A multicenter cohort study on transarterial chemoembolization with or without sorafenib for intermediate-stage hepatocellular carcinoma: Reconsidering combination-therapy trial design.

4080 Background: The proof of the superiority of combination therapy with sorafenib and transarterial chemoembolization (TACE) over TACE alone for hepatocellular carcinoma (HCC) in term of survival is lacking. We conducted this multicenter retrospective study to evaluate the efficacy of combination therapy over TACE alone, and to compare the overall survival (OS) between patients with ≥ grade 2 sorafenib-related dermatologic adverse events (AEs) in the combination therapy group and patients treated with TACE alone. Methods: From January 2009 to December 2012, 606 consecutive patients with intermediate stage HCC, Eastern Cooperative Oncology Group performance status 0-1, and Child-Pugh class A-B ( ≤ 7) were included. Of them 202 received combination therapy and 404 received TACE alone therapy, respectively. Results: There was no significant difference between the two groups in median OS although a trend toward longer survival was observed in the combination therapy group (22.3 vs. 18.1 months, P= 0.281). A...