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. PATIENTS AND 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. CONCLUSION:Perioperative administration of G-CSF failed to reduce postoperative morbidity, infection rate, or mortality in patients with esophageal cancer who underwent esophagectomy.

journal_name

Ann Surg

journal_title

Annals of surgery

authors

Schaefer H,Engert A,Grass G,Mansmann G,Wassmer G,Hubel K,Loehlein D,Ulrich BC,Lippert H,Knoefel WT,Hoelscher AH

doi

10.1097/01.sla.0000129705.00210.24

subject

Has Abstract

pub_date

2004-07-01 00:00:00

pages

68-75

issue

1

eissn

0003-4932

issn

1528-1140

pii

00000658-200407000-00011

journal_volume

240

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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