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
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
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.
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
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.