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.

• 152 total participants were evaluated.
• Mean age of the participants was 52.4 years, with a range of 30–75 years.
• All of the participants were women.
• The disease type was not stated. All were receiving doxorubicin and docetaxel chemotherapy every three weeks.
• Patients were excluded if they received systemic anti-infective treatment within 72 hours of chemotherapy.

• Multi-site
• Outpatient 
• 37 centers in Europe, Australia, and the United States

Active antitumor treatment

Double-blind randomized phase III

• Weekly blood samples for ANC determination
• Grade 4 neutropenia defined as ANC less than 0.5 x 10⁹/L
• Neutrophil recovery defined as ANC of 2.0 x 10⁹/L or greater

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.