title: Oral sucrosomial iron versus intravenous iron in anemic cancer patients without iron deficiency receiving darbepoetin alfa: a pilot study.
abstract: Erythropoiesis-stimulating agents (ESAs) are often used in treatment of patients with chemotherapy-induced anemia. Many studies have demonstrated an improved hemoglobin (Hb) response when ESA is combined with intravenous iron supplementation and a higher effectiveness of intravenous iron over traditional oral iron formulations. A new formulation of oral sucrosomial iron featuring an increased bioavailability compared to traditional oral formulations has recently become available and could provide a valid alternative to those by intravenous (IV) route. Our study evaluated the performance of sucrosomial iron versus intravenous iron in increasing hemoglobin in anemic cancer patients receiving chemotherapy and darbepoetin alfa, as well as safety, need of transfusion, and quality of life (QoL).
  
  
  
  The present study considered a cohort of 64 patients with chemotherapy-related anemia (Hb >8 g/dL <10 g/dL) and no absolute or functional iron deficiency, scheduled to receive chemotherapy and darbepoetin. All patients received darbepoetin alfa 500 mcg once every 3 weeks and were randomly assigned to receive 8 weeks of IV ferric gluconate 125 mg weekly or oral sucrosomial iron 30 mg daily. The primary endpoint was to demonstrate the performance of oral sucrosomial iron in improving Hb response, compared to intravenous iron. The Hb response was defined as the Hb increase ≥2 g/dL from baseline or the attainment Hb ≥ 12 g/dL.
  
  
  
  There was no difference in the Hb response rate between the two treatment arms. Seventy one percent of patients treated with IV iron achieved an erythropoietic response, compared to 70% of patients treated with oral iron. By conventional criteria, this difference is considered to be not statistically significant. There were also no differences in the proportion of patients requiring red blood cell transfusions and changes in QoL. Sucrosomial oral iron was better tolerated.
  
  
  
  In cancer patients with chemotherapy-related anemia receiving darbepoetin alfa, sucrosomial oral iron provides similar increase in Hb levels and Hb response, with higher tolerability without the risks or side effects of IV iron.
authors.affiliation: Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Via Melacrino Giuseppe, 21, 89124, Reggio Calabria, (RC), Italy. antoninomafodda@gmail.com.
authors.forename: Antonino
authors.initials: A
authors.lastname: Mafodda
authors.affiliation: Istituto Oncologico del Mediterraneo, Via Penninazzo, 7 - 95029, Viagrande, (Catania), Italy.
authors.forename: D
authors.initials: D
authors.lastname: Giuffrida
authors.affiliation: Istituto Oncologico del Mediterraneo, Via Penninazzo, 7 - 95029, Viagrande, (Catania), Italy.
authors.forename: A
authors.initials: A
authors.lastname: Prestifilippo
authors.affiliation: Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Via Melacrino Giuseppe, 21, 89124, Reggio Calabria, (RC), Italy.
authors.forename: D
authors.initials: D
authors.lastname: Azzarello
authors.affiliation: Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Via Melacrino Giuseppe, 21, 89124, Reggio Calabria, (RC), Italy.
authors.forename: R
authors.initials: R
authors.lastname: Giannicola
authors.affiliation: Istituto Oncologico del Mediterraneo, Via Penninazzo, 7 - 95029, Viagrande, (Catania), Italy.
authors.forename: M
authors.initials: M
authors.lastname: Mare
authors.affiliation: Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Via Melacrino Giuseppe, 21, 89124, Reggio Calabria, (RC), Italy.
authors.forename: R
authors.initials: R
authors.lastname: Maisano
mesh_terms: D000284:Administration, Oral; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000068256:Darbepoetin alfa / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010865:Pilot Projects; D011788:Quality of Life / Q000523:psychology*; D012189:Retrospective Studies
chemical_list: D006397:Hematinics; D000068256:Darbepoetin alfa; D007501:Iron
keywords: Chemotherapy-related anemia; Hb response; IV iron; Oral iron; Sucrosomial iron