[High-dose CEF (cyclophosphamide, epirubicin, fluorouracil) as primary chemotherapy in locally advanced breast cancer: long-term results].

Purpose: To determine wether primary CEF is effective in locally advanced breast cancer, as measured by response, local recurrences, disease free survival (DFS) and overall survival (OS). Patients and methods: From 1990 to 1998, 62 patients (pts) with stage III disease were enroled into a prospective study at Regina Elena Institute for Cancer Research, Rome. Inflammatory breast cancer (IBC) was included. Pts received three 21 d cycles of chemotherapy that consisted in epirubicin 50 mg/m, cyclophosphamide 400 mg/m and fluorouracil 500 mg/m i.v. on days 1 and 8. G-CSF (300 lg) was given subcutaneously every other day from days 5 to 17. After primary chemotherapy, whenever possible, mastectomy or conservative surgery was performed. Subsequently responding pts received the same regimen, whilst nonresponders were given a non-cross resistant chemotherapy. In case of conservative surgery or initial T4 tumour radiation therapy was performed at the end of adjuvant chemotherapy. ER positive pts received tamoxifen 20 mg/d for five years. Results: Median follow for the cohort was 109 months (range, 10–199). The local recurrence rate was 19.3%; two pts developed a new primary cancer in the contralateral breast. Distant metastases occurred in 29 pts (46.7%). The 5 years DFS rate for IIIA pts was 14.3% (median DFS: 27, CI 95% 17–37), for IIIB was 52.5% (median DFS: 87, CI 95% 10–175) for IBC was 20% (median DFS: 27 month, CI 95% 14–40), p-value 0.009. The 10-years OS for the IIIA pts was 28.6% (median OS: 43 month, CI 95% 30–56), for IIIB was 47.5% (median OS:116 month, CI 95% 47–185) and for IBC was 26.7% (median OS: 46 month, IC 26–66), p-value 0.11. Conclusion: Ten years of follow up of stage III breast cancer is rarely reported. In IIIB pts we obtained a good local control and interesting long term data of OS.