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Annals of Oncology 14:29-35, 2003
© 2003 European Society for Medical Oncology

Original Paper

A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy

M. D. Green1,+, H. Koelbl2, J. Baselga3, A. Galid4, V. Guillem5, P. Gascon6, S. Siena7, R. I. Lalisang8, H. Samonigg9, M. R. Clemens10, V. Zani11, B. C. Liang11, J. Renwick11 and M. J. Piccart On behalf of the International Pegfilgrastim 749 Study Group12,§

1 Royal Melbourne and Western Hospitals, Melbourne, Australia; 2 Martin Luther University, Halle-Wittenberg, Germany; 3 Hospital Vall d’Hebron, Barcelona, Spain; 4 Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria; 5 Instituto Valenciano de Oncologia, Valencia, Spain; 6 Hospital Clinic, Barcelona, Spain; 7 Ospedale Niguarda Ca’ Granda, Milan, Italy; 8 Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands; 9 Medizinische Universitaetsklinik, Graz, Austria; 10 Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany; 11 Amgen Inc, Thousand Oaks, CA, USA; 12 Institut Jules Bordet, Brussels, Belgium

Received 20 March 2002; revised 3 June 2002; accepted 17 July 2002

Background:

We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support.

Patients and methods:

Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded.

Results:

A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim.

Conclusions:

A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.

Key words: breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia


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