Effects of intravenous (IV) iron supplementation on responses to every-3-week (Q3W) darbepoetin alfa (DA) by baseline hemoglobin in patients (pts) with chemotherapy-induced anemia (CIA)

Abstract

9106 Background: Pts with CIA receiving erythropoiesis-stimulating agents (ESAs) may benefit from IV iron supplementation. This randomized, multicenter, open-label, 16-week, phase IIIb study evaluated the safety and efficacy of darbepoetin alfa in pts with CIA who also received IV iron versus oral iron/no iron. This exploratory analysis presents the clinical outcomes by subgroups based on baseline (BL) hemoglobin (Hb). Methods: Eligible pts were of legal age, had a non-myeloid malignancy, and had CIA (BL Hb < 11g/dL). All pts received DA 500 mcg administered Q3W using the Aranesp (darbepoetin alfa) prefilled SureClick autoinjector. Patients were randomly allocated 1:1 to receive either DA plus 200 mg IV iron (200 mg Q3W with DA Q3W or two 100 mg doses within 3 weeks) or DA plus oral iron/no iron. Randomization was stratified by tumor type and BL Hb category (< 10 or = 10 g/dL). The primary endpoint was the percentage of pts achieving a hematopoietic response (Hb = 12 g/dL or an increase = 2 g/dL). Results: A total of 396 pts were randomized and received = 1 dose of DA (IV iron arm = 200; oral iron/no iron arm = 196). Mean (SD) age was 61.0 (11.5) years; 61% (n = 240) were women; 28% (n = 111) had lung or gynecological tumors; and 45% (n = 178) had BL Hb < 10 g/dL. Pt demographics were similar between arms. Clinical outcomes are shown in the table by BL Hb. Conclusions: DA 500 mcg Q3W with IV iron supplementation appeared to improve clinical outcomes in this study, especially in pts with BL Hb < 10 g/dL; more pts achieved a hematopoietic response, fewer received transfusions, and more achieved the target Hb (= 11 g/dL) compared with those receiving oral iron/no iron. Also, in both treatment arms, pts with BL Hb = 10 g/dL demonstrated better clinical outcomes than pts with BL Hb < 10 g/dL. Benefits associated with initiating ESA treatment on time, ie before pts Hb falls < 10 g/dL, have been suggested previously (Lyman and Glaspy, Cancer 2006). [Table: see text] No significant financial relationships to disclose.