Document Detail

Encephalopathy after high-dose Ifosfamide: a retrospective cohort study and review of the literature.
MedLine Citation:
PMID:  18840018     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Encephalopathy occurs in 10-40% of patients treated with high-dose ifosfamide. Proposed risk factors for encephalopathy include hepatic or renal dysfunction, brain metastases, electrolyte imbalances and drug-drug interactions.
OBJECTIVE: The purpose of this retrospective cohort study and literature review was to estimate the prevalence of encephalopathy, identify characteristics associated with encephalopathy and evaluate the effectiveness of methylthioninium chloride (methylene blue) in its prevention.
STUDY DESIGN AND METHODS: A total of 19 patients received high-dose ifosfamide for soft tissue sarcoma during a 4-year period at our medical centre. Eight patients developed encephalopathy based on adverse drug event (ADE) reports submitted by a clinical pharmacist. These reports incorporate the Naranjo probability scale, which is used to assess the likelihood that a change in clinical status is the result of an ADE rather than the result of other factors, such as progression of disease. The demographics, concurrent medication therapy, co-existing illnesses and laboratory parameters were documented from the medical records. We also conducted a review of the literature by searching MEDLINE (1996-October 2007).
MAIN OUTCOME AND RESULTS: A total of 19 patients received high-dose ifosfamide; eight patients experienced encephalopathy (group I, 42%) and 11 patients did not experience encephalopathy (group II, 58%). More women than men developed encephalopathy (group I, 87.5% vs group II, 27.3%). Serum albumin (group I, 3.1 +/- 0.3 vs group II, 3.6 +/- 0.3 g/dL), haemoglobin (10.5 +/- 1.5 vs 12.4 +/- 1.7 g/dL) and total bilirubin (0.5 +/- 0.2 vs 0.8 +/- 0.3 mg/dL) levels were substantially lower in patients with encephalopathy, whereas the ratio of actual bodyweight to the ideal bodyweight (1.4 +/- 0.3 vs 1.1 +/- 0.2) was substantially higher in these patients. Five (62.5%) patients received a subsequent cycle of high-dose ifosfamide; all of these patients received methylthioninium chloride to minimize the risk of encephalopathy. All of these patients developed encephalopathy. Other reports have found that hypoalbuminaemia is associated with encephalopathy and that methylthioninium chloride does not prevent ifosfamide-induced encephalopathy.
CONCLUSIONS: In summary, female sex, low total bilirubin, albumin and haemoglobin levels, and obesity appear to be associated with ifosfamide-induced encephalopathy. Methylthioninium chloride did not appear to prevent encephalopathy with subsequent doses of high-dose ifosfamide.
Karen I Sweiss; Rakesh Beri; Stacy S Shord
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Review    
Journal Detail:
Title:  Drug safety     Volume:  31     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2008  
Date Detail:
Created Date:  2008-10-08     Completed Date:  2009-01-30     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  989-96     Citation Subset:  IM    
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MeSH Terms
Albumins / metabolism
Antineoplastic Agents, Alkylating / administration & dosage,  adverse effects*,  therapeutic use
Bilirubin / blood
Brain Diseases / chemically induced*,  drug therapy,  epidemiology
Cohort Studies
Enzyme Inhibitors / therapeutic use
Hemoglobins / metabolism
Ifosfamide / administration & dosage,  adverse effects*,  therapeutic use
Methylene Blue / therapeutic use
Middle Aged
Nervous System Diseases / chemically induced,  epidemiology
Obesity / complications,  epidemiology
Retrospective Studies
Risk Factors
Sarcoma / complications,  drug therapy,  pathology
Sex Factors
Reg. No./Substance:
0/Albumins; 0/Antineoplastic Agents, Alkylating; 0/Enzyme Inhibitors; 0/Hemoglobins; RFM9X3LJ49/Bilirubin; T42P99266K/Methylene Blue; UM20QQM95Y/Ifosfamide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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