Safety and efficacy of sorafenib in the treatment of advanced hepatocellular carcinoma: a single center experience

Autores de IIS La Fe

• Esteban Rodrigo Imedio

  Autor

• Roberto Pedro Díaz Beveridge

  Autor

• Jorge Aparicio Urtasun

  Autor

• Gema Bruixola Campos

  Autor

• David Lorente Estellés

  Autor

• Maria Fonemia Esparcia

  Autor

• Javier Caballero Daroqui

  Autor

• Ángel Agustín Segura Huerta

  Autor

• Alejandra Giménez Ortiz

  Autor

• Joaquin Montalar Salcedo

  Autor

Grupos

• Investigación Clínica y Traslacional en Cáncer

Abstract

Sorafenib is the standard treatment of patients with advanced hepatocellular carcinoma (HCC), with demonstrated outcome benefits in randomized clinical trials. We present a single-center experience with sorafenib with the aim to establish its efficacy and safety in daily clinical practice. A total of 62 patients were treated with sorafenib 400 mg/12 h until disease progression or unacceptable toxicity. Response rates, incidence of adverse events, actuarial disease-free survival, and overall survival (OS) were estimated. Univariate and multivariate analyses of prognostic factors for survival were also performed. Median treatment duration was 92 days. A 43 % disease control rate was achieved (partial response, 15 % and disease stabilization, 28 %). After a median follow-up of 24.1 months, the median progression-free survival and OS for the overall population were 5.8 and 6.7 months, respectively, with survival rates of 27 % at 1 year and 17 % at 2 years. The most common grade 3-4 adverse events were fatigue (19 %), hand-foot syndrome (8 %), hypertension (5 %), and diarrhea (3 %). The univariate analysis showed that patient performance status (PS), use of previous treatments, and albumin >3.5 g/dL were significant prognostic factors for survival. In the multivariate study, only PS, alcoholic etiology and albumin >3.5 g/dL remained as independent predictors of survival. Sorafenib is a safe and moderately effective drug in HCC, although patients must be properly selected before starting therapy. Baseline PS, Barcelona Clinic Liver Cancer staging, and liver function should be taken into account as prognostic factors. Results in daily practice are somewhat inferior than observed in clinical trials.

Keywords

• Child-Pugh score; Hepatocellular carcinoma; Sorafenib; Prognostic factors; BCLC staging