title: Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis.
abstract: BACKGROUND
  Few data are available on the safety and efficacy of sorafenib in patients with multifocal hepatocellular carcinoma (HCC) and advanced liver cirrhosis.
  
  
  METHODS
  Between May 2006 and December 2007, we treated 59 patients (Child-Pugh class A/B/C, 26/23/10) with unresectable HCC with sorafenib (daily target dose, 400 mg twice daily). Data were collected retrospectively. Survival curves were calculated via the Kaplan-Meier method.
  
  
  RESULTS
  One patient (Child-Pugh class B) had a partial response, 14 patients (Child-Pugh class A/B/C, 5/7/2) had stable disease, and 32 patients (Child-Pugh class A/B/C, 15/11/6) had progressive disease; 12 patients were not evaluable because they had no follow-up radiologic evaluation. In the intention-to-treat group, the median time to progression and overall survival (OS) time were 2.8 months (range, 1.4-6.5 months) and 6.5 months (range, 0.4-17.4 months), respectively. Well-preserved liver function and lower Barcelona Clinic Liver Cancer stage were associated with a longer OS time on univariate analysis. There were four severe gastrointestinal bleedings (grade 4-5; Child-Pugh class B/C, 2/2). Most drug-related side effects were low grade and manageable irrespective of liver function.
  
  
  CONCLUSIONS
  Sorafenib is effective and safe in patients with multifocal HCC and Child-Pugh class A cirrhosis. Survival in Child-Pugh class B patients is significantly less than in Child-Pugh class A patients, warranting a prospective randomized trial with a placebo group. Child-Pugh class C patients have a limited life expectancy despite sorafenib treatment because of their severe underlying disease and derive little benefit from sorafenib treatment.
authors.affiliation: Department of Gastroenterology, AKH & Medizinische Universität Wien, Wien, Austria.
authors.forename: Matthias
authors.initials: M
authors.lastname: Pinter
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Sieghart
authors.forename: Ivo
authors.initials: I
authors.lastname: Graziadei
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Vogel
authors.forename: Andreas
authors.initials: A
authors.lastname: Maieron
authors.forename: Robert
authors.initials: R
authors.lastname: Königsberg
authors.forename: Adalbert
authors.initials: A
authors.lastname: Weissmann
authors.forename: Gabriela
authors.initials: G
authors.lastname: Kornek
authors.forename: Christina
authors.initials: C
authors.lastname: Plank
authors.forename: Markus
authors.initials: M
authors.lastname: Peck-Radosavljevic
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 / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy*; D008113:Liver Neoplasms / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib