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Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study

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Abstract

Purpose

Lipegfilgrastim is a once-per-cycle glycoPEGylated granulocyte colony-stimulating factor (G-CSF). Noninferiority of lipegfilgrastim versus pegfilgrastim was demonstrated in a phase III trial in chemotherapy (CTx)-naïve breast cancer patients. Secondary outcomes relating to treatment burden are reported here.

Methods

Patients with high-risk stage II, III, or IV breast cancer were randomized to receive lipegfilgrastim 6 mg (n = 101) or pegfilgrastim 6 mg (n = 101) subcutaneously on day 2 of each CTx cycle. Doxorubicin 60 mg/m2 plus docetaxel 75 mg/m2 commenced on day 1, for up to four cycles. Secondary end points included days in the hospital or intensive care unit (ICU), use of intravenous antibiotics for febrile neutropenia (FN) or related infections, and measures of CTx delivery (dose delays, reductions, and omissions).

Results

One lipegfilgrastim recipient and two pegfilgrastim recipients were hospitalized in cycle 1 because of FN or associated infection. The lipegfilgrastim-treated patient spent 1 day in the ICU for FN, and the two pegfilgrastim-treated patients were hospitalized for FN for 5 and 6 days, respectively. All hospitalized patients received antibiotics. An additional pegfilgrastim-treated patient received antibiotics but was not hospitalized. Most patients received CTx as scheduled; over 98 % received their planned doxorubicin and docetaxel doses in all cycles. In the lipegfilgrastim group, no patients had a CTx dose reduced or omitted; eight patients in the pegfilgrastim group had a CTx dose reduced or omitted during cycles 2–4.

Conclusions

The burden of treatment associated with myelosuppressive CTx was similar in breast cancer patients treated with lipegfilgrastim or pegfilgrastim.

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Acknowledgments

This study was sponsored by Teva Branded Pharmaceutical Products R&D, Inc. Medical writing assistance was provided by Laurie Orloski, PharmD and Lisa Feder, PhD of Peloton Advantage and was funded by Teva Branded Pharmaceutical Products R&D, Inc. Teva provided a full review of the article.

Conflict of interest

Oleg A. Gladkov declares that he has no conflict of interest. Anton Buchner is an employee of Merckle GmbH. Peter Bias, Udo Müller, and Reiner Elsässer are employees of Teva Ratiopharm.

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Authors and Affiliations

  1. Chelyabinsk Regional Clinical Oncology Dispensary, 42 Blukhera str, Chelyabinsk, 454087, Russian Federation

    Oleg A. Gladkov

  2. Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany

    Anton Buchner

  3. Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany

    Peter Bias, Udo Müller & Reiner Elsässer

Authors
  1. Oleg A. Gladkov
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  2. Anton Buchner
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  3. Peter Bias
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  4. Udo Müller
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  5. Reiner Elsässer
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Correspondence to Oleg A. Gladkov.

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Gladkov, O.A., Buchner, A., Bias, P. et al. Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study. Support Care Cancer 24, 395–400 (2016). https://doi.org/10.1007/s00520-015-2803-9

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  • DOI: https://doi.org/10.1007/s00520-015-2803-9

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