关键词: 原发性肝癌, 射频消融术, 索拉菲尼, 生存期, 不良反应

Abstract: Objective To investigate the efficacy and safety of sorafenib in the treatment of patients with advanced primary liver cancer （aPLC）. Methods 82 patients with aPLC were recruited in our hospital between April 2013 and December 2016,and were divided randomly into two groups with 41 in each by computer-generated numbers. All patients received radiofrequency ablation （RFA）,patients in the observation group received oral sorafenib daily,and all patients were followed-up for 12 weeks. Serum basic fibroblast growth factor （bFGF） and vascular endothelial growth factor（VEGF） levels were detected by ELISA,and the efficacy was evaluated by the response evaluation criteria in solid tumors（RECIST）. Results Two patients in the observation group were kicked off because of bad obedience,and three in the control failed to revisit. At the end of 12 week follow-up,the disease control rate in the observation group was 61.5%,without significant difference as compared with 52.6% in control group （P>0.05）,while the Objective effective rate in the observation group was 48.7%,much higher than 26.3% in the control group,the difference was statistically significant（P<0.05）;serum levels of AFP,bFGF and VEGF were （184.7±10.5） μg/L,（3.8±1.3） pg/mL and （172.3±25.4） pg/mL in the observation group,much lower than（213.6±11.6）μg/L,（6.4±2.0） pg/mL and（210.5±28.3） pg/mL,respectively in the control（P<0.05）;the progression-free survival （PFS） in the observation group was 10.2 months（95%CI:7.4-11.5）,while it was 7.9 months （95%CI: 6.0-10.1） in the control,which was significantly different by Log-rank test （P<0.05）;the incidence rates of hand-foot skin syndrome,skin rash,leukopenia,oral mucositis,hair loss and abnormal liver function tests in the observation group were 43.6%,25.6%,17.9%,20.5%,25.6% and 23.1%,much higher than 0.0%,2.6%,0.0%,0.0%,0.0% and 5.3% in the control （P<0.05）. Conclusion Sorafenib might inhibit the growth of solid tumors in patients with aPLC, and might thereby prolong the progression-free survival. However,the application of sorafenib can cause a variety of adverse reactions,which should be taken into consideration and the clinicians should take measures in time to deal with them.

Key words: Hepatoma, Advanced, Radiofrequency ablation, Sorafenib, Survival, Adverse reactions