摘要
目的评估酪氨酸激酶抑制剂(TKI)联合免疫检查点抑制剂在中晚期肝细胞癌(HCC)二线治疗中的效果及安全性。方法收集2018年1月—2022年12月苏州大学附属第一医院介入科收治的经过经肝动脉化疗栓塞术(TACE)联合一线TKI治疗后进展/不耐受,换用二线TKI联合或者不联合免疫检查点抑制剂的63例中晚期HCC患者的临床资料。其中使用二线TKI联合免疫检查点抑制剂共32例(联合组),使用二线TKI共31例(单纯组)。依据改良实体瘤疗效评价标准(mRECIST)评估肿瘤反应,根据通用不良事件术语5.0标准(CTCAE 5.0)评估不良事件。使用Kaplan-Meier法计算两组的中位生存期(mOS)、中位无进展生存期(mPFS)。比较两组的客观缓解率(ORR)和疾病控制率(DCR)。基线资料及随访结果的组间比较采用χ^(2)检验。结果63例患者中位随访时间为16.5(3.2~53.4)个月。联合组mOS、mPFS分别为24.3个月(95%CI:20.0~28.6)和9.8个月(95%CI:7.5~12.1),15.8个月(95%CI:11.4~20.1)和4.1个月(95%CI:3.2~4.9),两组mOS、mPFS之间差异均有统计学意义(P值分别为0.029、0.038)。联合组ORR和DCR分别为47%和84%,单纯组为19%和65%,两组之间ORR差异有统计学意义(P=0.021),DCR差异无统计学意义(P=0.070)。联合组中4例(12.5%)、单纯组中3例(10.0%)发生Ⅲ~Ⅳ级严重不良事件,两组均无药物不良反应致死事件,两组患者不良事件的发生率比较,差异无统计学意义(P=0.783)。结论与单用TKI治疗相比,TKI联合免疫检查点抑制剂作为中晚期HCC二线治疗的疗效更显著,且不会增加严重不良反应。
Objective To investigate the efficacy and safety of tyrosine kinase inhibitor(TKI)combined with immune checkpoint inhibitor as the second-line therapy for advanced hepatocellular carcinoma(HCC).Methods A retrospective analysis was performed for the clinical data of 63 patients with advanced HCC who were admitted to Department of Interventional Radiology,The First Affiliated Hospital of Soochow University,from January 2018 to December 2022,and all patients experienced progression/intolerance after transcatheter arterial chemoembolization combined with first-line TKI and were switched to secondline TKI with or without immune checkpoint inhibitor.The 32 patients receiving second-line TKI with immune checkpoint inhibitor were enrolled as combination group,and the 31 patients receiving second-line TKI alone were enrolled as single treatment group.Modified Response Evaluation Criteria in Solid Tumors was used to evaluate tumor response,and Common Terminology Criteria for Adverse Events 5.0 was used to evaluate adverse events.The Kaplan-Meier method was used to calculate median overall survival(mOS)and median progression-free survival(mPFS)for the two groups,and the two groups were compared in terms of objective response rate(ORR)and disease control rate(DCR).The chi-square test was used for comparison of baseline data and follow-up results between groups.Results The median follow-up time was 16.5(3.2—53.4)months for the 63 patients.The combination group had an mOS of 24.3(95%confidence interval[CI]:20.0—28.6)months and an mPFS of 9.8(95%CI:7.5—12.1)months,while the single treatment group had an mOS of 15.8(95%CI:11.4—20.1)months and an mPFS of 4.1(95%CI:3.2—4.9)months,and there were significant differences in mOS and mPFS between the two groups(P=0.029 and 0.038).The combination group had an ORR of 47%and a DCR of 84%,while the single treatment group had an ORR of 19%and a DCR of 65%;there was a significant difference in ORR between the two groups(P=0.021),but with no significant difference in DCR between the
作者
聂宏
仲斌演
沈健
朱晓黎
NIE Hong;ZHONG Binyan;SHEN Jian;ZHU Xiaoli(Department of Interventional Radiology,The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu 215000,China)
出处
《临床肝胆病杂志》
CAS
北大核心
2024年第8期1620-1626,共7页
Journal of Clinical Hepatology
基金
江苏省科技厅重点研发计划(社会发展)项目(BE2021648)。
关键词
癌
肝细胞
分子靶向治疗
免疫疗法
免疫检查点抑制剂
Carcinoma,Hepatocellular
Molecular Targeted Therapy
Immunotherapy
Immune Checkpoint Inhibitors
