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Simple Darbepoetin (Aranesp) Regimen Reverses Chemotherapy-Induced Anemia: Presented at ICACT

By Jill Stein

PARIS, FRANCE -- February 3, 2006 -- Darbepoetin alfa (Aranesp) administered as a fixed 500 mcg starting dose Q3W represents an effective and safe method for treating cancer patients with chemotherapy-induced anemia, according to findings released at the 17^th International Congress on Anti-Cancer Treatment (ICACT).

Jean-Luc Canon, MD, Director, Hematology/Oncology Service, Centre Hospitalier Notre Dame et Reine Fabiola, Charleroi, Belgium, and co-workers examined the effect of darbepoetin dose reductions on hemoglobin levels..

Their analysis used data from a phase 3 double-blind, double-dummy trial that compared darbepoetin 500 mcg every 3 weeks to darbepoetin 2.25 mcg/kg weekly administration. His presentation here on January 31^st was limited to 353 patients who received a starting dose of darbepoetin every 3 weeks and the subset of 238 patients who had at least one dose reduction.

Results show that darbepoetin 500 mcg every 3 weeks was at least as effective as darbepoetin 2.25 mcg/kg/week with respect to transfusions, hemoglobin, and quality of life. In addition, a high percentage of patients experienced dose reductions compared with other phase 3 studies of erythropoiesis-stimulating proteins, Dr. Canon said.

The study drug was withheld if hemoglobin exceeded 13 g/dL. After the hemoglobin concentration decreased to less than 12 g/dL, the prior dose was decreased by 40% and reinstated.

If the hemoglobin level increased by at least 1 g/dL over a 14-day period in the absence of a red blood cell count transfusion, the dose was decreased by 40% at the next clinic visit. Further dose reductions proceeded in 40% dose decrements.

The present analysis was limited to the 353 patients who received a starting dose of darbepoetin and the subset of 238 patients who experienced at least one dose reduction.

The percentage of patients who achieved a target hemoglobin level of 11 to 13 g/dL was 73%. The median time to target hemoglobin was 36 days. The median time to first dose reduction was 43 days.

Most dose reductions (97%) were associated with a hemoglobin increase of at least 1 g/dL over a 14-day period.

Dose reductions in the range of 25% to 50% effectively maintained hemoglobin levels within the 11 to 13 g/dL recommended target range for treating patients with chemotherapy-induced anemia.

Overall, the 500 mcg starting dose group had an average weekly dose of 129.6 mcg and 12.8 weeks of dosing.

The transfusion rate was 19% from the first week to the end of treatment.

The frequency of adverse events and serious adverse events was the same as is normally seen in this population of cancer patients, Dr. Canon said.

The study was sponsored by Amgen.


[Presentation title: Correction of Chemotherapy-Induced Anemia and Maintenance of Hemoglobin Levels Using 500-mcg Darbepoetin Alfa Every Three Weeks: Analysis of Dose Reductions in a Randomized, Double-Blind, Active-Controlled Trial.]

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