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Medline ® Abstract for Reference 30

of 'General principles of neoadjuvant therapy for breast cancer'

30
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Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study.
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Schneeweiss A, Huober J, Sinn HP, von Fournier D, Rudlowski C, Beldermann F, Krauss K, Solomayer E, Hamerla R, Wallwiener D, Bastert G
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Eur J Cancer. 2004;40(16):2432.
 
Developing primary systemic chemotherapy (PST) regimens that induce higher pathological complete response (pCR) rates remains a challenge in operable breast cancer. We recruited 77 eligible patients into a multicentre phase I/II study to evaluate the maximum tolerated dose (MTD), toxicity and efficacy of preoperative gemcitabine day 1 and 8 (800 mg/m(2) fixed dose), epirubicin and docetaxel on day 1 (doses escalated from 60 mg/m(2)) (GEDoc), repeated 3-weekly for 6 cycles with filgrastim support. MTD for epirubicin was 90 mg/m(2) and for docetaxel 75 mg/m(2). Dose-limiting toxicities (DLTs) included febrile neutropenia and grade 3 diarrhoea. Clinical response rate was 92%, pCR rate was 26%. 79% of patients had breast-conserving surgery. Grade 3/4 leucopenia was the main toxicity, occurring in 55 (87%) of 63 patients treated at the MTD. Non-haematological toxicity caused no serious clinical problems. In conclusion, GEDoc is highly active as PST. Efficacy and toxicity compare favourably with other effective combinations.
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Department of Gynaecology and Obstetrics, University of Heidelberg, Vossstrasse 9, D-69115 Heidelberg, Germany. andreas_schneeweiss@med.uni-heidelberg.de
PMID