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Randomized, Multicenter, Controlled Trial Comparing the Efficacy and Safety of Darbepoetin Alfa Administered Every 3 Weeks With or Without Intravenous Iron in Patients With Chemotherapy-Induced Anemia

Laurent Bastit, An Vandebroek, Sevilay Altintas, Bernd Gaede, Tamás Pintér, Tamas S. Suto, Tony W. Mossman, Kay E. Smith, Johan F. Vansteenkiste

From the Centre Frédéric Joliot, Rouen, France; Ziekenhuisnetwerk Antwerpen and Campus Middelheim, Hemato-oncology, Antwerpen; University Hospital Antwerp, Edegem; University Hospital Gasthuisberg, Leuven, Belgium; Schwerpunktpraxis Haematology/Oncology (MediProjekt), Hannover, Germany; Petz Aladár Megyei Oktato Korhaz, Gyor, Hungary; Amgen (Europe) GmbH, Zug, Switzerland; and Amgen Ltd, Cambridge, United Kingdom

Corresponding author: Johan F. Vansteenkiste, MD, PhD, Respiratory Oncology Unit (Pulmonology), University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium; e-mail: johan.vansteenkiste{at}uz.kuleuven.ac.be

Purpose: The concomitant use of intravenous (IV) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial. This study was designed to evaluate the efficacy and safety of darbepoetin alfa given with IV iron versus with local standard practice (oral iron or no iron).

Patients and Methods: In this multicenter, randomized, open-label, phase III study, 396 patients with nonmyeloid malignancies and hemoglobin (Hb) less than 11 g/dL received darbepoetin alfa 500 µg with (n = 200) or without (n = 196) IV iron once every 3 weeks (Q3W) for 16 weeks.

Results: The hematopoietic response rate (proportion of patients achieving Hb 12 g/dL or Hb increase of 2 g/dL from baseline) was significantly higher in the IV iron group: 86% versus 73% in the standard practice group (difference of 13% [95% CI, 3% to 23%]; P = .011). Fewer RBC transfusions (week 5 to the end of the treatment period) occurred in the IV iron group: 9% versus 20% in the standard practice group (difference of –11% [95% CI, –18% to –3%]; P = .005). Both treatments were well tolerated with no notable differences in adverse events. Serious adverse events related to iron occurred in 3% of patients in the IV iron group and were mostly gastrointestinal in nature.

Conclusion: Addition of IV iron to darbepoetin alfa Q3W in patients with chemotherapy-induced anemia was well tolerated, resulting in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alfa alone.

Supported by Amgen (Europe) GmbH (study 20040156; ClinicalTrials.gov identifier: NTC00135317).

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA; the 11th Congress of the European Haematology Association, June 15-18, 2006, Amsterdam, the Netherlands; at the 31st European Society for Medical Oncology Congress, September 29-October 3, 2006, Istanbul, Turkey; at the 48th American Society of Hematology Annual Meeting, December 9-12, 2006, Orlando, FL; at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and at the 12th Congress of the European Hematology Association, June 7-9, 2007, Vienna, Austria.

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

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