670PD - Gideon (Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma [HCC] and of Its Treatment with Sorafenib [SOR]) 2nd Interim Analysis (IA): Subgroup Analysis by Disease Etiology

Abstract

ABSTRACT Background GIDEON is an ongoing, global, prospective non-interventional study of unresectable HCC pts receiving Sor in real-life practice. We present results of a descriptive, subgroup analysis by leading disease etiology. Methods Demographics/medical/disease history are recorded at study entry; adverse events (AEs) and efficacy at follow-up. Over 3000 pts were enrolled from 39 countries. Per protocol the 2nd IA was planned when ∼1500 treated pts were followed ≥4 months. Results In the safety population (N = 1571, 588 from Europe), leading disease etiologies were alcohol use (47%), hepatitis B virus (HBV; 37%), and hepatitis C virus (HCV; 32%). There were regional differences in liver disease etiology. Alcohol use was more common in the US (41%) and Europe (36%) than in Asia-Pacific (AP; 20%). HBV was more common in AP (83%); HCV was more common in the US (53%) and Japan (55%). Across etiologic subgroups, most pts were male (76-93%) and had Eastern Cooperative Oncology Group performance status 0 or 1 (83-84%). At study entry, more HBV pts (68%) had advanced Barcelona Clinic Liver Cancer stage (C or D) than HCV pts (51%). Safety data were comparable across etiologies. Preliminary median survival from initial diagnosis or first Sor dose (intent-to-treat population, N = 1612) was shorter for HBV and alcohol use pts than for HCV pts: time from initial diagnosis to death, 35.2 [95% CI 27.6-50.0], 25.6 [95% CI 19.0-36.8], and 45.6 [95% CI 33.0-64.8] months, respectively; overall survival (OS) from first Sor dose, 7.9 [95% CI 6.6-9.3], 8.1 [95% CI 6.9-8.7], and 9.5 [95% CI 8.4-12.6] months, respectively. Treatment-emergent AEs, %a Total (N = 1571) Alcohol use (n = 746) HBV (n = 575) HCV (n = 504) AEs 83 86 78 88 Drug-related AEs 64 64 57 71 Serious AEs 37 41 32 40 Drug-related serious AEs 9 9 5 12 Deaths 22 25 19 20 aMissing data not shown. Conclusions Preliminary 2nd IA results indicate HBV pts have more advanced disease at study entry than HCV pts. The lower median OS in HBV pts may reflect their poorer prognosis and natural history. Sor safety profile does not appear to be influenced by liver disease etiology. Disclosure J. Bronowicki: Bayer consultation and speaker fees. J. Marrero: Consultant for Bayer HealthCare Pharmaceuticals and Onyx; advisory committee/review panel member for Bayer HealthCare Pharmaceuticals and Onyx; Research grant received from Bayer HealthCare Pharmaceuticals. K. Nakajima: Employee of Bayer HealthCare, Own stocks. R. Lencioni: Lecture fees, Bayer Healthcare. All other authors have declared no conflicts of interest.