PURPOSE: We compared the efficacy and safety of sorafenib in patients with Child-Pugh (CP) class B and CP class A.
METHODS: Clinical data from 267 patients with HCC who had been treated with sorafenib were reviewed. Patients were grouped according to CP score (5-6, 7, and 8-9), and their tumor response, tolerance, and survival were assessed.
RESULTS: Median patient age was 55 years, and 87.6% were men. Gender, HCC etiology, and extrahepatic metastasis did not differ according to CP score. Of the 225 evaluable patients, 4 achieved partial response and 121 achieved stable disease, making the disease control rate 46.8%. DCR was higher in patients with CP A than CP B score, but did not differ between those with CP scores of 7 and 8-9. The incidence rates of grade 3/4 toxicities did not differ according to CP score. Many patients with CP score 8-9 (26.3%) had to stop sorafenib due to cirrhosis-related complications. At a median follow-up of 15.6 months, the median time to progression and overall survival of all patients were 2.6 and 7.9 months, respectively. OS was greater in patients with CP score 5-6 than in patients with CP scores of 7 or 8-9.
CONCLUSIONS: Sorafenib efficacy and survival outcomes were worse in patients with CP B function. Patients with a CP score of 7 had the same incidence of adverse events and cirrhosis-related complications as those with CP A liver function, suggesting that the former can be included in clinical trials of new agents.