title: Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study.
abstract: 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.
authors.affiliation: Department of Gynaecology and Obstetrics, University of Heidelberg, Vossstrasse 9, D-69115 Heidelberg, Germany. andreas_schneeweiss@med.uni-heidelberg.de
authors.forename: A
authors.initials: A
authors.lastname: Schneeweiss
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.forename: H-P
authors.initials: HP
authors.lastname: Sinn
authors.forename: D
authors.initials: D
authors.lastname: von Fournier
authors.forename: C
authors.initials: C
authors.lastname: Rudlowski
authors.forename: F
authors.initials: F
authors.lastname: Beldermann
authors.forename: K
authors.initials: K
authors.lastname: Krauss
authors.forename: E
authors.initials: E
authors.lastname: Solomayer
authors.forename: R
authors.initials: R
authors.lastname: Hamerla
authors.forename: D
authors.initials: D
authors.lastname: Wallwiener
authors.forename: G
authors.initials: G
authors.lastname: Bastert
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D017239:Paclitaxel; D000093542:Gemcitabine