670PD - Gideon (global investigation of therapeutic decisions in hepatocellular carcinoma [HCC] and of its treatment with sorafenib [SOR]) 2nd interim analy...

Date 01 October 2012
Event ESMO Congress 2012
Session Gastrointestinal tumors, non-colorectal
Topics Cytotoxic agents
Hepatobiliary Cancers
Therapy
Biological therapy
Presenter Jean-Pierre Bronowicki
Authors J. Bronowicki1, S. Ye2, M. Kudo3, J. Marrero4, A. Venook5, K. Nakajima6, R. Lencioni7
  • 1Department Of Gastroenterology And Hepatology, University Hospital of Nancy, Vandœuvre-lès-Nancy/FR
  • 2Zhongshan Hospital, Liver Cancer Institute, Shanghai/CN
  • 3Department Of Gastroenterology And Hepatology, Kinki University School of Medicine, Osaka/JP
  • 4Multidisciplinary Liver Tumor Clinic, University of Michigan, Ann Arbor/US
  • 5Division Of Medical Oncology, University of California, San Francisco/US
  • 6Bayer Healthcare Pharmaceuticals, Global Medical Affairs, Montville/US
  • 7Hepatology And Infectious Diseases, Division of Diagnostic Imaging and Intervention, Department of Liver Transplantation, Pisa/IT

 

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%).

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.

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.

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.