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Medline ® Abstract for Reference 30

of 'General principles of neoadjuvant therapy for breast cancer'

Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study.
Schneeweiss A, Huober J, Sinn HP, von Fournier D, Rudlowski C, Beldermann F, Krauss K, Solomayer E, Hamerla R, Wallwiener D, Bastert G
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.
Department of Gynaecology and Obstetrics, University of Heidelberg, Vossstrasse 9, D-69115 Heidelberg, Germany. andreas_schneeweiss@med.uni-heidelberg.de