Background: Primary systemic therapy (PST) with a combination of epirubicin and paclitaxel achieves high response rates in locally advanced breast cancer (LABC), but considerable toxicity occurs and the patient's compliance is poor. In this open-label phase II trial toxicity of a weekly administration schedule was evaluated.
Patients and methods: On days 1 and 8 of each 3-week cycle, 45 patients with non-inflammatory breast cancer received epirubicin (35 mg/m(2), intravenous bolus) followed by paclitaxel (80 mg/m(2) in 500 ml of normal saline infused over 3 h) for 3 cycles. Surgery was done 2 weeks after primary chemotherapy, followed by another 6 cycles of adjuvant CEF (cyclophosphamide 500 mg/m(2), epirubicin 70 mg/m(2), 5-fluorouracil 500 mg/m(2)) chemotherapy.
Results: The median tumor size before and after PST was 6.0 and 2.0 cm, respectively. The clinical response rate was 96%, including 24% complete remission; 5 patients (11%) achieved pathologically complete response (pCR) including 3 patients with carcinoma in situ. Only 5 (11%) patients underwent breast conserving surgery although there were 15 patients suitable. Axillary nodes were negative in 16 (36%) of the 45 patients. Febrile neutropenia was found in 1 patient. There was no severe cardiac toxicity or serious adverse events.
Conclusions: PST with weekly epirubicin and paclitaxel was an effective and well-tolerated combination for LABC, although only few patients underwent breast conserving surgery.