title: The effects of epoetin alfa on transfusion requirements in head and neck cancer patients: a prospective, randomized, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy of perioperative recombinant human erythropoietin (r-HuEPO, epoetin alfa) in stimulating hematopoiesis and reducing allogeneic blood transfusion requirements in major head and neck cancer surgery.
  
  
  METHODS
  Double-blinded, placebo-controlled, randomized, prospective clinical trial.
  
  
  METHODS
  Fifty-eight patients undergoing surgical resection of head and neck tumors at the University of Iowa hospitals completed this study. Patients were required to have a pre-study hemoglobin >/=10.0 g/dL and </=13.5 g/dL. Group 1 (29 patients) received three doses of 600 IU/kg epoetin alfa before surgery. Group 2 (29 patients) received a placebo. All patients received oral iron supplementation (150 mg FeSO4 twice per day).
  
  
  RESULTS
  The epoetin alfa group demonstrated a significant increase in baseline to day-of-surgery mean hemoglobin (0.57 g/dL, P =.016), hematocrit (2.04%, P =.015), and reticulocyte count (95.3 x 103 cells/mm3, P = <.001), whereas there was no significant change in these hematologic variables in the placebo group. The percent of patients who avoided transfusion in the epoetin alfa group was 34.5% versus 17.2% in the placebo group. Patients requiring allogeneic blood transfusions received an average of 3.16 units in the epoetin alfa group and 4.12 units in the placebo group.
  
  
  CONCLUSIONS
  In this single institution study, we demonstrated a significant improvement in hematopoietic parameters and a trend toward decreased transfusion requirements using perioperative epoetin alfa in a head and neck cancer patient population. Further studies may delineate additional benefits in treating qualified patients with epoetin alfa during therapy for head and neck malignancies.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, The University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, U.S.A.
authors.forename: Shaun N
authors.initials: SN
authors.lastname: Scott
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Boeve
authors.forename: Timothy M
authors.initials: TM
authors.lastname: McCulloch
authors.forename: Kari A
authors.initials: KA
authors.lastname: Fitzpatrick
authors.forename: Lucy H
authors.initials: LH
authors.lastname: Karnell
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D016063:Blood Loss, Surgical; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000601:surgery*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D011994:Recombinant Proteins
chemical_list: D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa