included patients with HER2-positive early breast cancer
T-DM1 significantly reduced the risk for death compared with trastuzumab (unstratified HR = 0.66; 95% CI, 0.51-0.87; P = .003). Seven-year overall survival for the T-DM1 and trastuzumab groups were 89.1% and 84.4%, respectively (difference, 4.7 percentage points). As of the trial’s cutoff date of October 5, 2023, 70.1% of patients assigned T-DM1 and 62.0% of patients assigned trastuzumab were alive and still in the trial.
Deaths occurred in 89 patients (12.0%) in the T-DM1 group and 126 patients (17.0%) in the trastuzumab group. Of these deaths, 70 (79%) and 108 (86%) patients, respectively, died from breast cancer.
Adverse events (AEs) grade 3 or higher occurred in 26.1% of patients treated with T-DM1 and 15.7% of patients treated with trastuzumab. Serious AEs occurred in 12.7% and 8.1% of patients, respectively.
Post-treatment AEs were less common for both groups but still more prevalent in the T-DM1 group, with 3.2% and 1.7% of patients assigned T-DM1 and trastuzumab, respectively, experiencing AEs of any grade during this period.
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