Naoki Hayashi1, Hiroshi Yagata2, Koichiro Tsugawa3, Yuka Kajiura4, Atsushi Yoshida4, Junko Takei4, Hideko Yamauchi4, Seigo Nakamura5. 1. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan. Electronic address: naokiha@luke.ac.jp. 2. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan; Department of Breast Care, Saitama Medical Center, Saitama, Japan. 3. Division of Breast and Endocrine Surgery, Department of Surgery, St Marianna University School of Medicine, Kawasaki, Tokyo, Japan. 4. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan. 5. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan; Department of Breast Surgical Oncology, Showa University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Although a docetaxel and cyclophosphomide (TC) regimen without anthracycline as adjuvant therapy became one of the standard regimens especially for ER-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) primary breast cancer, the efficacy of TC as neoadjuvant chemotherapy (NAC) is not known. We conducted the prospective trial to assess the efficacy of a TC regimen in the neoadjuvant setting for stage II to III ER+/HER2- primary breast cancer. PATIENTS AND METHODS: A TC regimen that included 75 mg/m2 of docetaxel and 600 mg/m2 of cyclophosphamide for 4 cycles every 3 weeks was administered as NAC. Primary endpoints are the rate of clinical response (clinical partial response and clinical complete response) and pathologic complete response; secondary endpoints are the disease-free survival and overall survival rates. RESULTS: Thirty (71.4%) of 42 tumors had clinical response. No patient achieved pathologic complete response. At the median follow-up period of 105.2 months (range, 12.1-119.7 months), the disease-free survival rate was 81.6%, and the distant disease-free survival rate was 86.8%. In terms of survival, only 1 patient died during the study period. The overall survival rate was 97.4% during the study period. Patients who developed distant recurrence had a trend to have progesterone receptor-negative or weakly positive compared with those who did not develop any recurrence (85.7% vs. 45.2%; P = .05). CONCLUSIONS: Our prospective study showed that a TC regimen as NAC achieved a high clinical response rate in stage II to III ER+/HER2- breast cancer. A TC regimen without anthracycline as NAC might be one of the options for patients with ER+/HER2- breast cancer without high-risk factors including progesterone receptor negativity.
BACKGROUND: Although a docetaxel and cyclophosphomide (TC) regimen without anthracycline as adjuvant therapy became one of the standard regimens especially for ER-positive (ER+)/humanepidermal growth factor receptor 2-negative (HER2-) primary breast cancer, the efficacy of TC as neoadjuvant chemotherapy (NAC) is not known. We conducted the prospective trial to assess the efficacy of a TC regimen in the neoadjuvant setting for stage II to III ER+/HER2- primary breast cancer. PATIENTS AND METHODS: A TC regimen that included 75 mg/m2 of docetaxel and 600 mg/m2 of cyclophosphamide for 4 cycles every 3 weeks was administered as NAC. Primary endpoints are the rate of clinical response (clinical partial response and clinical complete response) and pathologic complete response; secondary endpoints are the disease-free survival and overall survival rates. RESULTS: Thirty (71.4%) of 42 tumors had clinical response. No patient achieved pathologic complete response. At the median follow-up period of 105.2 months (range, 12.1-119.7 months), the disease-free survival rate was 81.6%, and the distant disease-free survival rate was 86.8%. In terms of survival, only 1 patientdied during the study period. The overall survival rate was 97.4% during the study period. Patients who developed distant recurrence had a trend to have progesterone receptor-negative or weakly positive compared with those who did not develop any recurrence (85.7% vs. 45.2%; P = .05). CONCLUSIONS: Our prospective study showed that a TC regimen as NAC achieved a high clinical response rate in stage II to III ER+/HER2- breast cancer. A TC regimen without anthracycline as NAC might be one of the options for patients with ER+/HER2- breast cancer without high-risk factors including progesterone receptor negativity.