PMID- 22698419
OWN - NLM
STAT- MEDLINE
DCOM- 20120917
LR  - 20220331
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 66
IP  - 7
DP  - 2012 Jul
TI  - First interim analysis of the GIDEON (Global Investigation of therapeutic 
      decisions in hepatocellular carcinoma and of its treatment with sorafeNib) 
      non-interventional study.
PG  - 675-83
LID - 10.1111/j.1742-1241.2012.02940.x [doi]
AB  - 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 medical and 
      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. Preplanned 
      subgroup 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-Pugh subgroups. 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.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Lencioni, R
AU  - Lencioni R
AD  - Division of Diagnostic Imaging and Intervention, Pisa University Hospital and 
      School of Medicine, Pisa, Italy. riccardo.lencioni@med.unipi.it
FAU - Kudo, M
AU  - Kudo M
FAU - Ye, S-L
AU  - Ye SL
FAU - Bronowicki, J-P
AU  - Bronowicki JP
FAU - Chen, X-P
AU  - Chen XP
FAU - Dagher, L
AU  - Dagher L
FAU - Furuse, J
AU  - Furuse J
FAU - Geschwind, J F
AU  - Geschwind JF
FAU - Ladron de Guevara, L
AU  - Ladron de Guevara L
FAU - Papandreou, C
AU  - Papandreou C
FAU - Sanyal, A J
AU  - Sanyal AJ
FAU - Takayama, T
AU  - Takayama T
FAU - Yoon, S K
AU  - Yoon SK
FAU - Nakajima, K
AU  - Nakajima K
FAU - Cihon, F
AU  - Cihon F
FAU - Heldner, S
AU  - Heldner S
FAU - Marrero, J A
AU  - Marrero JA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzenesulfonates)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Pyridines)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
EIN - Int J Clin Pract. 2012 Sep;66(9):912. de Guevara, L L [corrected to Ladron de 
      Guevara, L]
MH  - Antineoplastic Agents/*therapeutic use
MH  - Benzenesulfonates/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy
MH  - *Decision Making
MH  - Female
MH  - Humans
MH  - Liver Neoplasms/*drug therapy
MH  - Male
MH  - Multicenter Studies as Topic
MH  - Niacinamide/analogs & derivatives
MH  - Phenylurea Compounds
MH  - *Professional Practice
MH  - Pyridines/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Residence Characteristics
MH  - Sorafenib
MH  - Specialization/statistics & numerical data
EDAT- 2012/06/16 06:00
MHDA- 2012/09/18 06:00
CRDT- 2012/06/16 06:00
PHST- 2012/06/16 06:00 [entrez]
PHST- 2012/06/16 06:00 [pubmed]
PHST- 2012/09/18 06:00 [medline]
AID - 10.1111/j.1742-1241.2012.02940.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2012 Jul;66(7):675-83. doi: 10.1111/j.1742-1241.2012.02940.x.