Annals of Oncology Advance Access originally published online on September 9, 2007
Annals of Oncology 2008 19(2):292-298; doi:10.1093/annonc/mdm438
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breast cancer |
Pegfilgrastim ± ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study
1 German Breast Group, Neu-Isenburg
2 Universitäts-Frauenklinik, Charité, Berlin
3 Universitäts-Frauenklinik, Essen
4 Dr Horst-Schmidt-Klinik, Wiesbaden, Frauenklinik
5 Frauenklinik vom Roten Kreuz, Munich
6 Universitäts-Frauenklinik, Kiel
7 Universitäts-Frauenklinik Rostock
8 Henrietten Stift, Hannover, Frauenklinik
9 Universitäts-Frauenklinik, Tübingen
10 Universitäts-Frauenklinik, Magdeburg
11 Klinik für Gynäkologie und Geburtshilfe, Offenbach, Frauenklinik
12 Frauenklinik, Quedlinburg, Germany
13 Amgen (Europe) GmbH, Lucerne, Switzerland
14 Department of Internal Medicine–Hematoonkology, University Hospital, Brno, Czech Republic
15 Universitäts-Frauenklinik, Frankfurt, Germany
* Correspondence to: Dr G. von Minckwitz, German Breast Group/Universitäts-Frauenklinik Frankfurt, Schleussner Str. 42, 63263 Neu-Isenburg, Germany. Tel: +49-6102-798740; Fax:+49-6102-7987440; E-mail: minckwitz{at}germanbreastgroup.de
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.
Key words: breast cancer, ciprofloxacin, docetaxel, febrile neutropenia, granulocyte colony-stimulating factor, primary prophylaxis
Received for publication April 3, 2007. Revision received August 1, 2007. Accepted for publication August 7, 2007.