Epirubicin and Docetaxel as neoadjuvant treatment of hormone receptor positive, HER-2 negative breast cancer: results from two successive phase II studies
Background. We report on the activity of the combination of Epirubicin and Docetaxel administered for 4 and 8 cycles respectively in 2 successive series of patients as neoadjuvant chemotherapy of advanced, hormone receptor positive, HER-2 negative breast cancer.
Patients and Methods. Fifty patients were treated from 2002 to 2006 with Epirubicin 90 mg/m2 and Docetaxel 75 mg/m2 intravenously, every 3 weeks for 4 cycles before and 4 cycles after surgery (Series I – 13 patients), and from 2006 to 2010 with the same regimen administered for 8 cycles preoperatively (Series II – 37 patients), plus hormone therapy for 5 years and radiation therapy if indicated.
Results. Clinical response (Series I/Series II) included complete remission in 1/13 and partial remission in 10/21 patients (response rate 84/92%). All 50 patients underwent surgery (quadrantectomy in 4 Series I and 15 Series II patients). Histological examination of the breast and lymph nodes revealed no signs of disease in 1 Series I and 4 series II patients. G3-G4 toxicity included myelosuppression in 11 Series I and in all 37 Series II patients and mucositis in 1 series I and 4 Series II patients. No other G3-4 toxicities nor toxic deaths occurred. Five-year progression free survival was 38% and 90% in Series I and Series II patients respectively.Conclusions. The incidence of pathologic complete remissions was low in this patient population, confirming reported data. A longer duration of preoperative treatment seemed to be associated with a longer relapse-free survival.