TACE联合瑞戈非尼序贯治疗中晚期肝细胞癌的疗效和安全性

Clinical efficacy and safety of TACE combined with regorafenib sequential treatment for mid-advanced hepatocellular carcinoma

目的评估TACE联合瑞戈非尼二线序贯治疗中晚期肝细胞癌(HCC)的临床疗效和安全性。方法纳入2018年6月至2019年12月中国科学院大学附属肿瘤医院收治的中晚期HCC患者60例。患者均接受TACE联合索拉非尼一线靶向治疗,因疾病进展或无法耐受索拉非尼,口服瑞戈非尼二线序贯治疗。按mRECIST标准评价疗效,并观察患者的疾病进展时间和总生存期(OS),服药期间记录不良反应的发生。结果随访至2021年6月,60例患者中,存活38例,死亡12例,失访10例,客观有效率(ORR)为3.3%,疾病控制率(DCR)为56.6%,中位疾病进展时间(mTTP)为3.5个月(95%CI:2.9~4.1个月),中位总生存期(mOS)为11.3个月(95%CI:9.8~12.8个月),1年生存率为76%。TACE联合瑞戈非尼的不良反应有手足皮肤反应35例(58.3%),口腔黏膜炎18例(30%),疲乏16例(26.7%),腹泻22例(36.7%),高血压7例(11.7%),肝功能异常28例(46.7%),蛋白尿4例(6.7%),血小板减少27例(45%),中性粒细胞减少16例(26.7%),贫血32例(53.3%)等。结论TACE联合瑞戈非尼二线序贯治疗中晚期HCC安全有效,对于索拉非尼治疗进展或无法耐受患者,联合序贯治疗可改善疾病进展时间和OS,且不良反应1~2级多见,绝大部分患者可耐受。

Objective To evaluate the efficacy and safety of second-line sequential treatment using transcatheter arterial chemoembolization(TACE)plus regorafenib for mid-advanced hepatocellular carcinoma.Methods A total of 60 patients with mid-advanced hepatocellular carcinoma,who were admitted to the Affiliated Cancer Hospital of University of Chinese Academy of Sciences of China between June 2018 and December 2019,were enrolled in this study.All the 60 patients received first-line targeted therapy with TACE plus sorafenib,and received TACE combined with regorafenib as second-line sequential treatment because the disease progressed or the patient was unable to tolerate sorafenib.The modified RECIST criteria was used to evaluate the curative effect.The time to disease progression(TTP)and overall survival(OS)were calculated,and the occurrence of adverse reactions during the medication were recorded.Results The patients were followed up till June 2021.Among the 60 patients,38 survived,12 died,and 10 patients were lost in touch.The objective response rate(ORR)was 3.3%,the disease control rate(DCR)was 56.6%,the median time to progression(m TTP)was 3.5 months(95%CI=2.9-4.1 months),the median overall survival(mOS)was 11.3 months(95%CI=9.8-12.8 months),the one-year survival rate was 76%.The main adverse reactions of TACE combined with regorafenib included hand-foot skin reaction(n=35,58.3%),oral mucositis(n=18,30%),fatigue(n=16,26.7%),diarrhoea(n=22,36.7%),hypertension(n=7,11.7%),abnormal liver function(n=28,46.7%),proteinuria(n=4,6.7%),thrombocytopenia(n=27,45%),neutropenia(n=16,26.7%),anemia(n=32,53.3%),etc.Conclusion TACE combined with regorafenib as second-line sequential treatment for mid-advanced hepatocellular carcinoma is clinically safe and effective.For patients,whose disease progresses under sorafenib treatment or who is unable to tolerate sorafenib,TACE combined with regorafenib used as second-line sequential treatment can improve TTP and OS.Moreover,the adverse reactions of gradeⅠ-Ⅱare more commonly seen,which can be tolerated by most patients.(J Intervent Radiol,2022,31:1198-1202)