Perioperative granulocyte colony-stimulating factor does not prevent severe infections in patients undergoing esophagectomy for esophageal cancer: a randomized placebo-controlled clinical trial.
OBJECTIVE
Esophagectomy for esophageal cancer is associated with substantial postoperative morbidity as a result of infectious complications. In a prior phase II study, granulocyte colony-stimulating factor (G-CSF) was shown to improve leukocyte function and to reduce infection rates after esophagectomy. The aim of the current randomized, placebo-controlled, multicenter phase III trial was to investigate the clinical efficacy of perioperative G-CSF administration in reducing infection and mortality after esophagectomy for esophageal cancer.


METHODS
One hundred fifty five patients with resectable esophageal cancer were randomly assigned to perioperative G-CSF at standard doses (77 patients) or placebo (76 patients), administered from 2 days before until day 7 after esophagectomy. The G-CSF and placebo groups were comparable as regards age, gender, risk, cancer stage, frequency of neoadjuvant radiochemotherapy, and type of esophagectomy (transthoracic or transhiatal esophageal resection).


RESULTS
Of 155 randomized patients, 153 were eligible for the intention-to-treat analysis. The rate of infection occurring within the first 10 days after esophagectomy was 43.4% (confidence interval 32.8-55.9%) in the placebo and 44.2% (confidence interval 32.1-55.3%) in the G-CSF group (P = 0.927). 30-day mortality amounted to 5.2% in the G-CSF group versus 5.3% in the placebo group (P = 0.985). Similar results were found in the per-protocol analysis.


CONCLUSIONS
Perioperative administration of G-CSF failed to reduce postoperative morbidity, infection rate, or mortality in patients with esophageal cancer who underwent esophagectomy.
Schaefer
Hartmut
H
Department of Visceral and Vascular Surgery, University of Cologne, Germany.
Engert
Andreas
A
Grass
Guido
G
Mansmann
Georg
G
Wassmer
Gernot
G
Hubel
Kai
K
Loehlein
Dietrich
D
Ulrich
Bernward C
BC
Lippert
Hans
H
Knoefel
Wolfram T
WT
Hoelscher
Arnulf H
AH
D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007239:Infections / Q000209:etiology; D008297:Male; D008480:Mediastinitis / Q000209:etiology; D008875:Middle Aged; D019990:Perioperative Care; D011014:Pneumonia / Q000209:etiology; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D011994:Recombinant Proteins; D012307:Risk Factors; D018805:Sepsis / Q000209:etiology; D013530:Surgical Wound Infection / Q000517:prevention & control; D014552:Urinary Tract Infections / Q000209:etiology
D000890:Anti-Infective Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim