Ryoichi Matsunuma1,2, Toru Watanabe3, Yasuo Hozumi4,5, Kei Koizumi6, Yasushi Ito7, Shoko Maruyama8, Hiroyuki Ogura6, Keigo Goto7, Hiroki Mori9, Noriko Sawai3, Norihiko Shiiya6. 1. First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan. r-matsunuma@nifty.com. 2. Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Shizuoka, 420-8527, Japan. r-matsunuma@nifty.com. 3. Department of Medical Oncology, Hamamatsu Oncology Center, Hamamatsu, Shizuoka, 430-0929, Japan. 4. Department of Breast Surgery, Jichi Medical University Hospital, Shimotsuke, Tochigi, 329-0498, Japan. 5. Department of Breast Surgery, University of Tsukuba Hospital/Ibaraki Prefectural Central Hospital, Kasama, Ibaraki, 309-1793, Japan. 6. First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan. 7. Department of Breast Surgery, Iwata City Hospital, Iwata, Shizuoka, 438-8550, Japan. 8. Department of Surgery, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, 433-8558, Japan. 9. Department of Breast Surgery, Hamamatsu Medical Center, Hamamatsu, Shizuoka, 432-8580, Japan.
Abstract
PURPOSE:Luminal B-like breast cancer is sensitive to both chemotherapy and endocrine therapy. We aimed to assess the safety and efficacy of concomitant chemotherapy and endocrine therapy compared with chemotherapy alone in the preoperative setting in luminal B-like breast cancer. METHODS: This two-arm randomized clinical trial enrolled patients with luminal B-like human epithelial growth factor 2-negative breast cancer, who were randomly assigned at a 1:1 ratio to receive preoperative chemotherapy alone or preoperative endocrine therapy concurrent with chemotherapy for 24 weeks before surgery. The primary endpoint was the pathological complete response (pCR) rate. The secondary endpoints included the clinical response rate, toxicity, and health-related quality of life (HRQOL). RESULTS: Overall, 70 patients were randomly assigned to the chemotherapy and chemo-endocrine therapy groups. The pCR rates were 9.7% and 3.0% (P = 0.319), and the clinical complete response rates were 5.9% and 5.6% (P = 0.745) in the chemotherapy and chemo-endocrine therapy groups, respectively. There were no clear differences in treatment-related adverse events or HRQOL between the two groups. CONCLUSIONS: In patients with luminal B-like breast cancer, the pCR, clinical response rate, toxicity, and HRQOL with the concomitant administration of endocrine therapy and chemotherapy were not superior to chemotherapy alone in the preoperative setting.
RCT Entities:
PURPOSE: Luminal B-like breast cancer is sensitive to both chemotherapy and endocrine therapy. We aimed to assess the safety and efficacy of concomitant chemotherapy and endocrine therapy compared with chemotherapy alone in the preoperative setting in luminal B-like breast cancer. METHODS: This two-arm randomized clinical trial enrolled patients with luminal B-like human epithelial growth factor 2-negative breast cancer, who were randomly assigned at a 1:1 ratio to receive preoperative chemotherapy alone or preoperative endocrine therapy concurrent with chemotherapy for 24 weeks before surgery. The primary endpoint was the pathological complete response (pCR) rate. The secondary endpoints included the clinical response rate, toxicity, and health-related quality of life (HRQOL). RESULTS: Overall, 70 patients were randomly assigned to the chemotherapy and chemo-endocrine therapy groups. The pCR rates were 9.7% and 3.0% (P = 0.319), and the clinical complete response rates were 5.9% and 5.6% (P = 0.745) in the chemotherapy and chemo-endocrine therapy groups, respectively. There were no clear differences in treatment-related adverse events or HRQOL between the two groups. CONCLUSIONS: In patients with luminal B-like breast cancer, the pCR, clinical response rate, toxicity, and HRQOL with the concomitant administration of endocrine therapy and chemotherapy were not superior to chemotherapy alone in the preoperative setting.