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Phase II Trial of Dose Dense Docetaxel Followed by FEC100 as Neoadjuvant Chemotherapy in Patients With Operable Breast Cancer

Objectives:The aim of this study was to evaluate the efficacy and safety profile of 4 dose-dense cycles of docetaxel followed by 3 cycles of FEC100 neoadjuvant chemotherapy in patients with operable advanced breast cancer. Methods:Women were treated by 4 cycles of 100 mg/m2 docetaxel every 2 weeks, followed by 3 cycles of FEC100 given every 3 weeks. The primary end point was pathologic complete response. Results:Forty-five patients were treated. Ninety-three percent of the patients completed the planned 7 chemotherapy courses. The median relative dose intensity for docetaxel, 5-fluorouracil, epirubicin, and cyclophosphamide were 0.98, 0.97, 0.96, and 0.97, respectively. There were no therapy-related deaths. Two patients stopped chemotherapy because of cutaneous toxicity. During the docetaxel sequence, the most common grade 3–4 toxicities were (% pts): neutropenia (13.3), grade 3: cutaneous (24.4), myalgia and arthralgia (6.7). No clinical cardiac toxicity was observed. The pathologic complete response rate was 21.4% and 26.2% using Sataloff and Chevallier classifications, respectively. The conservative surgery rate was 62.2%. The median follow-up was 38.5 months. Two and 3-year disease-free survival rates were 79% and 64%, respectively. Two- and 3-year overall survival rate were 93% and 88%, respectively. Conclusions:This trial confirms the feasibility and efficacy of this dose dense docetaxel neoadjuvant regimen.