Neoadjuvant Epirubicin/Docetaxel (ET) Concomitant Chemotherapy for Primary Breast Cancer with Tumor Diameter ≥3.1 cm: Results of the Kyushu ET Therapy Phase II Trial

Aim: Neoadjuvant epirubicin/docetaxel (ET) combination chemotherapy was administered to breast cancer patients in order to investigate their clinical and pathological response. Moreover, the breast-conserving surgery (BCS) rate, disease-free (DFS) and overall survival (OS), safety profile and the correlation of biological markers were investigated. Patients and Methods: Out of the 46 enrolled patients, 45 patients were analyzed for clinical response, and 40 patients were examined for pathological response. Estrogen receptor (ER), progesterone receptor (PgR) and human epidermal growth factor receptor type2 (HER2) expression were examined immunohistologically. Results: The median tumor size was 4.5 cm in diameter. Complete (CR) and partial responses were seen in 3 and 30 patients, respectively. A pathological CR was achieved in 4 patients and correlated with ER and PgR negativity. Moreover, BCS was performed on 16 patients. The 5-year cumulative DFS was 60.7% and OS was 91.8%. Conclusion: ET therapy is clinically effective with a pathological CR rate of 10% for patients with a large tumor, and should be considered as a neoadjuvant treatment option. Recent advances in drug therapy and biological research on breast cancer have shown an important role of systemic therapy in breast cancer. Prolonged survival was reported by the Early Breast Cancer Trialists' Collaborative Group of patients with early breast cancer who were treated with systemic therapy (1). Hormone-dependent breast cancer responds well to endocrine therapy, while chemotherapy and anti-(HER2) therapy are also effective treatment options. Neoadjuvant chemotherapy (NAC) has been used for patients with locally advanced breast cancer