FOLFOX-HAIC联合仑伐替尼和免疫检查点抑制剂治疗TACE抵抗后肝细胞癌的疗效及安全性分析

FOLFOX-HAIC combined with lenvatinib and immune checkpoint inhibitors for hepatocellular carcinoma after the occurrence of TACE refractoriness:analysis of efficacy and safety

目的评价FOLFOX(fluorouracil and leucovorin and oxaliplatin)方案肝动脉灌注化疗(hepatic artery infusion chemotherapy,HAIC)联合仑伐替尼(lenvatinib,LEN)和免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)在经动脉化疗栓塞术(transcatheter arterial chemoembolization,TACE)抵抗后肝细胞癌(hepatocellular carcinoma,HCC)患者中的疗效及安全性。方法回顾分析2019年1月至2022年12月江苏省肿瘤医院54例HCC患者TACE抵抗后接受FOLFOX-HAIC联合LEN和ICIs的临床资料,采用改良实体瘤疗效评价标准(modified response evaluation criteria in solid tumors,mRECIST)统计分析临床疗效,常见不良事件通用术语标准5.0版(common terminology criteria for adverse events version 5.0,CTCAE 5.0)记录和评估治疗相关不良事件(treatment related adverse events,TRAEs),主要研究终点为无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS),次要研究终点为客观缓解率(objective response rate,ORR),疾病控制率(disease control rate,DCR)和安全性。结果中位无进展生存期(mPFS)为11.7个月(95%CI:8.124~15.276),中位总生存期(mOS)23.1个月(95%CI:19.508~26.692),ORR 46.3%,DCR 87.0%。各级最常见TRAEs是丙氨酸转氨酶升高(51.9%),最常见3/4级TRAEs是高血压(9.3%),未观察到与治疗相关死亡事件的发生。结论FOLFOX-HAIC联合LEN和ICIs治疗TACE抵抗后HCC患者安全、有效。

Objective To evaluate the efficacy and safety of fluorouracil and leucovorin and oxaliplatin(FOLFOX)regimen hepatic artery infusion chemotherapy(HAIC)combined with lenvatinib(LEN)and immune checkpoint inhibitors(ICIs)in treating patients with hepatocellular carcinoma(HCC)after the occurrence of transcatheter arterial chemoembolization(TACE)refractoriness.Methods The clinical data of 54 HCC patients who developed TACE refractoriness,were admitted to the Jiangsu Provincial Cancer Hospital of China to receive FOLFOX-HAIC combined with LEN and ICIs therapy between January 2019 and December 2022,were retrospectively analyzed.The modified Response Evaluation Criteria in Solid Tumors(mRECIST)was used to statistically analyze the clinical efficacy,the Common Terminology Criteria For Adverse Events version 5.0(CTCAE 5.0)was adopted to record and evaluate the treatment-related adverse events(TRAEs).The primary endpoints were progression-free survival(PFS)and overall survival(OS),the secondary endpoints were objective response rate(ORR),disease control rate(DCR),and safety.Results The median PFS was 11.7 months(95%CI:8.124-15.276 months),the median OS was 23.1 months(95%CI:19.508-26.692 months),the ORR was 46.3%,and the DCR was 87.0%.The most common TRAE at all levels was elevated alanine aminotransferase(51.9%),and the most common TRAE of grade 3/4 was hypertension(9.3%).No treatment-related death occurred.Conclusion For the treatment of HCC patients who developed TACE refractoriness,FOLFOX-HAIC combined LEN and ICIs is clinically safe and effective.