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Effectiveness of biosimilar filgrastim vs. original granulocyte colony-stimulating factors in febrile neutropenia prevention in breast cancer patients

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The purpose of this study is to describe the effectiveness of biosimilar filgrastim and original granulocyte colony-stimulating factors (G-CSFs), lenograstim and pegfilgrastim, in febrile neutropenia (FN) prevention in breast cancer patients receiving docetaxel/doxorubicin/cyclophosphamide (TAC) as adjuvant/neoadjuvant treatment and to analyze their treatment patterns.

Methods

A pharmacoepidemiology cohort study was developed in a university hospital (with 23 healthcare centers) with retrospective data collection (2012–2014). Effectiveness of G-CSFs was assessed by the FN incidence. Other parameters analyzed were as follows: moderate and severe neutropenia incidence, neutropenia-related hospitalizations, dosage, and duration. Data was analyzed using each cycle as a unit of analysis.

Results

We identified 98 patients representing 518 chemotherapy cycles, 215 with original G-CSFs (35 lenograstim and 180 pegfilgrastim) and 303 with biosimilar filgrastim. The FN incidence was similar in both groups (3.7% original vs. 3.3% biosimilar; p = 0.79). No statistically significant differences were found in moderate and severe neutropenia incidence (4.7 vs. 6.3%; p = 0.43) or neutropenia-related hospitalizations (3.3 vs. 3.6%; p = 0.19). When the three drugs were evaluated separately, a higher FN incidence was observed with lenograstim than with pegfilgratim or biosimilar (p = 0.024). The dosage and duration of biosimilar were lower than lenograstim (4.9 vs. 5.7 μg/kg/day; 5 vs. 7 days; p < 0.001).

Conclusion

An abbreviated 5-day course of biosimilar filgrastim provided optimal primary prophylaxis against FN post-chemotherapy TAC in patients with breast cancer. The clinical relevance of the highest FN incidence in the lenograstim cohort needs further attention.

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Acknowledgments

We thank the Pharmacy and Oncology Department for their sustained commitment to the study.

Author information

Authors and Affiliations

  1. Pharmacy Department, Lozano Blesa University Clinical Hospital, Zaragoza, Spain

    Isabel Puértolas, Alberto Frutos Pérez-Surio, María Aránzazu Alcácera & María del Tránsito Salvador

  2. Investigational Drug Service, Aragon Institute for Health Research, Zaragoza, Spain

    Isabel Puértolas

  3. Department of Microbiology, Preventive Medicine and Public Health, University of Zaragoza, Zaragoza, Spain

    Alberto Frutos Pérez-Surio

  4. Medical Oncology Department, Lozano Blesa University Clinical Hospital, Zaragoza, Spain

    Raquel Andrés

  5. Department of Medicine, Psychiatry and Dermatology, University of Zaragoza, Zaragoza, Spain

    Raquel Andrés

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  1. Isabel Puértolas
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Corresponding author

Correspondence to Isabel Puértolas.

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Ethical approval

The study received the ethical approval of the institutional review board (IRB) on June 2015 to guarantee the protection of the health information of human participants.

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The authors declare that they have no conflict of interest.

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All listed authors have contributed to the revision and approval of the final version of this manuscript.

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Puértolas, I., Frutos Pérez-Surio, A., Alcácera, M.A. et al. Effectiveness of biosimilar filgrastim vs. original granulocyte colony-stimulating factors in febrile neutropenia prevention in breast cancer patients. Eur J Clin Pharmacol 74, 315–321 (2018). https://doi.org/10.1007/s00228-017-2365-5

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  • DOI: https://doi.org/10.1007/s00228-017-2365-5

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