Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer

作者：Gϋnter von Minckwitz, Chiun‐Sheng Huang, Max S. Mano, Sibylle Loibl, Eleftherios P. Mamounas, Michael Untch, Norman Wolmark, Priya Rastogi, Andreas Schneeweiß, Andrés Redondo, Hans Holger Fischer, William Jacot, Alison Conlin, Claudia Arce-Salinas, Irene Wapnir, Christian Jackisch, Michael P. DiGiovanna, Peter A. Fasching, John Crown, P Wülfing, Zhimin Shao, Elena Rota Caremoli, Haiyan Wu, Lisa H. Lam, David Tesarowski, Melanie C. Smitt, Hannah Douthwaite, Stina Mui Singel, Charles E. Geyer · 发表于：New England Journal of Medicine · 年份：2018 · DOI：10.1056/nejmoa1814017 · 被引用次数：2677 · 研究领域：HER2/EGFR in Cancer Research、Breast Cancer Treatment Studies、Cancer Treatment and Pharmacology

BACKGROUND: Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor, provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus HER2-targeted therapy. METHODS: We conducted a phase 3, open-label trial involving patients with HER2-positive early breast cancer who were found to have residual invasive disease in the breast or axilla at surgery after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab. Patients were randomly assigned to receive adjuvant T-DM1 or trastuzumab for 14 cycles. The primary end point was invasive disease-free survival (defined as freedom from ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause). RESULTS: At the interim analysis, among 1486 randomly assigned patients (743 in the T-DM1 group and 743 in the trastuzumab group), invasive disease or death had occurred in 91 patients in the T-DM1 group (12.2%) and 165 patients in the trastuzumab group (22.2%). The estimated percentage of patients who were ...