Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: A multicenter dose-finding study in women with breast cancer

F. A. Holmes, S. E. Jones, J. O'Shaughnessy, S. Vukelja, T. George, M. Savin, D. Richards, J. Glaspy, L. Meza, G. Cohen, M. Dhami, D. R. Budman, J. Hackett, M. Brassard, B. B. Yang, B. C. Liang

Research output: Contribution to journalArticle

Abstract

Background: Neutropenia is common in patients receiving myelotoxic chemotherapy. Pegfilgrastim, a sustained-duration filgrastim is a once-per-cycle therapy for prophylactic neutrophil support. Patients and methods: Women, treated with four cycles of doxorubicin/docetaxel chemotherapy every 21 days, received pegfilgrastim or filgrastim 24 h after chemotherapy as a single subcutaneous injection per chemotherapy cycle (pegfilgrastim 30, 60 or 100 μg/kg) or daily subcutaneous injections (filgrastim 5 μg/kg/day). Safety, efficacy and pharmacokinetics were analyzed. Results: The incidence of grade 4 neutropenia in cycle 1 was 95, 90 and 74%, in patients who received pegfilgrastim 30, 60 and 100 μg/kg, respectively, and 76% in patients who received filgrastim. Mean duration of grade 4 neutropenia in cycle 1 was 2.7, 2 and 1.3 days for doses of pegfilgrastim, and 1.6 days for filgrastim. The pharmacokinetics of pegfilgrastim were non-linear and dependent on both dose and neutrophil count. Pegfilgrastim serum concentration was sustained until the neutrophil nadir occurred then declined rapidly as neutrophils started to recover, consistent with a self-regulating neutrophil-mediated clearance mechanism. The safety profiles of pegfilgrastim and filgrastim were similar. Conclusions: A single subcutaneous injection of pegfilgrastim 100 μg/kg provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim during multiple chemotherapy cycles.

Original languageEnglish (US)
Pages (from-to)903-909
Number of pages7
JournalAnnals of Oncology
Volume13
Issue number6
DOIs
StatePublished - Jul 22 2002

Keywords

  • Breast cancer
  • Chemotherapy
  • Filgrastim
  • Neutropenia
  • Pegylation
  • Phase II clinical trial

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Holmes, F. A., Jones, S. E., O'Shaughnessy, J., Vukelja, S., George, T., Savin, M., Richards, D., Glaspy, J., Meza, L., Cohen, G., Dhami, M., Budman, D. R., Hackett, J., Brassard, M., Yang, B. B., & Liang, B. C. (2002). Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: A multicenter dose-finding study in women with breast cancer. Annals of Oncology, 13(6), 903-909. https://doi.org/10.1093/annonc/mdf130