PMID- 25583146 OWN - NLM STAT- MEDLINE DCOM- 20161227 LR - 20181202 IS - 0210-5705 (Print) IS - 0210-5705 (Linking) VI - 38 IP - 4 DP - 2015 Apr TI - [Therapeutic decisions in the treatment of hepatocellular carcinoma and patterns of sorafenib use. Results of the international observational GIDEON trial in Spain]. PG - 263-73 LID - S0210-5705(14)00292-1 [pii] LID - 10.1016/j.gastrohep.2014.11.001 [doi] AB - INTRODUCTION: 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. OBJECTIVES: 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. CONCLUSION: 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. CI - Copyright (c) 2015. Published by Elsevier Espana. FAU - Turnes, Juan AU - Turnes J AD - Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Espana. Electronic address: jturnesv@gmail.com. FAU - Diaz, Roberto AU - Diaz R AD - Servicio de Oncologia Medica, Hospital La Fe, Valencia, Espana. FAU - Hernandez-Guerra, Manuel AU - Hernandez-Guerra M AD - Servicio de Aparato Digestivo, Hospital Universitario de Canarias. FAU - Gomez, Mariano AU - Gomez M AD - Servicio de Aparato Digestivo, Hospital Universitario de Getafe. FAU - Castells, Lluis AU - Castells L AD - Servicio de Medicina Interna-Hepatologia, Hospital Universitario Vall d'Hebron, Barcelona, Espana. FAU - Bustamante, Javier AU - Bustamante J AD - Servicio de Aparato Digestivo, Hospital de Cruces. FAU - Espinosa, M Dolores AU - Espinosa MD AD - Servicio de Aparato Digestivo, Hospital Virgen de las Nieves. FAU - Fernandez-Castroagudin, Javier AU - Fernandez-Castroagudin J AD - Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Espana. FAU - Serrano, Trinidad AU - Serrano T AD - Servicio de Aparato Digestivo, Hospital Clinico de Zaragoza. FAU - Rendon, Paloma AU - Rendon P AD - Servicio de Aparato Digestivo, Hospital Universitario Puerta del Mar. FAU - Andrade, Raul AU - Andrade R AD - Servicio de Aparato Digestivo, Hospital Virgen de la Victoria. FAU - Salgado, Mercedes AU - Salgado M AD - Servicio de Oncologia Medica, Hospital Santa Maria de Nai. FAU - Arenas, Juan AU - Arenas J AD - Servicio de Aparato Digestivo, Hospital de Donostia. FAU - Vergara, Mercedes AU - Vergara M AD - Servicio de Aparato Digestivo, Hospital Parc Tauli FAU - Sala, Margarita AU - Sala M AD - Servicio de Aparato Digestivo, Hospital Germans Trias i Pujol. FAU - Polo, Benjamin Arturo AU - Polo BA AD - Servicio de Aparato Digestivo, Fundacion Jimenez Diaz. FAU - Granizo, Ignacio Martin AU - Granizo IM AD - Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Vigo, Vigo, Espana. FAU - Gonzalvez, Maria Luisa AU - Gonzalvez ML AD - Servicio de Oncologia Medica, Hospital Virgen de la Arritxaca. FAU - Viudez, Antonio AU - Viudez A AD - Servicio de Oncologia Medica, Hospital de Navarra. LA - spa PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Observational Study TT - Decisiones terapeuticas en el tratamiento del carcinoma hepatocelular y patrones de uso de sorafenib. Resultados del estudio internacional observacional GIDEON en Espana. DEP - 20150109 PL - Spain TA - Gastroenterol Hepatol JT - Gastroenterologia y hepatologia JID - 8406671 RN - 0 (Antineoplastic Agents) RN - 0 (Phenylurea Compounds) RN - 0 (Protein Kinase Inhibitors) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Carcinoma, Hepatocellular/*drug therapy/therapy MH - Combined Modality Therapy MH - Diarrhea/chemically induced MH - Disease Progression MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Fatigue/chemically induced MH - Female MH - Hand-Foot Syndrome/etiology MH - Humans MH - Liver Neoplasms/*drug therapy/therapy MH - Male MH - Middle Aged MH - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use MH - Phenylurea Compounds/adverse effects/*therapeutic use MH - Prospective Studies MH - Protein Kinase Inhibitors/adverse effects/*therapeutic use MH - Salvage Therapy MH - Severity of Illness Index MH - Sorafenib MH - Spain MH - Treatment Outcome OTO - NOTNLM OT - Carcinoma hepatocelular OT - Efficacy OT - Eficacia OT - GIDEON OT - Hepatocellular carcinoma OT - Safety OT - Seguridad OT - Sorafenib EDAT- 2015/01/15 06:00 MHDA- 2016/12/28 06:00 CRDT- 2015/01/14 06:00 PHST- 2014/06/19 00:00 [received] PHST- 2014/10/27 00:00 [revised] PHST- 2014/11/03 00:00 [accepted] PHST- 2015/01/14 06:00 [entrez] PHST- 2015/01/15 06:00 [pubmed] PHST- 2016/12/28 06:00 [medline] AID - S0210-5705(14)00292-1 [pii] AID - 10.1016/j.gastrohep.2014.11.001 [doi] PST - ppublish SO - Gastroenterol Hepatol. 2015 Apr;38(4):263-73. doi: 10.1016/j.gastrohep.2014.11.001. Epub 2015 Jan 9.