PMID- 24283303
OWN - NLM
STAT- MEDLINE
DCOM- 20160422
LR  - 20220408
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Print)
IS  - 1368-5031 (Linking)
VI  - 68
IP  - 5
DP  - 2014 May
TI  - GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma 
      and Of its treatment with sorafeNib): second interim analysis.
PG  - 609-17
LID - 10.1111/ijcp.12352 [doi]
AB  - BACKGROUND: GIDEON (Global Investigation of therapeutic DEcisions in 
      hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, 
      prospective, non-interventional study undertaken to evaluate the safety of 
      sorafenib in patients with unresectable HCC in real-life practice, including 
      Child-Pugh B patients who were excluded from clinical trials. METHODS: Patients 
      with unresectable HCC, for whom the decision to treat with sorafenib, based on 
      the approved label and prescribing guidelines, had been taken by their physician, 
      were eligible for inclusion. Demographic data and disease/medical history were 
      recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at 
      follow-up visits. The second interim analysis was undertaken when ~1500 treated 
      patients were followed up for >/= 4 months. RESULTS: Of the 1571 patients evaluable 
      for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of 
      patients (74%) received the approved 800 mg initial sorafenib dose, regardless of 
      Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh 
      B patients. The majority of drug-related AEs were grade 1 or 2, and the most 
      commonly reported were consistent with previous reports. The incidence and nature 
      of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic 
      Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall 
      population. CONCLUSIONS: Consistent with the first interim analysis, overall 
      safety profile and dosing strategy are similar across Child-Pugh subgroups. 
      Safety findings also appear comparable irrespective of initial sorafenib dose or 
      BCLC stage. Final analyses in > 3000 patients are ongoing.
CI  - (c) 2013 The Authors. International Journal of Clinical Practice Published by John 
      Wiley & Sons Ltd.
FAU - Lencioni, R
AU  - Lencioni R
AD  - Division of Diagnostic Imaging and Intervention, Pisa University Hospital and 
      School of Medicine, Pisa, Italy.
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 - de Guevara, L Ladron
AU  - de Guevara LL
FAU - Papandreou, C
AU  - Papandreou C
FAU - Takayama, T
AU  - Takayama T
FAU - Yoon, S K
AU  - Yoon SK
FAU - Nakajima, K
AU  - Nakajima K
FAU - Lehr, R
AU  - Lehr R
FAU - Heldner, S
AU  - Heldner S
FAU - Sanyal, A J
AU  - Sanyal AJ
LA  - eng
GR  - UL1 TR000058/TR/NCATS NIH HHS/United States
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131128
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy
MH  - Female
MH  - Humans
MH  - Liver Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Phenylurea Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Sorafenib
MH  - Young Adult
PMC - PMC4265239
EDAT- 2013/11/29 06:00
MHDA- 2016/04/23 06:00
CRDT- 2013/11/29 06:00
PHST- 2013/11/29 06:00 [entrez]
PHST- 2013/11/29 06:00 [pubmed]
PHST- 2016/04/23 06:00 [medline]
AID - 10.1111/ijcp.12352 [doi]
PST - ppublish
SO  - Int J Clin Pract. 2014 May;68(5):609-17. doi: 10.1111/ijcp.12352. Epub 2013 Nov 
      28.