title: Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial.
abstract: OBJECTIVE
  Recombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients.
  
  
  METHODS
  This prospective, multicenter, open-label, randomized trial enrolled 157 patients with chemotherapy-related anemia (Hb <or= 105 g/L, serum ferritin <or= 450 pmol/L or <or= 675 pmol/L with transferrin saturation <or= 19%) receiving subcutaneously rHuEPO 40000 U once weekly to: (1). no-iron; (2). oral iron 325 mg twice daily; (3) iron dextran repeated 100mg IV bolus; or (4) iron dextran total dose infusion (TDI). Hb and quality of life (QOL) were measured at baseline and throughout.
  
  
  RESULTS
  All groups showed Hb (P <.0001) increases from baseline. Mean Hb increases for both IV iron groups were greater (P <.02) than for no-iron and oral iron groups. The percentage of patients with hematopoietic responses was higher (P <.01) in both IV iron groups (each case 68%) compared with no-iron (25%) and oral iron (36%) groups. IV iron groups showed increases in energy, activity, and overall QOL from baseline, compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group.
  
  
  CONCLUSIONS
  rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added.
authors.affiliation: Averbach Hematology-Oncology, Baltimore, MD, USA. mauerbachmd@aol.com
authors.forename: Michael
authors.initials: M
authors.lastname: Auerbach
authors.forename: Harold
authors.initials: H
authors.lastname: Ballard
authors.forename: J Richard
authors.initials: JR
authors.lastname: Trout
authors.forename: Marilyn
authors.initials: M
authors.lastname: McIlwain
authors.forename: Alan
authors.initials: A
authors.lastname: Ackerman
authors.forename: Huzefa
authors.initials: H
authors.lastname: Bahrain
authors.forename: Stefan
authors.initials: S
authors.lastname: Balan
authors.forename: Lance
authors.initials: L
authors.lastname: Barker
authors.forename: Jeevindra
authors.initials: J
authors.lastname: Rana
mesh_terms: D000014:Abnormalities, Drug-Induced; D000284:Administration, Oral; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage*; D007505:Iron-Dextran Complex / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D004921:Erythropoietin; D007505:Iron-Dextran Complex; D007501:Iron