Takaaki Fujii1, Jun Horiguchi2, Yasuhiro Yanagita3, Yukio Koibuchi4, Fumihiro Ikeda5, Nobuyuki Uchida6, Morihiko Kimura7. 1. Division of Breast and Endocrine Surgery, Department of General Surgical Science, Graduate School of Medicine, Gunma University, Gunma, Japan ftakaaki@gunma-u.ac.jp. 2. Breast Surgery, International University of Health and Welfare, Chiba, Japan. 3. Department of Breast Oncology, Gunma Prefectural Cancer Center, Gunma, Japan. 4. Breast and Endocrine Surgery, NHO Takasaki General Medical Center, Gunma, Japan. 5. Breast and Endocrine Surgery, Maebashi Red Cross Hospital, Gunma, Japan. 6. Surgery, Haramachi Red Cross Hospital, Gunma, Japan. 7. Breast Surgery, Ota Memorial Hospital, Gunma, Japan.
Abstract
AIM: Treatment strategies for patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC) have significantly progressed. The use of trastuzumab, a monoclonal antibody targeting the HER2 (human epidermal growth factor 2) protein, in combination with chemotherapy improves survival in patients with HER2-positive breast cancer. S-1, an oral combination of fluorouracil derivatives, is widely used in Japan and is more convenient than intravenous drugs. However, little is known about the combination of S-1 and trastuzumab in patients with HER2-positive MBC. PATIENTS AND METHODS: We conducted a single-arm, open-label, multicenter prospective phase II study to evaluate the efficacy of an S-1 plus trastuzumab regimen for HER2-positive MBC. S-1 was administered orally [80-120 mg, based on body surface area (BSA)] twice a day for 14 consecutive days in a 3-week cycle. Patients with BSA of <1.25 m2 received a total of 80 mg of S-1, those with BSA ≥1.5 m2 received 120 mg, and the remaining received 100 mg daily in two divided doses. Trastuzumab was administered intravenously at 8 mg/kg on day 1 of the first cycle and at 6 mg/kg on day 1 of subsequent cycles, i.e., every 3 weeks. RESULTS: Between December 2008 and March 2013, 10 patients were enrolled and received a median of 17 (range=3-76) cycles of treatment. Overall response and clinical benefit rates were 60.0% and 90.0%, respectively. Progression-free survival was 15.8 (95% confidence interval=9.4-29.6) months and overall survival was 45.5 (95% confidence interval=37.1-62.2) months. Grade 3/4 adverse events included were neutropenia and hyperglycemia in one patient each (10.0%). There was no clinically significant cardiotoxicity. CONCLUSION: The combination of S-1 and trastuzumab was tolerable and had excellent efficacy with good response and disease control in this study. S-1 plus anti-HER2 therapy is a feasible treatment option for HER2-positive MBC. Copyright
AIM: Treatment strategies for patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC) have significantly progressed. The use of trastuzumab, a monoclonal antibody targeting the HER2 (human epidermal growth factor 2) protein, in combination with chemotherapy improves survival in patients with HER2-positive breast cancer. S-1, an oral combination of fluorouracil derivatives, is widely used in Japan and is more convenient than intravenous drugs. However, little is known about the combination of S-1 and trastuzumab in patients with HER2-positive MBC. PATIENTS AND METHODS: We conducted a single-arm, open-label, multicenter prospective phase II study to evaluate the efficacy of an S-1 plus trastuzumab regimen for HER2-positive MBC. S-1 was administered orally [80-120 mg, based on body surface area (BSA)] twice a day for 14 consecutive days in a 3-week cycle. Patients with BSA of <1.25 m2 received a total of 80 mg of S-1, those with BSA ≥1.5 m2 received 120 mg, and the remaining received 100 mg daily in two divided doses. Trastuzumab was administered intravenously at 8 mg/kg on day 1 of the first cycle and at 6 mg/kg on day 1 of subsequent cycles, i.e., every 3 weeks. RESULTS: Between December 2008 and March 2013, 10 patients were enrolled and received a median of 17 (range=3-76) cycles of treatment. Overall response and clinical benefit rates were 60.0% and 90.0%, respectively. Progression-free survival was 15.8 (95% confidence interval=9.4-29.6) months and overall survival was 45.5 (95% confidence interval=37.1-62.2) months. Grade 3/4 adverse events included were neutropenia and hyperglycemia in one patient each (10.0%). There was no clinically significant cardiotoxicity. CONCLUSION: The combination of S-1 and trastuzumab was tolerable and had excellent efficacy with good response and disease control in this study. S-1 plus anti-HER2 therapy is a feasible treatment option for HER2-positive MBC. Copyright
Authors: Hae Won Lee; Sook Jin Seong; Woo Youl Kang; Boram Ohk; Mi-Ri Gwon; Bo Kyung Kim; Seungil Cho; Kyunghee Cho; Yong Kyung Sung; Young-Ran Yoon; Jong Gwang Kim Journal: Drug Des Devel Ther Date: 2019-09-03 Impact factor: 4.162