Jean-Luc Raoul1, Luigi Bolondi2, Anto Craxi3, Marius Moscovici4, Minghua Shan5, Dimitris Voliotis6, Jordi Bruix7,8, Josep Llovet8,9
1 Centre Eugène Marquis, Rennes, France, 2 Azienda Ospedaliera di Bologna - Policlinico S. Orsola-Malpighi, Bologna, Italy, 3 Azienda Ospedaliera Universitaria "Paolo Giaccone", Palermo, Italy, 4 Bayer Schering Pharma, Milan, Italy, 5 Bayer HealthCare Pharmaceuticals, West Haven, CT, USA, 6 Bayer Schering Pharma, Wuppertal, Germany, 7 Hospital Clinic i Provincial, Barcelona, Spain, 8 Mount Sinai School of Medicine Division of Liver Diseases Recanati/Miller Transplantation Institute, New York, NY, USA, 9 Barcelona Clinic Liver Cancer (BCLC) Group, Barcelona, Spain
Background : Macroscopic vascular invasion (MVI), extrahepatic spread (EHS) and ECOG performance status (PS) may impact sorafenib safety and efficacy in advanced HCC patients. We report 2 sub-analyses of stratification factors for the SHARP trial: ECOG PS (0 vs 1/2) and patients with/without MVI and/or EHS.
Methods : Patients with advanced, measurable HCC, ECOG PS 0-2, CP-A, received sorafenib (400mg bid) or placebo. Endpoints included overall survival (OS), time to progression (TTP), and safety. Radiologic assessment determined MVI presence.
Results : Efficacy data are tabulated below. No notable differences in the AE profile of sorafenib for PS 0 vs PS 1/2 patients were observed. Grade 3/4 drug-related AE incidence rates in the sorafenib arm for patients with/without MVI/EHS included diarrhea (5.3/15.7%), hand-foot skin reaction (6.7/10.1%), and fatigue (4.8/1.1%).
Conclusions : Regardless of ECOG PS or MVI/EHS presence, sorafenib extends survival in advanced HCC patients and is well-tolerated.