title: Safety and efficacy of sorafenib in hepatocellular carcinoma: the impact of the Child-Pugh score.
abstract: BACKGROUND
  Sorafenib increases median survival and time to radiological progression in patients with advanced hepatocellular carcinoma, but its benefit for Child-Pugh B patients remains uncertain.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of sorafenib in real-life clinical practice conditions and to assess the influence of Child-Pugh class B on safety and efficacy.
  
  
  METHODS
  All patients treated with sorafenib for advanced hepatocellular carcinoma in our institution were included prospectively. Adverse events, overall survival and time to progression were recorded. A case control study was performed to compare outcome of patients with comparable stages of hepatocellular carcinoma, but a different Child-Pugh class.
  
  
  RESULTS
  From March 2007 to May 2009, 120 patients were included. Overall survival was 11.1 months, Child-Pugh A patients (n=100) had significantly higher median survival than Child-Pugh B patients (n=20) (13 vs. 4.5 months, P=0.0008). In multivariate analysis, Child-Pugh class B, α-fetoprotein level and total size of lesions were independent predictive factors of death. Patients with radiological progression in the first 3 months had shorter median survival (5.4 vs. 17.4 months). In a case control study, time to symptomatic progression (2.5 vs. 3.6 months), frequency of adverse events and discontinuation of sorafenib were not correlated with Child-Pugh class.
  
  
  CONCLUSIONS
  Patients with advanced hepatocellular carcinoma treated with sorafenib had a median survival of 11 months. Sorafenib therapy must be considered with caution in Child-Pugh B patients due to their poor survival. Radiological assessment of tumour progression at an early stage may be advantageous when tailoring sorafenib therapy.
authors.affiliation: Service d'Hépato-Gastroentérologie, CHRU Lille, France.
authors.forename: A
authors.initials: A
authors.lastname: Hollebecque
authors.forename: S
authors.initials: S
authors.lastname: Cattan
authors.forename: O
authors.initials: O
authors.lastname: Romano
authors.forename: G
authors.initials: G
authors.lastname: Sergent
authors.forename: A
authors.initials: A
authors.lastname: Mourad
authors.forename: A
authors.initials: A
authors.lastname: Louvet
authors.forename: S
authors.initials: S
authors.lastname: Dharancy
authors.forename: E
authors.initials: E
authors.lastname: Boleslawski
authors.forename: S
authors.initials: S
authors.lastname: Truant
authors.forename: F-R
authors.initials: FR
authors.lastname: Pruvot
authors.forename: M
authors.initials: M
authors.lastname: Hebbar
authors.forename: O
authors.initials: O
authors.lastname: Ernst
authors.forename: P
authors.initials: P
authors.lastname: Mathurin
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000077157:Sorafenib; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib