Clinical experience with ferric carboxymaltose as treatment of cancer-associated anemia.

Abstract

e19561 Background: Controlled studies showed that intravenous iron can improve hemoglobin (Hb) levels and decrease the need for erythropoiesis-stimulating agents (ESAs) and blood transfusions in anemic cancer patients. This observational study provides data on effectiveness and safety of ferric carboxymaltose (FCM) in routine treatment of anemia in cancer patients. Methods: 642 cancer patients (≥18 years) with iron deficiency anemia were registered from Dec 2008 to Jul 2010 at 73 German hematology/oncology practices. FCM was administered without restriction on dose and concomitant ESA or blood transfusion use. This interim analysis assessed safety in 581 patients receiving at least one FCM dose, and evaluable Hb difference (effectiveness) in those also completing the study by August 2010 (n=401). Results: Patients (mean age 64 years; male 49%) mainly presented with solid tumors (90%) and received cytotoxic chemotherapy (72%); 20.9% were previously treated for anemia. Mean total iron dose per patient was 1,333 mg; 15.7% received also an ESA and 25.6% a blood transfusion. Mean Hb increased within 5 weeks and remained between 11–12 g/dL until the end of the 12-week study period (Table). Benefit was comparable in patients with mild and moderate-severe anemia. Hb also improved comparably in patients treated with FCM alone or with concomitant ESAs. FCM treatment was well tolerated. Possibly or probably drug-related adverse events (AEs), mainly nausea and diarrhea, were reported for 2.4% of patients. Two fatal cases occurred: one of unknown cause and unrelated to FCM and one after a possibly related respiratory insufficiency. Two serious AEs (tachycardia, dyspnea) were unlikely related to FCM. Conclusions: Hb of FCM-treated anemic cancer patients effectively stabilized at 11–12 g/dL independent of baseline Hb levels and concomitant erythropoietic therapy. This observational study suggests FCM is beneficial as anemia treatment in cancer patients. Hb at baseline (BL) and increase to Wk 5 and Wk 12 (g/dL). Patients (n) BL* DHb to Wk 5+ DHb to Wk 12+ All (401) 10.0 ± 1.4 1.0 1.4 BL Hb <10 g/dL (206) 9.0 ± 0.9 1.7 2.2 BL Hb 10-11 g/dL (116) 10.4 ± 0.3 0.7 1.1 FCM only (345) 10.1 ± 1.4 1.0 1.4 FCM + ESA (56) 9.4 ± 1.2 1.4 1.5 * Mean ± SD. + Difference of means vs BL.