Z Gastroenterol 2011; 49 - P289
DOI: 10.1055/s-0031-1285560

Sorafenib treatment and safety profile in Child Pugh B patients characterized in first interim results of GIDEON (global investigation of therapeutic decisions in hepatocellular carcinoma and of its treatment with sorafenib)

JP Bronowicki 1, HY Lim 2, P Stål 3, JM Marrero 4, M Kudo 5, A Venook 6, K Nakajima 7, SL Ye 8
  • 1Department of Gastroenterology and Hepatology, INSERM U954, University Hospital of Nancy, Vandœ uvre-lès-Nancy, France
  • 2Division of Haematology/Oncology, Department of Medicine, Samsung Medical Centre, Seoul, Korea, Democratic People's Republic of
  • 3Department of Gastroenterology and Hepatology, Karolinska University Hospital Huddinge, Stockholm, Sweden
  • 4Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, United States
  • 5Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan
  • 6Division of Medical Oncology, University of California, San Francisco, United States
  • 7Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Montville, United States
  • 8Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

Introduction: The aim of GIDEON, the largest ongoing, global, prospective, non-interventional study of patients (pts) with unresectable HCC (uHCC) eligible for systemic therapy and receiving sorafenib (Sor), is to evaluate Sor safety and efficacy in diverse real-life clinical settings and pt subgroups where data are limited, eg, Child Pugh B.

Methods: Demographic data, medical, disease and treatment history are recorded. At follow-up visits Sor dose, concomitant treatments, performance status, liver function, adverse events (AEs) and efficacy, assessed according to Response Evaluation Criteria in Solid Tumors, are recorded. From January 2009 to May 2010, over 1600 pts have been enrolled from 21 countries; target accrual is 3000 pts from >40 countries. Per protocol, the first interim analysis was triggered when 500 enrolled pts were followed over a minimum of 4 mos.

Results: In total, 479 patients were eligible for analysis [Child Pugh A (n=278, 58%) and B (n=134, 28%) pts; 11 (2%) pts were Child Pugh C and 56 (12%) pts did not have evaluable data]. The Sor starting dose was 800mg in the largest percentage of pts in the Child Pugh A (80%) and B (75%) groups, with no dose interruptions in 73% and 78% and no dose modifications in 55% and 63% of the Child Pugh A and B groups respectively. BCLC (Barcelona-Clinic Liver Cancer) Stage C and TNM (Tumor, Node, Metastasis) Stage IV were the most prevalent stages in Child Pugh A, 54% and 37% respectively, and in Child Pugh B, 53% and 31%. The most common previous treatment for HCC was TACE (transarterial chemoembolization) in both the Child Pugh A (48%) and Child Pugh B (38%) pts. The Sor safety profile was comparable in the Child Pugh A and B groups, with the exception that a greater percentage of Child Pugh B pts (40% vs. 25%) discontinued Sor therapy due to AEs. Additional comparisons of the Child Pugh data at study entry to that recorded at initial diagnosis will be presented.

Conclusions: GIDEON is collecting important data on Child Pugh B pts treated with Sor, and to date while there were more on-treatment AEs and deaths within the Child-Pugh B group, we believe these represent the natural history of the liver disease as opposed to a drug effect.