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Researchers from Loyola University have reported that the combination of Mylotarg® (gemtuzumab ozogamicin) and Vidaza® (azacitidine) produces a high rate of response in elderly patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The details of this study were presented at the 2006 meeting of the American Society of Hematology.

Acute myeloid leukemia (AML) is a cancer of the bone marrow and blood that is characterized by the rapid, uncontrolled growth of immature white blood cells known as myelocytes. The disease is more common in adults than in children; average age at diagnosis is more than 65 years.

There have been relatively large improvements in survival of younger patients with AML over the past two decades due to increased dose-intensity of therapy; this includes stem cell transplants. However, there has been little if any improvement in the treatment of elderly patients with AML, often because elderly patients are not able to tolerate the more aggressive treatments used for younger patients.

Myelodysplastic syndromes (MDS) are a group of diseases marked by abnormal production of blood cells by the bone marrow. Healthy bone marrow produces immature blood cells-called blasts-that then develop into red blood cells, white blood cells, and platelets. MDS disrupts this normal process so that the bone marrow is overactive, producing many immature cells. These blasts, however, do not fully develop into mature blood cells. As a result patients with MDS have fewer mature blood cells, and those they do have may be abnormal and not function properly. In some cases MDS develops into AML.

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Vidaza was the first drug approved by the U.S. Food and Drug Administration for the treatment of MDS. Mylotarg is used in the treatment of certain patients with AML.

To evaluate the combination of Vidaza and Mylotarg in the treatment of elderly patients with newly diagnosed AML or MDS, researchers conducted a Phase II clinical trial. The study enrolled 11 patients with AML and two patients with MDS. All study participants were over the age of 60, and all were treated with the combination of Vidaza and Mylotarg.

  • 10 of the 13 patients (76%) experienced a complete remission following treatment.
  • Nine patients remain in remission after two to 13 months.

The results indicate that the combination of Vidaza and Mylotarg produces a high rate of response in elderly patients with AML or MDS. If confirmed, these findings may have a major impact on the treatment of this patient population.

Reference: Nand S, Godwin J, Smith S, et al. Azacitidine plus gemtuzumab ozogamicin (GO): A novel combination in the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in the elderly. Proceedings from at the 2006 meeting of the American Society of Hematology. *Blood.*2006;108:561a.