Abstract
Sara Hurvitz and colleagues report that first-line trastuzumab emtansine (T-DM1), an antibody–cytotoxic drug conjugate bound with a stable thioether linker, significantly improved the primary endpoints of progression-free survival (PFS) and safety in a randomised, open-label, phase 2 trial in 137 women with HER2-positive, unresectable, locally advanced or metastatic breast cancer. Participants were given T-DM1 (3·6 mg/kg, n=67), or trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) plus docetaxel (75 mg/m2 or 100 mg/m2; n=70). All drugs were given every 3 weeks, intravenously. Median PFS was 14·2 months in the T-DM1 group versus 9·2 months in the trastuzumab plus docetaxel group (hazard ratio 0·59, 95% CI 0·36–0·97; log-rank p=0·035). 46·4% of 69 patients in the T-DM1 group and 90·9% of 66 in the combination group had adverse events of grade 3 or greater. Adverse events that were serious or resulted in patients discontinuing treatment were less frequent in the T-DM1 group (20·3% and 7·2%, respectively) than in the trastuzumab plus docetaxel group (25·8% and 40·9%, respectively).
Published Version
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