Darbepoetin alfa for Anemia of Cancer

Interim data from a randomized, multi-center study indicate that darbepoetin alfa (Aranesp®, Amgen) is beneficial in correcting anemia in cancer patients who are not undergoing chemotherapy. The results were presented at the 45th annual meeting of the American Society of Hematology, from December 6-9, 2003 (Abstract No. 1816).

The hemoglobin counts at the baseline examination were 10.1 g/dl in the Aranesp® group and 10.4 g/dl in the control group. After 12 weeks of treatment, the mean change in hemoglobin was 1.9 g/dl for the Aranesp® group and 0.2 g/dl in the controls, who received standard care.
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Patients in the Aranesp® group received 3 mcg/kg every other week for 21 weeks; the controls were observed for 12 weeks, then received nine weeks of Aranesp® therapy. The Kaplan-Meier estimates (95%) of hematopoietic response were 81% for the Aranesp® group and 26% for the controls.

Although anemia is recognized as a common problem in cancer patients receiving chemotherapy, other patients may have anemia because of the cancer itself; the anemia is unrelated to chemotherapy. Common symptoms of anemia of cancer include physical and mental fatigue.

In July 2002, the FDA approved Ara-nesp® to treat chemotherapy-induced anemia in patients with nonmyeloid malignancies. In September 2001, Ara-nesp® was approved for the treatment of anemia associated with chronic renal failure (chronic kidney disease) in both dialysis and non-dialysis patients.

Aranesp® is a recombinant erythro-poietic protein that stimulates production of oxygen-carrying red blood cells. Compared with earlier products, it offers more activity with the added benefit of less frequent administration.

This medication is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; the dose should be reduced if the hemoglobin increase exceeds 1.0 g/dl in any two-week period.
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Commonly reported side effects in trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.