To evaluate the clinical efficacy of sorafenib in preventing the recurrence of primary liver cancer after radical surgery.

Seventy patients with primary liver cancer undergoing radical surgery in the Third Affiliated Hospital of Sun Yat-sen University between June 2009 and June 2012 were enrolled in this prospective study. The informed consents of all patients were obtained and the local ethical committee approval had been received. According to different postoperative therapies, the patients were divided into the sorafenib group (n=24) and control group (n=46). In the sorafenib group, there were 22 males and 2 females with a mean age of (48±10) years. A dose of 400 mg sorafenib was orally administered twice daily for consecutive 6 months. In the control group, there were 40 males and 6 females with a mean age of (48±11) years. The patients were orally administered with placebo. All patients received postoperative follow-up. Postoperative recurrence rate, survival rate and drug-induced adverse reactions were observed. Postoperative recurrence rate and incidence of adverse reactions of two groups were compared using Chi-square test or Fisher exact probability test. Postoperative survival rate was analyzed by Kaplan-Meier plot and Log-rank test.

In the sorafenib group, the 1-, 2- and 3-year recurrence rates were 25% (6/24), 42% (10/24), 50% (12/24) respectively, and 28% (13/46), 46% (21/46), 53% (25/46) respectively in the control group. No significant difference was observed between two groups (χ²=0.020, 0.102, 0.120; P>0.05). The 1-, 2- and 3-year cumulative survival rates in the sorafenib group were 95.83%, 87.50% and 70.83%, and no significant difference was observed compared with 91.30%, 82.61% and 63.04% in the control group (χ²=0.078, P>0.05). In the sorafenib group, the incidence of hand-foot skin reaction, diarrhea, hypertension and erythema were 42% (10/24), 29% (7/24), 21% (5/24) and 25% (6/24), which were significantly higher compared with 7% (3/46), 7% (3/46), 2% (1/46) and 4% (2/46) in the control group (χ²=10.663, 4.885, 4.828, 4.762; P<0.05).

Sorafenib can neither decrease postoperative recurrence of peimary liver cancer after radical surgery nor enhance the overall survival rate.