Retrospective analysis of sorafenib efficacy and safety in Chinese patients with high recurrence rate of post-hepatic carcinectomy

Desheng Wang,1,*, Weridong Jia,2,*, Zhiming Wang,3 Tianfu Wen,4 Wei Ding,5 Feng Xia,6 Ling Zhang,7 Feixiang Wu,8 Tao Peng,9 Bin Liu,10 Cuncai Zhou,11 Qichang Zheng,12 Xiongying Miao,13 Junping Peng,14 Zhiyong Huang,15 Kefeng Dou11Department of Hepatobiliary Surgery, Xijing Hospital, Shaanxi, China; 2Department of Hepatobiliary Surgery, Anhui Provincial Hospital, Hefei, China; 3Department of Hepatobiliary Surgery, Xiangya Hospital, Changsha, China; 4Department of Hepatobiliary Surgery, West China Hospital, Chengdu, China; 5Department of Hepatobiliary Surgery, Cancer Hospital of Xinjiang, Urumqi, China; 6Department of Hepatobiliary Surgery, Southwest Hospital, Chongqing, China; 7Department of Hepatobiliary Surgery, Cancer Hospital of Henan, Zhengzhou, China; 8Department of Hepatobiliary Surgery, Cancer Hospital of Guangxi Medical University, Nanning, China; 9Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China; 10Department of Hepatobiliary Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China; 11Department of Hepatobiliary Surgery, Cancer Hospital of Jiangxi, Nanchang, China; 12Department of Hepatobiliary Surgery, Wuhan Union Hospital, Wuhan, China; 13Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Xiangya, Changsha, China; 14Department of Hepatopancreatobiliary Surgery, Cancer Hospital of Sichuan, Chengdu, China; 15Department of Hepatobiliary Surgery, Wuhan Tongji Hospital, Wuhan, China*These authors contributed equally to this workBackground: There is no guideline recommendation for preventing hepatocellular carcinoma (HCC) recurrence after hepatic resection. Moreover, an unmet need exists on the effectiveness of sorafenib therapy in recurrent HCC.Purpose: We therefore assessed the efficacy and safety of sorafenib in Chinese HCC patients with high risk of recurrence.Patients and methods: Data were collected retrospectively from 15 Chinese research centers from January 1, 2012 to November 15, 2013, by chart reviews of patients with moderate-advanced HCC who received hepatic carcinectomy. The primary end point was recurrence-free survival rate at 1 year in patients with a high recurrence risk. Secondary end points included 1-year survival rate, time to recurrence and safety assessment.Results: A total of 209 high-risk patients (sorafenib, n=98; control, n=111) who underwent carcinectomy were analyzed. There was no significant difference in the proportion of patients with recurrence-free survival at 1 year between the sorafenib and control (70.43% vs 68.90%: χ2=0.007, P=0.934). One-year survival rate was significantly higher with sorafenib than observed with control (95.5% vs 83.35%; χ2=7.441, P=0.006). Time to recurrence between sorafenib and control groups was similar. Incidences of all the adverse events (AEs) were similar in both the groups and transaminase elevation was most common in both groups (20.37% vs 24.79%). Thrombocytopenia incidence was significantly lower with the sorafenib group than with control (1.85% vs 9.40%; P=0.015).Conclusion: Sorafenib may be considered as a feasible option in the treatment of HCC recurrence.Keywords: hepatocellular carcinoma, recurrence, sorafenib, survival, carcinectomy, Chinese