title: Sorafenib in advanced hepatocellular carcinoma: hypertension as a potential surrogate marker for efficacy.
abstract: BACKGROUND
  Advanced hepatocellular cancer (HCC) is an incurable disease with limited options for systemic treatment. Sorafenib was approved for advanced HCC based on trials in patients with Child-Pugh class A. We reviewed our experience retrospectively in patients with HCC who were treated with sorafenib with a focus on Child-Pugh B (CP-B) liver cirrhosis and effect of hypertension (HTN) on survival.
  
  
  METHODS
  We retrospectively reviewed medical charts of patients with documented advanced HCC who received sorafenib since 2007. Survival data were plotted according to Child-Pugh class and HTN.
  
  
  RESULTS
  Results of 41 patients 39% had CP-B. Eighty-five percent were male and 67% had HCC due to viral hepatitis. Fifty-six percent received localized treatment before sorafenib. Five percent had a partial response and 39% had stable disease. Time to progression and overall survival (OS) for all patients were 3.2 and 6.2 months, respectively. Time to progression and OS were 4 and 8.4 months in Child-Pugh class A patients and 2 and 3.2 months in CP-B patients, which were statistically significant. Patients who had documented HTN while on treatment according to Common Terminology Criteria for Adverse Events version 3.0 had significantly better OS (18.2 vs. 4.5 mo; P=0.016).
  
  
  CONCLUSIONS
  Development of HTN with sorafenib seems to be associated with a favorable effect on prognosis. Future trials should examine this observation.
authors.affiliation: Medical Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: Bassam
authors.initials: B
authors.lastname: Estfan
authors.forename: Michael
authors.initials: M
authors.lastname: Byrne
authors.forename: Richard
authors.initials: R
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000378:metabolism; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D015331:Cohort Studies; D016208:Databases, Factual; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000175:diagnosis; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011379:Prognosis; D016016:Proportional Hazards Models; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage; D012189:Retrospective Studies; D018570:Risk Assessment; D000077157:Sorafenib; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib