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Darbepoietin Effective for Chemotherapy-Induced Anemia: Presented at ICACT

By Jill Stein

PARIS, FRANCE -- January 30, 2006 -- Darbepoietin alfa (Aranesp) has been confirmed as an effective treatment for anemia secondary to chemotherapy, investigators reported on January 30^th at the 17^th International Congress on Anti-Cancer Treatment (ICACT).

Bonne Biesma, MD, Staff Oncologist, Jeroen Bosch Hospital, Roermond, The Netherlands, presented interim results of a clinical trial that assessed the use of a fixed 500-mcg dose of darbepoietin alfa administered every 3 weeks to patients with chemotherapy-induced anemia.

The analysis included 209 patients from 36 European centers.

Darbepoietin alfa was administered at an initial dose of 500 mcg every 3 weeks using pre-filled syringes. Additional doses were at 300 mcg every 3 weeks. Darbepoietin alfa was administered whenever hemoglobin level decreased to 13 g/dL or less.

An average of three doses of darbepoietin alfa every 3 weeks were administered corresponding to an average treatment duration of 10 weeks.

Darbepoietin alfa therapy was rated from adequate to very good in providing recovery of red blood cell counts for 82% of patients with recorded data.

The ease of use of the ready-to-use syringe was rated from good to very good for 95% of patients with recorded data; problems with the syringe were reported for two patients (less than 1%).

The transfusion and hemoglobin endpoints demonstrated the effectiveness of 500 mcg darbepoietin alfa administered every 3 weeks, Dr. Biesma said. Thus, among 156 patients with baseline hemoglobin levels less than 11 g/dL, hemoglobin changes from baseline (mean 9.8g/dL) at weeks 4, 7, and 10 were 0.83, 1.43, and 1.26 g/dL, respectively (0.83 g/dL, 1.29 g/dL, and 1.28 g/dL, using last observation carried forward imputation).

Of these patients whose baseline hemoglobin was below 11 g/dL, 74% did not require red blood cell transfusions from week 1 to the end of treatment.

These data suggest that the effectiveness of a fixed 500-mcg dose of darbepoietin alfa administered every 3 weeks in the clinical practice setting is comparable to that reported in two phase three clinical trials, Dr. Biesma said.

An every 3 weeks regimen of darbepoietin alfa 6.75 mcg/kg (equivalent to a 500-mcg fixed dose for an average 74 kg person) was recently licensed in Europe.

The study was sponsored by Amgen.


[Presentation title: A Prospective Registry of Patients Treated with Darbepoietin Alfa Administered Every Three Weeks For Chemotherapy-Induced Anaemia in Europe.]

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