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| |  Intravenous Iron Not Superior to Oral Iron in Chemotherapy-Associated Anaemia Treated With Darbepoetin Alfa: Presented at ASH By Betty S. Riggs NEW ORLEANS -- December 8, 2009 -- In combination with darbepoetin alfa, treatment with intravenous (IV) iron is not superior to oral iron in patients with anaemia receiving chemotherapy for nonmyeloid neoplasms, according to a study presented here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. The results of the randomised, placebo-controlled study were presented by David P. Steensma, MD, Department of Hematological Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts, on December 7. For the study, patients receiving chemotherapy for a nonmyeloid neoplasm were randomised to receive either sodium ferric gluconate complex in sucrose 187.5 mg IV over 90 minutes every 3 weeks, oral ferrous sulfate 325 mg once daily, or oral placebo once daily. Patients were excluded if they had nutritional anaemia, myelodysplastic syndrome, recent surgery or transfusion, an erythropoiesis-stimulating agent within 3 months, thrombosis within 1 year, or genetic haemochromatosis. All patients were receiving darbepoetin alfa 500 mcg subcutaneously every 3 weeks until haemoglobin (Hb) level was >11 g/dL, followed by 300 mcg every 3 weeks as maintenance therapy. Darbepoetin alfa was held for Hb >13 g/dL until Hb fell to <12 g/dL, then restarted with 25% dose reduction. Researchers measured blood counts, iron parameters, and quality of life (QOL) at baseline and at weeks 7 and 16. The primary endpoint was the proportion of patients achieving Hb >=12.0 g/dL or a >=2.0 g/dL Hb increment from baseline by the end of the 16-week study. Secondary endpoints included transfusion requirements, changes in QOL, changes in iron parameters, and adverse events (AEs). Planned enrolment was 582 patients, but the study met an early stopping rule due to an excess of serious AEs in the IV iron arm. Of the 502 patients enrolled, 490 were evaluable. Baseline characteristics were comparable between groups. With respect to the primary endpoint, 70% of IV iron-treated patients achieved the Hb response, compared with 67% with oral iron, and 65% with placebo (P = 0.73 for IV vs placebo). There were no significant differences in the proportion of patients requiring red blood cell transfusion between the IV iron (13%), the oral iron (13%), and the placebo (14%) group (P = .42). There were also no significant differences in QOL. In the IV iron arm, 5% of patients died, versus 2% in the oral iron arm, and 1% in the placebo arm. Grade 3 or higher AEs occurred in 55% of IV iron patients compared with 45% for oral iron and 47% placebo (P = .03). Funding for this study was provided by Amgen. [Presentation title: A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Patients With Chemotherapy-Associated Anemia: A Study of the Mayo Clinic Cancer Research Consortium (MCCRC). Abstract 630]
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