Phase II trial of dose dense docetaxel followed by FEC100 as neoadjuvant chemotherapy in patients with operable breast cancer.

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. 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. 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. This trial confirms the feasibility and efficacy of this dose dense docetaxel neoadjuvant regimen.