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Darbepoetin Alfa Effective for Cancer-Related Anemia When Given Once Every 3 Weeks

Darbepoetin alfa, given once every 3 weeks, effectively and safely ameliorates anaemia due to chemotherapy, according to the findings of a randomised trial.

Anaemia is a common side effect and contributes to fatigue in cancer patients receiving chemotherapy. Recombinant human erythropoietin is often given on a once-a-week dosing schedule.

Darbepoetin alfa is a modified long-acting form of endogenous erythropoietin. Dusan Kotasek, MD, with the Ashford Cancer Centre, Australia, and colleagues assessed the feasibility of further reducing the dosing schedule to once every 3 weeks in patients receiving darbepoetin alfa.

In the first part of the study, 249 patients (haemoglobin 110 g/L or less) were randomised to receive 1 of 6 doses of darbepoetin alfa (4.5, 6.75, 9.0, 12.0, 13.5 and 15.0 micrograms/kilogram) (n=198) or placebo (n=51) once every 3 weeks for 12 weeks.

In second part of the study, patients received open-label darbepoetin alfa for an additional 12 weeks and were evaluated for safety, haemoglobin endpoints and red blood cell transfusions over 6 more weeks of follow-up.

The researchers found that darbepoetin alfa given at doses ranging from 4.5 to 15.0 micrograms/kilogram once every 3 weeks was well tolerated and comparable to placebo in terms of safety. In addition, neutralising antibodies were not detected.

Furthermore, all doses (from 4.5 to 15 micrograms/kilogram) reduced transfusions compared with placebo and resulted in more than half of patients achieving a haematopoietic response.

"While the haemoglobin response rate in the 4.5 microgram/kilogram group (the lowest of the doses studied) was 24%, a substantial proportion of patients had a haematopoietic response at this dose (51%) indicating that clinically meaningful erythropoiesis was evident," the researchers note.

They also found that the mean change in haemoglobin tended to increase with increasing darbepoetin alfa dose (p=0.01).

"The ability to administer darbepoetin alfa as infrequently as once every 3 weeks...represents an opportunity to simplify the treatment of anaemia in cancer patients undergoing chemotherapy," the researchers conclude.



Eur J Cancer 2003 Sep;39:14:2026-2034. "Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study"

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