title: Evaluation of the Hematologic Safety of Same Day Versus Standard Administration (24- to 72-Hour Delay) of Pegfilgrastim in Gynecology Oncology Patients Undergoing Cytotoxic Chemotherapy.
abstract: OBJECTIVE
  We assessed the safety and efficacy of administration of pegfilgrastim on the same day compared with standard administration 24 to 72 hours after chemotherapy in patients with gynecologic malignancies.
  
  
  METHODS
  A retrospective review was conducted on patients undergoing pegfilgrastim to mitigate the myelosuppressive consequences of chemotherapy. The primary outcome was incidence of grade 3 to 4 neutropenia following pegfilgrastim for same-day administration (D1) versus standard administration (D2+). Secondary outcomes included dose delay, regimen change, hospitalization due to neutropenia, and incidence of febrile neutropenia.
  
  
  RESULTS
  Four hundred twenty-one patients with 2071 administrations of pegfilgrastim were included. Five hundred six administrations of pegfilgrastim were given on D1 compared with 1565 administrations on D2+. The most common malignancy was ovarian cancer (79.1%), followed by endometrial (14.5%). Comparing the D1 and D2+ cohorts, noninferiority was not established for the incidence of grade 3 to 4 neutropenia (2.6% vs 1.8%, adjusted relative risk [aRR], 1.6; 90% confidence interval [CI], 0.87-3.2) or dose modification (6.5% vs 4.9%; aRR, 1.3; 90% CI, 0.9-1.8). However, the rate of treatment delays (7.3% vs 9.4%; aRR, 0.8; 90% CI, 0.6-1.1) in the D1 and D2+ groups suggested that delays in the D1 group were not more common than in the D2+ group.
  
  
  CONCLUSIONS
  The incidence of hematologic toxicities and dose modification in patients receiving same-day pegfilgrastim were not as low as in those undergoing standard administration. However, treatment delays were found to be no more frequent in those receiving same-day pegfilgrastim versus standard administration. Same-day administration of pegfilgrastim is a reasonable option.
authors.affiliation: *Division of Gynecology Oncology, Department of Obstetrics and Gynecology, College of Medicine, †Department of Pharmacy, Richard J. Solove Research Institute, ‡Department of Obstetrics and Gynecology, College of Medicine, and §Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH.
authors.forename: Caroline C
authors.initials: CC
authors.lastname: Billingsley
authors.forename: Samuel N
authors.initials: SN
authors.lastname: Jacobson
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Crafton
authors.forename: Aleia K
authors.initials: AK
authors.lastname: Crim
authors.forename: Quan
authors.initials: Q
authors.lastname: Li
authors.forename: Erinn M
authors.initials: EM
authors.lastname: Hade
authors.forename: David E
authors.initials: DE
authors.lastname: Cohn
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Fowler
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Copeland
authors.forename: Ritu
authors.initials: R
authors.lastname: Salani
authors.forename: Floor J
authors.initials: FJ
authors.lastname: Backes
authors.forename: David M
authors.initials: DM
authors.lastname: O'Malley
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D005500:Follow-Up Studies; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000473:pathology; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D011092:Polyethylene Glycols; D011379:Prognosis; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012449:Safety; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim