Tampa, FL (Oct. 5 , 2006) -- H. Lee Moffitt Cancer Center & Research Institute announced publication of the final results from a pivotal Phase II trial of Revlimid in patients with an incurable blood cancer know as myelodysplastic syndromes (MDS) in the October 5 issue of the New England Journal of Medicine. The data published found that more than 75 percent of patients reduced their need for transfusions and two-thirds were completely freed from the need for transfusions. Most significantly, in 45 percent of patients, there was no detectable trace of the cancer. After two years of follow-up, patients continue to respond and do well on treatment, representing a breakthrough in treatment for MDS patients.
"These new, landmark data demonstrate that Revlimid in some cases, eliminates all signs of the cancer's genetic cause, an abnormality on the chromosome 5, can reduce or even eliminate the need for transfusions in many patients with MDS, and after two years these responses have continued to hold," says Dr. Alan List, Professor of Oncology and Medicine, and Chief Division of Hematologic Malignancies at Moffitt, author of the publication and lead investigator of the study. "It is very rewarding to see patients treated with Revlimid, living three or four years transfusion free and living with a better quality of life."
MDS, a cancer in which the bone marrow fails to make enough functioning blood cells, affects 300,000 people worldwide, killing 60,000 to 70,000 a year. MDS patients suffer from anemia and fatigue and need whole-body blood transfusions as much as twice a month. Repeated transfusions can lead to a toxic buildup called "iron overload" that severely damages the heart, liver and pancreas, and patients eventually succumb to the disease.
Sponsored by the manufacturer of Revlimid, the Celgene Corporation, the study evaluated response in 148 patients. In addition to significantly reducing transfusion requirements, REVLIMID also induced a cytogenic response in 73 percent of evaluable patients, with 45 percent a complete cytogenic remission.
In December 2005, the Food and Drug Administration approved Revlimid for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
In 2001, H. Lee Moffitt Cancer Center & Research Institute earned NCI Comprehensive Cancer Center status in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. 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 the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt's sole mission is to contribute to the prevention and cure of cancer.
Journal
New England Journal of Medicine