A phase III randomized controlled study comparing iron sucrose intravenously (IV) to no iron treatment of anemia in cancer patients undergoing chemotherapy and erythropoietin stimulating agent (ESA) therapy

9109 Background: The effect of using IV iron sucrose in managing cancer chemotherapy-related anemia has not been previously reported. To investigate this issue, we conducted a randomized study of IV iron sucrose in patients (pts) with cancer chemotherapy-related anemia who completed 8 prior wks of ESA therapy. Methods: This prospective, multicenter, randomized, open label, Phase III clinical trial enrolled 375 pts with chemotherapy induced anemia (Hgb levels = 10.0 g/dL) and was conducted in 2 stages. During Stage I (8-wk duration), pts received treatment with fixed ESA doses (100-mcg of darbepoetin or 40,000 units epoetin wkly or 200 mcg of darbepoetin every other wk). Pts were classified as either ESA responders (= 1 g/dL increase in Hgb) or ESA non-responders with each group randomized (Stage 2) separately to receive either 12 wks of fixed doses of ESA plus up to 1,500 mg of iron sucrose (given in 3 divided doses of up to 500mg) or 12 wks of fixed doses of ESA alone. Laboratories (including iron indice...