Document Detail


Severe sustained cholestatic hepatitis following temozolomide in a patient with glioblastoma multiforme: case study and review of data from the FDA adverse event reporting system.
MedLine Citation:
PMID:  22394496     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor in adults. Its established first-line adjuvant treatment is radiotherapy in combination with temozolomide (TZM). Hematotoxicity is listed as a frequent adverse drug reaction in the US prescribing information and hepatotoxicity has been reported infrequently in the postmarketing period. We here present the case of a patient diagnosed with GBM who developed severe sustained cholestatic hepatitis following treatment with TZM. The cholestasis was not reversible after withdrawal of TZM during 6 months before the patient's death. Another 2 published case reports of sustained cholestasis following TZM treatment were identified; however, the sustained nature of cholestasis was not emphasized in these reports. Sixteen cases of cholestatic hepatitis/cholestasis associated with TZM were identified in the FDA spontaneous reporting system between 2007 and 2010. Information on the course of the cholestasis in these cases could not be retrieved. In the literature there are other published reports of hepatotoxicity associated with TZM that have reported reversibility upon withdrawal of the drug. Thus, TZM appears to cause different types of hepatotoxicity. Particular attention should be paid to sustained cholestasis as a very serious type of TZM-associated liver toxicity.
Authors:
Giselle Sarganas; Hans D Orzechowski; Andreas Klimpel; Michael Thomae; Wolfgang Kauffmann; Hermann Herbst; Elisabeth Bronder; Edeltraut Garbe
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Publication Detail:
Type:  Case Reports; Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2012-03-06
Journal Detail:
Title:  Neuro-oncology     Volume:  14     ISSN:  1523-5866     ISO Abbreviation:  Neuro-oncology     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-27     Completed Date:  2012-08-29     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  100887420     Medline TA:  Neuro Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  541-6     Citation Subset:  IM    
Affiliation:
Clinical Pharmacology and Toxicology, Charité Universitätsmedizin Berlin, Berlin, Germany.
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems*
Antineoplastic Agents, Alkylating / adverse effects*
Brain Neoplasms / drug therapy
Cholestasis / chemically induced*
Dacarbazine / adverse effects,  analogs & derivatives*
Drug-Induced Liver Injury / etiology*
Glioblastoma / drug therapy*
Hepatitis / etiology*
Humans
Male
Middle Aged
Prognosis
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Antineoplastic Agents, Alkylating; 4342-03-4/Dacarbazine; 85622-93-1/temozolomide
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