Perioperative prophylaxis with granulocyte colony-stimulating factor (G-CSF) in high-risk colorectal cancer patients for an improved recovery: A randomized, controlled trial.
BACKGROUND
We aimed to improve the postoperative outcome of high-risk patients (American Society of Anesthesiologists class 3 and 4) recovering from colorectal cancer surgery by using recombinant human G-CSF (filgrastim) as perioperative prophylaxis.


METHODS
In a double-blinded, placebo-controlled trial, 80 patients undergoing left-sided colorectal resection were randomized to filgrastim or placebo. Filgrastim (5 mug/kg) or placebo was administered in the afternoon on day -1, 0, and +1 relative to the operation. Primary endpoints were in a hierarchic order: quality of life (QoL) over time (determined at discharge, 2 and 6 months after operation with the European Organization for Research and Treatment of Cancer questionnaire) and the McPeek recovery score, which measures death and duration of stays in the intensive care unit and hospital. Predefined secondary endpoints were global QoL, subdomains of QoL, postoperative recovery, duration of stay, 6-month overall survival, complication rates, and cellular and immunologic parameters.


RESULTS
There were no significant differences in both primary endpoints between the treatment groups. A significant improvement (P < .05) was obtained by filgrastim prophylaxis in the QoL subdomain family life /- social functioning,; thus, more patients recovered to their preoperative state (14 vs 4 with placebo) as determined by structured interviews. Duration of hospital stay (14 vs 12 days) and noninfectious complications were decreased from 8% to 3%.


CONCLUSIONS
High-risk patients undergoing major operation for colorectal cancer profited from filgrastim prophylaxis with regard to duration of hospital stay, noninfectious complications, social QoL, and subjective recovery from operation. These endpoints, however, were secondary, and the primary endpoints (overall QoL and the McPeek index) did not show comparable benefits. A new confirmatory trial with the successful endpoints of this trial, as well as a cost analysis, will be needed to confirm the results before a general recommendation for the prophylactic use of G-CSF in high-risk cancer patients can be given.
Bauhofer
Artur
A
Institute of Theoretical Surgery, Philipps-University Marburg, Germany. a-bauhofer@web.de
Plaul
Ulrike
U
Torossian
Alexander
A
Koller
Michael
M
Stinner
Benno
B
Celik
Ilhan
I
Sitter
Helmut
H
Greger
Bernd
B
Middeke
Martin
M
Schein
Moshe
M
Wyatt
Jeremy
J
Nyström
Per-Olof
PO
Hartung
Thomas
T
Rothmund
Matthias
M
Lorenz
Wilfried
W
D000230:Adenocarcinoma / Q000601:surgery*; D000368:Aged; D000369:Aged, 80 and over; D003082:Colectomy; D015179:Colorectal Neoplasms / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006401:Hematologic Agents / Q000627:therapeutic use*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D011994:Recombinant Proteins
D006401:Hematologic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim