Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer

摘要: Background Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)–targeted antitumor properties of tras tuz u mab with cytotoxic activity microtubule-inhibitory agent DM1. The antibody and are conjugated by means a stable linker. Methods We randomly assigned patients HER2-positive advanced breast cancer, who had previously been treated taxane, to T-DM1 or la pa ti nib plus cap e ci ta bine. primary end points were progression-free survival (as assessed independent review), overall survival, safety. Secondary included (investigator-assessed), objective response rate, time symptom progression. Two interim analyses conducted. Results Among 991 patients, median as review was 9.6 months versus 6.4 bine (hazard ratio for progression death from any cause, 0.65; 95% confidence interval [CI], 0.55 0.77; P<0.001), at second analysis crossed stopping boundary efficacy (30.9 vs. 25.1 months; hazard 0.68; CI, 0.85; P<0.001). rate higher (43.6%, 30.8% bine; P<0.001); results all additional secondary favored T-DM1. Rates adverse events grade 3 above pati than (57% 41%). incidences thrombocytopenia increased serum aminotransferase levels T-DM1, whereas diarrhea, nausea, vomiting, palmar–plantar erythro dysesthesia Conclusions significantly prolonged less toxicity in cancer taxane. (Funded F. Hoffmann– La Roche/Genentech; EMILIA ClinicalTrials.gov number, NCT00829166.)