1Department of Oncology, G Rummo Hospital, Benevento, Italy.
2Department of Medical Oncology, Fundeni Clinical Institute, Bucharest, Romania.
3Department of Medical Oncology, University Hospital of Larissa, Larissa, Greece.
4Department of Hepatogastroenterology, Centre Hospitalier Universitaire de Nancy, Université Henri Poincaré-Nancy, Vandoeuvre-lès-Nancy, France.
5Services des Maladies de l'Appareil Digestif, Hôpital Claude Huriez, Lille, France.
6Center of Gastroenterology, Liver Unit, Hospital de Santa Maria, Faculty of Medicine, Lisbon, Portugal.
7Department of Gastroenterology & Hepatology, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
8Gastroenterology Department, Hospital de Montecelo, Complejo Hospitalario de Pontevedra, Pontevedra, Spain.
9Service d'Hépato-Gastroentérologie, Université Pierre et Marie Curie and Hospital Pitié Salpêtrière, Paris, France.
10Department of Oncology, St László Teaching Hospital, Budapest, Hungary.
SUMMARY Aims: To evaluate sorafenib dosing and safety in the Global Investigation of therapeutic GIDEON study's European subpopulation.
PATIENTS & METHODS:
Patient demographics, disease characteristics and treatment history were recorded at enrollment; dose, adverse events and efficacy were recorded at follow-up.
Of 1113 evaluable patients, 82% started on 800 mg/day sorafenib; patients starting on 400 mg/day were slightly older, had baseline characteristics indicative of greater disease progression and higher adverse events incidences (96 vs 88%). Treatment duration (18.0 vs 13.0 weeks) and median overall survival (12.1 vs 9.4 months) were longer in patients receiving 800 mg/day.
Imbalances in independent predictive factors may have led to longer survival in patients receiving 800 mg/day sorafenib; nonetheless, results suggest that the majority can start on this dose.