Addition of intravenous iron to epoetin beta increases hemoglobin response and decreases epoetin dose requirement in anemic patients with lymphoproliferative malignancies: a randomized multicenter study

Abstract

This randomized study assessed if intravenous iron improves hemoglobin (Hb) response and permits decreased epoetin dose in anemic (Hb 9-11 g/dl), transfusion-independent patients with stainable iron in the bone marrow and lymphoproliferative malignancies not receiving chemotherapy. Patients (n ¼ 67) were randomized to subcutaneous epoetin beta 30 000 IU once weekly for 16 weeks with or without concomitant intravenous iron supplementation. There was a significantly (Po0.05) greater increase in mean Hb from week 8 onwards in the iron group and the percentage of patients with Hb increase X2 g/dl was significantly higher in the iron group (93%) than in the noiron group (53%) (per-protocol population; P ¼ 0.001). Higher serum ferritin and transferrin saturation in the iron group indicated that iron availability accounted for the Hb response difference. The mean weekly patient epoetin dose was significantly lower after 13 weeks of therapy (P ¼ 0.029) and after 15 weeks approximately 10 000 IU (425%) lower in the iron group, as was the total epoetin dose (P ¼ 0.051). In conclusion, the Hb increase and response rate were significantly greater with the addition of intravenous iron to epoetin treatment in iron-replete patients and a lower dose of epoetin was required.

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

“…Patients receiving IV iron had larger increases in hemoglobin levels, and hemoglobin response occurred earlier compared with patients not receiving IV iron. This is consistent with findings from other studies that have reported significant improvements in hemoglobin levels for patients receiving ESA therapy in combination with IV iron in the CIA setting [17][18][19][20][21]. In the present study, RBC transfusions were not different for the IV iron usage groups, consistent with findings from most studies evaluating iron usage in CIA patients [17,[19][20][21].…”

“…Anaphylactoid reactions were reported in two patients after administration of IV iron, both of whom recovered uneventfully without hospitalization. The report of these anaphylactoid reactions in response to LMW iron is surprising and has not been observed in a number of similar studies [17][18][19]21,27]. No other safety signal was reported when darbepoetin alfa was dosed concurrently with IV iron in this population.…”

“…Several studies have shown that IV iron supplementation during ESA therapy in the CIA setting is well tolerated and increases treatment response [17][18][19][20][21]. In a Phase 3 study in CIA patients receiving darbepoetin alfa 500 lg Q3W, IV iron administered as iron-sucrose increased the hematopoietic response rate (proportion of patients achieving hemoglobin 12 g dL 21 or hemoglobin increase of 2 g dL 21 ) and lowered incidence of RBC transfusions [18].…”

“…That study excluded patients with absolute and functional iron deficiency by requiring serum ferritin levels 100 ng mL 21 and Tsat 20%. In a study of anemic patients with lymphoproliferative malignancies and positive marrow hemosiderin receiving an ESA but not receiving chemother-apy (anemia of cancer) [19], increased mean hemoglobin was reported in patients receiving IV iron compared with patients not receiving IV iron.…”

Iron Supplementation in Nephrology and Oncology: What Do We Have in Common?

“…iron, oral iron, and no iron groups [40]. Hedenus et al [41] investigated the addition of i.v. iron to erythropoietin therapy in anemic patients with lymphoproliferative malignancies in a randomized multicenter study, and again found higher hemoglobin response rates and lower erythropoietin dosage requirements than in a group receiving no iron (hemoglobin response, 93% versus 53% in the per protocol population) [41].…”