The initial application of sorafenib in liver transplantation patients of primary hepatic carcinoma exceeding Milan criteria / 中华肝胆外科杂志

ABSTRACT

ObjectiveTo observe the efficacy of using sorafenib in preventing and treating tumor recurrence after liver transplantation for patients with primary hepatic carcinoma exceeding Milan criteria.MethodsFrom March 2008 to June 2010,30 patients of liver transplantation with primary hepatic carcinoma exceeding Milan criteria were randomized into 2 groups,each group of 15 cases.The experimental group received oral administration of sorafenib (400 mg bid) ; the control group received capecitabine (1500 mg bid) for 14 days every 4 weeks.The patient without recurrence in 18 months after transplantation stoped taking the medication.The recurrent patients maintained the original dose until they were not suitable for the medication.Patients with serious adverse reactions must reduce the dose or stop the medication.ResultsThe 1 year recurrence rate of experimental group was 53.3％,the control group was 86.6％,the difference between 2 groups was statistically significant (x2 =3.968,P＜0.05).The 1 year survival rate of experimental group was 93.3％,the control group was 46.6％,the difference between 2 groups was statistically significant (x2 =7.777,P＜0.05).The mean survival time of experimental group was (28.3±2.5)months (7～36 months),the control group was (17.9±3.5)months (5 ～ 41 months),the experimental group patients' survival time was longer than the control group,the differences was statistically significant (x2=5.702,P＜0.05 ).Most adverse reactions in 2 groups were grade Ⅰ - Ⅱ.The incidence of diarrhea and hand-foot syndrome in experimental group was higher than in control group.ConclusionUsing sorafenib for patients with primary hepatic carcinoma exceeding Milan criteria after liver transplantation probably may reduce or delay the process of carcinoma recurrence,can prolong the survival time of those patients,and side effects can be tolerated.