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Pegfilgrastim ± ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study

von Minckwitz, G. ; Kümmel, S. ; du Bois, A. ; Eiermann, W. ; Eidtmann, H. ; Gerber, B. ; Hilfrich, J. ; Huober, J. ; Costa, S. D. ; Jackisch, C. ; Grasshoff, S.-T ; Vescia, S. ; Skacel, T. ; Loibl, S. ; Mehta, K. M. ; Kaufmann, M.

In: Annals of Oncology, 2007, vol. 19, no. 2, p. 292-298

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    Titre
    • Pegfilgrastim ± ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study
    Auteur
    • von Minckwitz, G.. German Breast Group, Neu-Isenburg
    • Kümmel, S.. Universitäts-Frauenklinik, Charité, Berlin
    • du Bois, A.. Dr Horst-Schmidt-Klinik, Wiesbaden, Frauenklinik
    • Eiermann, W.. Frauenklinik vom Roten Kreuz, Munich
    • Eidtmann, H.. Universitäts-Frauenklinik, Kiel
    • Gerber, B.. Universitäts-Frauenklinik Rostock
    • Hilfrich, J.. Henrietten Stift, Hannover, Frauenklinik
    • Huober, J.. Universitäts-Frauenklinik, Tübingen
    • Costa, S. D.. Universitäts-Frauenklinik, Magdeburg
    • Jackisch, C.. Klinik für Gynäkologie und Geburtshilfe, Offenbach, Frauenklinik
    • Grasshoff, S.-T. Frauenklinik, Quedlinburg, Germany
    • Vescia, S.. German Breast Group, Neu-Isenburg
    • Skacel, T.. Amgen (Europe) GmbH, Lucerne, Switzerland
    • Loibl, S.. German Breast Group, Neu-Isenburg
    • Mehta, K. M.. German Breast Group, Neu-Isenburg
    • Kaufmann, M.. Universitäts-Frauenklinik, Frankfurt, Germany
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2007, vol. 19, no. 2, p. 292-298. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:300252
    Summary
    Background: TAC (docetaxel/doxorubicin/cyclophosphamide) is associated with high incidences of grade 4 neutropenia and febrile neutropenia (FN). This analysis compared the efficacies of four regimens for primary prophylaxis of FN and related toxic effects in breast cancer patients receiving neoadjuvant TAC. Patients and methods: Patients with stage T2-T4 primary breast cancer were scheduled to receive 6-8 cycles of TAC. Primary prophylaxis was: ciprofloxacin 500 mg orally twice daily on days 5-14 (n = 253 patients; 1478 cycles), daily granulocyte colony-stimulating factor (G-CSF) (filgrastim 5 μg/kg/day or lenograstim 150 μg/m2/day) on days 5-10 (n = 377; 2400 cycles), pegfilgrastim 6 mg on day 2 (n = 305; 1930 cycles), or pegfilgrastim plus ciprofloxacin (n = 321; 1890 cycles). Results: Pegfilgrastim with/without ciprofloxacin was significantly more effective than daily G-CSF or ciprofloxacin in preventing FN (5% and 7% versus 18% and 22% of patients; all P < 0.001), grade 4 neutropenia, and leukopenia. Pegfilgrastim plus ciprofloxacin completely prevented first cycle FN (P < 0.01 versus pegfilgrastim alone) and fatal neutropenic events. Conclusion: Ciprofloxacin alone, or daily G-CSF from day 5-10 (as in common practice), provided suboptimal protection against FN and related toxic effects in patients receiving TAC. Pegfilgrastim was significantly more effective in this setting, especially if given with ciprofloxacin