Conferences   /   Conference and Meeting Announcements   /   2005   /   October

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

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:

• This study shows a fixed dose of Pegylated Filgrastin administered on the first day of each chemotherapy cycle is just as effective as daily dosing, without a change in the toxicity profile.
• Clearly, this will benefit patients by way of convenience and higher likelihood of compliance to the prescribed treatment course.

  Also See Abstract 27: A single Dose of Pegylated Filgrastim (SD/01) is as effective as Daily Filgrastim for Hematologic Support of Chemotherapy in Breast Cancer Patients: Results of a Randomized,k Double-Blind, Phase 3 Trial