title: GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis.
abstract: BACKGROUND
  GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials.
  
  
  METHODS
  Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months.
  
  
  RESULTS
  Of the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population.
  
  
  CONCLUSIONS
  Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.
authors.affiliation: Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Lencioni
authors.forename: M
authors.initials: M
authors.lastname: Kudo
authors.forename: S-L
authors.initials: SL
authors.lastname: Ye
authors.forename: J-P
authors.initials: JP
authors.lastname: Bronowicki
authors.forename: X-P
authors.initials: XP
authors.lastname: Chen
authors.forename: L
authors.initials: L
authors.lastname: Dagher
authors.forename: J
authors.initials: J
authors.lastname: Furuse
authors.forename: J F
authors.initials: JF
authors.lastname: Geschwind
authors.forename: L Ladrón
authors.initials: LL
authors.lastname: de Guevara
authors.forename: C
authors.initials: C
authors.lastname: Papandreou
authors.forename: T
authors.initials: T
authors.lastname: Takayama
authors.forename: S K
authors.initials: SK
authors.lastname: Yoon
authors.forename: K
authors.initials: K
authors.lastname: Nakajima
authors.forename: R
authors.initials: R
authors.lastname: Lehr
authors.forename: S
authors.initials: S
authors.lastname: Heldner
authors.forename: A J
authors.initials: AJ
authors.lastname: Sanyal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D000077157:Sorafenib; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib