title: A risk-adapted protocol for delayed administration of filgrastim after high-dose chemotherapy and autologous stem cell transplantation.
abstract: BACKGROUND
  The routine use of recombinant human granulocyte-colony stimulating factor (rhG-CSF) after high-dose chemotherapy and autologous stem cell transplantation (auto-SCT) is associated with increased costs. We prospectively explored a strategy that used prophylactic delayed filgrastim only in patients with risk factors.
  
  
  METHODS
  This sequential cohort analysis compared the outcomes of consecutive patients, treated on the risk-adapted protocol (RAP) (risk factors: prior febrile neutropenia; age >60 years; and CD34+ cell infused dose of <2 × 10(6/)/kg), who received filgrastim from day +6 after auto-SCT with a historical cohort (historical day-1 cohort [HD1]), who received filgrastim from day +1.
  
  
  RESULTS
  Eighty-two patients were treated in the RAP cohort and compared with 115 patients in the HD1 cohort. There were no differences in median age (55 years) or median CD34+ cell dose (5.21 × 10(6)/kg [range, 2-62.2 × 10(6)/kg] vs. 5.24 × 10(6)/kg [range, 2.4-29.8 × 10(6)/kg]). Filgrastim was used for 6 fewer days in the RAP cohort (median 5 days [range, 0-11 days] vs. 11 days [range, 9-47 days]). There was a small absolute but significant difference in median time to neutrophil recovery in the HD1 cohort for the whole group, 10 days (range, 8-46 days) vs. 11 days (range, 9-22 days) (P = .03) and in patients with myeloma; 10 days (range, 9-14 days) vs. 11 days (range, 9-18 days) (P < .0001) as compared to the RAP cohort. There was no difference in median inpatient duration, 13 days (range, 10-26 days) vs. 12 days (range, 1-38 days) (P = .22) and 3-year survival (79% vs. 83% [P = .43]) between HD1 and RAP cohorts respectively.
  
  
  CONCLUSIONS
  The use of a RAP to identify patients likely to benefit from prophylactic filgrastim is safe and results in cost savings. Patients with myeloma benefit from earlier introduction of filgrastim in terms of neutrophil recovery; this disease-specific observation is an important consideration for future studies.
authors.affiliation: Department of Haematology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. amit.khot@petermac.org
authors.forename: Amit
authors.initials: A
authors.lastname: Khot
authors.forename: Michael
authors.initials: M
authors.lastname: Dickinson
authors.forename: Kerrie
authors.initials: K
authors.lastname: Stokes
authors.forename: Simon
authors.initials: S
authors.lastname: Harrison
authors.forename: Kate
authors.initials: K
authors.lastname: Burbury
authors.forename: Shaun
authors.initials: S
authors.lastname: Fleming
authors.forename: Dominic
authors.initials: D
authors.lastname: Wall
authors.forename: Peter
authors.initials: P
authors.lastname: Gambell
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: John F
authors.initials: JF
authors.lastname: Seymour
authors.forename: David
authors.initials: D
authors.lastname: Ritchie
mesh_terms: D000328:Adult; D000368:Aged; D001792:Blood Platelets / Q000187:drug effects; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000188:drug therapy* / Q000601:surgery*; D009504:Neutrophils / Q000187:drug effects; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D012307:Risk Factors; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim