title: Sorafenib for non-selected patient population with advanced hepatocellular carcinoma: efficacy and safety data according to liver function.
abstract: OBJECTIVE
  Sorafenib is the standard treatment of patients with advanced hepatocellular carcinoma, regardless of the liver functional reserve. We present a single institutional series of Child-Pugh A and Child-Pugh B patients treated with sorafenib with the aim to establish the efficacy and safety of sorafenib in patients of daily clinical conditions and to compare these results between Child-Pugh A and Child-Pugh B patients.
  
  
  METHODS
  A total of 51 patients were treated with sorafenib 400 mg/12 h until disease progression or unacceptable toxicity.
  
  
  RESULTS
  The median progression-free survival and overall survival for the overall population were 3.5 and 8.2 months, respectively, with a 1-year survival rate of 27 %. Overall survival was significantly longer for patients Child-Pugh A compared with those with Child-Pugh B liver function (8.7 vs. 4.7 months, respectively). The most common adverse events were fatigue (62.7 %), diarrhea (58 %), hypertension (31.3 %), and hand-foot syndrome (31.3 %), and in most cases grade 1 or 2 according to the NCI-CTC 3.0. Grade 4 liver-related events occurred mainly in Child-Pugh B patients with decompensated cirrhosis at the time of sorafenib initiation (54.5 % of that group).
  
  
  CONCLUSIONS
  The benefit of sorafenib in Child-Pugh B patients, if exist, may be limited by frequent liver-related events, especially in decompensated patients, and then, toxicity and impact in quality of life should be carefully monitored.
authors.affiliation: Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), c/Martin Lagos s/n, 28040, Madrid, Spain.
authors.forename: Jon
authors.initials: J
authors.lastname: Zugazagoitia
authors.forename: Aránzazu
authors.initials: A
authors.lastname: Manzano
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Jose María
authors.initials: JM
authors.lastname: Ladero
authors.forename: Javier
authors.initials: J
authors.lastname: Puente
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib