Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer.
Publication Title
The New England journal of medicine
Document Type
Article
Publication Date
1-16-2025
Keywords
oregon; chiles; Humans; Breast Neoplasms; Female; Ado-Trastuzumab Emtansine; Receptor, ErbB-2; Middle Aged; Adult; Trastuzumab; Disease-Free Survival; Aged; Neoplasm, Residual; Antineoplastic Agents, Immunological; Antineoplastic Combined Chemotherapy Protocols; Kaplan-Meier Estimate; Neoadjuvant Therapy; Chemotherapy, Adjuvant; Survival Analysis; Follow-Up Studies
Abstract
BACKGROUND: Patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer with residual invasive disease after neoadjuvant systemic therapy have a high risk of recurrence and death. The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with trastuzumab alone.
METHODS: We randomly assigned patients with HER2-positive early breast cancer with residual invasive disease in the breast or axilla after neoadjuvant systemic treatment with taxane-based chemotherapy and trastuzumab to receive T-DM1 or trastuzumab for 14 cycles. Here, we report the prespecified final analysis of invasive disease-free survival and the second interim analysis of overall survival.
RESULTS: With a median follow-up of 8.4 years, T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab (unstratified hazard ratio for invasive disease or death, 0.54; 95% confidence interval [CI], 0.44 to 0.66). Seven-year invasive disease-free survival was 80.8% with T-DM1 and 67.1% with trastuzumab (difference, 13.7 percentage points). T-DM1 also led to a significantly lower risk of death than trastuzumab (unstratified hazard ratio, 0.66; 95% CI, 0.51 to 0.87; P = 0.003). Seven-year overall survival was 89.1% with T-DM1 and 84.4% with trastuzumab (difference, 4.7 percentage points). Adverse events of grade 3 or higher were noted in 26.1% of the patients in the T-DM1 group and 15.7% of those in the trastuzumab group.
CONCLUSIONS: As compared with trastuzumab, T-DM1 improved overall survival with sustained improvement in invasive disease-free survival among patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy. (Funded by F. Hoffmann-La Roche/Genentech; KATHERINE ClinicalTrials.gov number, NCT01772472.).
Area of Special Interest
Cancer
Area of Special Interest
Women & Children
Specialty/Research Institute
Oncology
DOI
10.1056/NEJMoa2406070
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