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Annals of Oncology 13:903-909, 2002
© 2002 European Society for Medical Oncology

Original Paper

Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer

F. A. Holmes1,+, S. E. Jones2, J. O’Shaughnessy2, S. Vukelja1, T. George1, M. Savin1, D. Richards1, J. Glaspy3, L. Meza4, G. Cohen5, M. Dhami6, D. R. Budman7, J. Hackett8, M. Brassard8, B. B. Yang8 and B. C. Liang8

1US Oncology Research, Houston, TX; 2Baylor-Sammons Cancer Center, Dallas, TX; 3UCLA, Los Angeles, CA; 4Southwest Oncology Associates, Lafayette, LA; 5GBMC Healthcare, Baltimore, MD; 6Eastern Connecticut Hematology/Oncology Associates, Norwich, CT; 7Northshore University Hospital, Manhasset, NY; 8Amgen Inc., Thousand Oaks, CA, USA

Received 27 July 2001; revised 12 November 2001; accepted 26 November 2001.

Background

Neutropenia is common in patients receiving myelotoxic chemotherapy. Pegfilgrastim, a sustained-duration filgrastim is a once-per-cycle therapy for prophylactic neutrophil support.

Patients and methods

Women, treated with four cycles of doxorubicin/docetaxel chemotherapy every 21 days, received pegfilgrastim or filgrastim 24 h after chemotherapy as a single subcutaneous injection per chemotherapy cycle (pegfilgrastim 30, 60 or 100 µg/kg) or daily subcutaneous injections (filgrastim 5 µg/kg/day). Safety, efficacy and pharmacokinetics were analyzed.

Results

The incidence of grade 4 neutropenia in cycle 1 was 95, 90 and 74%, in patients who received pegfilgrastim 30, 60 and 100 µg/kg, respectively, and 76% in patients who received filgrastim. Mean duration of grade 4 neutropenia in cycle 1 was 2.7, 2 and 1.3 days for doses of pegfilgrastim, and 1.6 days for filgrastim. The pharmacokinetics of pegfilgrastim were non-linear and dependent on both dose and neutrophil count. Pegfilgrastim serum concentration was sustained until the neutrophil nadir occurred then declined rapidly as neutrophils started to recover, consistent with a self-regulating neutrophil-mediated clearance mechanism. The safety profiles of pegfilgrastim and filgrastim were similar.

Conclusions

A single subcutaneous injection of pegfilgrastim 100 µg/kg provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim during multiple chemotherapy cycles.

Key words: breast cancer, chemotherapy, filgrastim, neutropenia, pegylation, phase II clinical trial


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