Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib (GIDEON) study

Riccardo Lencioni, J. Marrero, A. Venook, S. L. Ye, M. Kudo

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Background: Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments. Aims: The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited. Discussion: This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.

Original languageEnglish (US)
Pages (from-to)1034-1041
Number of pages8
JournalInternational Journal of Clinical Practice
Volume64
Issue number8
DOIs
StatePublished - Jul 2010
Externally publishedYes

Fingerprint

Hepatocellular Carcinoma
Therapeutics
Knowledge Bases
sorafenib
Comorbidity
Language
Databases
Physicians
Safety
Incidence
Neoplasms

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib (GIDEON) study. / Lencioni, Riccardo; Marrero, J.; Venook, A.; Ye, S. L.; Kudo, M.

In: International Journal of Clinical Practice, Vol. 64, No. 8, 07.2010, p. 1034-1041.

Research output: Contribution to journalArticle

@article{190d96595f6f4582aaecb92c538d468c,
title = "Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib (GIDEON) study",
abstract = "Background: Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments. Aims: The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited. Discussion: This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.",
author = "Riccardo Lencioni and J. Marrero and A. Venook and Ye, {S. L.} and M. Kudo",
year = "2010",
month = "7",
doi = "10.1111/j.1742-1241.2010.02414.x",
language = "English (US)",
volume = "64",
pages = "1034--1041",
journal = "International Journal of Clinical Practice",
issn = "1368-5031",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with sorafeNib (GIDEON) study

AU - Lencioni, Riccardo

AU - Marrero, J.

AU - Venook, A.

AU - Ye, S. L.

AU - Kudo, M.

PY - 2010/7

Y1 - 2010/7

N2 - Background: Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments. Aims: The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited. Discussion: This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.

AB - Background: Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments. Aims: The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited. Discussion: This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.

UR - http://www.scopus.com/inward/record.url?scp=77953820596&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77953820596&partnerID=8YFLogxK

U2 - 10.1111/j.1742-1241.2010.02414.x

DO - 10.1111/j.1742-1241.2010.02414.x

M3 - Article

C2 - 20642705

AN - SCOPUS:77953820596

VL - 64

SP - 1034

EP - 1041

JO - International Journal of Clinical Practice

JF - International Journal of Clinical Practice

SN - 1368-5031

IS - 8

ER -