After 2 years, study shows Revlimid patients live longer and remain transfusion free

Moffitt research on MDS presented at 48th Annual American Society of Hematology Meeting

Orlando, FL – (December 11, 2006) -- Dr. Alan List, from the H. Lee Moffitt Cancer Center & Research Institute, presented the final results from a pivotal Phase II trial evaluating Revlimid in patients with an incurable blood cancer known as myelodysplastic syndromes (MDS) at this year’s American Society of Hematology (ASH) meeting. This breakthrough data showed that in MDS patients with chromosome 5q deletion treatment with Revlimid can provide long-term durable results and help them to achieve blood transfusion independence and remain transfusion free.

"These landmark data demonstrate that Revlimid, in many cases, eliminates all signs of the cancer’s genetic cause, on partial deletion of chromosome 5, and as a consequence reduce or even eliminate the need for transfusions in many patients with MDS. After over two years of follow up, these responses have sustained," said List, Professor of Oncology and Medicine and Chief, Division of Hematology Malignancies at Moffitt, and lead investigator of the study. "It is very rewarding to see patients treated with Revlimid, living longer, living three or four years transfusion free and having a better quality of life overall."

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.

The data presented by List showed that two-thirds of patients who received Revlimid were completely freed from the need for blood transfusions. More significantly, in 44 percent of patients, there was no detectable trace of the cancer and after two years of follow-up the median duration has not yet been achieved.

Additional data on MDS presented at the ASH meeting included data evaluating Revlimid in MDS not associated with a chromosome 5q abnormality. In this Phase II trial, nearly one-third of Revlimid patients achieved blood transfusion independence and remained blood transfusion free for a median duration of 41 weeks. These data results demonstrate that Revlimid can provide long-term clinical benefit in MDS patients with or without the chromosome 5q abnormality and dramatically help to improve their quality of life.

Revlimid is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid is also used as treatment in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.

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About H. Lee Moffit Cancer Center
Located in Tampa, Florida on the University of South Florida campus, H. Lee Moffitt Cancer Center & Research Institute 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 16 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. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.


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