The effects of epoetin alfa on transfusion requirements in head and neck cancer patients: a prospective, randomized, placebo-controlled study.

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. STUDY
DESIGN: 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.
CONCLUSION: 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.

RCT Entities:   Population Interventions Outcomes