索拉非尼联合经导管肝动脉化疗栓塞治疗无远处转移的晚期肝细胞癌

Clinical observation of sorafenib together with TACE in advanced hepatocellular carcinoma with no extrahepatic metastasis

目的观察多靶点分子靶向治疗药物索拉非尼联合经导管肝动脉化疗栓塞(TACE)治疗不伴远处转移的晚期或进展期肝细胞癌的疗效和不良反应。方法2007年4月至2009年9月,中国医学科学院肿瘤医院收治45例不伴有远处转移的晚期或进展期肝细胞癌患者,口服索拉非尼治疗,其中18例联合TACE(1～5次),27例单用索拉非尼。索拉非尼起始剂量400mg,每日2次,治疗过程中根据不良反应发生情况调整用量。每2个月评价疗效和不良反应,并随访中位至疾病进展时间(TTP)和中位总生存时间(OS)。结果至2009年12月,40例患者达到临床评价要求(联合TACE18例,单用索拉非尼22例)。两组不良反应发生率无显著差异,主要治疗相关不良反应为手足皮肤反应、腹泻和高血压。两组患者均无4级严重不良反应。索拉非尼联合TACE组中位TTP为10.0个月,中位OS16.0个月;单用索拉非尼组中位TTP为4.5个月,中位OS5.3个月。两组OS和TTP差异有统计学意义(P<0.01)。结论病变局限在肝内且不合并远处转移的晚期或进展期肝细胞癌患者,口服索拉非尼联合TACE不增加并发症发生率,且生存预后改善。

Objective To evaluate the efficacy and safety of molecular targeted agent sorafenib together with TACE in advanced hepatocellular carcinoma without extrahepatic metastasis.Methods From Apr.2007,to Sep.2009,45 advanced hepatocelluar carcinoma patients without extrahepatic metastasis were orally treated with sorafenib at a dose of 400 mg twice daily.Among them,18 patients were treated with TACE（1-5times）.Results The most common adverse events in both groups were hand foot skin reaction,diarrhea and hypertension.There were no grade 4 adverse events and no discontinuation of the drug due to severe adverse events in both groups.The median overall survival time was 16.0 months in sorafenib-TACE group and 5.3 months in sofafenib group（P0.01）.The median time to progression was 10.0 months in sorafenib-TACE group and 4.3 in sofafenib group（P0.01）.Conclusion TACE does not promote the adverse events in advanced hepatocelluar carcinoma without extrahepatic metastasis treated with sorafenib.Sorafenib combind with TACE prolongs the median overall survival time and the time to progression in these patients.