title: Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia.
abstract: BACKGROUND
  To study the effects of deferring pegfilgrastim until day 4 on the reduction of chemotherapy-induced leukocytopenia.
  
  
  METHODS
  Patients of age 61-80 years with aggressive lymphoma were randomly assigned to receive 6 mg pegfilgrastim on day 2 or 4 of a 2-week chemotherapy regimen (R-CHOP-14).
  
  
  RESULTS
  Two hundred and ninety-two and 313 chemotherapy cycles were evaluable in 103 patients. Post-nadir pegfilgrastim serum levels were higher after day 4 than after day 2 application. This was associated with an attenuated leukocyte nadir after day 4 pegfilgrastim and there were fewer days with leukocytes <2 × 10(3)/mm(3) compared with day 2 pegfilgrastim. Grade 3 and 4 leukocytopenias (70% versus 43.3%; P < 0.001) and grade 4-only leukocytopenias (47% versus 20.5%; P < 0.001) were more frequent after day 2 pegfilgrastim. There were more chemotherapy cycles with grade 3 and 4 infections after day 2 than day 4 pegfilgrastim (9.4% versus 6.0%; P = 0.118). Interventional antibiotics were given more often after day 2 than after day 4 pegfilgrastim (30.7% versus 21.9% of cycles; P = 0.008). There were five deaths during leukocytopenia after day 2 and none after day 4 pegfilgrastim (P = 0.027).
  
  
  CONCLUSIONS
  Administration of pegfilgrastim on day 4 was more effective in reducing severe leukocytopenias and resulted in fewer deaths during leukocytopenia. Pegfilgrastim should be given on day 4 to better exploit its myeloprotective potential.
authors.affiliation: Department of Oncology, Saarland University Medical School, Homburg, Germany. carsten.zwick@uks.eu
authors.forename: C
authors.initials: C
authors.lastname: Zwick
authors.forename: F
authors.initials: F
authors.lastname: Hartmann
authors.forename: S
authors.initials: S
authors.lastname: Zeynalova
authors.forename: V
authors.initials: V
authors.lastname: Pöschel
authors.forename: C
authors.initials: C
authors.lastname: Nickenig
authors.forename: M
authors.initials: M
authors.lastname: Reiser
authors.forename: E
authors.initials: E
authors.lastname: Lengfelder
authors.forename: N
authors.initials: N
authors.lastname: Peter
authors.forename: G
authors.initials: G
authors.lastname: Schlimok
authors.forename: J
authors.initials: J
authors.lastname: Schubert
authors.forename: N
authors.initials: N
authors.lastname: Schmitz
authors.forename: M
authors.initials: M
authors.lastname: Loeffler
authors.forename: M
authors.initials: M
authors.lastname: Pfreundschuh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D006801:Humans; D007958:Leukocyte Count; D007970:Leukopenia / Q000139:chemically induced / Q000401:mortality / Q000517:prevention & control*; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011092:Polyethylene Glycols; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D014750:Vincristine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim; D011241:Prednisone