Two randomized clinical trials published in the April 1, 2008 issue of the Journal of Clinical Oncology demonstrated that the administration of intravenous iron and Aranesp® (darbepoetin) improved hemoglobin response compared with Aranesp alone in patients with chemotherapy-related anemia.[1],[2]

Among patients with chemotherapy-induced anemia, there is some suggestion from Phase II clinical trials that administration of IV iron along with an erythropoiesis-stimulating agent may improve clinical response.

To evaluate the safety and effectiveness of this approach, researchers in Europe are conducting a Phase IIIB clinical trial among patients with non-myeloid malignancies and chemotherapy-induced anemia. Patients are randomized to receive Aranesp 500 mcg every three weeks with either: 1) IV iron (200 mcg every three weeks on the same schedule as Aranesp or, if required, as two doses (200 mcg total) within a three-week period; or 2) with iron administered according to standard practice (oral iron or no iron).

• Among patients treated with Aranesp and IV iron, 86% reached the target hemoglobin level of 12 g/dL or greater than 2 g/dL from baseline compared with 73% in the control group.
• 9% of the iron-treated patients were transfused compared with 20% in the control group

The second study was carried out in several Italian institutions and involved 149 patients with non-myeloid malignancies with a hemoglobin value of 11 g/L or less. Patients were randomized to receive weekly intravenous iron and Aranesp or Aranesp alone during 12 weeks of chemotherapy.

• On an intent-to-treat basis, hemoglobin response was 77% for the Aranesp plus iron group and 62% for the Aranesp-alone group.
• Restricting the analysis to patients who received at least four doses of Aranesp increased the response rate in the iron group to 93% compared with 70% in the control group.

Comments: These data show that the addition of intravenous iron improves response to Aranesp in patients who are not iron deficient. Whether or not this tactic is widely adopted remains to be seen.

Related News:

IV Iron Decreases Epoetin Dose Requirements and Improves Hemoglobin Responses (04/13/2007)

Aranesp® Plus IV Iron May Benefit Patients with Chemotherapy-Induced Anemia (06/12/2006)

Intravenous Iron Enhances Response to Procrit® (04/13/2004)