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Title: Azacitidine (Vidaza) Is First Drug to Show Survival Benefit in Geriatric Myelodysplastic Syndromes: Presented at ASH

"Azacitidine (Vidaza) Is First Drug to Show Survival Benefit in Geriatric Myelodysplastic Syndromes: Presented at ASH"

By Bruce Sylvester ATLANTA, GA -- December 12, 2005 -- A significantly higher percentage of elderly patients with high-risk myelodysplastic syndromes (MDS) who received treatment with injectable azacitidine (Vidaza) were alive after 1 year compared with those who received standard supportive care, according to research reported here at the 47[^th Annual Meeting of the American Society of Hematology (ASH).

Study subjects also reported that azacitidine also significantly delayed transformation of acute MDS to acute myelogenous leukemia (AML), which is eventually diagnosed in about 40% of MDS patients and which has a poor prognosis for survival.

"We have demonstrated for the first time a survival benefit for any MDS treatment," said lead investigator Lewis Silverman, MD, associate professor of medicine, Mount Sinai School of Medicine, New York, New York.

In this phase 3, retrospective study of 68 high-risk MDS patients, the investigators found a significant difference in overall survival rates between the 31 azacitidine patients and the 37 supportive care patients at 1 year. Treated patients had a median overall survival of 19.5 months and supportive care patients had a median survival of 14 months.

Median time to AML transformation with azacitidine was 42 months compared with 17.7 months for supportive care. And median time to a combined endpoint of death or AML transformation was 19.1 months for the azacitidine group compared with 9.2 months for supportive care.

"These findings call us to rethink a passive 'watchful waiting' approach to care and to now look at high-risk elderly patients as eligible for treatment," Dr. Silverman said.

"Now we have a drug that can change the course of the disease for elderly, high-risk patients who are not eligible for bone marrow transplant. This will change how we do what we do for these people and how we practice medicine in our specialty," he added.

Azacitidine (Vidaza) is the only treatment approved by the US Food and Drug Administration for all subtypes of MDS.

[Presentation title: Azacitidine Prolongs Survival and Time to AML Transformation in High-Risk Myelodysplastic Syndrome (MDS) Patients Greater Than or Equal to 65 Years of Age. Session Type: Poster Session 728-II. Abstract 2524]

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