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 in | Journal of hepatology Vol. 65; no. 6; pp. 1140 - 1147 | 
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , | 
| Format | Journal Article | 
| Language | English | 
| Published | 
        Netherlands
          Elsevier B.V
    
        01.12.2016
     Elsevier Science Ltd  | 
| Subjects | |
| Online Access | Get full text | 
| ISSN | 0168-8278 1600-0641 1600-0641  | 
| DOI | 10.1016/j.jhep.2016.07.020 | 
Cover
| 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. | 
    
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| 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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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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