title: [Therapeutic decisions and treatment with sorafenib in hepatocellular carcinoma: final analysis of GIDEON study in Italy].
abstract: BACKGROUND
  Sorafenib, an oral multikinase inhibitor, is the only targeted agent approved for the treatment of patients with hepatocellular carcinoma (HCC) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) is the largest, global, non-interventional, prospective study of patients with uHCC (n>3200) treated with sorafenib in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of patients.
  
  
  METHODS
  Patients with unresectable HCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Patients demographics disease characteristics and treatment history were recorded at baseline visit. Sorafenib dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study.
  
  
  RESULTS
  In the Italian cohort of the GIDEON study 278 patients were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were diarrhea (24%), fatigue (23%), dermatological (14%), rash/exfoliation (10%), hypertension (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 patients (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 patients (41%) with a 30% of disease control rate.
  
  
  CONCLUSIONS
  The safety profile of sorafenib in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.
authors.forename: Salvatore
authors.initials: S
authors.lastname: D'Angelo
authors.forename: Domenico
authors.initials: D
authors.lastname: Germano
authors.forename: Teresa
authors.initials: T
authors.lastname: Zolfino
authors.forename: Domenico
authors.initials: D
authors.lastname: Sansonno
authors.forename: Lydia
authors.initials: L
authors.lastname: Giannitrapani
authors.forename: Antonio
authors.initials: A
authors.lastname: Benedetti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Montesarchio
authors.forename: Adolfo
authors.initials: A
authors.lastname: Attili
authors.forename: Angela
authors.initials: A
authors.lastname: Buonadonna
authors.forename: Sandro
authors.initials: S
authors.lastname: Barni
authors.forename: Antonio
authors.initials: A
authors.lastname: Gasbarrini
authors.forename: Michela E
authors.initials: ME
authors.lastname: Burlone
authors.forename: Umberto
authors.initials: U
authors.lastname: Cillo
authors.forename: Simona
authors.initials: S
authors.lastname: Marenco
authors.forename: Erica
authors.initials: E
authors.lastname: Villa
authors.forename: Petros
authors.initials: P
authors.lastname: Giovanis
authors.forename: Ilaria
authors.initials: I
authors.lastname: Proserpio
authors.forename: Carlo
authors.initials: C
authors.lastname: Saitta
authors.forename: Giulia
authors.initials: G
authors.lastname: Magini
authors.forename: Rita
authors.initials: R
authors.lastname: Cengarle
authors.forename: Giammarco
authors.initials: G
authors.lastname: Fava
authors.forename: Filiana
authors.initials: F
authors.lastname: Cuttone
authors.forename: Nicola
authors.initials: N
authors.lastname: Calvani
authors.forename: Mario
authors.initials: M
authors.lastname: Angelico
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: Alfonso
authors.initials: A
authors.lastname: Noto
authors.forename: Guido
authors.initials: G
authors.lastname: Poggi
authors.forename: Massimo
authors.initials: M
authors.lastname: Marignani
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
authors.forename: Domenico
authors.initials: D
authors.lastname: Amoroso
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Palmieri
authors.forename: Elena
authors.initials: E
authors.lastname: Massa
authors.forename: Lory Saveria
authors.initials: LS
authors.lastname: Crocè
authors.forename: Antonio
authors.initials: A
authors.lastname: Picardi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Tumulo
authors.forename: Claudia
authors.initials: C
authors.lastname: Erminero
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lencioni
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib