A pilot prospective randomized trial of postoperative epoetin alfa in patients undergoing major operation for upper gastrointestinal malignancy.
BACKGROUND
Strategies to reduce red blood transfusion utilization in cancer patients undergoing operation are needed.


OBJECTIVE
Postoperative epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) is associated with improved hematologic parameters in patients undergoing major abdominal surgery for malignancy.


METHODS
Prospective, blinded, randomized trial of epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) versus placebo in patients undergoing major abdominal operation for malignancy. Primary endpoints were immature reticulocyte fraction, reticulocyte count, and hemoglobin, which were measured on postoperative days 4, 7, and between 14 and 20. Secondary endpoints were transfusions and complications in the 2 groups.


RESULTS
Forty patients were enrolled. There were no significant differences in immature reticulocyte fraction (P = 0.78), reticulocyte count (P = 0.42), or hemoglobin (0.35) in patients randomized to receive epoetin alfa versus placebo. There was no significant difference in red blood cell transfusion rate or postoperative complications in patients who received epoetin alfa compared with placebo.


CONCLUSIONS
The use of postoperative epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) in patients undergoing major operation for abdominal or pelvic malignancy is not supported by this randomized trial.
Grobmyer
Stephen R
SR
Departments of Surgery, University of Florida, Gainesville, FL, USA. Stephen.Grobmyer@surgery.ufl.edu
Hemming
Alan W
AW
Harris
Neil
N
Behrns
Kevin
K
Logan
Henrietta
H
Kim
Robin D
RD
Chang
Myron
M
Cance
William G
WG
Hochwald
Steven N
SN
D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011182:Postoperative Care / Q000379:methods; D011379:Prognosis; D011446:Prospective Studies; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome
D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa