Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: The GIDEON study

[Display omitted] 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 d...

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Published inJournal of hepatology Vol. 65; no. 6; pp. 1140 - 1147
Main Authors Marrero, Jorge A., Kudo, Masatoshi, Venook, Alan P., Ye, Sheng-Long, Bronowicki, Jean-Pierre, Chen, Xiao-Ping, Dagher, Lucy, Furuse, Junji, Geschwind, Jean-Francois H., de Guevara, Laura Ladrón, Papandreou, Christos, Takayama, Tadatoshi, Sanyal, Arun J., Yoon, Seung Kew, Nakajima, Keiko, Lehr, Robert, Heldner, Stephanie, Lencioni, Riccardo
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 01.12.2016
Elsevier Science Ltd
Subjects
Online AccessGet full text
ISSN0168-8278
1600-0641
1600-0641
DOI10.1016/j.jhep.2016.07.020

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Abstract [Display omitted] 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. 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. 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 800mg, 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]). 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. 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.
AbstractList [Display omitted] 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. 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. 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 800mg, 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]). 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. 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.
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. 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. 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 800mg, 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]). 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. 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.
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.BACKGROUND & AIMSGIDEON (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.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.METHODSBaseline 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.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 800mg, 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]).RESULTSIn 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 800mg, 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]).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.CONCLUSIONSIn 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.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.LAY SUMMARYThe 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.
Graphical abstract
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.
Author Lehr, Robert
Marrero, Jorge A.
de Guevara, Laura Ladrón
Kudo, Masatoshi
Papandreou, Christos
Takayama, Tadatoshi
Lencioni, Riccardo
Geschwind, Jean-Francois H.
Bronowicki, Jean-Pierre
Chen, Xiao-Ping
Ye, Sheng-Long
Furuse, Junji
Dagher, Lucy
Yoon, Seung Kew
Nakajima, Keiko
Venook, Alan P.
Heldner, Stephanie
Sanyal, Arun J.
Author_xml – sequence: 1
  givenname: Jorge A.
  surname: Marrero
  fullname: Marrero, Jorge A.
  email: jorge.marrero@utsouthwestern.edu
  organization: Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA
– sequence: 2
  givenname: Masatoshi
  surname: Kudo
  fullname: Kudo, Masatoshi
  organization: Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan
– sequence: 3
  givenname: Alan P.
  surname: Venook
  fullname: Venook, Alan P.
  organization: Medical Oncology and Translational Research, University of California, San Francisco, CA, USA
– sequence: 4
  givenname: Sheng-Long
  surname: Ye
  fullname: Ye, Sheng-Long
  organization: Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
– sequence: 5
  givenname: Jean-Pierre
  surname: Bronowicki
  fullname: Bronowicki, Jean-Pierre
  organization: University Henri Poincaré by University of Lorraine, Nancy, France
– sequence: 6
  givenname: Xiao-Ping
  surname: Chen
  fullname: Chen, Xiao-Ping
  organization: Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
– sequence: 7
  givenname: Lucy
  surname: Dagher
  fullname: Dagher, Lucy
  organization: Policlínica Metropolitana, Caracas, Venezuela
– sequence: 8
  givenname: Junji
  surname: Furuse
  fullname: Furuse, Junji
  organization: Kyorin University School of Medicine, Mitaka, Tokyo, Japan
– sequence: 9
  givenname: Jean-Francois H.
  surname: Geschwind
  fullname: Geschwind, Jean-Francois H.
  organization: Vascular and Interventional Radiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
– sequence: 10
  givenname: Laura Ladrón
  surname: de Guevara
  fullname: de Guevara, Laura Ladrón
  organization: Hospital Angeles Clínica Londres, Mexico City, Mexico
– sequence: 11
  givenname: Christos
  surname: Papandreou
  fullname: Papandreou, Christos
  organization: University Hospital of Larissa, Larissa, Greece
– sequence: 12
  givenname: Tadatoshi
  surname: Takayama
  fullname: Takayama, Tadatoshi
  organization: Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan
– sequence: 13
  givenname: Arun J.
  surname: Sanyal
  fullname: Sanyal, Arun J.
  organization: Virginia Commonwealth University Medical Center, Richmond, VA, USA
– sequence: 14
  givenname: Seung Kew
  surname: Yoon
  fullname: Yoon, Seung Kew
  organization: The Catholic University of Korea, Seoul, Republic of Korea
– sequence: 15
  givenname: Keiko
  surname: Nakajima
  fullname: Nakajima, Keiko
  organization: Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA
– sequence: 16
  givenname: Robert
  surname: Lehr
  fullname: Lehr, Robert
  organization: Clinical Statistics, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA
– sequence: 17
  givenname: Stephanie
  surname: Heldner
  fullname: Heldner, Stephanie
  organization: Global Medical Affairs and Pharmacovigilance, Bayer HealthCare Pharmaceuticals, Inc., Berlin, Germany
– sequence: 18
  givenname: Riccardo
  surname: Lencioni
  fullname: Lencioni, Riccardo
  organization: Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy
BackLink https://www.ncbi.nlm.nih.gov/pubmed/27469901$$D View this record in MEDLINE/PubMed
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Issue 6
Keywords ECOG PS
Child-Pugh
TNM
AE
CI
Sorafenib
BCLC
HCC
Hepatocellular carcinoma
INR
GIDEON
Nexavar
sorafenib
adverse event
international normalized ratio
Eastern Cooperative Oncology Group performance status
Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib
tumor node metastasis
confidence interval
Barcelona Clinic Liver Cancer
hepatocellular carcinoma
Language English
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Snippet [Display omitted] GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) is a prospective,...
Graphical abstract
GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) is a prospective, observational registry...
Background & Aims: GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) is a prospective,...
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SubjectTerms Antineoplastic Agents
Carcinoma, Hepatocellular
Child
Child-Pugh
Clinical medicine
Drug therapy
Gastroenterology and Hepatology
GIDEON
HCC
Hepatocellular carcinoma
Humans
Liver cancer
Liver diseases
Liver Neoplasms
Medical treatment
Nexavar
Niacinamide - analogs & derivatives
Niacinamide - therapeutic use
Patient handling
Patients
Phenylurea Compounds - therapeutic use
Prospective Studies
Registries
Safety
Sorafenib
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Title Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: The GIDEON study
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