Purpose: To retrospectively analyze the efficacy and safety of transcatheter arterial chemoembolization (TACE) in combination with sorafenib for the treatment of patients with intermediate-advanced hepatocellular carcinoma (HCC) and assess the prognostic impact of baseline characteristics.
Methods: Patients with intermediate-advanced HCC received TACE combined with sorafenib in this Phase 2 clinical trial. The primary outcome was median time to disease progression (mTTP). Secondary outcomes were median overall survival (mOS), the disease benefit rate and the sorafenib-related adverse events (AEs). Baseline characteristics' impacts on prognosis were analyzed by univariate COX proportional hazards regression model.
Results: From June 2008 to June 2013, 75 patients were enrolled. At the end of the study, 54 patients were dead or lost to follow-up and 21 patients survived. This combination therapy resulted in a mTTP of 7.09 months (95 % CI, 1.5-45 months) and a mOS of 11.44 months (95 % CI, 1.5-45 months). The disease benefit rate was 88 %. Child-Pugh score (P = 0.000), Eastern Cooperative Oncology Group performance status (P = 0.001), Barcelona Clinic Liver Cancer stage (P = 0.000), sorafenib treatment regimen (P = 0.001), presence of extrahepatic metastasis (P = 0.002), and type of tumor (P = 0.027) were significantly correlated with OS. Multivariate analysis revealed Child-Pugh score (P = 0.001) and BCLC stage (P = 0.002) as significant independent prognostic predictors for OS. AEs were HFSR (18.7 %), gastrointestinal reactions (13.3 %), liver dysfunction (6.7 %), myelosuppression (5.3 %), fatigue (4 %), and hypertension (1.3 %).
Conclusions: TACE in combination with sorafenib might have acceptable safety and efficiency in the treatment of intermediate-advanced HCC.