Junichiro Watanabe1, Yoshinori Ito2, Toshiaki Saeki3, Norikazu Masuda4, Toshimi Takano5, Shintaro Takao6, Kazuhiko Nakagami7, Koichiro Tsugawa8, Shintaro Nakagawa9, Kazumitsu Kanatani9, Takahiro Nakayama10. 1. Breast Oncology, Shizuoka Cancer Center, Shizuoka, Japan j.watanabe@scchr.jp. 2. Breast Medical Oncology, Breast Oncology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 3. Department of Breast Oncology, Saitama International Medical Center, Saitama Medical University, Saitama, Japan. 4. Department of Surgery, Breast Surgery, Osaka National Hospital, Osaka, Japan. 5. Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan. 6. Department of Breast Surgery and Oncology, Hyogo Cancer Center, Hyogo, Japan. 7. Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan. 8. Division of Breast and Endocrine Surgery, Department of Surgery, St. Marianna University School of Medicine, Kanagawa, Japan. 9. Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. 10. Department of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
Abstract
BACKGROUND/AIM: Tolerability and safety of trastuzumab emtansine (T-DM1) was investigated in Japanese patients with HER2-positive advanced breast cancer who were previously treated with chemotherapy and trastuzumab. PATIENTS AND METHODS: Patients with inoperable or recurrent breast cancer who were previously treated with chemotherapy and trastuzumab in adjuvant and/or metastatic disease were included. T-DM1 3.6 mg/kg was administered intravenously every 21 days. The administration dosage or schedule of T-DM1 was modified based on laboratory tests on the administration day. RESULTS: Among 232 patients analyzed, adverse events were reported in 228 patients (98.3%); five patients (2.2%) discontinued due to adverse events and twenty patients (8.6%) had serious adverse events. The most commonly reported grade ≥3 adverse event of special interest was thrombocytopenia (69 patients; 29.7%), followed by hepatotoxicity (26 patients; 11.2%). CONCLUSION: T-DM1 was well tolerated in Japanese patients with HER2-positive advanced breast cancer and no new safety signals were observed. Copyright
BACKGROUND/AIM: Tolerability and safety of trastuzumab emtansine (T-DM1) was investigated in Japanese patients with HER2-positive advanced breast cancer who were previously treated with chemotherapy and trastuzumab. PATIENTS AND METHODS: Patients with inoperable or recurrent breast cancer who were previously treated with chemotherapy and trastuzumab in adjuvant and/or metastatic disease were included. T-DM1 3.6 mg/kg was administered intravenously every 21 days. The administration dosage or schedule of T-DM1 was modified based on laboratory tests on the administration day. RESULTS: Among 232 patients analyzed, adverse events were reported in 228 patients (98.3%); five patients (2.2%) discontinued due to adverse events and twenty patients (8.6%) had serious adverse events. The most commonly reported grade ≥3 adverse event of special interest was thrombocytopenia (69 patients; 29.7%), followed by hepatotoxicity (26 patients; 11.2%). CONCLUSION:T-DM1 was well tolerated in Japanese patients with HER2-positive advanced breast cancer and no new safety signals were observed. Copyright
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