Does quality of life improvement precede anemia correction in patients with chemotherapy-induced anemia treated with intravenous iron?

Abstract

9082 Background: Combining intravenous (IV) iron with erythropoiesis-stimulating (ESA) therapy has been shown to increase Hgb response in treating anemia of cancer and chemotherapy. As part of a trial in anemic cancer patients on chemotherapy being treated with an ESA, we compared the effects of IV iron, oral iron, and no iron, on changes in patient-reported HRQOL. Methods: Prospective, randomized, controlled, multicenter trial. Major inclusions: pt starting chemotherapy cycle, Hb <11g/dL, ferritin >100 ng/mL or transferrin saturation >15%. Major exclusions: recent transfusion, ESA, or IV iron use, infection. All pts received epoetin alfa (40,000 U SQ/Wk for first 4 wks, then dose- adjusted per protocol). Pts were randomized to: No iron, PO FeSO4 325 mg tid, or IV ferric gluconate 125 mg IV weekly, for 8 weeks. Change in HRQOL was measured 4 weeks after start and at end of study (week 10, or last observation carried forward) using Functional Assessment of Cancer Therapy (FACT)-Anemia. Results: There were no significant between-group differences at baseline in mean Hb (10.2g/dL), TSAT (31.3%), or serum ferritin (421ng/mL) for the 129 evaluable patients, (mean age 65.3, 69% female). See Table . Hgb responses were significantly greater by end of study in evaluable pts receiving IV FG than oral iron or no iron. Only pts receiving FG reported a significant improvement in FACT-Fatigue subscale (FACT-F). This difference began at 4 weeks, while Hgb response was still similar between groups. No significant improvement in fatigue was reported by either the no iron (ESA alone) nor oral iron group. Conclusions: Combining IV iron with ESA therapy lead to an early and sustained clinically significant (=3) improvement in fatigue score, which preceded the improvement in Hgb response. [Table: see text] [Table: see text]