Preoperative dose-dense sequential chemotherapy of epirubicin/cyclophosphamide followed by docetaxel/capecitabine in patients with early breast cancer

10598 Background: The use of preoperative chemotherapy for breast cancer has been shown to result in similar disease-free and overall survival as postoperative adjuvant chemotherapy. Additionally, the rate of pathologic complete response (pCR) in the breast after preoperative chemotherapy has been shown to correlate with survival. The objective of this study was to evaluate the activity and safety of a dose-dense and sequential chemotherapy of epirubicin/cyclophosphamide (EC) followed by docetaxel/capecitabine (DXe) given preoperatively in patients with early breast cancer not candidate to breast-conserving surgery. Methods: Forty-one women with histologically/cytologically confirmed primary breast cancer (T2–3, N0–2, M0) received 4 cycles of EC (cyclophosphamide, 600 mg/m2 and epirubicin, 90 mg/m2) q2 weeks followed by two cycles of DXe (docetaxel, 36 mg/m2 days 1, 8, and 15 and capecitabine, 1250 mg/m2 days 5–18) q 28 days, with pegfilgrastim support. The study was designed as a Simon’s two-step phase II study. The primary end point of the study was the incidence of pCR defined as the absence of invasive cancer in the breast at definitive surgery. Results: Thirty-nine out of 41 enrolled patients were evaluable for response to treatment (one patient withdrew from the study for G4 neutropenia after the first EC cycle, and the other for therapy refusal after the 4 EC cycles). A pCR was observed in 10 patients for a total pCR rate of 25.6%. Interestingly, all but one of the 10 pCR cases showed ER/PR-negative/Her2-positive tumors. A clinical response (CR or PR) detected by palpation and by imaging was observed in 37 patients, for an overall response rate of 95%. Twenty-nine patients (75%) underwent breast-conserving surgery. The treatment was well tolerated: one patient experienced G3 mucositis and another patient required a 25% dose reduction of capecitabine because of hand-foot syndrome. There was no case of cardiac toxicity, thrombocytopenia or any other serious adverse event. Conclusions: The dose-dense sequential combination EC/DXe is endowed with good antitumor activity and limited toxicity, allowing a high rate of pCR and breast conservation. Thus, this regimen can be considered for further clinical trial. No significant financial relationships to disclose.