A Randomized, Double-blind, Phase III Study Evaluating Fixed Dose, Once-Per-Cycle Pegylated Filgrastim (SD/01) vs Daily Filgrastim to Support Chemotherapy for Breast Cancer

James Metz, MD

University of Pennsylvania Cancer
Last Modified: May 12, 2001

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Presenter: M. Green
Affiliation: Multicenter Trial

Background:

    It has been shown prolonged neutropenia associated with chemotherapy administration can be significantly decreased by daily Filgrastim. Pegylated Filgrastim is a sustained duration form administered once per chemotherapy cycle. This study was performed to compare the administration of daily Filgrastim vs. once per cycle Pegylated Filgrastim

Materials and Methods:

  • Double-blind randomized study of high risk breast cancer patients, stage II-IV.
  • Chemotherapy consisted of 4 cycles of Doxorubicin and Docetaxel
  • 157 patients were randomized to receive Pegylated Filgrastim at a single fixed dose of 6 mg on day 1 of each cycle of chemotherapy vs. daily Filgrastim.
  • Those patients on the Pegylated Figrastin arm received a placebo injection on all other days of the chemotherapy cycle.
  • Baseline demographics were equally matched between the two groups

Results:

  • The duration of severe neutropenia in cycle 1 was not significantly different at 1.6 vs 1.8 days.
  • There was no difference in the mean duration of neutropenia with any of the chemotherapy cycles between the two groups
  • The fixed dose of Pegylated Filgrastim was adequate for all weights of patients in this study
  • Chemotherapy compliance was > 90% for both groups
  • Cytokine related bone pain was not significantly different at 42% (Figrastim) vs 37% (Pegylated Filgrastim)
  • Overall, adverse events were not significantly different.

Authors' Conclusions

  • A 6 mg dose of Pegylated Filgrastim on day 1 of each chemotherapy cycle is as effective as daily Filgrastin
  • Pegylated Filgrastim and daily Filgrastim are equally tolerated
  • Weight of the patients did not effect the efficacy or toxicity of Pegylated Filgrastim
  • This fixed dose of Pegylated Filgrastim may increase compliance and efficacy of treatment

Clinical/Scientific Implications:

ASCO Abstract 90

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OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen



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