Document Detail

Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome.
MedLine Citation:
PMID:  22547607     Owner:  NLM     Status:  MEDLINE    
PURPOSE: This 3-year, prospective, multicenter trial assessed the safety and efficacy of deferasirox in low- or intermediate-1-risk myelodysplastic syndrome (MDS).
PATIENTS AND METHODS: Eligible patients had serum ferritin ≥ 1,000 μg/L and had received ≥ 20 units of RBCs with ongoing transfusion requirements. The starting dose of deferasirox was 20 mg/kg/d, with dose escalation up to 40 mg/kg/d permitted.
RESULTS: A total of 176 patients were enrolled, and 173 patients received therapy. Median serum ferritin decreased 23% in the 53% of patients who completed 12 months of treatment (n = 91), 36.7% in patients who completed 2 years (n = 49), and 36.5% in patients who completed 3 years (n = 33) despite continued transfusion requirement. Reduction in serum ferritin significantly correlated with ALT improvement (P < .001). Labile plasma iron (LPI) was measured quarterly during the first year of the study. Sixty-eight patients (39.3%) had elevated LPI at baseline. By week 13, LPI levels normalized in all patients with abnormal baseline level. Fifty-one (28%) of 173 patients experienced hematologic improvement by International Working Group 2006 criteria; of these, only seven patients received growth factors or MDS therapy. Over the 3-year study, 138 (79.8%) of 173 patients discontinued therapy, 43 patients (24.8%) because of adverse events or disease progression and 23 patients (13.2%) because of abnormal laboratory values. The most common drug-related adverse events were gastrointestinal disturbances and increased serum creatinine. There were 28 deaths, none of which were considered related to deferasirox.
CONCLUSION: Deferasirox reduces serum ferritin and LPI in transfusion-dependent patients with MDS. A subset of patients had an improvement in hematologic and hepatic parameters.
Alan F List; Maria R Baer; David P Steensma; Azra Raza; Jason Esposito; Noelia Martinez-Lopez; Carole Paley; John Feigert; Emmanuel Besa
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-04-30
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  30     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-11     Completed Date:  2012-08-23     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2134-9     Citation Subset:  IM    
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.
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MeSH Terms
Aged, 80 and over
Benzoates / pharmacology*
Erythrocyte Transfusion / methods*
Ferritins / blood*
Histocompatibility Antigens Class I / genetics
Iron / blood*
Iron Chelating Agents / pharmacology*
Membrane Proteins / genetics
Middle Aged
Myelodysplastic Syndromes / blood*,  drug therapy*
Prospective Studies
Time Factors
Treatment Outcome
Triazoles / pharmacology*
Reg. No./Substance:
0/Benzoates; 0/HFE protein, human; 0/Histocompatibility Antigens Class I; 0/Iron Chelating Agents; 0/Membrane Proteins; 0/Triazoles; 7439-89-6/Iron; 9007-73-2/Ferritins; V8G4MOF2V9/deferasirox

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