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Randomized Trial of Intravenous Iron Supplementation in Patients With Chemotherapy-Related Anemia Without Iron Deficiency Treated With Darbepoetin Alfa

Paolo Pedrazzoli, Antonio Farris, Salvatore Del Prete, Filomena Del Gaizo, Daris Ferrari, Clara Bianchessi, Giuseppe Colucci, Alberto Desogus, Teresa Gamucci, Alessandro Pappalardo, Giuseppe Fornarini, Paola Pozzi, Alessandra Fabi, Roberto Labianca, Francesco Di Costanzo, Simona Secondino, Enrico Crucitta, Federica Apolloni, Antonio Del Santo, Salvatore Siena

From the Oncologia Medica Falck, Ospedale Niguarda Ca’ Granda; Oncologia Medica, Polo Universitario Ospedale San Paolo; Dompé Biotec, Milano; Clinica Medica Generale e Terapia Medica, Università degli Studi di Sassari; Ospedale S. Giovanni di Dio, Frattaminore (NA); Ospedale San Giuseppe Moscati, Avellino; Medicina Oncologica, Ospedale Maggiore di Crema; IRCCS Ospedale Oncologico, Bari; Ospedale Oncologico A. Businco, Cagliari; Ospedale SS. Trinità, Soro (FR), Oncologia Medica, Ospedale O. Morgagni, Catania; Oncologia Medica, Ospedale San Martino, Genova; Oncologia Medica, Ospedale Civile di Vimercate, Milano; Istituto Regina Elena, Roma; Oncologia Medica, Ospedali Riuniti di Bergamo; and Oncologia Medica, Ospedale Careggi, Firenze, Italy

Corresponding author: Paolo Pedrazzoli, MD, Divisione di Oncologia Medica Falck, Ospedale Niguarda Ca’ Granda, Piazza Ospedale Maggiore 20162, Milano, Italy; e-mail: paolo.pedrazzoli{at}ospedaleniguarda.it

Purpose: Unresponsiveness to erythropoiesis-stimulating agents, occurring in 30% to 50% of patients, is a major limitation to the treatment of chemotherapy-related anemia. We have prospectively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin.

Patients and Methods: Between December 2004 and February 2006, 149 patients with lung, gynecologic, breast, and colorectal cancers and 12 weeks of planned chemotherapy were enrolled from 33 institutions. Patients were required to have hemoglobin 11 g/L and no absolute or functional iron deficiency. All patients received darbepoetin 150 µg subcutaneously once weekly for 12 weeks and were randomly assigned to sodium ferric gluconate 125 mg intravenously (IV) weekly for the first 6 weeks (n = 73) or no iron (n = 76). Primary end point of the study was the percentage of patients achieving hematopoietic response (hemoglobin 12 g/dL or 2 g/dL increase).

Results: Hematopoietic response by intention-to-treat analysis was 76.7% (95%CI, 65.4% to 85.8%) in the darbepoetin/iron group and 61.8% (95%CI, 50.0% to 72.7%) in the darbepoetin group (P = .0495). Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations, hematopoietic responses in the darbepoetin/iron group (n = 53) and in the darbepoetin-only group (n = 50) were 92.5% (95% CI, 81.8% to 97.9%) and 70% (95% CI, 55.4% to 82.1%), respectively (P = .0033). Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on. The safety profile was comparable in the two arms.

Conclusion: In patients with chemotherapy-related anemia and no iron deficiency, IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity.

Supported by Dompé Biotec. S.S. is recipient of a research contract supported in part by Oncologia Ca’ Granda ONLUS Fondazione.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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