Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2010;70(2):215-39. doi: 10.2165/11203700-000000000-00000.
Trastuzumab (Herceptin) is a humanized IgG(1) kappa monoclonal antibody, specifically targeted against the extracellular domain of the human epidermal growth factor receptor 2 (HER2), and is indicated for the treatment of HER2-positive early or metastatic breast cancer. This review discusses the available data regarding its use in early breast cancer. Trastuzumab, when administered concurrently with chemotherapy regimens, consistently prolonged disease-free survival (primary endpoint) and overall survival (secondary endpoint) in patients with HER2-positive early breast cancer in well designed trials; studies evaluating sequential trastuzumab treatment have produced mixed results for these endpoints. Further study is required to ascertain the optimal trastuzumab treatment regimen, including the duration of treatment. Trastuzumab was generally well tolerated when added to, or administered following, a chemotherapy regimen in clinical trials. While cardiac adverse events, such as a decreased left ventricular ejection fraction and congestive heart failure, are a concern, these effects are treatable and appear to be mostly reversible. Thus, trastuzumab is a valuable component of treatment regimens for HER2-positive early breast cancer.
曲妥珠单抗（赫赛汀）是一种人源化 IgG1κ 单克隆抗体，特异性针对人表皮生长因子受体 2（HER2）的细胞外结构域，用于治疗 HER2 阳性早期或转移性乳腺癌。本文讨论了其在早期乳腺癌中的应用的现有数据。在精心设计的试验中，曲妥珠单抗与化疗方案联合使用时，可显著延长 HER2 阳性早期乳腺癌患者的无病生存期（主要终点）和总生存期（次要终点）；评估序贯曲妥珠单抗治疗的研究结果对这些终点不一。需要进一步研究确定最佳的曲妥珠单抗治疗方案，包括治疗持续时间。在临床试验中，曲妥珠单抗与化疗方案联合应用或序贯应用时通常具有良好的耐受性。虽然心脏不良事件，如左心室射血分数降低和充血性心力衰竭是令人关注的问题，但这些影响是可治疗的，并且似乎大多是可逆的。因此，曲妥珠单抗是 HER2 阳性早期乳腺癌治疗方案中的一个有价值的组成部分。
