Sorafenib in hepatocellular carcinoma - a post marketing evaluation

Immunopharmacol Immunotoxicol. 2012 Jun;34(3):419-22. doi: 10.3109/08923973.2011.617373. Epub 2011 Oct 8.

Abstract

Background: Sorafenib is an orally active multikinase inhibitor licensed for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Patients and methods: The web-based registry, used for appraisal on new drugs, allows developing the observational prospective analysis of innovative drug therapies. To establish clinical impact of Sorafenib, institutional data were collected prospectively through the registry.

Results: A total of 81 patients treated with Sorafenib were reviewed (median age = 65 years) and the follow-up duration was 30 months. Every patient was checked for length of treatment, toxicity and outcomes. Based on the study sample, the median time to progression was 3 months and median overall survival was 8 months. We found 52% progressions at first evaluation and the disease control rate was 32%.

Conclusion: Our data from real life practice showed that the clinical benefit of Sorafenib in unresectable HCC was gained in selected responder patients.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Benzenesulfonates / administration & dosage*
  • Benzenesulfonates / adverse effects
  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / mortality*
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / mortality*
  • Male
  • Middle Aged
  • Niacinamide / analogs & derivatives
  • Phenylurea Compounds
  • Product Surveillance, Postmarketing*
  • Protein Kinase Inhibitors / administration & dosage*
  • Protein Kinase Inhibitors / adverse effects
  • Pyridines / administration & dosage*
  • Pyridines / adverse effects
  • Registries
  • Sorafenib
  • Survival Rate

Substances

  • Benzenesulfonates
  • Phenylurea Compounds
  • Protein Kinase Inhibitors
  • Pyridines
  • Niacinamide
  • Sorafenib