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Aranesp® Effective in Low-Intermediate Risk MDS

According to the results of a recent study published in the British Journal of Hematology, Aranesp® (darbepoetin alfa) improves anemia in patients with myelodysplastic syndromes.

Myelodysplastic syndromes (MDS) are a group of diseases involving the bone marrow resulting in inadequate production of red blood cells, white blood cells and platelets. This group of diseases ultimately progresses to bone marrow failure or acute leukemia. The only curative treatment for this group of diseases is allogeneic stem cell transplantation. However, MDS tends to occur in elderly people who often have significant other medical problems that preclude transplantation.

Current treatments for MDS generally fall into the category of supportive care, especially with recombinant growth factors such as erythropoietin (EPO), which corrects a low red blood cell count and granulocyte colony stimulating factors (G-CSF), such as Neupogen®, which corrects a low white blood cell count. Patients with more advanced disease are treated with chemotherapy with drugs such as Vidaza® (5-azacytidine), which has recently been approved for treatment of MDS by the US Food and Drug Administration.

The recent availability of treatment options for MDS has resulted in an increase in the documented incidence of MDS from 12,000 cases per year in the U.S. to more than 20,000 cases. This is because more bone marrow studies are now performed in elderly patients with mild low blood cell counts to reach a precise diagnosis, which may document MDS and allow early interventions. There are many classification systems, and the International Prognostic Scoring System (IPSS) is now commonly used. The IPSS divides patients based on the percent of marrow blasts (leukemia cells in the bone marrow, karyotype (cytogenetic abnormalities of bone marrow cells) and degree of cytopenias (numbers of red blood cells, white blood cells and platelets) into low, intermediate 1, intermediate 2 and high-risk groups, with median survival of 5.6, 3.1, 1.2 and 0.4 years, respectively.

Recombinant human erythropoietin, or epoetin alfa, is a commonly used drug for cancer patients receiving treatment. Epoetin alfa has been shown to reduce the severity of anemia and reduce symptoms of fatigue in patients receiving treatment by stimulating the bone marrow to produce more red blood cells. Currently, Procrit® is the form of epoetin alfa most often utilized for the treatment of anemia in the United States. More recently, however, Aranesp®, which requires less frequent dosing than Procrit®, has been approved by the FDA for the treatment of anemia caused by chemotherapy in non-myeloid cancers, or cancers that do not originate in blood cells.

Less frequent dosing results in fewer injections and fewer office visits for patients, reducing the need for patients and caregivers to take time off from work or leisure. Furthermore, this allows caregivers to spend less time scheduling appointments and giving inpatient care to treat anemia and more time to attend to other patients and work-related activities. The use of Aranesp® is gaining momentum in the clinical setting as results from clinical trials continue to indicate its effectiveness in comparison to Procrit®. Preliminary studies have suggested that Aranesp® is at least as effective and possibly more effective than Procrit® for the treatment of MDS.

This study evaluated a single weekly dose of Aranesp® for at least 12 weeks in 37 patients with low or intermediate risk MDS. Thirteen patients achieved a major rise in hemoglobin and 2 had minor improvements. Thirteen responders are continuing treatment at 7-22 months. These authors did not observe any adverse side effects. They also reported that patients with a low level of endogenous erythropoietin were more likely to respond as were patients with no blasts in the bone marrow and/or had a cellular bone marrow. These authors concluded that Aranesp® may be effective in a significant proportion of these patients. Patients with low or intermediate risk MDS may wish to discuss this therapy with their physician.

Reference: Musto P, Lanza F, Balleari E, et al. Darbopoetin alfa for the treatment of anaemia in low-intermediate risk myelodysplastic syndromes. British Journal of Haematology. 2005;128:204-209

Tulane doctor studies leukemia-killing molecule

NEW ORLEANS February 17, 2005 - The Leukemia and Lymphoma Society has awarded a grant of more than $350,000 to a local pediatrician to study a molecule that kills the leukemia cells of individuals who have an aggressive form of acute lymphoblastic leukemia.

Scientists believe that the disease can arise when genetic material contained in chromosomes of developing blood cells is broken and rearranged. Charles S. Hemenway, an associate professor of pediatrics at Tulane University School of Medicine, is the recipient of the award and will carry out the study.

Leukemia is a malignant disease of the bone marrow and blood. In Louisiana there are approximately 500 new cases of leukemia diagnosed each year and approximately 400 deaths each year attributed to leukemia, according to the Leukemia & Lymphoma Society. In fact, leukemia causes more deaths than any other cancer among children and young adults under the age of 20.

For more information, go to the Tulane Cancer Center website: www.som.tulane.edu/cancer/pr20050217.html

About LEUKINE

LEUKINE, a man-made form of a naturally occurring growth factor that helps fight infection and disease in appropriate patients by enhancing cells of the immune system, was approved in the United States in 1991, and is marketed by Berlex, Inc.

LEUKINE is the only growth factor approved in the United States for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death.

LEUKINE has also been approved in the U.S. for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay. LEUKINE has been administered to more than 300,000 patients.

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