The MDS Beacon™

Vidaza (azacitidine) improves survival compared to conventional care regimens in higher-risk myelodysplastic syndromes (MDS) patients who are 75 years or older, according to an analysis performed by researchers on an earlier Phase 3 clinical trial.

Researchers concluded that age alone should not be the deciding factor for treatment choice and that more elderly patients should be considered for targeted chemotherapies, such as Vidaza.

Elderly MDS patients generally have limited treatment options due to other age-related diseases, functional impairment, and poor tolerability or ineffectiveness of available therapies. Doctors may also be reluctant to actively treat MDS in this patient population. In addition, there is currently little data available showing improvement in survival in these patients if they receive treatment.

Vidaza is approved in the United States for all types of MDS patients. It generally delays disease progression of MDS to acute myeloid leukemia and improves overall survival in patients with higher-risk MDS.

In their analysis of an earlier Vidaza trial, researchers examined efficacy and side effects of Vidaza treatment in patients ages 75 years and older with higher-risk MDS.

Of the 87 elderly patients in the study, 38 received Vidaza treatment. They were given 75 mg/m² of Vidaza per day, injected below the skin, for seven days every 28 days.  Patients received a minimum of six Vidaza cycles, with 7.5 being the median number of Vidaza cycles.

Those patients who did not receive Vidaza treatment were assigned to one of three potential conventional care regimens: best supportive care, which included blood transfusions and antibiotics; low-dose chemotherapy; and intensive chemotherapy.

Researchers found that at two years, 55 percent of elderly patients who received Vidaza were alive compared to 15 percent who received conventional care regimens.

At the median follow-up of 17.7 months, the median overall survival of the Vidaza treatment group was not reached. The median overall survival of the conventional care regimen group was 10.8 months.

Of the patients who were dependent on blood transfusions at the beginning of the study, 43 percent of patients on Vidaza achieved transfusion independence compared to 22 percent of patients who received conventional care.

Vidaza was generally well tolerated. Side effects were similar in this patient population compared to patients younger than 75 years. The most common side effects were low platelet counts, low white blood cell counts, and infection for both the Vidaza treatment group and the conventional care regimen group.

Patients experienced Vidaza-related side effects during early treatment cycles. Side effects decreased with continued dosing.

For more information, please see the study in Critical Reviews in Oncology/Hematology (abstract) or a previous Beacon article about Vidaza treatments for elderly MDS patients.