title: Safety and effectiveness of sorafenib in patients with hepatocellular carcinoma in clinical practice.
abstract: BACKGROUND
  Sorafenib is currently the only approved systemic treatment for hepatocellular carcinoma.
  
  
  OBJECTIVE
  to evaluate safety and effectiveness of sorafenib in the field of practice.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  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 642 mg. 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.
  
  
  CONCLUSIONS
  In daily clinical practice, sorafenib confirmed its safety and efficacy in hepatocellular carcinoma patients.
authors.affiliation: Liver Unit, Cardarelli Hospital, Naples, Italy. ggdicostanzo@libero.it
authors.forename: Giovan Giuseppe
authors.initials: GG
authors.lastname: Di Costanzo
authors.forename: Raffaella
authors.initials: R
authors.lastname: Tortora
authors.forename: Luca
authors.initials: L
authors.lastname: Iodice
authors.forename: Alfonso Galeota
authors.initials: AG
authors.lastname: Lanza
authors.forename: Filippo
authors.initials: F
authors.lastname: Lampasi
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Tartaglione
authors.forename: Francesco Paolo
authors.initials: FP
authors.lastname: Picciotto
authors.forename: Silvana
authors.initials: S
authors.lastname: Mattera
authors.forename: Massimo
authors.initials: M
authors.lastname: De Luca
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001557:Benzenesulfonates / Q000009:adverse effects* / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use; D011859:Radiography; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib