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

Abstract

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-up (range; 1–45), only 4 relapses, and one death have occurred. Grade 3–4 neutropenia, and anemia occurred in 27% and 5% of patients, respectively. Emesis, diarrhea, and mucositis were the main non-hematologic toxicities; however, they were severe in less than 10% of patients. Peripheral neuropathy was frequent, but never severe. Conclusions: A Two-month weekly treatment with PET represents a well tolerated and highly effective approach in large operable breast cancer patients. It is worth-noting that in spite of the short duration of chemotherapy more than one-third of patients achieved a complete eradication of the tumor in both breast and axilla. The accrual is still ongoing (planned sample size being 50 patients), and we expect that final results will be available at the time of the meeting. No significant financial relationships to disclose.