The MDS Beacon™

Vidaza (azacytidine) may be as effective and well tolerated in myelodysplastic syndromes (MDS) patients aged 80 years and above as compared to patients less than 80 years old, according to a retrospective analysis by French researchers.

The findings were presented at the 51st Annual American Society of Hematology (ASH) meeting and exposition in December.

MDS patients aged 80 years and above make up 30 to 35 percent of all MDS patients. These patients are usually not candidates for chemotherapy, even at low doses, because older patients typically do not respond well to the side effects of chemotherapy. Instead, they generally only receive supportive care, which may help improve quality of life but does not treat MDS.

However, this analysis showed that response rates, survival, and side effects associated with Vidaza may be similar in MDS patients of all ages.

Researchers collected data on 41 MDS patients ages 80 years and older who were treated with Vidaza at hematology clinics in France. Vidaza was given to these patients on a compassionate use basis, where the drug was given to seriously ill patients with few or no treatment options before Vidaza was officially approved in France.

Two dosing regimens were used. The first dosing regimen was given to 54 percent of the patients and followed the European Medicines Agency-approved schedule of 75 mg/m² of Vidaza for seven days every four weeks.

The second dosing regimen was given to 46 percent of the patients and was identified as less intensive, following a schedule of 75 mg/m² of Vidaza for five days every four weeks, or in some cases less than 75 mg/m² a day.

Patients received a median of four cycles of treatment within a median follow-up time of 12 months.

Of the patients being analyzed, the overall response rate was 34 percent, which is comparable to the response rate in patients less than 80 years old. Six of those patients (15 percent) achieved a complete response, and two patients (5 percent) achieved a partial response.

The median overall survival rate was 17 months, similar to the 15 month survival of patients less than 80 years old. However, five patients (12 percent) died before the completion of four cycles of treatment, which is also similar to the rate for patients less than 80 years (10 percent).

The most common drug-related side effect in both age groups was a condition characterized by both fever and a low number of white blood cells.

The study did not report whether Vidaza delayed progression of MDS to acute myeloid leukemia in patients at least 80 years old.

Researchers concluded that Vidaza treatment in MDS patients 80 years and older was associated with significant overall response and survival rates, comparable to those observed in patients less than 80 years.

Unlike with chemotherapy, Vidaza did not cause an increased drug-related toxicity in patients 80 years and older when compared with MDS patients less than 80 years, according to researchers.

For more information, see abstract 1773 at the ASH Meeting Web site. For information about the safety and effectiveness of Dacogen (decitabine) in elderly MDS patients, see a related Beacon article.