Safety and effectiveness of sorafenib in patients with hepatocellular carcinoma in clinical practice

Digestive and Liver Diseases, 05/31/2012

In daily clinical practice, sorafenib confirmed its safety and efficacy in hepatocellular carcinoma patients.


  • The authors report a single–centre experience on 116 advanced hepatocellular carcinoma patients treated with sorafenib between February 2008 and March 2011.
  • Every 4 weeks, adverse events were graded using Common Toxicity Criteria version 3.0, and every 3 months tumour response was assessed according to modified Response Evaluation Criteria in Solid Tumours for hepatocellular carcinoma.


  • Cirrhosis was present in 95.7% of patients (83.6% Child–Pugh A class), hepatitis C was the main etiological factor.
  • Median therapy duration was 3 months and median daily dose was 642mg.
  • Median time–to–radiological progression in the per–protocol population was 12 months and median overall survival in the intention–to–treat population was 13 months. 91.4% of patients experienced mild adverse events (grade 1 or 2), the most frequent were gastrointestinal and dermatological.
  • Jaundice and bleeding were the main causes of definitive drug discontinuation.
  • 3–month overall disease control rate was 70.6%: stable disease in 37.2%, partial response in 30.8%, and complete response in 2.6% patients.
  • The 3–month radiological response correlated with overall survival.

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