title: Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma.
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.
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Leonardo Gomes
authors.initials: LG
authors.lastname: DA Fonseca
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Romualdo
authors.initials: R
authors.lastname: Barroso-Sousa
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Afonso DA Silva Alves
authors.initials: AD
authors.lastname: Bento
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Bruna Paccola
authors.initials: BP
authors.lastname: Blanco
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Gabriel Luis
authors.initials: GL
authors.lastname: Valente
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Tulio Eduardo Flesch
authors.initials: TE
authors.lastname: Pfiffer
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Paulo Marcelo
authors.initials: PM
authors.lastname: Hoff
authors.affiliation: Cancer Institute of the State of Sao Paulo, University of Sao Paulo, Sao Paulo, SP 01255-000, Brazil.
authors.forename: Jorge
authors.initials: J
authors.lastname: Sabbaga
keywords: hepatocellular carcinoma; liver cirrhosis; liver disease; sorafenib