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Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline- and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial

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Abstract

Purpose

To evaluate the safest timing of pegfilgrastim administration in dose-dense anthracycline- and taxane-based chemotherapy, three different cohorts of patients enrolled in the Gruppo Italiano Mammella (GIM) 2 study and treated at the coordinating center received pegfilgrastim 24 h (cohort A) or 72 h (cohort B) or 96 h (cohort C) after chemotherapy.

Methods

A total of 41 patients were included. The safety of pegfilgrastim administration in terms of occurrence of early and late leukocytosis and the behavior of white blood cells (WBC) counts in the three cohorts across all chemotherapy cycles were evaluated. Anthracycline and taxane cycles were analyzed separately.

Results

The occurrence of early leukocytosis was a more common event in patients in cohort A in both anthracycline and taxane cycles (75 and 66.7 %) as compared to cohort B (50 and 60 %) and cohort C (66.7 and 33.3 %). More patients in cohort C developed late leukocytosis in both anthracycline and taxane cycles (50 and 100 %) as compared to cohort A (0 and 66.7 %) and cohort B (35.7 and 86.7 %). Patients in cohort A experienced the highest median value of WBC count 24 h after pegfilgrastim administration in both anthracycline and taxane cycles (61.2 × 103/μl and 67.8 × 103/μl). Patients in cohort C experienced the highest median value of WBC count at day 13 in both anthracycline and taxane cycles (19.4 × 103/μl and 24.2 × 103/μl).

Conclusions

For the prevention of leukocytosis, the safest timing of pegfilgrastim administration based on WBC count in dose-dense anthracycline- and taxane-based regimens seems to be 72 h after chemotherapy.

Trial registration

This study is registered with https://clinicaltrials.gov/ct2/show/NCT00433420.

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Acknowledgments

We thank all the study participants as well as all the study personnel and investigators. This paper is dedicated to the memory of Dr. Marco Venturini, leader of the Gruppo Italiano Mammella (GIM) group, who left us too early.

Conflict of interest

ML received a 2014 Conquer Cancer Foundation of ASCO Merit Award for the presentation at the 2014 ASCO Annual Meeting. PP disclosed advisory role for Amgen Dompè SPA. All the other authors have no conflict of interest to disclose. The main GIM2 study received funding by Bristol-Meyers Squibb, Pharmacia, and Dompè Biotec, Italy. This ancillary study did not receive additional funding.

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Authors and Affiliations

  1. Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy

    Matteo Lambertini, Francesca Poggio, Simona Pastorino, Giovanni Gardin, Claudia Bighin & Paolo Pronzato

  2. Department of Epidemiology, IRCCS AOU San Martino-IST, Genova, Italy

    Paolo Bruzzi

  3. Department of Medical Oncology, U.O. Oncologia Medica, Ospedali Galliera, Genova, Italy

    Matteo Clavarezza

  4. Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino-IST, Genova, Italy

    Lucia Del Mastro

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  1. Matteo Lambertini
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  2. Paolo Bruzzi
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  9. Lucia Del Mastro
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Correspondence to Matteo Lambertini.

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Lambertini, M., Bruzzi, P., Poggio, F. et al. Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline- and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial. Support Care Cancer 24, 1285–1294 (2016). https://doi.org/10.1007/s00520-015-2907-2

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  • DOI: https://doi.org/10.1007/s00520-015-2907-2

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