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Table 1.  

Adverse Effects of Deferasirox in the EPIC Study*

Table 2.  

Adverse Effects of Deferasirox in the US03 Trial*

Table 3.  

Representative Clinical Guidelines Concerning Iron Chelation Therapy for Patients with MDS


The Role of Iron Chelation Therapy for Patients With Myelodysplastic Syndromes

  • Authors: David P. Steensma, MD
  • CME Released: 1/14/2011
  • Valid for credit through: 1/14/2012, 11:59 PM EST
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Target Audience and Goal Statement

This activity is intended for hematologists and other physicians who care for patients with MDS.

The goal of this activity is to evaluate the balance of benefits vs potential harms of iron chelation therapy among patients with MDS.

Upon completion of this activity, participants will be able to:

  1. Describe the association between MDS and anemia
  2. Evaluate iron overload in patients with MDS
  3. Distinguish benefits of iron chelation therapy among patients with iron overload in MDS
  4. Identify adverse events associated with oral iron chelation therapy


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  • David P. Steensma, MD

    Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachussets


    Disclosure: David P. Steensma, MD, has disclosed the following relevant financial relationships:
    Served on the advisory board for: Novartis Pharmaceuticals Corporation


  • Kerrin M. Green, MA

    Assistant Managing Editor, Journal of the National Comprehensive Cancer Network


    Disclosure: Kerrin M. Green, MA, has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P. Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine


    Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Nafeez Zawahir, MD

    CME Clinical Director, Medscape, LLC


    Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

  • Sarah Fleischman

    CME Program Manager, Medscape, LLC


    Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

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The Role of Iron Chelation Therapy for Patients With Myelodysplastic Syndromes

Authors: David P. Steensma, MDFaculty and Disclosures

CME Released: 1/14/2011

Valid for credit through: 1/14/2012, 11:59 PM EST


Abstract and Introduction


The appropriate role of iron chelation therapy in the management of patients with myelodysplastic syndromes (MDS) is currently controversial. Some investigators interpret data to indicate that careful attention to iron parameters, with early initiation of iron chelation in patients with evidence suggesting transfusion-associated iron overload, is an important component of high-quality MDS patient care. Other physicians are more skeptical, noting that chelation can be cumbersome or costly, has associated risks, and has not yet been shown to reduce morbidity or mortality in the MDS setting. This article reviews the extent to which iron chelation therapy might be either an important clinical intervention in MDS or a distraction from more pressing clinical concerns. (JNCCN 2011;9:65–75)


More than 90% of patients with myelodysplastic syndromes (MDS) are anemic at the time of diagnosis,[1] and most patients will require red blood cell (RBC) transfusions at some point during the course of their illness. Patients with MDS who require RBC transfusions experience worse outcomes than transfusion-independent patients, even when the cohorts are matched for other known disease-associated prognostic markers.[2,3]

The specific reasons why patients with MDS requiring transfusions experience more rapid disease progression and shorter overall survival are currently unclear. RBC transfusion dependence might mark patients who have intrinsically more severe marrow failure and more dangerous disease, but the RBC transfusions themselves also likely confer risks. Several recent investigations have focused on the specific risk of transfusion-associated iron overload (hemosiderosis) in MDS, because each RBC unit contains approximately 200 to 250 mg of elemental iron, and humans lack a physiologic excretion mechanism for excess iron. Iron overload from increased gut iron absorption in the setting of ineffective erythropoiesis, exacerbated by RBC transfusions, has proven to be a leading cause of death in several congenital forms of anemia, such as severe β-thalassemia.[4]

The risk of iron overload in chronic acquired anemic states, such as MDS, could be clinically relevant, because this risk is potentially modifiable with iron chelation therapy (ICT). However, which patients with MDS should be offered ICT is currently an area of uncertainty in clinical practice.[5] Although the advent of an effective orally bioavailable iron chelator, deferasirox (Exjade, approved by the FDA in 2005; deferiprone [L1], another orally administered iron chelator, is available in many countries but not in the United States) promised increased convenience for patients compared with injectable deferoxamine (Desferal, FDA-approved in 1968), ICT is costly and confers risks, and thus far no completed randomized clinical trials have shown that patients with MDS benefit from ICT. This article discusses the evidence supporting the concept that iron overload is harmful to patients with MDS, benefits and risks of ICT, preliminary data from phase II deferasirox clinical trials, and the various consensus guidelines on management of excess iron in patients with MDS.