BACKGROUND AND OBJECTIVES: To compare the impact of concurrent TACE + sorafenib versus TACE alone on overall survival (OS) and time to progression (TTP) in patients with unresectable hepatocellular carcinoma (uHCC). A secondary goal was to determine if sorafenib use increases the interval between courses of TACE. METHODS: This study enrolled 150 patients with uHCC from June 2011 to June 2014, including 50 treated with TACE + sorafenib and 100 treated with TACE alone. Factors associated with OS and TTP were identified by univariate and multivariate Cox-regression model analyses. Average TACE interval was defined as TTP/TACE frequency. RESULTS: The median OS (21.7 vs. 11.5 months) and TTP (10.2 vs. 6.7 months) were longer in the TACE + sorafenib group compared to the TACE group. Patients receiving combination therapy had higher survival rate (P < 0.032) and longer average interval to TACE (P < 0.001), but lower progression rate (P < 0.001). TACE + sorafenib therapy was associated with improved OS (P ≤ 0.009) and TTP (P ≤ 0.021). The majority of AEs identified in patients receiving the combination therapy were classified as Grades 1 and 2, and skin-related reactions and fatigue were the most common. CONCLUSION: Concurrent sorafenib with TACE provides survival benefits over TACE monotherapy, which may be related to a prolonged interval between subsequent TACE courses. J. Surg. Oncol. 2016;113:672-677.
BACKGROUND AND OBJECTIVES: To compare the impact of concurrent TACE + sorafenib versus TACE alone on overall survival (OS) and time to progression (TTP) in patients with unresectable hepatocellular carcinoma (uHCC). A secondary goal was to determine if sorafenib use increases the interval between courses of TACE. METHODS: This study enrolled 150 patients with uHCC from June 2011 to June 2014, including 50 treated with TACE + sorafenib and 100 treated with TACE alone. Factors associated with OS and TTP were identified by univariate and multivariate Cox-regression model analyses. Average TACE interval was defined as TTP/TACE frequency. RESULTS: The median OS (21.7 vs. 11.5 months) and TTP (10.2 vs. 6.7 months) were longer in the TACE + sorafenib group compared to the TACE group. Patients receiving combination therapy had higher survival rate (P < 0.032) and longer average interval to TACE (P < 0.001), but lower progression rate (P < 0.001). TACE + sorafenib therapy was associated with improved OS (P ≤ 0.009) and TTP (P ≤ 0.021). The majority of AEs identified in patients receiving the combination therapy were classified as Grades 1 and 2, and skin-related reactions and fatigue were the most common. CONCLUSION: Concurrent sorafenib with TACE provides survival benefits over TACE monotherapy, which may be related to a prolonged interval between subsequent TACE courses. J. Surg. Oncol. 2016;113:672-677.