Green, M.D., Koelbl, H., Baselga, J., Galid, A., Guillem, V., Gascon, P., . . . International Pegfilgrastim 749 Study Group. (2003). A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Annals of Oncology, 14, 29–35.
The purpose of the study was to evaluate the efficacy of a single fixed 6 mg dose of pegfilgrastim compared with daily filgrastim.
Patients were randomly assigned to receive either a single fixed dose injection of 6 mg pegfilgrastim on day 2 of their treatment cycle or daily injections of filgrastim 5 mcg/kg per day, begun about 24 hours after chemotherapy until documented absolute neutrophil count (ANC) of 10 x 109/L or greater. Chemotherapy dose reductions were permitted if patients had grade 3-4 non-hemopoetic toxicities.
Active antitumor treatment
Double-blind randomized phase III
In cycle 1, mean duration of neutropenia was 1.8 days with pegfilgrastim and 1.6 days in the filgrastim group—no significant difference. There were no differences between groups for duration of grade 4 neutropenia during other treatment cycles. The safety profile of pegfilgrastim was similar to that for filgrastim.
A single fixed dose of pegfilgrastim per chemotherapy cycle is as safe and effective as daily filgrastim injections.
No significant study limitations were identified.
This study demonstrated that a single fixed dose of pegfilgrastim was as safe and effective as daily filgrastim in these patients. The ability to provide the same effectiveness with fewer injections can be beneficial to patients.