Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: A multicenter, open-label, randomized trial

Purpose Recombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients. Methods This prospective, multicenter, open-label, randomized trial enrolled 157 patients with chemotherapy-related anemia (Hb less than or equal to 105 g/L, serum ferritin less than or equal to 450 pmol/L or : 675 pmol/L with transferrin saturation less than or equal to 19%) receiving subcutaneously rHuEPO 40,000 U once weekly to: (1) no-iron; (2) oral iron 325 mg twice daily; (3) iron dextran repeated 100mg IV bolus; or (4) iron dextran total dose infusion (TDI), Hb and quality of life (QOL) were measured at baseline and throughout. Results All groups showed Hb (P<.0001) increases from baseline. Mean Hb increases for both IV iron groups were greater (P<.02) than for no-iron and oral iron groups. The percentage of patients with hematopoietic responses was higher (P<.01) in both IV iron groups (each case 68%) compared with no-iron (25%) and oral iron (36%) groups. IV iron groups showed increases in energy, activity, and overall QOL from baseline, compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group. Conclusion rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added. (C) 2004 by American Society of Clinical Oncology.