title: [Therapeutic decisions in the treatment of hepatocellular carcinoma and patterns of sorafenib use. Results of the international observational GIDEON trial in Spain].
abstract: BACKGROUND
  GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients.
  
  
  OBJECTIVE
  To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns.
  
  
  METHODS
  Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose.
  
  
  RESULTS
  We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs. 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups.
  
  
  CONCLUSIONS
  The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival.
authors.affiliation: Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, España. Electronic address: jturnesv@gmail.com.
authors.forename: Juan
authors.initials: J
authors.lastname: Turnes
authors.affiliation: Servicio de Oncología Médica, Hospital La Fe, Valencia, España.
authors.forename: Roberto
authors.initials: R
authors.lastname: Díaz
authors.affiliation: Servicio de Aparato Digestivo, Hospital Universitario de Canarias.
authors.forename: Manuel
authors.initials: M
authors.lastname: Hernandez-Guerra
authors.affiliation: Servicio de Aparato Digestivo, Hospital Universitario de Getafe.
authors.forename: Mariano
authors.initials: M
authors.lastname: Gómez
authors.affiliation: Servicio de Medicina Interna-Hepatología, Hospital Universitario Vall d'Hebron, Barcelona, España.
authors.forename: Lluís
authors.initials: L
authors.lastname: Castells
authors.affiliation: Servicio de Aparato Digestivo, Hospital de Cruces.
authors.forename: Javier
authors.initials: J
authors.lastname: Bustamante
authors.affiliation: Servicio de Aparato Digestivo, Hospital Virgen de las Nieves.
authors.forename: M Dolores
authors.initials: MD
authors.lastname: Espinosa
authors.affiliation: Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, España.
authors.forename: Javier
authors.initials: J
authors.lastname: Fernández-Castroagudín
authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico de Zaragoza.
authors.forename: Trinidad
authors.initials: T
authors.lastname: Serrano
authors.affiliation: Servicio de Aparato Digestivo, Hospital Universitario Puerta del Mar.
authors.forename: Paloma
authors.initials: P
authors.lastname: Rendón
authors.affiliation: Servicio de Aparato Digestivo, Hospital Virgen de la Victoria.
authors.forename: Raúl
authors.initials: R
authors.lastname: Andrade
authors.affiliation: Servicio de Oncología Médica, Hospital Santa María de Nai.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Salgado
authors.affiliation: Servicio de Aparato Digestivo, Hospital de Donostia.
authors.forename: Juan
authors.initials: J
authors.lastname: Arenas
authors.affiliation: Servicio de Aparato Digestivo, Hospital Parc Taulí
authors.forename: Mercedes
authors.initials: M
authors.lastname: Vergara
authors.affiliation: Servicio de Aparato Digestivo, Hospital Germans Trias i Pujol.
authors.forename: Margarita
authors.initials: M
authors.lastname: Sala
authors.affiliation: Servicio de Aparato Digestivo, Fundación Jiménez Díaz.
authors.forename: Benjamín Arturo
authors.initials: BA
authors.lastname: Polo
authors.affiliation: Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Vigo, Vigo, España.
authors.forename: Ignacio Martín
authors.initials: IM
authors.lastname: Granizo
authors.affiliation: Servicio de Oncología Médica, Hospital Virgen de la Arritxaca.
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Gonzálvez
authors.affiliation: Servicio de Oncología Médica, Hospital de Navarra.
authors.forename: Antonio
authors.initials: A
authors.lastname: Viudez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000628:therapy; D003131:Combined Modality Therapy; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000139:chemically induced; D060831:Hand-Foot Syndrome / Q000209:etiology; D008113:Liver Neoplasms / Q000188:drug therapy / Q000628:therapy; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D016879:Salvage Therapy; D012720:Severity of Illness Index; D000077157:Sorafenib; D013030:Spain; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009536:Niacinamide; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D000077157:Sorafenib
keywords: Carcinoma hepatocelular; Efficacy; Eficacia; GIDEON; Hepatocellular carcinoma; Safety; Seguridad; Sorafenib