Phase II study of combined docetaxel, epirubicin, and cyclophosphamide as a neoadjuvant chemotherapy regimen in patients with locally advanced breast cancer in a single institution.

Abstract

e11040 Background: Neoadjuvant chemotherapy with anthracycline and taxane combinations is a standard approach for locally advanced breast cancer. One commonly used regimen is docetaxel, doxorubicin and cyclophosphamide. Epirubicin is another anthracycline used in breast cancer but the combined use of epirubicin and taxane is not well established. We conducted a single institution, phase II study to assess the efficacy of combined docetaxel, epirubicin and cyclophosphamide (TEC) as a neoadjuvant chemotherapy regimen. Methods: Eligible patients were female with newly diagnosed locally advanced breast cancer defined as T2 > 3 cm, T3-4, any N, or any T, N1-3, M0. A chemotherapy regimen of docetaxel 75 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2 was given with growth factor support every 3 weeks for 6 cycles. All patients had surgery within 3-6 weeks after completion of chemotherapy. Primary end-point was pathologic complete response (pCR). Results: Twenty-one patients were registered from December 2003 to December 2006. One patient was excluded because of history of thyroid cancer. Median age was 51 (29-70). Eight patients (40%) were premenopausal. Ten patients (50%) had negative tumor hormone receptors. Four patients (20%) who had HER2/neu overexpression received adjuvant trastuzumab. All but one patient completed 6 cycles of TEC chemotherapy. One patient refused to receive the last cycle of chemotherapy. Fourteen patients (70%) had lumpectomy and 6 patients (30%) underwent mastectomy. The pCR rate was 25%. Eight of 16 patients with N1-3 disease (50%) had pathological negative lymph nodes. With a median follow up of 57.5 (16-71) months, 4 patients (20%) relapsed with 1 died from recurrence. The estimated 5-year relapse free survival is 79%. No patient had cardiac failure or death during treatment. The most common grade 3-4 toxicity was neutropenia (35%). Conclusions: Combined TEC regimen is a feasible, well-tolerated and effective neoadjuvant chemotherapy regimen for locally advanced breast cancer that results in a pCR rate of 25%. No significant financial relationships to disclose.