First Interim Analysis Of The Gideon (Global Investigation

ORIGINAL PAPER

First interim analysis of the GIDEON (Global Investigation
of therapeutic DEcisions in hepatocellular carcinoma and
Of its treatment with sorafeNib) non-interventional study
R. Lencioni,1 M. Kudo,2 S.-L. Ye,3 J.-P. Bronowicki,4 X.-P. Chen,5 L. Dagher,6 J. Furuse,7
J. F. Geschwind,8 L. L. de Guevara,9 C. Papandreou,10 A. J. Sanyal,11 T. Takayama,12 S. K. Yoon,13
K.Nakajima,14 F. Cihon,15 S. Heldner,16 J. A. Marrero17

1

SUMMARY

What’s known

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 medicaland 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. Preplannedsubgroup 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-Pughsubgroups.
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.

Introduction
Liver cancer is the fifth most prevalentneoplasm
worldwide but the second most common cause of
cancer-related mortality in men (1). In women, it is
the seventh most common cancer but the sixth leading cause of cancer-related death (1). This is in part
because of the poor prognosis for many patients,
more than 70% of whom present with advanced disease (2,3). The highest incidence of liver cancer is
found in East and South-East Asia andin middle
and West Africa (1). Although the incidence rate in
more developed regions of the world is lower,
including central Europe and the USA, liver cancer

• Currently, there is no global consensus on the
management of patients with uHCC. A worldwide
study of regional uHCC treatment practices is
therefore needed to advance the management of
uHCC
• The oral multikinase inhibitorsorafenib is the
only systemic therapy indicated for the treatment
of uHCC, but data from Child-Pugh B patients
are limited

What’s new
• The non-interventional GIDEON study is
evaluating sorafenib in uHCC under real-life
clinical practice conditions and therefore includes
a broader patient demographic than that
represented in controlled clinical trials
• GIDEON allows global variations inuHCC
management to be evaluated in a single robust
study, and the prespecified first interim analysis
results highlight differences in patient and
disease characteristics, aetiology, and risk factors
for uHCC, and sorafenib dosing, by region and
physician specialty
• The type and incidence of AEs is as expected and
appears to be similar in Child-Pugh A and B patients

incidence rates in...