title: Trajectory of absolute neutrophil counts in patients treated with pegfilgrastim on the day of chemotherapy versus the day after chemotherapy.
abstract: OBJECTIVE
  Risk of infection increases with severity and duration of chemotherapy-induced neutropenia (CIN). Pegfilgrastim is approved for use on the day after chemotherapy to reduce incidence of infection, as manifested by febrile neutropenia (FN), in patients receiving myelosuppressive chemotherapy. In this study, we compared severity and duration of absolute neutrophil count (ANC) suppression in patients who received pegfilgrastim on the same day as chemotherapy versus the next day.
  
  
  METHODS
  We combined individual patient data from four Amgen-sponsored clinical trials in which patients with cancer were randomized to receive pegfilgrastim either the same day as chemotherapy or the next day. Severity and duration of ANC suppression were calculated using area over the curve (AOC, the area over the ANC-time response curve and below a given clinical threshold). AOC of ANC and incidences of CIN and FN were compared by day of pegfilgrastim use.
  
  
  RESULTS
  The analysis included 95 same-day patients and 97 next-day patients. Despite similar ANC at baseline, ANC at nadir was higher among next-day patients than same-day patients. Mean AOC of ANC (cutoff 0.5 × 10(9)/L) among next-day patients was lower by 0.30 (95 % confidence interval: 0.16, 0.43) 10(9)/L × day than same-day patients in cycle 1. Next-day patients had lower incidences of CIN than same-day patients, but there were no significant differences in incidences of FN.
  
  
  CONCLUSIONS
  Patients who received pegfilgrastim the day after chemotherapy had less severe and shorter suppression of ANC than patients who received pegfilgrastim the same day as chemotherapy.
authors.affiliation: Center for Observational Research, Amgen Inc., 1150 Veterans Blvd, South San Francisco, CA 94080, USA. yanli.li@amgen.com.
authors.forename: Yanli
authors.initials: Y
authors.lastname: Li
authors.affiliation: Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Zandra
authors.initials: Z
authors.lastname: Klippel
authors.affiliation: SimulStat Inc., San Diego, CA, USA.
authors.forename: Xiaolong
authors.initials: X
authors.lastname: Shih
authors.affiliation: TechData Service Company, LLC, King of Prussia, PA, USA.
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
authors.affiliation: Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Maureen
authors.initials: M
authors.lastname: Reiner
authors.affiliation: Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Page
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D009504:Neutrophils / Q000166:cytology*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim
keywords: Area over the curve; Chemotherapy-induced neutropenia; Febrile neutropenia; Next-day administration; Pegfilgrastim; Same-day administration