Journal
LIVER CANCER
Volume 5, Issue 1, Pages 37-46Publisher
KARGER
DOI: 10.1159/000367757
Keywords
GIDEON; Hepatocellular carcinoma; Sorafenib; TACE; Transarterial chemoembolization
Categories
Ask authors/readers for more resources
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. Copyright (C) 2015 S. Karger AG, Basel
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available