Trastuzumab Emtansine in HER2+ Recurrent Metastatic Non-Small-Cell Lung Cancer: Study Protocol

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• 作者：Kadoaki Ohashi¹ ; ^{kohashi@cc.okayama-u.ac.jp} ; Katsuyuki Hotta² ; Taizo Hirata² ; Keisuke Aoe³ ; Toshiyuki Kozuki⁴ ; Kiichiro Ninomiya⁵ ; Hiroe Kayatani⁵ ; Hiroyuki Yanai⁶ ; Shinichi Toyooka⁷ ; Shiro Hinotsu² ; Minoru Takata⁸ ; Katsuyuki Kiura¹
• 关键词：HER2 amplification ; HER2 mutations ; HER2 over-expression ; NSCLC ; Trastuzumab emtansine
• 刊名：Clinical Lung Cancer
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：18
• 期：1
• 页码：92-95
• 全文大小：372 K
• 卷排序：18

文摘

The treatment outcome has been unsatisfactory for patients with non–small-cell lung cancer (NSCLC) refractory to standard first-line chemotherapy. Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with a vinca alkaloid, has been approved for clinical use in HER2+ breast cancer in many countries. Approximately 5% of NSCLC tumors possess HER2 alterations, and T-DM1 has shown excellent antitumor effects against HER2+ lung cancer cell lines in preclinical models. Therefore, we hypothesized that T-DM1 could significantly inhibit the growth of HER2+ lung cancers. We have launched a nonrandomized phase II trial of T-DM1 monotherapy for patients with HER2+ lung cancers. The major eligibility criteria are as follows: age ≥ 20 years, pathologically diagnosed NSCLC with documented HER2 positivity (immunohistochemistry 3+, both immunohistochemistry 2+ and fluorescence in situ hybridization positive, or exon 20 insertion mutation), and previous chemotherapy. Thirty patients will receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate. This trial will provide information on whether T-DM1 monotherapy is effective against HER2+ lung cancer.