Feasibility of docetaxel, epirubicin, and capecitabine (TEX) plus pegfilgrastim as neoadjuvant treatment for primary breast cancer: A pilot stud

Abstract

714 Background: Preoperative chemotherapy in patients with primary breast cancer treated with anthracyclines and taxanes results in high response rates, allowing breast conserving surgery in patients primarily not suitable for this procedure. Capecitabine, as a well tolerated, highly effective, and convenient alternative to parental 5-FU, plays potentially a key role in the treatment of patients with advanced breast cancer. A current phase II study demonstrated that TEX regimen has substantially activity as first-line treatment in patients with metastatic breast cancer and impressive activity in patients with locally advanced breast cancer, of whom approximately 30% achieved a pathological complete response. However 51% of the patients developed grade 3/4 neutropenia and febrile neutropenia occurred in 16%. Methods: Based on these results we are conducting a pilot trial adding capecitabine to epirubicin and taxotere in patients with primary breast cancer. Oral capecitabine, 1000 mg/m², is administered twice daily on days 1–14 of each 3-week treatment cycle. Epirubicin, 75 mg/m², and docetaxel, 75 mg/m², is administered as a short i.v. infusion and a 1-hour infusion on day 1 of each treatment cycle, respectively. As primary prophylaxis to prevent neutropenia pegfilgrastim 6 mg s.c. on day 2 of each cycle is applied. Conclusions: Aim of this study is the concern about the concomitant application of a G-CSF to continuous chemotherapy and therefore to evaluate the feasibility and toxicity of this therapy regimen. Toxicity and efficacy data will be presented at ASCO meeting 2004. No significant financial relationships to disclose.