Publication

Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study

Journal Paper/Review - Nov 1, 2004

Units
PubMed
Doi

Citation
Schneeweiss A, Wallwiener D, Hamerla R, Solomayer E, Krauss K, Beldermann F, Rudlowski C, von Fournier D, Sinn H, Huober J, Bastert G. Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study. European journal of cancer (Oxford, England : 1990) 2004; 40:2432-8.
Type
Journal Paper/Review (English)
Journal
European journal of cancer (Oxford, England : 1990) 2004; 40
Publication Date
Nov 1, 2004
Issn Print
0959-8049
Pages
2432-8
Brief description/objective

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.