Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients
Masataka SawakiDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, JapanAbstract: Anti-HER2 agents, such as trastuzumab, lapatinib, trastuzumab emtansine (T-DM1), and pertuzumab, are standard agents in the treatment of breast cancer overexpressing the human epidermal growth factor...
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doaj-ab485b74f2304aa78880c777589918a62020-11-25T00:28:31ZengDove Medical PressBreast Cancer : Targets and Therapy1179-13142014-04-012014default374116469Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patientsSawaki M Masataka SawakiDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, JapanAbstract: Anti-HER2 agents, such as trastuzumab, lapatinib, trastuzumab emtansine (T-DM1), and pertuzumab, are standard agents in the treatment of breast cancer overexpressing the human epidermal growth factor receptor 2 (HER2). Trastuzumab is the first approved HER2-targeted agent. Subsequent developments include agents with different mechanisms. In this paper, we review the results of clinical trials of T-DM1, a new anti-HER2 agent, with a focus on Japanese patients with breast cancer. On the basis of results from a Phase I study (JO22591), the maximum tolerated dose was determined to be 3.6 mg/kg every 3 weeks for both Japanese and western patients. In a Phase II study (JO22997), the overall response rate was 38.4% (90% confidence interval 28.8–48.6). T-DM1 was well tolerated in Japanese patients; however, the incidence of grade 3 or 4 thrombocytopenia was higher than that observed in earlier western studies, but was not associated with clinically important symptoms. Pharmacokinetic parameters for T-DM1 and its metabolites were consistent with those reported previously from a Phase I or II study in non-Japanese patients, and the data obtained showed no suggestion of ethnic differences. Several Phase III studies of T-DM1 are ongoing throughout the world, including in Japanese patients with breast cancer.Keywords: breast cancer, HER2/neu, trastuzumab emtansine, anti-HER2 therapyhttp://www.dovepress.com/trastuzumab-emtansine-in-the-treatment-of-her2-positive-metastatic-bre-a16469 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sawaki M |
spellingShingle |
Sawaki M Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients Breast Cancer : Targets and Therapy |
author_facet |
Sawaki M |
author_sort |
Sawaki M |
title |
Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients |
title_short |
Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients |
title_full |
Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients |
title_fullStr |
Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients |
title_full_unstemmed |
Trastuzumab emtansine in the treatment of HER2-positive metastatic breast cancer in Japanese patients |
title_sort |
trastuzumab emtansine in the treatment of her2-positive metastatic breast cancer in japanese patients |
publisher |
Dove Medical Press |
series |
Breast Cancer : Targets and Therapy |
issn |
1179-1314 |
publishDate |
2014-04-01 |
description |
Masataka SawakiDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, JapanAbstract: Anti-HER2 agents, such as trastuzumab, lapatinib, trastuzumab emtansine (T-DM1), and pertuzumab, are standard agents in the treatment of breast cancer overexpressing the human epidermal growth factor receptor 2 (HER2). Trastuzumab is the first approved HER2-targeted agent. Subsequent developments include agents with different mechanisms. In this paper, we review the results of clinical trials of T-DM1, a new anti-HER2 agent, with a focus on Japanese patients with breast cancer. On the basis of results from a Phase I study (JO22591), the maximum tolerated dose was determined to be 3.6 mg/kg every 3 weeks for both Japanese and western patients. In a Phase II study (JO22997), the overall response rate was 38.4% (90% confidence interval 28.8–48.6). T-DM1 was well tolerated in Japanese patients; however, the incidence of grade 3 or 4 thrombocytopenia was higher than that observed in earlier western studies, but was not associated with clinically important symptoms. Pharmacokinetic parameters for T-DM1 and its metabolites were consistent with those reported previously from a Phase I or II study in non-Japanese patients, and the data obtained showed no suggestion of ethnic differences. Several Phase III studies of T-DM1 are ongoing throughout the world, including in Japanese patients with breast cancer.Keywords: breast cancer, HER2/neu, trastuzumab emtansine, anti-HER2 therapy |
url |
http://www.dovepress.com/trastuzumab-emtansine-in-the-treatment-of-her2-positive-metastatic-bre-a16469 |
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