OBJECTIVES: This French multicenter observational study aims to describe clinical practice Ferric carboxymaltose (FCM) use in patients with hematological malignancies or solid tumors. METHODS: Two cohorts of patients (1:1) are enrolled. Cohort 1 (retrospective): patients treated in 2010 with any intravenous iron (IV) or red blood cell transfusion if no IV iron; Cohort 2 (prospective): patients treated with FCM after July 1st 2011. Patient characteristics were collected for a period of 3 months pre and post intervention. Outcomes of the first 100 patients are described below. RESULTS: Fifty patients were analyzed in each cohort (mean age, 62 and 66 y.; solid tumors, 84% and 100%; metastatic, 61% and 63% for Cohorts 1 and 2, respectively). In Cohort 1, 16 patients received intravenous iron (iron sucrose (IS)) and 34 were transfused. The mean total iron dose was 706 mg for IS in cohort 1 and 960 mg for FCM in cohort 2; the mean number of infusions was 3.8 and 1.8 for IS and FCM respectively. In cohort 2, 69% of the administrations were done at  home. In patients receiving FCM without erythropoietin stimulating agents (ESA), mean Hb (g/dL) increased from 10.9 to 12.1, from baseline to Month 3. ESA use was 44% in cohort 1 vs 22% in cohort 2 during observational period. No serious adverse events related to IS or FCM were observed. CONCLUSIONS: FCM was well tolerated and effective in treating iron deficiency anemia. FCM was mostly given at home with fewer infusions required compared to IS. Interim results to be confirmed by the final analysis.