TACE联合索拉非尼治疗BCLC-C期肝癌的有效性及安全性

Efficacy and safety of TACE combined with Sorafenib in treatment of BCLC-C stage hepatocellular carcinoma

目的观察TACE联合索拉非尼(Sorafenib)治疗巴塞罗那临床肝癌(BCLC)-C期肝细胞癌(HCC)的有效性和安全性。方法回顾性分析73例BCLC-C期HCC患者,其中35例接受TACE联合索拉菲尼治疗(TACE+Sorafenib组),38例单纯接受TACE治疗(TACE组)。比较2组治疗1个月后的疗效和不良反应,统计总生存期(OS)及疾病进展时间(TTP)。结果术后1个月,TACE+Sorafenib组疾病控制率(DCR)高于TACE组(P=0.04),2组客观缓解率(ORR)差异无统计学意义(P=0.32)。2组主要不良反应包括胃肠道反应、骨髓抑制、皮肤反应及肝功能异常,均无严重不良反应发生;TACE+Sorafenib组皮肤反应、口腔黏膜炎、高血压发生率高于TACE组(P均<0.05)。TACE+Sorafenib组中位OS为13.6个月,中位TTP为6.5个月,均高于TACE组(分别为6.5、3.3个月,P=0.004、0.007)。结论TACE联合索拉非尼治疗BCLC-C期HCC安全、有效,可改善患者预后。

Objective To observe the efficacy and safety of TACE combined with Sorafenib in treatment of Barcelona clinic liver cancer(BCLC)-C stage hepatocellular carcinoma(HCC).Methods Data of 73 patients with BCLC-C stage HCC were analyzed retrospectively.Among them,35 patients underwent TACE combined with Sorafenib(TACE+Sorafenib group)and 38 underwent TACE alone(TACE group).The therapeutic effect,adverse reactions,overall survival(OS)and time to progression(TTP)of disease 1 month after operation were compared between 2 groups.Results One month after operation,the disease control rate(DCR)in TACE+Sorafenib group was higher than that in TACE group(P=0.04).There was no significant difference of objective response rate(ORR)between groups(P=0.32).The adverse reactions mainly included gastrointestinal reaction,bone marrow suppression,skin reaction and liver function.No serious adverse reaction occurred in both groups.The incidence of skin reaction,oral mucositis and hypertension in TACE+Sorafenib group were higher than those in TACE group(all P<0.05).The median OS and TTP of TACE+Sorafenib group were 13.6 months and 6.5 months,respectively,higher than those in TACE group(6.5 months and 3.3 months,P=0.004,0.007,respectively).Conclusion TACE combined with Sorafenib was effective and safe for treating BCLC-C stage HCC,which might improve the prognosis.