The MDS Beacon™

Italian researchers have found that elderly patients with myelodysplastic syndromes (MDS), who also have other diseases, can achieve the same response as patients without other diseases and do not experience additional side effects while receiving Vidaza (azacitidine) treatment. These results were presented at the 2010 European Hematology Association (EHA) Congress in Barcelona, Spain.

MDS is a disease that mainly afflicts older patients who frequently already have other diseases. Recent clinical trials have shown that Vidaza is safe and effective in MDS patients of all ages and improves survival in elderly higher-risk MDS patients (see related Beacon news).

The Italian researchers wanted to determine if the same results can be achieved outside the clinical trial setting. They also examined whether other diseases that elderly patients may have affected the patients’ response to Vidaza.

They analyzed the data of 39 MDS patients between the ages of 60 and 82 who underwent Vidaza treatment at their treatment center. Nine patients had one additional disease, and four patients had two or more additional diseases.

The patients received 75 mg/kg Vidaza per day for seven days every 28 days. The mean number of treatment cycles patients received was 11.

Researchers found that 44 percent of patients responded to the Vidaza treatment, and 34.1 percent of patients achieved stable disease. They also found that patients’ response was unrelated to age and the number of additional diseases, although overall survival did seem to be negatively affected by the number of additional diseases.

The median overall survival of the patients studied (29.5 months) was comparable to that of patients from a recent Phase 3 Vidaza trial (24.6 months). There was no significant difference in overall survival between patients ages 60 to 75 and those older than 75.

The results also showed that side effects were independent of age group. Seventy-five percent of patients did not experience any blood-related side effects, and 64 percent of patients did not experience other side effects.

Researchers concluded that elderly MDS patients with additional diseases may be successfully treated with Vidaza without a substantial increase in side effects.

For more information, please see abstract 0905 at the EHA meeting website.