Perioperative Granulocyte Colony-Stimulating Factor Does Not Prevent Severe Infections in Patients Undergoing Esophagectomy for Esophageal Cancer
Open Access
- 1 July 2004
- journal article
- clinical trial
- Published by Ovid Technologies (Wolters Kluwer Health) in Annals of Surgery
- Vol. 240 (1), 68-75
- https://doi.org/10.1097/01.sla.0000129705.00210.24
Abstract
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.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).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.Perioperative administration of G-CSF failed to reduce postoperative morbidity, infection rate, or mortality in patients with esophageal cancer who underwent esophagectomy.Keywords
This publication has 30 references indexed in Scilit:
- Recursive Combination TestsJournal of the American Statistical Association, 2002
- Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test DesignsDrug Information Journal, 2001
- Randomized Prospective Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor as Adjunctive Therapy for Limb-Threatening Diabetic Foot InfectionAntimicrobial Agents and Chemotherapy, 2001
- Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: Interim analysis of a prospective, placebo-controlled, double-blind studyCritical Care Medicine, 2000
- A Randomized Controlled Trial of Filgrastim for the Treatment of Hospitalized Patients with Multilobar PneumoniaThe Journal of Infectious Diseases, 2000
- TRANSHIATAL VERSUS IVOR‐LEWIS OESOPHAGECTOMY: IS THERE A DIFFERENCE?Anz Journal of Surgery, 1999
- Impaired neutrophil bactericidal activity correlates with the infection occurring after surgery for esophageal cancerJournal of Surgical Oncology, 1992
- Multivariate analysis of postoperative complications after esophageal resectionThe Annals of Thoracic Surgery, 1992
- Pulmonary complications after subtotal oesophagectomyBritish Journal of Surgery, 1988
- Prediction of postoperative pulmonary complications in oesophagogastric cancer surgeryBritish Journal of Surgery, 1987