Is sorafenib (S) safe and effective in patients (pts) with hepatocellular carcinoma (HCC) and Child-Pugh B (CPB) cirrhosis?

Prognostic factors in patients with advanced hepatocellular carcinoma treated with sorafenib

“…Indeed, it is possible that an analysis of outcomes according to each BCLC stage of disease with respect to Child-Pugh class would provide us with further details of the true benefits of sorafenib in each of these patient subsets, but the low patient numbers prevented such an analysis in this study. Nevertheless, the alignment of our findings in CP-A patients with those reported in SHARP, 9 and in CP-B patients with previously reported prospective and retrospective studies, 8,9,13,25,26 support the validity of our findings.…”

Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma

“…In the phase II trial of sorafenib for HCC, stable disease for 4 or more months was noted in 49% of patients with C-P class A cirrhosis (n = 98) and 26% of patients with C-P class B cirrhosis (n = 38). Patients with C-P class B cirrhosis had higher rate of elevated bilirubin (18 vs. 40%), encephalopathy (2 vs. 11%), and worsening ascites (11 vs. 18%) than patients with C-P class A cirrhosis, despite a similar incidence of all other adverse events and serious adverse events between these two groups of patients [349]. In the phase III SHARP trial, the incidence of serious hepatobiliary events was similar between the sorafenib group (11%) and the placebo group (9%).…”

Molecular Targeted Therapy for Growth Factors in Hepatocellular Carcinoma

“…In regard to the differences in the pharmacokinetics between the Child-Pugh class A and B patients, although both the area under the concentration-time curve for 0-12 h and the maximal concentration in the steady state were slightly lower in the Child-Pugh class B patients than in the Child-Pugh class A patients, there were no major differences in the incidence or grade of drug-related adverse events between the Child-Pugh class A and B groups; however, hypertension, hand-foot skin reactions, and rash were reported more frequently in the Child-Pugh class B group [18]. Especially, grade 3-4 adverse events of elevated bilirubin, ascites, and encephalopathy occurred at a greater frequency in Child-Pugh class B patients than in the Child-Pugh class A patients [20]. Thus, the efficacy or safety of sorafenib in HCC patients categorized as Child-Pugh class B are not clear yet.…”