title: Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: US Regional Analysis of the GIDEON Registry.
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.
authors.affiliation: Radiology and Oncology, Department of Radiology and Imaging Sciences, Yale University School of Medicine, NewHaven, Conn., USA.
authors.forename: Jean-Francois H
authors.initials: JF
authors.lastname: Geschwind
authors.affiliation: Case Western Reserve University, Liver Center of Excellence, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
authors.forename: Pierre M
authors.initials: PM
authors.lastname: Gholam
authors.affiliation: NYU Medical School, New York, N.Y., USA.
authors.forename: Alec
authors.initials: A
authors.lastname: Goldenberg
authors.affiliation: The Liver Institute, Methodist Dallas Medical Center, Dallas, Tex., USA.
authors.forename: Parvez
authors.initials: P
authors.lastname: Mantry
authors.affiliation: Division of Surgical Oncology, University of Louisville, Louisville, Ky., USA.
authors.forename: Robert C G
authors.initials: RC
authors.lastname: Martin
authors.affiliation: Montefiore Medical Center, Bronx, N.Y., USA.
authors.forename: Bilal
authors.initials: B
authors.lastname: Piperdi
authors.affiliation: Onyx Pharmaceuticals, South San Francisco, Calif., USA.
authors.forename: Ellen
authors.initials: E
authors.lastname: Zigmont
authors.affiliation: FibroGen, Inc, San Francisco, Calif., USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Imperial
authors.affiliation: Bayer HealthCare Pharmaceuticals, Whippany, N.J., USA.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Babajanyan
authors.affiliation: Blue Ocean Pharma LLC, Annandale, N.J., USA.
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Foreman
authors.affiliation: Rocky Mountain Cancer Center, US Oncology, Denver, Colo., USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Cohn
keywords: GIDEON; Hepatocellular carcinoma; Sorafenib; TACE; Transarterial chemoembolization