Two-month cisplatin-epirubicin-paclitaxel (PET) weekly administration for the treatment of large operable breast cancer. SICOG 0105 phase II study

601 Purpose: The present study was aimed at defining the antitumor activity of 8 PET weekly cycles with G-CSF support in patients with large operable breast cancer. Methods: Breast cancer (T2-T3 N0–1) patients received 8 weekly cycles of cisplatin 30 mg/sqm, epirubicin 50 mg/sqm, paclitaxel 120 mg/sqm, with G-CSF (5 microgr./kg days 3–5) support. Results: To date 47 patients (T2/T3=19/28; N0/N+=8/39) have been enrolled. Forty patients have completed the planned chemotherapy plan, and are evaluable for clinical and pathological response. Twenty Complete (50%), 19 Partial (48%), and 1 Minor Responses have been recorded, giving a 98% response rate [95% confidence interval, 84–100%]. Breast-sparing surgery was performed in 24/40 patients (in 15 radical mastectomy had been planned at diagnosis). At pathological assessment, 20 patients (50%) showed absence of residual disease in breast and 19 (48%) had negative axilla. In 14 women both breast and axilla were found disease-free (35%). At a 33-month median follow...