瑞戈非尼联合程序性死亡受体1抑制剂二线治疗晚期肝细胞癌的疗效观察及预后影响因素分析  

Efficacy of regorafenib combined with programmed death receptor 1 inhibitor as second-line treatment for advanced hepatocellular carcinoma and analysis of prognostic influencing factors

作　　者：张宇 郑鹏 黄涛[1] ZHANG Yu;ZHENG Peng;HUANG Tao(Department of Hepatobiliary Surgery,Henan Cancer Hospital,Zhengzhou 450003,China)

机构地区：[1]河南省肿瘤医院肝胆外科,河南郑州450003

出　　处：《山东医药》2025年第4期73-77,共5页Shandong Medical Journal

摘　　要：目的观察瑞戈非尼联合程序性死亡受体1(PD-1)抑制剂二线治疗晚期肝细胞癌(HCC)的疗效,并分析其预后影响因素。方法晚期HCC患者52例,采用瑞戈非尼联合PD-1抑制剂治疗,观察治疗效果及不良反应。另采用单因素分析法和多因素Cox回归分析法分析52例晚期HCC患者预后影响因素。结果52例晚期HCC患者经瑞戈非尼联合PD-1抑制剂治疗后,完全缓解(CR)1例(1.92%),部分缓解(PR)15例(28.85%),疾病稳定(SD)21例(40.38%),疾病进展(PD)15例(28.85%);客观缓解率(ORR)为30.77%(16/52),疾病控制率(DCR)为71.15%(37/52);中位无进展生存期(mPFS)为8.4个月,中位总生存期(mOS)为15.8个月(95%CI 13.706~17.894)。最常见的不良反应为手足综合征(25例),其次为腹泻(18例)和高血压(18例),随后依次为疲劳(13例)、疼痛(12例)、恶心(11例)、厌食(11例)、转氨酶升高(11例)、胆红素升高(8例)、甲状腺功能减退症(8例)、皮疹(7例)、呕吐(7例)、发热(6例)、脚麻(4例)、咳血(4例)、胃肠道出血(3例)、牙龈出血(2例)。单因素分析显示,既往无肝外转移、既往接受过局部治疗、Child-Pugh分级A级、BCLC分期B期患者mPFS明显延长,差异具有统计学意义(P均<0.05);多因素分析显示,Child-Pugh分级B级、BCLC分期C期为接受瑞戈非尼联合PD-1抑制剂治疗晚期HCC患者mPFS的独立危险因素。结论瑞戈非尼联合PD-1抑制剂二线治疗晚期HCC患者疗效显著,且不良反应可控,Child-Pugh分级B级和BCLC分期C期是HCC患者预后不佳的独立危险因素。Objective To observe the efficacy of regorafenib combined with programmed death receptor 1(PD-1)inhibitor as second-line treatment for advanced hepatocellular carcinoma(HCC)and to analyze the prognostic in-fluencing factors.Methods Fifty-two patients with advanced HCC were treated with regorafenib combined with PD-1 inhibitor.The treatment effect and adverse reactions were observed.Univariate analysis and multivariate Cox re-gression analysis were used to analyze the prognostic factors of 52 patients with advanced HCC.Results After treatment with regorafenib combined with PD-1 inhibitor,52 patients with advanced HCC achieved complete remis-sion(CR)in 1 case(1.92%),partial remission(PR)in 15 cases(28.85%),stable disease(SD)in 21 cases(40.38%),and progressive disease(PD)in 15 cases(28.85%);the objective response rate(ORR)was 30.77%(16/52),and the disease control rate(DCR)was 71.15%(37/52);the median progression-free survival(mPFS)was 8.4 months,and the median overall survival(mOS)was 15.8 months.The most common adverse re-actions were hand-foot syndrome(25 cases),followed by diarrhea(18 cases)and hypertension(18 cases).Subse-quent reactions in descending order of frequency included fatigue(13 cases),pain(12 cases),nausea(11 cases),anorexia(11 cases),elevated transaminases(11 cases),hyperbilirubinemia(8 cases),hypothyroidism(8 cases),rash(7 cases),vomiting(7 cases),fever(6 cases),foot numbness(4 cases),hemoptysis(4 cases),gastroin-testinal bleeding(3 cases),and gingival bleeding(2 cases).Univariate analysis showed that patients without extra-hepatic metastasis in the past,who had received local treatment in the past,with Child-Pugh grade A,and at BCLC-B stage,had significantly prolonged mPFS,and the differences were statistically significant(all P<0.05);multivari-ate analysis showed that Child-Pugh grade B and BCLC-C stage were independent risk factors for mPFS in patients with advanced HCC treated with regorafenib combined with PD-1 inhibitor.Conclusions Regorafenib combined with PD-1 inhibitor as second-line treat

关 键 词：瑞戈非尼 程序性死亡受体1抑制剂 肝细胞癌 CHILD-PUGH分级 BCLC分期 

分 类 号：R735.7[医药卫生—肿瘤]