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Addition of Intravenous Iron to Recombinant Human Erythropoietin May Improve Response in Patients With Chemotherapy-Related Anaemia

Addition of intravenously administered iron optimises the effect of recombinant human erythropoietin (rHuEPO), which increases haemoglobin (Hb) levels and improves quality of life (QOL) in patients with cancer who experience chemotherapy-related anaemia, new research shows.

To examine the effect of iron therapy and the optimal method of administration (intravenous [IV] vs. oral) in patients receiving rHuEPO, Michael Auerbach, MD, Auerbach Hematology-Oncology, Baltimore, Maryland, United States, and colleagues conducted a prospective, open-label, randomised trial of 157 cancer patients with chemotherapy-related anaemia at 4 sites in the eastern United States.

Eligibility criteria included a histologic diagnosis of cancer with chemotherapy scheduled during the study period, Eastern Cooperative Oncology Group performance status less than or equal to 2, life expectancy of greater than or equal to 6 weeks, Hb level less than or equal to 105 g/L, and serum ferritin less than or equal to 450 pmol/L or less than or equal to 675 pmol/L with transferrin saturation less than or equal to 19%.

Patients were randomised to 1 of 4 treatment arms: (1) no iron; (2) oral iron (ferrous sulfate) 325 mg twice daily; (3) iron dextran 100 mg IV bolus at each visit to calculated dose for iron replacement; or (4) iron dextran total dose infusion (TDI). All patients received subcutaneous rHuEPO 40,000 units once weekly and were followed for at least 6 weeks.

Hb levels were measured at baseline and weekly throughout the study, as was QOL, using the 100-mm linear analog scale assessment (LASA) of energy level, ability to perform daily activities, and overall QOL. Haematopoietic response to rHuEPO (defined as an increase in Hb of greater than or equal to 20 g/L or achieving Hb greater than or equal to 120 g/L without transfusion during the study) was also analysed.

The authors reported that all 4 treatment groups showed significant increase in Hb level from baseline (P < .0001). Mean increase for the no iron, oral iron, IV bolus, and TDI groups was 9, 15, 25, and 24 g/L, respectively.

Mean Hb increase in the IV bolus and TDI groups was significantly higher than that in the no iron and oral iron groups (P < .02). No significant difference in mean Hb increase was noted between the no iron and oral iron groups (P = .21) or between the IV bolus and TDI groups (P = .53).

Sixty-eight percent of patients in both the IV bolus and TDI groups had haematopoietic responses, compared with 36% of patients in the oral iron group and 25% of patients in the no iron group.

Patients in the IV bolus and TDI groups showed increase in energy, activity, and overall QOL, whereas no change in activity or overall QOL was found in the oral iron group. Decreased energy and activity was reported in the no iron group.

"As clinicians gain a better understanding of the concept of functional iron deficiency, it is clear that IV iron therapy is critical for optimizing the response to rHuEPO treatment for chemotherapy-related anemia," the authors concluded.





J Clin Oncol 2004 Apr 1;22:7:1301-7. "Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial"

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