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Annals of Oncology 2005 16(1):56-63; doi:10.1093/annonc/mdi001
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© 2005 European Society for Medical Oncology

In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer: the GEPARTRIO pilot study

G. von Minckwitz1,*, J.-U. Blohmer2, G. Raab3, A. Löhr4, B. Gerber5, G. Heinrich6, H. Eidtmann7, M. Kaufmann8, J. Hilfrich9, C. Jackisch10, I. Zuna11 and S. D. Costa12 On behalf of the German Breast Group

1 The German Breast Group, Frankfurt; 2 Charité Women's Hospital, Berlin; 3 Red Cross Women's Hospital, Munich; 4 Horst Schmidt Kliniken, Department of Gynaecology, Wiesbaden; 5 First Women's Hospital, LMU-University of Munich, Munich; 6 Gynäkologische Schwerpunktpraxis, Fürstenwalde; 7 University Women's Hospital, Kiel; 8 University Women's Hospital Frankfurt; 9 Henrietten Women's Hospital, Hannover; 10 University Women's Hospital, Marburg; 11 Creative Research Solution, Wiesbaden; 12 Markus-Women's Hospital, Frankfurt, Germany

* Correspondence to: Dr G. von Minckwitz, University of Frankfurt/German Breast Group (GBG), Schleussner Str. 42, 63263 Neu-Isenburg, Germany. Tel: +49-69-6102-798740; Fax: +49-69-6102-7987440; Email: minckwitz{at}germanbreastgroup.de

Background: Response to the first two cycles of preoperative chemotherapy might differentiate subgroups of breast cancer patients with high or minimal chances for a pathologic complete response (pCR) and may be used as an in vivo chemosensitivity test.

Methods: Breast cancer patients were treated with two cycles of TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 every 21 days). Patients whose tumors showed a response received four more cycles. Patients whose tumors did not respond were randomized to four additional cycles TAC or NX (vinorelbine 25 mg/m2 days 1 and 8, capecitabine 2000 mg/m2 days 1–14, every 21 days). The primary end point was pCR at surgery.

Results: Two hundred and eighty-five patients showed a clinical response, in 73.0% after two cycles, in 88.4% at surgery, and a pCR was seen in 17.9%. Breast conservation was possible in 72.2%. Responding patients obtained a pCR in 22.6% whereas non-responding patients reached a pCR in 7.3% and 3.1% with TAC or NX, respectively. Grade III/IV neutropenia and febrile neutropenia were observed during TAC in 70.2% and 13.5%, respectively. Significantly less toxicity were observed with NX.

Conclusion: Early response to TAC can reliably identify patients with a high chance of achieving a pCR. New effective treatments need to be explored for patients without an early response.

Key words: breast cancer, docetaxel, in vivo chemosensitivity test, preoperative


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