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Journal of Clinical Oncology, Vol 22, No 7 (April 1), 2004: pp. 1301-1307
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.08.119
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Intravenous Iron Optimizes the Response to Recombinant Human Erythropoietin in Cancer Patients With Chemotherapy-Related Anemia: A Multicenter, Open-Label, Randomized Trial

Michael Auerbach, Harold Ballard, J. Richard Trout, Marilyn McIlwain, Alan Ackerman, Huzefa Bahrain, Stefan Balan, Lance Barker, Jeevindra Rana

From Averbach Hematology-Oncology, Baltimore, MD; New York University School of Medicine, New York, NY; Department of Statistics, Rutgers University, New Brunswick; Watson Laboratories, Morristown, NJ; Mount Sinai Medical Center, Miami Beach, FL; Mount Ayr Medical Center, Mount Ayr, IA

Address reprint requests to Michael Auerbach, MD, FACP, 9110 Philadelphia Rd, Suite 314, Baltimore, MD 21237; e-mail: mauerbachmd{at}aol.com

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 <= 105 g/L, serum ferritin <= 450 pmol/L or <= 675 pmol/L with transferrin saturation <= 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.

Supported by Watson Pharmaceuticals Inc.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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Related Correspondence

  • Iron Supplement in Cancer Patients Receiving Erythropoietin
    Paolo Pedrazzoli, Cinzia Tullio, Giulio Cerea, and Salvatore Siena
    JCO 2004 22: 4428 [Full Text]
  • Intravenous Iron and Recombinant Human Erythropoietin in Cancer Patients
    Yves Beguin
    JCO 2005 23: 651-652 [Full Text]
  • Increased Importance of Intravenous Iron in Chemotherapy-Induced Anemia
    Michael Auerbach and David H. Henry
    JCO 2007 25: 2145-2146 [Full Text]

Related Reply

  • In Reply:
    Michael Auerbach, Harold Ballard, and Marilyn McIlwain
    JCO 2004 22: 4428-4429 [Full Text]


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