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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.

AbstractOBJECTIVE:
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.
AuthorsCaroline C Billingsley, Samuel N Jacobson, Sarah M Crafton, Aleia K Crim, Quan Li, Erinn M Hade, David E Cohn, Jeffrey M Fowler, Larry J Copeland, Ritu Salani, Floor J Backes, David M O'Malley
JournalInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) Vol. 25 Issue 7 Pg. 1331-6 (Sep 2015) ISSN: 1525-1438 [Electronic] England
PMID26067861 (Publication Type: Comparative Study, Journal Article, Research Support, N.I.H., Extramural)
Chemical References
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • pegfilgrastim
  • Polyethylene Glycols
  • Filgrastim
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects)
  • Drug Administration Schedule
  • Female
  • Filgrastim
  • Follow-Up Studies
  • Genital Neoplasms, Female (drug therapy, pathology)
  • Granulocyte Colony-Stimulating Factor (therapeutic use)
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • Neutropenia (chemically induced, prevention & control)
  • Polyethylene Glycols
  • Prognosis
  • Recombinant Proteins (therapeutic use)
  • Retrospective Studies
  • Safety
  • Young Adult

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