Sorafenib for hepatocellular carcinoma according to Child-Pugh class of liver function

Abstract

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.