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In Reply:

Baltimore, MD

The comments of Pedrazzoli et al are not only cogent but prescient. The criteria we used to define absolute iron deficiency were a truly low ferritin (below the lower limit of normal in the reference labs used) or a low percent transferrin saturation (< 19) in a patient with a high (390 to 420 µg/dL) total iron binding capacity (TIBC). Of the 157 patients in the study, 12 had true iron deficiency. Among the four treatment groups, there was no difference in the number of truly iron deficient patients (no iron, three patients; oral iron, four patients; bolus intravenous [IV] iron, two patients; total dose IV iron, three patients). We could find no statistical difference in responsiveness based on entry iron/TIBC or ferritin level. Although the study was not powered to detect intragroup differences, when the entire patient population was evaluated, baseline iron studies made no statistical difference in responsiveness of Hb, hematopoietic response, or quality of life parameters. These findings support our recommendation that all patients receiving recombinant human erythropoietin (rHuEPO) for the anemia of cancer chemotherapy should receive supplemental parenteral iron.¹

A recent study presented at the 2004 American Society of Clinical Oncology Annual Meeting uncovered a surprising prevalence of iron deficiency in anemic cancer patients undergoing chemotherapy and presenting for rHuEPO therapy. This study was an analysis of screening data from an ongoing trial designed to compare hematopoietic response when IV iron, oral iron, or no iron is added to rHuEPO therapy.² Of 261 patients screened, 59% had a transferrin saturation of less than 20%, 17% had a serum ferritin less than 100 ng/mL, and 27% had a reticulocyte hemoglobin content less than 32 pg. In many patients (46%) low transferrin saturation coexisted with an elevated ferritin. Thus, reliance of measurement of ferritin alone to assess iron status may be misleading.

Although, as of the time this letter is published the data are not available, we have completed accrual on a study that was powered to detect differences within the treatment groups based on entrance iron criteria. Patients received either darbepoietin alone or darbepoietin plus IV ferric gluconate. This study should answer the question: "Does IV iron benefit all patients receiving erythropoietic therapy irrespective of their baseline iron parameters?"

Lastly, we all agree that in those patients who are truly iron deficient, vigorous iron repletion should be accomplished before or at the initiation of either darbepoietin or rHuEPO. Based on our published data,¹ the iron repletion should be by the IV route.

Authors' Disclosures of Potential Conflicts of Interest

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Employment: Marilyn McIlwain, Watson Laboratories. Stock Ownership: Marilyn McIlwain, Watson Laboratories. For a detailed description of these categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration form and the ‘Disclosures of Potential Conflicts of Interest’ section of Information for Contributors found in the front of every issue.

REFERENCES

1. Auerbach M, Ballard H, Trout JR, et al: Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy related anemia: A multicenter, open-label, randomized trial. J Clin Oncol 22:1301-1307, 2004[Abstract/Free Full Text]

2. Henry DH, Dahl NV: Iron and B12 parameters in anemic cancer patients on chemotherapy presenting for epoetin alpha (EPO) therapy. Proc Am Soc Clin Oncol 23:145, 2004 (abstr 8091)

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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
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Related Correspondence

• Iron Supplement in Cancer Patients Receiving Erythropoietin
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