Every-2-Week Darbepoetin Alfa Is Comparable to rHuEPO in Treating Chemotherapy-Induced Anemia

ABSTRACT: The safety and efficacy of darbepoetin alfa (Aranesp) at 3.0 µg/kgadministered every 2 weeks and recombinant human erythropoietin (rHuEPO) givenas 40,000 U weekly or 150 U/kg three times weekly were evaluated by pooling datafrom three darbepoetin alfa clinical studies. All studies enrolled anemic(hemoglobin ≤ 11.0 g/dL) patients receiving multicycle chemotherapy. Open-labelstudy drug was administered by subcutaneous injection. Hemoglobinconcentrations, red blood cell transfusion requirements, and standard safetyparameters were evaluated. Of 260 patients who received darbepoetin alfa at 3.0µg/kg every 2 weeks and 115 patients who received rHuEPO three times weeklyor once weekly, hematopoietic response (change in hemoglobin from baseline of ³2 g/dL or hemoglobin concentration of ³ 12 g/dL) was achieved in 71% (95%confidence interval [CI] = 65%-78%) of patients who received darbepoetin alfaevery 2 weeks, comparable to the response in patients who received rHuEPO (71%;95% CI = 61%-81%). The mean increase in hemoglobin concentration over13 weeks was also similar: 1.48 g/dL (95% CI = 1.28-1.68 g/dL) fordarbepoetin alfa and 1.31 g/dL (95% CI = 0.97-1.64 g/dL) for rHuEPO. Theproportion of patients in the darbepoetin alfa group requiring transfusions waslower (7%; 95% CI = 4%-11%) than that in the rHuEPO group (14%; 95% CI = 8%-22%).Darbepoetin alfa every 2 weeks was well tolerated with a safety profilecomparable to that of rHuEPO. In conclusion, darbepoetin alfa at a dose of 3.0µg/kg given every 2 weeks safely increases hemoglobin concentration to the sameextent as rHuEPO. [ONCOLOGY 16(Suppl 11):31-36, 2002]

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