Tuesday, August 15, 2006

Aranesp® Effective for Treating Anemia Associated with “Low-Risk” MDS

According to an article published in the British Journal of Haematology, Aranesp® (darbepoetin alfa) is effective in treating anemia in patients with lower-risk myelodysplastic syndrome (MDS).

Myelodysplastic syndromes are a group of diseases involving the bone marrow. MDS results in inadequate production of red blood cells, white blood cells, and platelets. Therefore, initial treatment is often aimed at restoring levels of these cells to normal. This group of diseases ultimately leads to bone marrow failure or acute leukemia. However, some MDS patients achieve long-term survival with minimal intervention.

MDS tends to occur in elderly people who may have other significant medical problems that prevent aggressive treatment. Current treatments for MDS generally fall into the category of supportive care, particularly with agents that restore red or white blood cell levels. Patients with more advanced disease may also be treated with chemotherapy drugs.

Anemia is a common symptom among patients with MDS. It is characterized by low levels of circulating red blood cells, which are responsible for delivering oxygen to tissues throughout the body.

Common symptoms of anemia are severe fatigue, shortness of breath, diminished activity levels, and a reduced overall feeling of well-being.

Severe anemia often requires treatment with blood transfusions, which have associated risks of infection, rejection, and increased medical costs. Furthermore, severe anemia may cause a delay in cancer treatment, resulting in less favorable chances of a cure or optimal long-term survival.

Use of medications to treat anemia has been shown to have several benefits in cancer patients, including increased quality of life and decreased need for blood transfusions. The effect on survival, however, has been uncertain.

Aranesp treats chemotherapy-induced anemia by stimulating cells in the bone marrow to produce functioning red blood cells, ultimately providing sustained normal levels of red blood cells in the body. It is also being evaluated for the treatment of anemia that is directly caused by the cancer.

Researchers have been evaluating the schedule and dosing of Aranesp in an effort to establish the fewest number of doses that maintain effectiveness. Fewer doses require less time for the patient and physician, fewer medical resources, and reduce pain and cost.

Aranesp was previously approved at a dose of once per week. It is now the only agent approved for every three-week dosing in the management of chemotherapy-induced anemia.

Researchers from France recently conducted a clinical trial to evaluate the use of Aranesp in patients with low-risk MDS (MDS that is considered to be the least aggressive and associated with the greatest survival). This trial included 62 patients with anemia who were treated with Aranesp.

71% of patients responded to treatment with Aranesp with an improvement in their anemia.
Of the 13 patients who had not responded to treatment with epoetin alfa, eight responded to subsequent treatment with Aranesp.
After a median of 40 weeks, 36 of 46 patients who responded to Aranesp continued to respond to Aranesp.
The researchers concluded that treatment with Aranesp significantly improves anemia in patients with low-risk MDS.

Reference: Mannone L, Gardin C, Quarre MC, et al. High-dose darbepoetin alpha in the treatment of anaemia of lower risk myelodycplastic syndrome. Results of a phase II study. British Journal of Haematology. 2006;133:513-519.

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