RALOX-HAIC联合免疫检查点抑制剂及靶向药物治疗中晚期肝癌的疗效分析  

Efficacy of RALOX-HAIC combined with immune checkpoint inhibitors and targeted treatment for intermediate and advanced hepatocellular carcinoma

作　　者：李榕[1] 李文利 胡晓云[1] 李祺[1] 袁国盛 陈锦章[1] 臧梦雅 Rong Li;Wenli Li;Xiaoyun Hu;Qi Li;Guosheng Yuan;Jinzhang Chen;Mengya Zang(Department of Infectious Diseases and Hepatology,Nanfang Hospital,Southern Medical University,Guangdong Provincial Key Laboratory of Viral Hepatitis Research,Guangzhou 510515,China)

机构地区：[1]南方医科大学南方医院感染内科,广东省病毒性肝炎研究重点实验室,广州市510515

出　　处：《中国肿瘤临床》2023年第11期555-560,共6页Chinese Journal of Clinical Oncology

基　　金：国家自然科学基金项目(编号:82102879);广东省自然科学基金项目(编号:2022A1515010526,2021A1515012518,2020A1515110941)资助。

摘　　要：目的:探讨雷替曲塞+奥沙利铂方案肝动脉灌注化疗(RALOX-HAIC)联合免疫及靶向药物三联治疗中晚期肝细胞癌(hepatocellular carcinoma,HCC)的疗效与安全性。方法:回顾性分析2020年6月至2021年12月收治于南方医科大学南方医院39例行RALOX-HAIC联合靶免治疗的中晚期HCC患者,以首次HAIC治疗为起点,以患者疾病进展、死亡、不可耐受不良反应为终点,按照RECIST 1.1标准进行疗效评估,随访时间截至2022年10月。主要研究终点为客观缓解率(objective response rate,ORR),次要研究终点为疾病控制率(disease control rate,DCR)、中位无进展生存期(median progression-free survival,mPFS)、中位总生存期(median overall survival,mOS)及安全性。结果:ORR为41.0%,DCR达87.2%,m PFS为7.3个月(95%CI:5.0~9.6),mOS为14.6个月(95%CI:10.8~18.5),其中1例患者成功转化行手术治疗后完全缓解至今。常见的不良反应有HAIC术后发热、腹痛;化疗药物引起的骨髓抑制;肝功能异常、高血压、手足综合征等,无治疗相关死亡事件发生。结论:RALOX-HAIC联合免疫检查点抑制剂及靶向药物治疗中晚期HCC的DCR高,安全性良好,不良反应可耐受,为后续前瞻性临床研究奠定了基础。Objective:To investigate the efficacy and safety of hepatic arterial infusion chemotherapy(HAIC)with raltitrexed plus oxaliplatin(RALOX)combined with immune and targeted therapy in patients with intermediate and advanced hepatocellular carcinoma(HCC).Methods:We retrospectively enrolled 39 patients with intermediate and advanced HCC who received RALOX-HAIC combined with immune checkpoint inhibitors and targeted therapy from June 2020 to December 2021,in Nanfang Hospital,Southern Medical University.The initial HAIC treatment was used as the starting point.Disease progression,death,or unacceptable toxicity resulted in treatment discontinuation.The tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1),and patients were followed up until October 2022.The primary endpoint was the objective response rate(ORR).The secondary endpoints were disease control rate(DCR),median progression-free survival(mPFS),median overall survival(mOS),and safety.Results:The ORR and DCR were 41.0%and 87.2%,respectively.The mPFS was 7.3 months[95%confidence interval(CI):5.0-9.6],and the mOS was 14.6 months(95%CI:10.8-18.5).One patient underwent surgical resection and achieved complete response.The most common adverse events were fever,abdominal pain,bone marrow suppression,elevated aspartate aminotransferase levels,hypertension,and hand-foot skin reaction,with no treatment-related death reported.Conclusions:RALOX-HAIC combined with immune and targeted therapy was effective and safe in patients with intermediate and advanced HCC,laying a foundation for future prospective clinical research.

关 键 词：肝动脉灌注化疗 雷替曲塞 奥沙利铂 免疫治疗 靶向治疗 

分 类 号：R735.7[医药卫生—肿瘤]