2023022210);江苏省科技厅重点研发计划(社会发展)项目(BE2021648)。
摘 要:目的研究改良白蛋白-胆红素分级(m ALBI分级)对经导管动脉化疗栓塞术(TACE)联合免疫及抗血管生成药物治疗(以下简称靶免治疗)的Child-Pugh A级的不可切除肝细胞癌患者预后的评估价值。方法回顾性分析2020年1月—2023年1月在苏州大学附属第一医院和温州医科大学附属第五医院符合纳排标准的76例接受TACE联合靶免治疗的Child-Pugh A级不可切除肝细胞癌患者的资料,根据mALBI分级将其分为mALBI 1/2a组(n=38)和2b组(n=38)。主要研究终点为总生存期(OS),次要研究结局为无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)。评估标准包括完全缓解、部分缓解、疾病稳定以及疾病进展。符合正态分布的计量资料组间比较采用成组t检验,不符合正态分布的计量资料组间比较采用Wilcoxon秩和检验。计数资料两组间比较采用χ^(2)检验。Kaplan-Meier法绘制生存曲线,Log-rank检验比较组间中位生存期(mOS)和中位无进展生存期(mPFS)。采用单因素和多因素Cox比例风险模型分析影响患者预后的因素。结果2组患者的Alb水平、肿瘤负荷情况比较,差异均有统计学意义(P值均<0.05)。76例患者的m OS为25.2(95%CI:18.4~32.0)个月,mPFS为9.4(95%CI:7.1~11.7)个月,ORR为63.2%,DCR为82.9%。其中mALBI 1/2a组和2b组患者mOS分别为30.1(95%CI:19.8~40.4)个月和19.5(95%CI:7.1~31.9)个月,两组mOS差异有统计学意义(χ^(2)=4.490,P=0.034)。mALBI 1/2a组和2b组患者mPFS分别为10.2(95%CI:8.4~12.0)个月和7.6(95%CI:4.6~10.6)个月,ORR分别为71.1%和55.3%,DCR分别为86.8%和78.9%,mPFS、ORR和DCR比较,差异均无统计学意义(P值均>0.05)。ECOG评分、肿瘤负荷、mALBI分级、门静脉侵犯和肝外转移是影响TACE联合靶免治疗患者mOS的独立危险因素(P值均<0.05)。没有发生与治疗相关的死亡。结论mALBI分级对预测TACE联合靶免治疗的Child-Pugh A级不可切除肝细胞癌患者的生存有较好的预测价值。Objective To investigate the ability of the modified albumin-bilirubin(mALBI)grade in predicting the prognosis of patients with Child-Pugh A unresectable hepatocellular carcinoma(uHCC)after transcatheter arterial chemoembolization(TACE)combined with immunotherapy and anti-angiogenic drugs(hereafter referred to as targeted immunotherapy).Methods A retrospective analysis was performed for the data of 76 patients with Child-Pugh A uHCC who met the inclusion criteria and underwent TACE combined with targeted immunotherapy in The First Affiliated Hospital of Soochow University from January 2020 to January 2023,and according to the mALBI grade,they were divided into mALBI 1/2a group with 38 patients and mALBI 2b group with 38 patients.The primary endpoint was overall survival(OS),and the secondary endpoints were progression-free survival(PFS),objective response rate(ORR),and disease control rate(DCR).Evaluation criteria included complete remission,partial remission,stable disease,and progressive disease.The independent-samples t test was used for comparison of normally distributed continuous data between groups,and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between groups;the chi-square test was used for comparison of categorical variables between two groups.The Kaplan-Meier method was used to plot survival curves,and the Log-rank test was used for comparison of median OS(mOS)and median PFS(mPFS)between groups.The univariate and multivariate Cox proportional hazards models were used to analyze the influencing factors for prognosis.Results There were significant differences in albumin and tumor burden between the two groups(both P<0.05).The 76 patients had an mOS of 25.2 months(95%confidence interval[CI]:18.4—32.0),an mPFS of 9.4 months(95%CI:7.1—11.7),an ORR of 63.2%,and a DCR of 82.9%.The mOS was 30.1 months(95%CI:19.8—40.4)in the mALBI 1/2a group and 19.5 months(95%CI:7.1—31.9)in the mALBI 2b group,and there was a significant difference in mOS between the tw
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