title: Cediranib (AZD2171) in patients with advanced hepatocellular carcinoma: a phase II North Central Cancer Treatment Group Clinical Trial.
abstract: OBJECTIVE
  Vascular endothelial growth factor has been shown to be overexpressed in several studies of hepatocellular carcinoma (HCC). Cediranib is a potent inhibitor of vascular endothelial growth factor signaling. We assessed the efficacy and toxicity of cediranib in patients with HCC.
  
  
  METHODS
  Twenty-eight patients with unresectable or metastatic HCC were enrolled in this study. Patients received 45 mg of cediranib orally, once daily, for 28-day cycles. The primary objective of this phase II study was to assess 6-month survival. Secondary objectives were to assess tumor response, time to progression, and toxicity.
  
  
  RESULTS
  All 28 patients were evaluable for efficacy outcomes. Twelve patients (42.9%) survived 6 months, 15 (53.6%) died within 6 months, and 1 (3.6%) was lost to follow-up before 6 months. The median overall survival was 5.8 months (95% confidence interval, 3.4-7.3 mo). No patients experienced confirmed response. The median time to progression was 2.8 months (95% confidence interval, 2.3-4.4 mo). Twenty-six patients (93%) experienced a grade 3+ adverse event with the most common adverse event s being fatigue (46%), anorexia (25%), hypertension (21%), and elevated alanine aminotransferase (18%).
  
  
  CONCLUSIONS
  Owing to the toxicity, cediranib at this dose and schedule is not an effective treatment in patients with unresectable or metastatic HCC.
authors.affiliation: Mayo Clinic Rochester, MN, USA.
authors.forename: Steven Robert
authors.initials: SR
authors.lastname: Alberts
authors.forename: Tom R
authors.initials: TR
authors.lastname: Fitch
authors.forename: George P
authors.initials: GP
authors.lastname: Kim
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Morlan
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Howard M
authors.initials: HM
authors.lastname: Gross
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011379:Prognosis; D011799:Quinazolines / Q000627:therapeutic use*; D015996:Survival Rate; D007211:Indoles
chemical_list: D011799:Quinazolines; C500926:cediranib; D007211:Indoles