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

Abstract

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 indices and acute phase reactants), quality of life and adverse events were assessed at baseline and throughout. Results: Iron sucrose plus ESA compared to ESA alone resulted in greater mean maximum Hgb levels and greater number of pts who achieved Hgb increases = 2.0 and ≥ 3.0 g/dl in both prior ESA responders and non-responders. There was also a statistically significant improvement in fatigue and iron stores in the iron sucrose treated pts. Baseline iron status did not predict responsiveness to iron sucrose therapy. Three serious but non-life threatening iron sucrose related adverse events were observed including one case of significant, transient hypotension in a female weighing 50 kg. Conclusions: IV iron sucrose increased Hgb levels and iron stores significantly and is well tolerated in doses up to 500 mg increments in ESA treated patients with cancer chemotherapy- related anemia. IV iron sucrose should be considered in combination with erythropoietic therapy in anemic cancer patients receiving chemotherapy. [Table: see text]