Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer

Ernst Kubista, John Glaspy, Frankie Ann Holmes, Michael D. Green, James Hackett, Theresa Neumann, Franklin Marques, Luis Meza, David Miles, Melvin Moore, Joyce O'Shaughnessy, Martine J. Piccart, Gary E. Richardson, Hellmutt Samonigg, Armando Santoro, Michael Savin, Martin Ronald Schaafsma, Salvatore Siena, Jeffrey Shogan, Svetislava VukeljaIsrael Wiznitzer

Research output: Contribution to journalArticle

48 Scopus citations

Abstract

Bone pain is a common side effect of treatment with filgrastim. Pegfilgrastim is a pegylated long-acting analogue of filgrastim that is administered once per chemotherapy cycle. The profile of prospectively defined, patient-reported bone pain judged by the investigators as related to study drug was analyzed retrospectively for each drug using data from two comparable phase III trials. These multicenter, randomized, double-blind, noninferiority trials compared once-per-cycle pegfilgrastim (6 mg, study 1 or 100 μg/kg, study 2) to daily filgrastim 5 μg/kg in patients with stage II-IV breast cancer undergoing multiple cycles of myelosuppressive chemotherapy (doxorubicin/docetaxel). Subcutaneous once-per-cycle pegfilgrastim 6-mg and 100-μg/kg doses were administered to 76 and 150 patients, respectively; subcutaneous daily filgrastim 5 μg/kg was administered to a total of 227 patients. Because bone pain in study 1 was higher (P = 0.044) in every cycle compared with study 2, all analyses were performed separately for each study. No statistically significant differences in incidence, severity, or duration were observed between patients receiving either once-per-cycle pegfilgrastim or daily filgrastim in either study. Bone pain incidence and severity were significantly greater (P < 0.001) in cycle 1 of both studies compared with later cycles. Among patients with bone pain, a trend towards earlier onset with pegfilgrastim was observed but was not associated with increased bone pain severity or duration. In patients who received a fixed 6-mg dose of pegfilgrastim, the overall bone pain incidence was similar when analyzed by body weight (< 60 kg, 60-100 kg, > 100 kg). No patients were withdrawn from either study for bone pain.

Original languageEnglish (US)
Pages (from-to)391-398
Number of pages8
JournalClinical breast cancer
Volume3
Issue number6
DOIs
StatePublished - Feb 2003
Externally publishedYes

Keywords

  • Fixed-weight dosing
  • Neutrophil growth factor
  • Phase III clinical trial
  • Retrospective analysis

ASJC Scopus subject areas

  • Cancer Research

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    Kubista, E., Glaspy, J., Holmes, F. A., Green, M. D., Hackett, J., Neumann, T., Marques, F., Meza, L., Miles, D., Moore, M., O'Shaughnessy, J., Piccart, M. J., Richardson, G. E., Samonigg, H., Santoro, A., Savin, M., Schaafsma, M. R., Siena, S., Shogan, J., ... Wiznitzer, I. (2003). Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer. Clinical breast cancer, 3(6), 391-398. https://doi.org/10.3816/CBC.2003.n.003