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Efficacy of transcatheter arterial chemoembolization (TACE) in combination with sorafenib for the treatment of unresectable hepatocellular carcinoma in Chinese patients.

279 Background: The purpose of this prospective trial is to evaluate the efficacy and safety of the concurrent use of TACE and sorafenib in a group of patients with unresectable HCC.The treatment outcomes of this group of patients were also compared in a retrospective fashion with a group of HCC patients with similar characteristics of patient and disease in a case controlled setting.


METHODS
A total of 45 patients (BCLC stage B/C: 16/29) with unresectable HCC were enrolled between June 2008 and Feb 2011 as experimental group and were treated with combination of sorafenib and TACE according to an institutional protocol. To evaluate the efficacy of the combination therapy, a group of 45 HCC patients (n=45, BCLC stage B/C: 17/28) with comparable baseline characteristics who had been treated with TACE alone in our institute were retrospectively selected as control group to compare the treatment outcomes. Median overall survival was compared between the two groups. Adverse events related to sorafenib were assessed according to CTCAE3.0 to observe safety endpoints. The study was approved by the Institutional Ethics Committee at Zhongshan Hospital, Fudan University, China.


RESULTS
The median follow-up time for the entire group of patients was 21 months (12.66 - 29.33). The median survival time for the TACE/sorafenib group was 27 months (21.89 - 32.10), and that for TACE alone group was 17 months (8.9 - 25.04) (P<0.05). The most common adverse events associated with sorafenib were hand-foot skin reaction (82.2%), rash (57.94%) and diarrhea (48.91%). Most of the drug-related adverse events were manageable with dose modification, and no CTCAE Grade 4 adverse event was observed.


CONCLUSIONS
The combination treatment of TACE and sorafenib significantly prolonged median survival in Chinese patients with unresectable HCC, with well tolerated safety profile.