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目的研究应用不同方案行索拉非尼联合经皮肝动脉化疗栓塞(TACE)及射频消融(RFA)(局部介入术前开始应用索拉非尼以及局部介入术后开始应用索拉非尼)治疗中晚期>5cm肝癌的适用性及安全性,初步观察其疗效。方法 2008年11月始筛选纳入>5cm的中晚期肝癌患者。随机分为2组,A组为先行TACE联合RFA,术后开始口服索拉非尼;B组为先口服索拉非尼1～2周,再行TACE及RFA。规律随访,观察毒副反应的发生情况及患者生存情况。结果截至2013年2月21日,A组与B组分别纳入患者15例。肝癌直径(8.9±3.1)cm,患者随访时间(27±11.8)月。两组均未发生与治疗相关的死亡,索拉非尼主要相关不良反应有手足皮肤反应(53.3%vs66.7%,P=0.710)、食欲下降(53.3%vs46.7%,P=0.999)、乏力(53.3%vs40.0%,P=0.715)以及腹泻(33.3%vs46.7%,P=0.710)等,只有1例患者出现4级的上消化道出血,两组比较差异均无统计学意义。两组患者的远期生存疗效差异无统计学意义(中位生存时间:A组31月vsB组32月,χ2=0.050,P=0.822)。结论两种联合方案在治疗中晚期大肝癌均是安全适用的,且治疗风险相当。生存分析并未显示出应用哪一种联合方案更具有优势。
Objective To investigate the feasibility and safety of sorafenib combined with percutaneous transhepatic arterial chemoembolization (TACE) and radiofrequency ablation (RFA) with different schedules (Sorafenib started before local intervention and Sorafenib started after local intervention) The application of 5cm advanced hepatocellular carcinoma and its safety, preliminary observation of its efficacy. Methods From November 2008, patients with advanced hepatocellular carcinoma who were included in> 5cm were enrolled. Group A was TACE combined with RFA before operation, and started oral administration of sorafenib. Group B received oral sorafenib for 1 to 2 weeks before TACE and RFA. Regular follow-up, observation of the occurrence of side effects and patient survival. Results As of February 21, 2013, 15 patients were enrolled in Group A and Group B, respectively. The diameter of liver cancer was (8.9 ± 3.1) cm and the follow-up time was (27 ± 11.8) months. No treatment-related deaths occurred in either group, with major side effects associated with sorafenib (53.3% vs66.7%, P = 0.710), loss of appetite (53.3% vs46.7%, P = 0.999) (53.3% vs 40.0%, P = 0.715) and diarrhea (33.3% vs46.7%, P = 0.710). Only one patient had grade 4 upper gastrointestinal bleeding, and there was no statistical difference between the two groups Significance of learning. There was no significant difference in long-term survival between the two groups (median survival time: 31 months in group A vs. 32 months in group B, χ2 = 0.050, P = 0.822). Conclusion Both of the two combined regimens are safe and suitable for the treatment of large hepatocellular carcinoma in the advanced stage, and the treatment risk is quite high. Survival analysis did not show which combination of solutions was more advantageous.