Source

Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China Department of Gastroenterology and Hepatology, INSERM U954, University Hospital of Nancy, University Henri Poincaré, Vandœuvre-lès-Nancy, France Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China Policlínica Metropolitana, Caracas, Venezuela Kyorin University, Mitaka, Tokyo, Japan Vascular and Interventional Radiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA Hospital Angeles Clínica Londres, Mexico City, Mexico University Hospital of Larissa, Larissa, Greece Virginia Commonwealth University Medical Center, Richmond, VA, USA Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan The Catholic University of Korea, Seoul, Korea Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Montville, NJ, USA Clinical Statistics, Bayer HealthCare Pharmaceuticals, Montville, NJ, USA Global Medical Affairs and Pharmacovigilance, Bayer HealthCare Pharmaceuticals, Berlin, Germany Department of Medicine, University of Michigan, Ann Arbor, MI, USA.

Abstract

Aims:  Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON), a global, non-interventional, surveillance study, aims to evaluate the safety of sorafenib in all patients with unresectable hepatocellular carcinoma (uHCC) under real-life practice conditions, particularly Child-Pugh B patients, who were not well represented in clinical trials. Methods:  Treatment decisions are determined by each physician according to local prescribing guidelines and clinical practice. Patients with uHCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Demographic data and medical and disease history are recorded at entry. Sorafenib dosing and adverse events (AEs) are collected throughout the study. Results:  From January 2009 to April 2011, >3000 patients from 39 countries were enrolled. The prespecified first interim analysis was conducted when the initial approximately 500 treated patients had been followed up for ≥4 months; 479 were valid for safety evaluation. Preplanned subgroup analyses indicate differences in patient characteristics, disease aetiology and previous treatments by region. Variation in sorafenib dosing by specialty are also observed; Child-Pugh status did not appear to influence the starting dose of sorafenib. The type and incidence of AEs was consistent with findings from previous clinical studies. AE profiles were comparable between Child-Pugh subgroups. Discussion:  The GIDEON study is generating a large, robust database from a broad population of patients with uHCC. First interim analyses have shown global and regional differences in patient characteristics, disease aetiology and practice patterns. Subsequent planned analyses will allow further evaluation of early trends.