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Relationship between baseline hepatic status and outcome, and effect of sorafenib on liver function: SHARP trial subanalyses.

ΤίτλοςRelationship between baseline hepatic status and outcome, and effect of sorafenib on liver function: SHARP trial subanalyses.
Publication TypeJournal Article
Year of Publication2012
AuthorsRaoul, J-L., Bruix J., Greten T. F., Sherman M., Mazzaferro V., Hilgard P., Scherubl H., Scheulen M. E., Germanidis G., Dominguez S., Ricci S., Nadel A., Moscovici M., Voliotis D., & Llovet J. M.
JournalJ Hepatol
Volume56
Issue5
Pagination1080-8
Date Published2012 May
ISSN1600-0641
Λέξεις κλειδιάAdult, Aged, Aged, 80 and over, Alanine Transaminase, alpha-Fetoproteins, Antineoplastic Agents, Aspartate Aminotransferases, Benzenesulfonates, Bilirubin, Biological Markers, Carcinoma, Hepatocellular, Female, Humans, Liver, Liver Neoplasms, Male, Middle Aged, Niacinamide, Phenylurea Compounds, Prognosis, Pyridines, Survival Rate, Treatment Outcome
Abstract

BACKGROUND & AIMS: Hepatic markers are utilized in many classification systems of patients with hepatocellular carcinoma and, by measuring organ damage and tumor stage, can influence treatment. Moreover, elevated serum concentrations of aminotransferases and alpha-fetoprotein are indicators of poor prognosis in patients with hepatocellular carcinoma. We examined the effects of sorafenib on hepatic markers by performing exploratory subset analyses of the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial in patients categorized by baseline concentrations of alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, and bilirubin; and by evaluating the effects of sorafenib on bilirubin concentrations during treatment.METHODS: Patients (n=602) were grouped by baseline concentrations of alanine aminotransferase/aspartate aminotransferase (not significantly elevated, mildly elevated, or moderately elevated), alpha-fetoprotein (normal or elevated), and bilirubin (normal or elevated). Bilirubin was measured at baseline and on day 1 of each cycle.RESULTS: Patients with elevated baseline concentrations of alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin had shorter overall survival (OS) than those with normal baseline concentrations, irrespective of treatment group. No notable differences in safety profiles were observed between patients with normal vs. elevated alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin. Median changes from baseline in bilirubin concentration at the last cycle of treatment were +0.17 and +0.19 mg/dl in the sorafenib and placebo groups, respectively.CONCLUSIONS: These subset analyses suggest that sorafenib is safe and effective for hepatocellular carcinoma, irrespective of baseline alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin concentration and that hepatic function remains stable over the course of sorafenib therapy.

DOI10.1016/j.jhep.2011.12.009
Alternate JournalJ. Hepatol.
PubMed ID22245896

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