title: A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study).
abstract: OBJECTIVE
  To evaluate in a multicentre randomised study the effect on duration of febrile neutropenia (FN), the safety and cost-effectiveness of a single subcutaneous pegfilgrastim injection compared with daily injections of filgrastim after peripheral blood stem cell transplantation in patients receiving high dose chemotherapy for myeloma and lymphoma.
  
  
  METHODS
  Patients were randomly assigned to a single dose of pegfilgrastim at day 5 (D5) or daily filgrastim from D5 to the recovery of absolute neutrophil count (ANC) to 0.5 G/L. Duration of FN, of neutrophil and platelet recovery, transfusion and antibiotic requirements were the main end-points of the study. Costs were calculated from D0 until transplant unit discharge. The incremental cost-effectiveness ratio was expressed as the cost per day of FN prevented. Probabilistic sensitivity analysis was performed by non-parametric bootstrap methods.
  
  
  RESULTS
  Between October 2008 and September 2009, 10 centres enrolled 151 patients: 80 patients with lymphoma and 71 patients with myeloma. The mean duration of FN was 3.07 days (standard deviation (SD) 1.96) in the pegfilgrastin arm and 3.29 (SD 2.54) in the filgrastim one. Mean total costs were 23,256 and 25,448 euros for pegfilgrastim and filgrastim patients, respectively. There was a 62% probability that pegfilgrastim strictly dominates filgrastim.
  
  
  CONCLUSIONS
  Pegfilgrastim after PBSC transplantation in myeloma and lymphoma is safe, effective when compared with filgrastim and could represent a cost-effective alternative in this setting.
authors.affiliation: Hematology Department, Cancer Centre Léon Bérard, Lyon, France. catherine.sebban@lyon.unicancer.fr
authors.forename: C
authors.initials: C
authors.lastname: Sebban
authors.forename: A
authors.initials: A
authors.lastname: Lefranc
authors.forename: L
authors.initials: L
authors.lastname: Perrier
authors.forename: P
authors.initials: P
authors.lastname: Moreau
authors.forename: D
authors.initials: D
authors.lastname: Espinouse
authors.forename: A
authors.initials: A
authors.lastname: Schmidt
authors.forename: L
authors.initials: L
authors.lastname: Kammoun
authors.forename: H
authors.initials: H
authors.lastname: Ghesquieres
authors.forename: C
authors.initials: C
authors.lastname: Ferlay
authors.forename: J O
authors.initials: JO
authors.lastname: Bay
authors.forename: S
authors.initials: S
authors.lastname: Lissandre
authors.forename: D
authors.initials: D
authors.lastname: Pérol
authors.forename: M
authors.initials: M
authors.lastname: Michallet
authors.forename: P
authors.initials: P
authors.lastname: Quittet
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000191:economics / Q000209:etiology; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D009503:Neutropenia / Q000188:drug therapy* / Q000191:economics / Q000209:etiology; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim