title: Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support.
abstract: BACKGROUND
  American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC.
  
  
  METHODS
  Eighty patients were assigned to FIL at a daily dose of 5 mug/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) <0.5 x 10(9)/l and of days to reach an ANC >0.5 x 10(9)/l.
  
  
  RESULTS
  The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 x 10(9)/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 x 10(9)/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively.
  
  
  CONCLUSIONS
  PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: L
authors.initials: L
authors.lastname: Castagna
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan. Electronic address: stefania.bramanti@humanitas.it.
authors.forename: S
authors.initials: S
authors.lastname: Bramanti
authors.affiliation: Division of Hematology, Ospedale SS Antonio e Biagio, Alessandria.
authors.forename: A
authors.initials: A
authors.lastname: Levis
authors.affiliation: Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano.
authors.forename: M G
authors.initials: MG
authors.lastname: Michieli
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: A
authors.initials: A
authors.lastname: Anastasia
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: R
authors.initials: R
authors.lastname: Mazza
authors.affiliation: Statistic Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Giordano
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: B
authors.initials: B
authors.lastname: Sarina
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: E
authors.initials: E
authors.lastname: Todisco
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: A I
authors.initials: AI
authors.lastname: Gregorini
authors.affiliation: Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
authors.forename: A
authors.initials: A
authors.lastname: Santoro
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000473:pathology / Q000628:therapy*; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012074:Remission Induction; D015996:Survival Rate; 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