Concurrent sorafenib therapy extends the interval to subsequent TACE for patients with unresectable hepatocellular carcinoma

Aim/Background

Sorafenib and transarterial chemoembolization (TACE) alone and in combination have been used in patients with unresectable hepatocellular carcinoma (HCC); however, the effects of addition of sorafenib on the interval to subsequent TACE are unknown. The aim of this prospective, nonrandomized, comparative study was to examine the impact of concurrent TACE + sorafenib on overall survival (OS), time to progression (TTP), and the interval between courses of TACE.

Methods

This study enrolled 150 patients with unresectable HCC, including 50 patients in the TACE + sorafenib group and 100 patients in the TACE group, from June 2011 to June 2014. Patients in the TACE + sorafenib group received an initial dose of 400 mg administered orally twice a day, which was reduced or temporarily suspended in the event of an adverse event (AE). The factors associated with OS and TTP were identified by univariate and multivariate Cox-regression model analyses.

Results

The median OS was 21.7 months (95% CI 18.3 - 25.1) in the TACE + sorafenib group and 11.5 months (95% CI 7.8, 15.2) in the TACE group. The median TTP was 10.2 (95% CI 9.7-10.7) and 6.7 (95% CI 6.1, 7.2) months in the TACE + sorafenib and TACE groups, respectively. Patients receiving the combination therapy had a higher survival rate (p < 0.032) and longer average interval to TACE (p < 0.001), but lower progression rate (p < 0.001) as compared to those treated with TACE. Multivariate analysis revealed that the combination therapy, BCLC stage, and the absence of progression were all associated with improved OS (p ≤ 0.009) while the treatment, BCLC stage, and AFP levels were significantly associated with TTP (all p ≤ 0.021). The majority of AEs identified in patients receiving the combination therapy were classified as Grades 1 and 2, all grade AE showed skin related reaction (including hand-foot skin reaction (58%) and rash (20%)), and fatigue (52%) being the most common.

Conclusions

Thus, sorafenib delivered concurrently with TACE provides survival benefits over TACE monotherapy, and these benefits may be related to a prolonged interval between subsequent TACE courses.

Clinical trial identification

no applicable

Disclosure

All authors have declared no conflicts of interest.