Perioperative treatment with Filgrastim stimulates granulocyte function and reduces infectious complications after esophagectomy

We investigated the effects of recombinant G-CSF (Filgrastim) on the functi on of neutrophils and the rate of infectious complications in an open-label , nonrandomized study of patients with esophageal cancer undergoing esophag ectomy. In this single-center phase-II trial 20 sequential patients (19 eva luable) received Filgrastim at standard doses (300 mu g or 480 mu g) subcut aneously for 2 days prior to and up to 7 days after surgery. The phagocytot ic activity of neutrophils and the oxidative burst in the study group and i n an experimental control group (n = 27) were measured on days -2, 2, and 1 0. Neutrophil function was enhanced in the Filgrastim-treated group by fact or 1.2 for phagocytosis (p = 0.016) and 1.4 for oxidative burst (p = 0.154) . Leukocyte counts increased from 7.6 x 10(9)/l (day -2) to a maximum of 45 x 10(9)/l on day 6. No infection was reported in the study group (mean age 59.7 years; 13 men, seven women) up to 10 days after surgery. In contrast, 23 patients (29.9%) in a historical control group (mean age 56 years; 67 m en, ten women) treated at the same center developed infections within the f irst 10 days (p = 0.008). In addition, no postoperative deaths occurred in the study group, compared with 9.1% in the group of historical controls. Th us, in this study, administration of Filgrastim stimulated neutrophil funct ion in patients undergoing esophagectomy, and it might be effective in redu cing infectious complications related to the surgical procedure.