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 language | English |
|---|---|
| Pages (from-to) | 1783-1791 |
| Number of pages | 9 |
| Journal | New England Journal of Medicine |
| Volume | 367 |
| Issue number | 19 |
| DOIs | |
| Publication status | Published - Nov 8 2012 |
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ASJC Scopus subject areas
- Medicine(all)
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Trastuzumab emtansine for HER2-positive advanced breast cancer. / Verma, Sunil; Miles, David; Gianni, Luca; Krop, Ian E.; Welslau, Manfred; Baselga, José; Pegram, Mark; Oh, Do Youn; Diéras, Véronique; Guardino, Ellie; Fang, Liang; Lu, Michael W.; Olsen, Steven; Blackwell, Kim.
In: New England Journal of Medicine, Vol. 367, No. 19, 08.11.2012, p. 1783-1791.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Trastuzumab emtansine for HER2-positive advanced breast cancer
AU - Verma, Sunil
AU - Miles, David
AU - Gianni, Luca
AU - Krop, Ian E.
AU - Welslau, Manfred
AU - Baselga, José
AU - Pegram, Mark
AU - Oh, Do Youn
AU - Diéras, Véronique
AU - Guardino, Ellie
AU - Fang, Liang
AU - Lu, Michael W.
AU - Olsen, Steven
AU - Blackwell, Kim
PY - 2012/11/8
Y1 - 2012/11/8
N2 - 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
AB - 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
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U2 - 10.1056/NEJMoa1209124
DO - 10.1056/NEJMoa1209124
M3 - Article
VL - 367
SP - 1783
EP - 1791
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 19
ER -