Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study
Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study
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DOI：
10.1111/j.1742-1241.2010.02414.x
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发表时间：
2010-07-01
影响因子：
2.6
通讯作者：
Kudo, M.
中科院分区：
文献类型：
--
作者：
Lencioni, R.;Marrero, J.;Kudo, M.
P>背景：肝细胞癌（HCC）是一种受多种混杂因素影响的复杂疾病，使得最佳的患者管理极具挑战性。种族、诊断分期、合并症和肿瘤形态会影响结果，并且因地区而异，并且没有共同的语言来评估患者预后并提出治疗建议。尽管最近努力降低 HCC 的发病率，但大多数患者仍患有无法切除的疾病。非手术治疗包括消融、经动脉化疗栓塞和多激酶抑制剂索拉非尼，但它们对所有患者亚组的影响尚不清楚，需要进一步的信息来优化这些治疗的使用。目的：肝细胞癌治疗决策及其索拉非尼治疗的全球调查 (GIDEON) 研究（ClinicalTrials.gov 标识符） NCT00812175；http://clinicaltrials.gov/）是一项正在进行的全球性、前瞻性、非干预性研究，对象是符合全身治疗条件且已决定在现实生活条件下接受索拉非尼治疗的不可切除的 HCC 患者。本研究的目的是评估索拉非尼在不同亚组中的安全性和有效性，特别是数据有限的Child-Pugh B。讨论：本研究将招募来自超过40个国家的3000名患者，并对他们进行约5年的跟踪，以编制一个庞大而强大的信息数据库，用于分析本地、区域和全球基线特征、疾病病因、治疗实践模式和治疗结果的差异，以期改善用于指导医生治疗决策和改善患者的治疗效果。
P>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.