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, M. Kudo, S. L. Ye, J. P. Bronowicki, X. P. Chen, L. Dagher, J. Furuse, J. F. Geschwind, L. L. De Guevara, C. Papandreou, A. J. Sanyal, T. Takayama, S. K. Yoon, K. Nakajima, F. Cihon, S. Heldner, J. A. Marrero

Research output: Contribution to journalArticle

92 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)675-683
Number of pages9
JournalInternational Journal of Clinical Practice
Volume66
Issue number7
DOIs
StatePublished - Jul 2012

Fingerprint

Hepatocellular Carcinoma
Therapeutics
Safety
sorafenib
Practice Guidelines
Demography
Clinical Trials
Databases
Physicians
Incidence
Population

ASJC Scopus subject areas

  • Medicine(all)

Cite this

First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) non-interventional study. / Lencioni, R.; Kudo, M.; Ye, S. L.; Bronowicki, J. P.; Chen, X. P.; Dagher, L.; Furuse, J.; Geschwind, J. F.; De Guevara, L. L.; Papandreou, C.; Sanyal, A. J.; Takayama, T.; Yoon, S. K.; Nakajima, K.; Cihon, F.; Heldner, S.; Marrero, J. A.

In: International Journal of Clinical Practice, Vol. 66, No. 7, 07.2012, p. 675-683.

Research output: Contribution to journalArticle

Lencioni, R, Kudo, M, Ye, SL, Bronowicki, JP, Chen, XP, Dagher, L, Furuse, J, Geschwind, JF, De Guevara, LL, Papandreou, C, Sanyal, AJ, Takayama, T, Yoon, SK, Nakajima, K, Cihon, F, Heldner, S & Marrero, JA 2012, 'First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) non-interventional study', International Journal of Clinical Practice, vol. 66, no. 7, pp. 675-683. https://doi.org/10.1111/j.1742-1241.2012.02940.x
Lencioni, R. ; Kudo, M. ; Ye, S. L. ; Bronowicki, J. P. ; Chen, X. P. ; Dagher, L. ; Furuse, J. ; Geschwind, J. F. ; De Guevara, L. L. ; Papandreou, C. ; Sanyal, A. J. ; Takayama, T. ; Yoon, S. K. ; Nakajima, K. ; Cihon, F. ; Heldner, S. ; Marrero, J. A. / First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) non-interventional study. In: International Journal of Clinical Practice. 2012 ; Vol. 66, No. 7. pp. 675-683.
@article{7cdf4832a9d74a92918d206436fa718d,
title = "First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) non-interventional study",
abstract = "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.",
author = "R. Lencioni and M. Kudo and Ye, {S. L.} and Bronowicki, {J. P.} and Chen, {X. P.} and L. Dagher and J. Furuse and Geschwind, {J. F.} and {De Guevara}, {L. L.} and C. Papandreou and Sanyal, {A. J.} and T. Takayama and Yoon, {S. K.} and K. Nakajima and F. Cihon and S. Heldner and Marrero, {J. A.}",
year = "2012",
month = "7",
doi = "10.1111/j.1742-1241.2012.02940.x",
language = "English (US)",
volume = "66",
pages = "675--683",
journal = "International Journal of Clinical Practice",
issn = "1368-5031",
publisher = "Wiley-Blackwell",
number = "7",

}

TY - JOUR

T1 - First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib) non-interventional study

AU - Lencioni, R.

AU - Kudo, M.

AU - Ye, S. L.

AU - Bronowicki, J. P.

AU - Chen, X. P.

AU - Dagher, L.

AU - Furuse, J.

AU - Geschwind, J. F.

AU - De Guevara, L. L.

AU - Papandreou, C.

AU - Sanyal, A. J.

AU - Takayama, T.

AU - Yoon, S. K.

AU - Nakajima, K.

AU - Cihon, F.

AU - Heldner, S.

AU - Marrero, J. A.

PY - 2012/7

Y1 - 2012/7

N2 - 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.

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.

UR - http://www.scopus.com/inward/record.url?scp=84862737988&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84862737988&partnerID=8YFLogxK

U2 - 10.1111/j.1742-1241.2012.02940.x

DO - 10.1111/j.1742-1241.2012.02940.x

M3 - Article

C2 - 22698419

AN - SCOPUS:84862737988

VL - 66

SP - 675

EP - 683

JO - International Journal of Clinical Practice

JF - International Journal of Clinical Practice

SN - 1368-5031

IS - 7

ER -