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According to an article recently published in the Journal of Clinical Oncology, the agent Vidaza® (azacitidine) is effective for the treatment of myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML) that has occurred from MDS.

Myelodysplastic syndromes are a group of blood (hematologic) disorders that are diagnosed in 10,000 to 20,000 individuals annually in the U.S. MDS occurs when immature blood cells do not mature properly and cannot perform their intended function. They instead crowd out normal blood cells in the bone marrow, often inhibiting other cells from performing their intended functions.

MDS can also develop into an aggressive form of leukemia, AML. Preventing or delaying the development of MDS into AML is an important consideration because long-term survival for AML is not favorable.

The different classifications of MDS range from low-risk to high-risk. Low-risk patients often have less aggressive disease, which may be managed with blood transfusions (referred to as transfusion-dependent); this requires the infusion of a donor’s red blood cells (cells that deliver oxygen throughout the body) or infusion of a donor’s platelets (cells that help the blood to clot appropriately). High-risk patients may need more aggressive management of their disease.

Researchers recently analyzed data from three large clinical trials that were previously conducted to evaluate Vidaza in the treatment of MDS. These trials, referred to as Studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B, included 309 patients with either MDS or AML who were treated with Vidaza. A number of patients in these trials did not receive therapy (control group).

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  • 10%–17% of patients with MDS achieved a complete disappearance of cancer.
  • 23%–36% of patients with MDS achieved an improvement in their blood cell levels (hematologic improvement).
  • 35%–48% of patients with AML achieved a hematologic improvement.
  • Half of the patients with AML who were treated with Vidaza were alive at 19.3 months compared to only 12.9 months for patients in the control group.
  • Treatment with Vidaza did not increase the rates of infection or bleeding.

The researchers concluded that treatment with Vidaza is an active agent in the treatment of MDS or AML that has occurred from MDS. Patients with MDS or AML may wish to speak with their physician regarding their individual risks and benefits of treatment with Vidaza.

Reference: Silverman L, McKenzie D, Peterson B, et al. Further Analysis of Trials With Azacitidine in Patients With Myelodysplastic Syndrome: Studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. Journal of Clinical Oncology. 2006;24:3895-3903.

Related News:Further Evidence that Vidaza® Reduces Need for Transfusions in Myelodysplastic Syndromes (6/8/2006)

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