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

Jean Francois H. Geschwind, Pierre M. Gholam, Alec Goldenberg, Parvez Mantry, Robert C.G. Martin, Bilal Piperdi, Ellen Zigmont, Joanne Imperial, Svetlana Babajanyan, Pamela K. Foreman, Allen Cohn

Research output: Contribution to journalArticle

24 Citations (Scopus)

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 drugrelated 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.

Original languageEnglish (US)
Pages (from-to)37-46
Number of pages10
JournalLiver Cancer
Volume5
Issue number1
DOIs
StatePublished - Feb 1 2016

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Registries
Hepatocellular Carcinoma
Safety
sorafenib
Incidence
Therapeutics
Liver Neoplasms
Demography
Physicians
Survival
Neoplasms

Keywords

  • GIDEON
  • Hepatocellular carcinoma
  • Sorafenib
  • TACE
  • Transarterial chemoembolization

ASJC Scopus subject areas

  • Hepatology
  • Oncology

Cite this

Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma : US Regional Analysis of the GIDEON Registry. / Geschwind, Jean Francois H.; Gholam, Pierre M.; Goldenberg, Alec; Mantry, Parvez; Martin, Robert C.G.; Piperdi, Bilal; Zigmont, Ellen; Imperial, Joanne; Babajanyan, Svetlana; Foreman, Pamela K.; Cohn, Allen.

In: Liver Cancer, Vol. 5, No. 1, 01.02.2016, p. 37-46.

Research output: Contribution to journalArticle

Geschwind, JFH, Gholam, PM, Goldenberg, A, Mantry, P, Martin, RCG, Piperdi, B, Zigmont, E, Imperial, J, Babajanyan, S, Foreman, PK & Cohn, A 2016, 'Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: US Regional Analysis of the GIDEON Registry', Liver Cancer, vol. 5, no. 1, pp. 37-46. https://doi.org/10.1159/000367757
Geschwind, Jean Francois H. ; Gholam, Pierre M. ; Goldenberg, Alec ; Mantry, Parvez ; Martin, Robert C.G. ; Piperdi, Bilal ; Zigmont, Ellen ; Imperial, Joanne ; Babajanyan, Svetlana ; Foreman, Pamela K. ; Cohn, Allen. / Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma : US Regional Analysis of the GIDEON Registry. In: Liver Cancer. 2016 ; Vol. 5, No. 1. pp. 37-46.
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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 drugrelated 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.",
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T2 - US Regional Analysis of the GIDEON Registry

AU - Geschwind, Jean Francois H.

AU - Gholam, Pierre M.

AU - Goldenberg, Alec

AU - Mantry, Parvez

AU - Martin, Robert C.G.

AU - Piperdi, Bilal

AU - Zigmont, Ellen

AU - Imperial, Joanne

AU - Babajanyan, Svetlana

AU - Foreman, Pamela K.

AU - Cohn, Allen

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N2 - 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 drugrelated 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.

AB - 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 drugrelated 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.

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