Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma

Abstract

Abstract. Sorafenib demonstrated a survival benefit in the treatment of advanced hepatocellular carcinoma (HCC) in phase III trials. However, almost all the patients included in those trials exhibited well-preserved liver function (Child-Pugh A). The aim of this study was to describe our experience with sorafenib in Child-Pugh B HCC patients. A database of patients with advanced HCC treated with sorafenib was retrospectively evaluated. The median overall survival of Child-Pugh B patients (n=20) was 2.53 months [95% confidence interval ( CI): 0.33-5.92 months] and of Child-Pugh A patients (n=100) 9.71 months (95% CI: 6.22-13.04). Child-Pugh B patients had a significantly poorer survival compared to Child-Pugh A patients (P=0.002). The toxicities were similar between the two groups. Metastasis, vascular invasion and α-fetoprotein level >1,030 ng/ml were not associated with survival among Child-Pugh B patients (P=0.281, 0.189 and 0.996, respectively). Although the survival outcomes were worse in Child-Pugh B patients treated with sorafenib, the toxicity profile was manageable. Therefore, there remains the question of whether to treat this subgroup of patients and more data are required to define the role of sorafenib in the context of liver dysfunction.

Sorafenib for Advanced Hepatocellular Carcinoma: A Real-Life Experience

“…HCV infection, alcohol abuse, and fatty liver disease are the major risk factors associated with the development of the disease. These findings corroborate other studies [3,5,19,20].…”

“…These results are probably due to a higher rate of cessation of treatment because of adverse reactions. These data corroborate those found in other studies, which demonstrated that the prescribed dose of SOR was similar among patients with CP-A and CP-B scores, although the duration of treatment was shorter in cases with CP-B [7,19].…”

“…Hypertension as well is associated with a better response to the therapy, but it was not a frequent finding in the present study [23]. Previous studies have reported similarities between the rates of adverse reactions in patients with CP-A and CP-B scores, demonstrating that SOR can be administered to both groups with safety and tolerability [5,10,18,19,22]. Abou-Alfa et al [24] reported differences in the incidence of adverse reactions among patients with CP-A and CP-B; however, it cannot be determined if such differences are related to the drug or the progression of the disease.…”

“…In most cases, HCC develops within the context of chronic liver disease [18,19]. Heterogeneity in the worldwide incidence reflects variations in the distribution of the main risk factors [3].…”

Survival and cost‐effectiveness of sorafenib therapy in advanced hepatocellular carcinoma: An analysis of the SEER–Medicare database

“…(3) The Global Investigation of Therapeutic Decision in Hepatocellular Carcinoma and of Its Treatment with Sorafenib (GIDEON) data suggest sorafenib is well tolerated by patients with Childs-Pugh class B cirrhosis and advanced HCC with a median survival of 5.2 months, but this post-marketing study did not have a comparator arm so analyses of survival benefit have relied on comparisons to historical controls. (4,5) Further, we lack an understanding of how health system characteristics (e.g., being seen at a tertiary care referral center, impact treatment effectiveness and survival). The population of patients with HCC is shifting to a more elderly demographic, largely due to an aging population with chronic hepatitis C virus infection; thus, the impact of age and accumulated comorbidities is becoming increasingly relevant when making HCC treatment decisions.…”