TY - JOUR
T1 - Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups
T2 - The GIDEON study
AU - Marrero, Jorge A.
AU - Kudo, Masatoshi
AU - Venook, Alan P.
AU - Ye, Sheng Long
AU - Bronowicki, Jean Pierre
AU - Chen, Xiao Ping
AU - Dagher, Lucy
AU - Furuse, Junji
AU - Geschwind, Jean Francois H.
AU - de Guevara, Laura Ladrón
AU - Papandreou, Christos
AU - Takayama, Tadatoshi
AU - Sanyal, Arun J.
AU - Yoon, Seung Kew
AU - Nakajima, Keiko
AU - Lehr, Robert
AU - Heldner, Stephanie
AU - Lencioni, Riccardo
N1 - Funding Information:
GIDEON was sponsored by Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, an Amgen subsidiary.
Funding Information:
The authors would like to thank all participating clinical sites that contributed to the GIDEON study. All data management-related activities for GIDEON were coordinated and overseen by Anja Laske at Bayer HealthCare Pharmaceuticals, Inc. The contract research organization Kantar Health GmbH (Munich, Germany) is responsible for the data management system, data capture, quality review, statistical analysis, and report writing. Kieran Davey, PhD, at Complete HealthVizion provided assistance in the preparation and revision of the draft manuscript, funded by Bayer HealthCare AG. The authors take full responsibility for the scope, direction, and content of the manuscript. GIDEON is funded by Bayer HealthCare AG and Onyx Pharmaceuticals, an Amgen subsidiary.
Publisher Copyright:
© 2016 European Association for the Study of the Liver
PY - 2016/12/1
Y1 - 2016/12/1
N2 - Background & Aims GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) is a prospective, observational registry study evaluating the safety of sorafenib and treatment practices in hepatocellular carcinoma patients. This large global database allowed for assessment of the use and tolerability of sorafenib in patients with liver dysfunction. Methods Baseline characteristics and medical/treatment history were collected in patients for whom a decision to treat with sorafenib had been made. Adverse event, dosing, and outcomes data were collected during follow-up. Results In the overall safety population (n = 3202), 1968 patients (61%) had Child-Pugh A status and 666 (21%) had Child-Pugh B. The majority of Child-Pugh A (72%) and Child-Pugh B (70%) patients received an initial sorafenib dose of 800 mg, consistent with the label, and dose reduction rates were 40% and 29%, respectively. The type and incidence of adverse events were generally consistent across Child-Pugh subgroups. The incidence of drug-related adverse events leading to discontinuation was similar between Child-Pugh A and Child-Pugh B patients (17% and 21%). In the intent-to-treat population (n = 3213), median overall survival (months [95% confidence interval]) was longer in Child-Pugh A patients (13.6 [12.8–14.7]) compared with Child-Pugh B patients (5.2 [4.6–6.3]). Conclusions In clinical practice, the safety profile of sorafenib appeared to be consistent across Child-Pugh A and Child-Pugh B patients. Findings suggest sorafenib may be safely used in some Child-Pugh B patients and indicate the importance of careful patient evaluation when making treatment decisions. Lay summary The GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) study is a large prospective registry of patients with liver cancer who were treated with sorafenib. The aims were to evaluate the safety and tolerability of sorafenib among those in which the liver was not functioning properly. The study showed that the safety profile of sorafenib was consistent across patients with preserved liver function and those in which the liver was not functioning properly, and therefore, suggesting that sorafenib may be a valid treatment for some patients with liver impairment.
AB - Background & Aims GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) is a prospective, observational registry study evaluating the safety of sorafenib and treatment practices in hepatocellular carcinoma patients. This large global database allowed for assessment of the use and tolerability of sorafenib in patients with liver dysfunction. Methods Baseline characteristics and medical/treatment history were collected in patients for whom a decision to treat with sorafenib had been made. Adverse event, dosing, and outcomes data were collected during follow-up. Results In the overall safety population (n = 3202), 1968 patients (61%) had Child-Pugh A status and 666 (21%) had Child-Pugh B. The majority of Child-Pugh A (72%) and Child-Pugh B (70%) patients received an initial sorafenib dose of 800 mg, consistent with the label, and dose reduction rates were 40% and 29%, respectively. The type and incidence of adverse events were generally consistent across Child-Pugh subgroups. The incidence of drug-related adverse events leading to discontinuation was similar between Child-Pugh A and Child-Pugh B patients (17% and 21%). In the intent-to-treat population (n = 3213), median overall survival (months [95% confidence interval]) was longer in Child-Pugh A patients (13.6 [12.8–14.7]) compared with Child-Pugh B patients (5.2 [4.6–6.3]). Conclusions In clinical practice, the safety profile of sorafenib appeared to be consistent across Child-Pugh A and Child-Pugh B patients. Findings suggest sorafenib may be safely used in some Child-Pugh B patients and indicate the importance of careful patient evaluation when making treatment decisions. Lay summary The GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) study is a large prospective registry of patients with liver cancer who were treated with sorafenib. The aims were to evaluate the safety and tolerability of sorafenib among those in which the liver was not functioning properly. The study showed that the safety profile of sorafenib was consistent across patients with preserved liver function and those in which the liver was not functioning properly, and therefore, suggesting that sorafenib may be a valid treatment for some patients with liver impairment.
KW - Child-Pugh
KW - GIDEON
KW - HCC
KW - Hepatocellular carcinoma
KW - Nexavar
KW - Sorafenib
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U2 - 10.1016/j.jhep.2016.07.020
DO - 10.1016/j.jhep.2016.07.020
M3 - Article
AN - SCOPUS:84994500708
SN - 0168-8278
VL - 65
SP - 1140
EP - 1147
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 6
ER -