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MDS Patients’ Pretreatment Risk Level Predicts Outcome Of Vidaza Treatments (EHA 2009)

No Comment By The MDS Beacon Staff
Published: Jul 13, 2009 11:57 am

At the 14th Congress of the European Hematology Association (EHA), researchers from several South Korean hospitals presented a two year study in which they analyzed the outcome of Vidaza (azacitidine) treatments in myelodysplastic syndromes (MDS) patients who had a variety of pretreatment risk assessments. Their results indicated that patients’ pretreatment risk groups were a significant factor in predicting their response to this treatment.

Before starting any type of treatment, patients are assessed and analyzed so that doctors can determine the best course of therapy in terms of treatment intensity. They take into account biologic and genetic characteristics which, when added to classic clinical staging, has helped doctors assign patients to the appropriate risk group. These criteria include the age of the patient, extent of disease spread, microscopic appearance, and genetic features. They are then placed into one of three pre-treament risk groups: low, intermediate, or high risk disease.

This particular study, which ran from August 2006 to June 2008, analyzed the ability of pretreatment risk groups to predict the prognosis of MDS patients receiving Vidaza. The study originally included 129 patients, with a median age of 64 years, but only 126 patients who received more than two cycles were analyzed. The cycle included 75 mg/m2 of Vidaza per day, which was received for seven consecutive days, then repeated every 28 days.

As a result of the treatment, 60 patients (48 percent) had responses at a median of three cycles. Nineteen percent of all participants responded by the third cycle, 14 percent showed response after the third cycle, 13 percent after the fourth cycle, and only 2 percent after the fifth cycle.

After repeated cycles, 17 percent of the patients displayed complete responses, resulting in the formation of healthy, mature red blood cells and the disappearance of MDS symptoms. Five percent of patients displayed partial responses with general improvement, and twenty-six percent of patients displayed general improvements in hematological (blood) health.

The study identified significant survival benefits over a three year period. Younger patients (less than 60 years old) displayed better survival rates than older patients (greater than 60 years old). Patients with lower pretreatment risk demonstrated superior survival rates than those with higher pretreatment risk. In addition, the progression to acute leukemia was more common in patients with higher pretreatment risk scores.

Generally, Vidaza produced higher overall survival rates for patients with lower pretreatment risk scores than patients with higher pretreatment risk scores. As a result, young, low risk patients may utilize Vidaza treatments to improve marrow health and overall survival; however, older, high risk patients should consider alternative, more effective therapy for MDS.

For more information on this study, see abstract 0255 from the “Myelodysplastic Syndromes I” session of the 14th Congress of the EHA.

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