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J Hepatol. 2016 Dec;65(6):1140-1147. doi: 10.1016/j.jhep.2016.07.020. Epub 2016 Jul 25.

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

Author information

1
Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: jorge.marrero@utsouthwestern.edu.
2
Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan.
3
Medical Oncology and Translational Research, University of California, San Francisco, CA, USA.
4
Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.
5
University Henri Poincaré by University of Lorraine, Nancy, France.
6
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
7
Policlínica Metropolitana, Caracas, Venezuela.
8
Kyorin University School of Medicine, Mitaka, Tokyo, Japan.
9
Vascular and Interventional Radiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
10
Hospital Angeles Clínica Londres, Mexico City, Mexico.
11
University Hospital of Larissa, Larissa, Greece.
12
Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
13
Virginia Commonwealth University Medical Center, Richmond, VA, USA.
14
The Catholic University of Korea, Seoul, Republic of Korea.
15
Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA.
16
Clinical Statistics, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA.
17
Global Medical Affairs and Pharmacovigilance, Bayer HealthCare Pharmaceuticals, Inc., Berlin, Germany.
18
Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy.

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 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]).

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.

KEYWORDS:

Child-Pugh; GIDEON; HCC; Hepatocellular carcinoma; Nexavar; Sorafenib

PMID:
27469901
DOI:
10.1016/j.jhep.2016.07.020
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