title: A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial.
abstract: BACKGROUND
  Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease. Furthermore, these patients typically experience profound neutropenia following induction and/or consolidation chemotherapy and this may result in serious, potentially life-threatening, infection. This randomized, double-blind, phase 2 clinical trial compared the efficacy and tolerability of pegfilgrastim with filgrastim for assisting neutrophil recovery following induction and consolidation chemotherapy for de novo AML in patients with low-to-intermediate risk cytogenetics.
  
  
  METHODS
  Patients (n = 84) received one or two courses of standard induction chemotherapy (idarubicin + cytarabine), followed by one course of consolidation therapy (high-dose cytarabine) if complete remission was achieved. They were randomized to receive either single-dose pegfilgrastim 6 mg or daily filgrastim 5 mug/kg, beginning 24 hours after induction and consolidation chemotherapy.
  
  
  RESULTS
  The median time to recovery from severe neutropenia was 22.0 days for both pegfilgrastim (n = 42) and filgrastim (n = 41) groups during Induction 1 (difference 0.0 days; 95% CI: -1.9 to 1.9). During Consolidation, recovery occurred after a median of 17.0 days for pegfilgrastim versus 16.5 days for filgrastim (difference 0.5 days; 95% CI: -1.1 to 2.1). Therapeutic pegfilgrastim serum concentrations were maintained throughout neutropenia. Pegfilgrastim was well tolerated, with an adverse event profile similar to that of filgrastim.
  
  
  CONCLUSIONS
  These data suggest no clinically meaningful difference between a single dose of pegfilgrastim and multiple daily doses of filgrastim for shortening the duration of severe neutropenia following chemotherapy in de novo AML patients with low-to-intermediate risk cytogenetics.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00114764.
authors.affiliation: Division of Clinical Hematology, Hospital de Santa Creu i Sant Pau, Barcelona, Spain. jsierra@santpau.es
authors.forename: Jorge
authors.initials: J
authors.lastname: Sierra
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Szer
authors.forename: Jeannine
authors.initials: J
authors.lastname: Kassis
authors.forename: Richard
authors.initials: R
authors.lastname: Herrmann
authors.forename: Mario
authors.initials: M
authors.lastname: Lazzarino
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Noga
authors.forename: Nigel
authors.initials: N
authors.lastname: Baker
authors.forename: Roger
authors.initials: R
authors.lastname: Dansey
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects; D015470:Leukemia, Myeloid, Acute / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000097:blood / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D009504:Neutrophils / Q000187:drug effects* / Q000276:immunology / Q000473:pathology*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D020127:Recovery of Function / Q000187:drug effects* / Q000276:immunology; D012074:Remission Induction
chemical_list: D011994:Recombinant Proteins; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim; D015255:Idarubicin