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.