title: Randomized phase III trial of pegfilgrastim versus filgrastim after autologus peripheral blood stem cell transplantation.
abstract: Nonrandomized trials suggest that pegfilgrastim, a pegylated granulocyte colony-stimulating factor, could be used in lieu of filgrastim after autologus peripheral blood stem cell transplantation. This phase III, randomized, double-blinded, placebo-controlled trial compared the efficacy, costs, and safety of single-dose pegfilgrastim (single 6 mg dose) versus daily filgrastim (5 microg/kg/day) for this indication. Seventy-eight patients, matched for age, sex, underlying disease, stage, and CD34/kg transplant dose were enrolled. Cytokines were started on day +1 posttransplant and continued to an absolute neutrophil count (ANC) of 5x10(9)/L for 3 days or 10x10(9)/L for 1 day. The median time to neutrophil engraftment (ANC >1.5x10(9)/L for 3 days or 5x10(9)/L for 1 day) was the same in both groups (12 days). No differences in platelet engraftment (11 versus 13 days), number of platelet transfusions (5 versus 4), percent with positive cultures for bacterial pathogens (23% versus 15%), days of fever (1 versus 2), deaths prior to engraftment (1 versus 1), or duration of hospital stay (19 versus 19 days) were seen between the pegfilgrastim and filgrastim groups, respectively. Using the average wholesale price for doses used in this trial, there was a per-patient savings of $961 for the pegfilgrastim group (P < .001). This phase III study failed to demonstrate a difference in time to neutrophil engraftment or any clinical sequelae between pegfilgrastim and filgrastim when given post-APBSCT, with pegfilgrastim achieving a cost savings over filgrastim.
authors.affiliation: Department of Medicine, Loyola University, Maywood, Illinois, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Gerds
authors.forename: Mary
authors.initials: M
authors.lastname: Fox-Geiman
authors.forename: Kevin
authors.initials: K
authors.lastname: Dawravoo
authors.forename: Tulio
authors.initials: T
authors.lastname: Rodriguez
authors.forename: Amir
authors.initials: A
authors.lastname: Toor
authors.forename: Scott
authors.initials: S
authors.lastname: Smith
authors.forename: Karen
authors.initials: K
authors.lastname: Kiley
authors.forename: Donna
authors.initials: D
authors.lastname: Fletcher-Gonzalez
authors.forename: Chindo
authors.initials: C
authors.lastname: Hicks
authors.forename: Patrick
authors.initials: P
authors.lastname: Stiff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000502:physiology; D003365:Costs and Cost Analysis; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000502:physiology; D036102:Peripheral Blood Stem Cell Transplantation / Q000191:economics / Q000379:methods*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012038:Regeneration; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim