title: Perioperative granulocyte colony-stimulating factor does not prevent severe infections in patients undergoing esophagectomy for esophageal cancer: a randomized placebo-controlled clinical trial.
abstract: 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.
authors.affiliation: Department of Visceral and Vascular Surgery, University of Cologne, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Schaefer
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.forename: Guido
authors.initials: G
authors.lastname: Grass
authors.forename: Georg
authors.initials: G
authors.lastname: Mansmann
authors.forename: Gernot
authors.initials: G
authors.lastname: Wassmer
authors.forename: Kai
authors.initials: K
authors.lastname: Hubel
authors.forename: Dietrich
authors.initials: D
authors.lastname: Loehlein
authors.forename: Bernward C
authors.initials: BC
authors.lastname: Ulrich
authors.forename: Hans
authors.initials: H
authors.lastname: Lippert
authors.forename: Wolfram T
authors.initials: WT
authors.lastname: Knoefel
authors.forename: Arnulf H
authors.initials: AH
authors.lastname: Hoelscher
mesh_terms: 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
chemical_list: D000890:Anti-Infective Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim