| Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. | |
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MedLine Citation:
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PMID: 22547607 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2012-04-30 |
Journal Detail:
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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:
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Created Date: 2012-06-11 Completed Date: 2012-08-23 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 2134-9 Citation Subset: IM |
Affiliation:
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H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. alan.list@moffitt.org |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Benzoates / pharmacology* Erythrocyte Transfusion / methods* Female Ferritins / blood* Histocompatibility Antigens Class I / genetics Humans Iron / blood* Iron Chelating Agents / pharmacology* Male Membrane Proteins / genetics Middle Aged Mutation Myelodysplastic Syndromes / blood*, drug therapy* Prospective Studies Time Factors Treatment Outcome Triazoles / pharmacology* |
| Chemical | |
Reg. No./Substance:
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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 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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