The MDS Beacon™

The National Comprehensive Cancer Network (NCCN) has updated their most recent Clinical Practice Guidelines in Oncology, and mentions Vidaza (azacitidine) as superior to conventional care for patients with Intermediate-2 and high-risk myelodysplastic syndromes (MDS). The guidelines state that Vidaza “should be considered for treating MDS patients with progressing or relatively high-risk disease.”

The NCCN Guidelines provide recommendations to physicians for managing most types of cancers. The guidelines include a “decision pathway” that outlines recommended care for MDS patients.

The NCCN upgraded Vidaza’s status to Category 1, or “preferred” therapy, for high-risk MDS patients, who are most likely to progress to acute myeloid leukemia (AML). This recommendation is based on preliminary data from a large international Phase 3 clinical trial presented at the 50th Annual Meeting of the American Society of Hematology. Results showed the drug significantly increased survival rates of high-risk MDS patients.

The study enrolled 358 high-risk MDS patients, 113 of whom had already progressed to AML. Patients who received Vidaza were given 75 mg/m² by subcutaneous injection for seven days during each 28 day cycle. Others received either intensive chemotherapy, low doses of the chemotherapy drug cytarabine, or best supportive care.

The study’s overall results showed those who received Vidaza survived a median of 25 months after treatment, and 51 percent of patients were still living after two years. Those receiving conventional care survived a median of 15 months, with only 26 percent still living after the two year follow-up.

In the AML patient subset, median overall survival for patients who received Vidaza was 25 months, compared to 16 months with conventional care. In addition, 50 percent of AML patients who received Vidaza were still living two years after treatment, compared to 16 percent of patients who were given conventional care.

Vidaza has been shown to have the unprecedented ability to delay AML progression and improve survival in patients already diagnosed with AML. Its potential for helping all high-risk MDS patients is reflected in the NCCN recommendation.

In addition to Vidaza, the NCCN guidelines also mention encouraging results for studies involving Dacogen (decitabine) and Revlimid (lenalidomide), two other drugs approved by the U.S. Food and Drug Administration for treating MDS.

For more information, please see The MDS Foundation press release (pdf) or the NCCN Clinical Guidelines for MDS (pdf).