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Liver Cancer. 2016 Feb;5(1):37-46. doi: 10.1159/000367757. Epub 2015 Dec 15.

Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: US Regional Analysis of the GIDEON Registry.

Author information

1
Radiology and Oncology, Department of Radiology and Imaging Sciences, Yale University School of Medicine, NewHaven, Conn., USA.
2
Case Western Reserve University, Liver Center of Excellence, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
3
NYU Medical School, New York, N.Y., USA.
4
The Liver Institute, Methodist Dallas Medical Center, Dallas, Tex., USA.
5
Division of Surgical Oncology, University of Louisville, Louisville, Ky., USA.
6
Montefiore Medical Center, Bronx, N.Y., USA.
7
Onyx Pharmaceuticals, South San Francisco, Calif., USA.
8
FibroGen, Inc, San Francisco, Calif., USA.
9
Bayer HealthCare Pharmaceuticals, Whippany, N.J., USA.
10
Blue Ocean Pharma LLC, Annandale, N.J., USA.
11
Rocky Mountain Cancer Center, US Oncology, Denver, Colo., USA.

Abstract

BACKGROUND:

Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Treatment with Sorafenib (GIDEON) is a worldwide, prospective, non-interventional study to evaluate the safety of sorafenib in a variety of patient subsets.

METHODS:

Eligible patients had unresectable hepatocellular carcinoma for whom the decision had been made to treat with sorafenib. Treatment strategies were instituted at the physician's discretion. Patient and disease characteristics, treatment practices, incidences of adverse events (AEs), and overall survival were collected.

RESULTS:

In the United States, 563 patients were evaluable for safety. Subgroup analysis was performed for patients who underwent transarterial chemoembolization (TACE) prior to the initiation of sorafenib (group A, n=158), after the initiation of sorafenib only (group B, n=29), both (group C, n=38), or did not undergo TACE (n=318). Patient demographics were similar across the groups. In group A, 29% had Child-Pugh score B or C at diagnosis, and 19% had Barcelona Clinic Liver Cancer tumor stage C or D. In group B, 48% had Child-Pugh score B or C at study entry, and 31% had BCLC stage C or D. The majority of patients in all groups initially received full-dose sorafenib. Incidences of grade ≥3 drug-related AEs were 30%, 17%, and 16% in groups A, B, and C, respectively, and 22% in patients who did not undergo TACE. No new safety signals emerged.

CONCLUSIONS:

The results from GIDEON reaffirm that sorafenib can be safely used in the context of TACE.

KEYWORDS:

GIDEON; Hepatocellular carcinoma; Sorafenib; TACE; Transarterial chemoembolization

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