Dose-dense epirubicin with paclitaxel as preoperative treatment in locally advanced breast cancer: Phase II trial

Abstract

e11633 Background: Treatment of locally advanced breast cancer (LABC) with anthracycline-based regimens have pathological complete response (pCR) of 10–15%, and with anthracyclin-taxane therapy have pCR 18–30%. Combined or sequential are both acceptable with the most important agents. Methods: We use a dose- dense regimen epirubicin and paclitaxel for 12 weeks to determine the effectiveness in the neoadjuvant setting could increase pCR and safety of the regimen. This phase II study investigated women with untreated locally advanced breast cancer assigned to receive epirrubicina 25 mg/m2 and paclitaxel 70 mg/m2 for twelve weeks. Results: 21 patients were enrolled at median follow up of eight months. The median age was 55 years old (28–67). The distribution by TNM was IIB (15%), IIIA (52%), IIIB (24%) y IIIC (9%) and tumor type was lobular (24%) and ductal (76%). The mean tumor size was 8 cm (5 -14 cm). Ninety percent completed twelve cycles of chemotherapy with a two hundred forty five cycles administered. In six patients had dose reduction by 10–20% in subsequent doses and one patient withdrawn from de study because of chemotherapy related toxicity. In 9 percent of patients we use G-SCF. Surgery was performed in 18 patients. Eleven patients (52%) achieved a clinical response (PR o CR) after twelve cycles. Complete pathological response and partial was 11% y 14%. Subset analysis of the effect of Independent predictors included receptor status, Her2 neu, tumor size, and histology was no statistically significant (p.68). Treatment was generally well tolerated. Grade 3/4 non-hematologic adverse events (neurotoxicity, nauseas and palmar plantar dysesthesia) events occurred in 5% of patients. No cardiac toxicity was found. Conclusions: Despite the small sample size, it was representative of our population of LABC. These data indicate that the combined regimen in dose-dense epirubicin and paclitaxel is a regimen with acceptable toxicity. However we have low percent of cPR, maybe we have a high percent of patients with stage IIIA and IIIB with large diameter of tumor size. No significant financial relationships to disclose.