Abstract
Purpose Data on the efficacy and safety of sorafenib in combination with transarterial chemoembolization (TACE) are limited, particularly for advanced hepatocellular carcinoma (HCC) patients. We evaluated the outcome of the combination therapy in advanced HCC patients with preserved liver function, determined the predictors of survival, and proposed a new prognostic score to stratify the advanced HCC. Materials and Methods In the multicenter retrospective single-arm study, 222 consecutive HCC patients receiving the combination therapy were enrolled between June 2008 and July 2011. Results Chronic hepatitis B was the predominant cause of HCC (86%). 80% patients were in Barcelona Clinic Liver Cancer (BCLC) stage C and 86% patients were at Child-Pugh (CP) A class. The median number of TACE procedure was 2 (range 1-8); and the median duration of sorafenib treatment was 8.1 months (range 0.1-33.9). After a median follow-up of 10.4 months, 148 patients had died. The overall median survival was 12 months (95% CI 10.1-13.9); and it was 13.1 months in CP-A patients and 7.6 months in CP-B patients. The overall incidence of adverse events (AEs) was 87%; and the most common AEs were diarrhea (50%), hand-foot-skin reaction (40%), rash (39%), and fatigue (33%). In 177 BCLC-C patients, performance status, the number of HCC nodules, Child-Pugh score and macrovascular invasion were significantly associated with overall survival and were included in the final score. Risk scores (R)= 5*(Vascular invasion: 0 if no, 1 yes) + 6*(CP: 0 if A, 1 if B) + 7*(No. of lesions: 0 if 1-2, 1 ≥3) + 8*(ECOG: 0 if 0, 1 ≥1). Conclusion Sorafenib in combination with TACE should be considered a safe and effective therapy for advanced HCC with well-preserved liver function. It is necessary to stratify the BCLC stage C to achieve the individualized optimal treatment. Further validation of the new subgroup of BCLC-C stage is warranted in an independent patient cohort.
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