Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer

Background: This phase III clinical study was designed to investigate whether 6 cycles of epirubicin plus docetaxel (ED) is more effective than 4 cycles of ED as neoradjuvant chemotherapy (NC) in patients with stage II or III breast cancer. Patients and methods: Women with breast cancer that had tumors larger than 3 cut were prospectively randomized to receive 4 or 6 cycles of epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2) every 3 weeks. The primary end point was the clinical response to NC. Results: A total of 176 patients were randomly assigned, and 150 patients were assessable for efficacy and toxicity. Groups were well balanced for clinicopathologic parameters. The median age was 42 years (range 30-58). Overall clinical response was observed in 72% with ED4 and 82% with ED6.pCR was observed in 11% with ED4 and in 24% with ED6 (p = 0.047). 47% of the ED4 group underwent breast conserving surgery (BCS) whereas 58% of ED6 group underwent BCS. Grade 3/4 neutropenia was observed in 27% in EN and 31% in FD6. Febrile neutropenia occurred in 17% with FD4 and 19% with ED6. Grade 3 mucositis was observed in 8% with ED4 and in 6% with ED6. Conclusion: Six cycles of ED enhanced the rates of pCR and BCS compared with 4 cycles without increasing treatment-related toxicities. (C) 2009 Elsevier Ltd. All rights reserved.