Trastuzumab emtansine for HER2-positive advanced breast cancer

Sunil Verma, David Miles, Luca Gianni, Ian E. Krop, Manfred Welslau, José Baselga, Mark Pegram, Do Youn Oh, Véronique Diéras, Ellie Guardino, Liang Fang, Michael W. Lu, Steven Olsen, Kim Blackwell

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Abstract

BACKGROUND: Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)-targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubule-inhibitory agent DM1. The antibody and the cytotoxic agent are conjugated by means of a stable linker. METHODS: We randomly assigned patients with HER2-positive advanced breast cancer, who had previously been treated with trastuzumab and a taxane, to T-DM1 or lapatinib plus capecitabine. The primary end points were progression-free survival (as assessed by independent review), overall survival, and safety. Secondary end points included progression-free survival (investigator-assessed), the objective response rate, and the time to symptom progression. Two interim analyses of overall survival were conducted. RESULTS: Among 991 randomly assigned patients, median progression-free survival as assessed by independent review was 9.6 months with T-DM1 versus 6.4 months with lapatinib plus capecitabine (hazard ratio for progression or death from any cause, 0.65; 95% confidence interval [CI], 0.55 to 0.77; P

Original languageEnglish
Pages (from-to)1783-1791
Number of pages9
JournalNew England Journal of Medicine
Volume367
Issue number19
DOIs
Publication statusPublished - Nov 8 2012

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ASJC Scopus subject areas

  • Medicine(all)

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Verma, S., Miles, D., Gianni, L., Krop, I. E., Welslau, M., Baselga, J., Pegram, M., Oh, D. Y., Diéras, V., Guardino, E., Fang, L., Lu, M. W., Olsen, S., & Blackwell, K. (2012). Trastuzumab emtansine for HER2-positive advanced breast cancer. New England Journal of Medicine, 367(19), 1783-1791. https://doi.org/10.1056/NEJMoa1209124