The Moffitt Cancer Center today said findings from a study presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago further validated that VIDAZA (azacitidine) significantly extends overall survival for patients with myelodysplastic syndromes (MDS) compared to conventional care regimens (CCR). Based on this study, investigators have concluded that achieving complete remission is not obligatory for extending survival in higher–risk MDS patients.
In the study, patients who received VIDAZA versus those who received conventional care had higher one–year survival rates in all response categories including partial remission, stable disease and hematologic improvement without necessarily achieving complete remission.
"We are very excited about the findings from this study because it shows that the survival benefit, from VIDAZA in patients with higher–risk myelodysplastic syndromes extends to all measures of response without the need to achieve complete remission as in conventional chemotherapy to maximize the disease modifying effect," said Dr. Alan List, Chief, Division of Hematologic Malignancies of the Moffitt Cancer Center. "This study reinforces the role VIDAZA plays in the treatment for MDS patients, helping to change what was previously an incurable blood cancer into a chronic, manageable disease."
The study presented today was a follow–up study to a large, Phase III international trial published in the American Society of Hematology proceedings last year which showed that VIDAZA was the first MDS treatment to significantly extend overall survival in MDS patients compared to CCR. The study found that VIDAZA was associated with a median survival of approximately two and a half years, more than 9 months longer than those receiving CCR.
MDS is a cancer in which the bone marrow fails to make enough functioning blood cells – either red blood cells, white blood cells or platelets. It is not known exactly how many people have MDS, however, it is estimated that approximately 300,000 people are affected worldwide and about 20,000 to 25,000 new cases are diagnosed each year in the U.S.
VIDAZA is the first and only epigenetic therapy, a new class of anti–cancer compounds which can change the regulation of gene expression, to have demonstrated a survival benefit in any cancer.
In May 2004, VIDAZA became the first drug approved by the FDA for the treatment of all five MDS subtypes, which includes both low–risk and high–risk patients. The drug is currently under review in Europe for the treatment of high–risk MDS patients and is currently being studied in other malignancies and cancers where hypermethylation is believed to play a key role in tumor development and progression.
About Moffitt Cancer Center
Located in Tampa, Florida, Moffitt Cancer Center (www.moffitt.org) is the only Florida–based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country´s leading cancer centers, and is listed in U.S. News & World Report as one of "America´s Best Hospitals" for cancer and ear, nose and throat. Moffitt´s sole mission is to contribute to the prevention and cure of cancer.
