title: Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha.
abstract: OBJECTIVE
  Unresponsiveness to erythropoiesis-stimulating agents, occurring in 30% to 50% of patients, is a major limitation to the treatment of chemotherapy-related anemia. We have prospectively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin.
  
  
  METHODS
  Between December 2004 and February 2006, 149 patients with lung, gynecologic, breast, and colorectal cancers and >or= 12 weeks of planned chemotherapy were enrolled from 33 institutions. Patients were required to have hemoglobin <or= 11 g/L and no absolute or functional iron deficiency. All patients received darbepoetin 150 microg subcutaneously once weekly for 12 weeks and were randomly assigned to sodium ferric gluconate 125 mg intravenously (IV) weekly for the first 6 weeks (n = 73) or no iron (n = 76). Primary end point of the study was the percentage of patients achieving hematopoietic response (hemoglobin >or= 12 g/dL or >or= 2 g/dL increase).
  
  
  RESULTS
  Hematopoietic response by intention-to-treat analysis was 76.7% (95%CI, 65.4% to 85.8%) in the darbepoetin/iron group and 61.8% (95%CI, 50.0% to 72.7%) in the darbepoetin group (P = .0495). Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations, hematopoietic responses in the darbepoetin/iron group (n = 53) and in the darbepoetin-only group (n = 50) were 92.5% (95% CI, 81.8% to 97.9%) and 70% (95% CI, 55.4% to 82.1%), respectively (P = .0033). Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on. The safety profile was comparable in the two arms.
  
  
  CONCLUSIONS
  In patients with chemotherapy-related anemia and no iron deficiency, IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity.
authors: Divisione di Oncologia Medica Falck, Ospedale Niguarda Ca' Granda, Piazza Ospedale Maggiore 20162, Milano, Italy. paolo.pedrazzoli@ospedaleniguarda.it
authors: Paolo
authors: P
authors: Pedrazzoli
authors: Antonio
authors: A
authors: Farris
authors: Salvatore
authors: S
authors: Del Prete
authors: Filomena
authors: F
authors: Del Gaizo
authors: Daris
authors: D
authors: Ferrari
authors: Clara
authors: C
authors: Bianchessi
authors: Giuseppe
authors: G
authors: Colucci
authors: Alberto
authors: A
authors: Desogus
authors: Teresa
authors: T
authors: Gamucci
authors: Alessandro
authors: A
authors: Pappalardo
authors: Giuseppe
authors: G
authors: Fornarini
authors: Paola
authors: P
authors: Pozzi
authors: Alessandra
authors: A
authors: Fabi
authors: Roberto
authors: R
authors: Labianca
authors: Francesco
authors: F
authors: Di Costanzo
authors: Simona
authors: S
authors: Secondino
authors: Enrico
authors: E
authors: Crucitta
authors: Federica
authors: F
authors: Apolloni
authors: Antonio
authors: A
authors: Del Santo
authors: Salvatore
authors: S
authors: Siena
mesh_terms: D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009369:Neoplasms / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D007501:Iron