Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer

作者：Peter Schmid, Javier Cortes, Rebecca Alexandra Dent, Heather L. McArthur, Lajos Pusztai, Sherko Kümmel, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Seock‐Ah Im, Michael Untch, Peter Andreas Fasching, Marie‐Ange Mouret‐Reynier, Theodoros Foukakis, Marta Salvador Ferreira, Fátima Cardoso, Xuan Zhou, Vassiliki Karantza, Konstantinos Tryfonidis, Gursel Aktan, Joyce A O'Shaughnessy · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2409932 · 被引用次数：551 · 研究领域：Breast Cancer Treatment Studies、Cancer Immunotherapy and Biomarkers、Cancer Research and Treatments

BACKGROUND: In patients with early-stage triple-negative breast cancer, the phase 3 KEYNOTE-522 trial showed significant improvements in pathological complete response and event-free survival with the addition of pembrolizumab to platinum-containing chemotherapy. Here we report the final results for overall survival. METHODS: We randomly assigned, in a 2:1 ratio, patients with previously untreated stage II or III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks plus paclitaxel and carboplatin, followed by four cycles of pembrolizumab or placebo plus doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, patients received adjuvant pembrolizumab (pembrolizumab-chemotherapy group) or placebo (placebo-chemotherapy group) every 3 weeks for up to nine cycles. The primary end points were pathological complete response and event-free survival. Overall survival was a secondary end point. RESULTS: Of the 1174 patients who underwent randomization, 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group. At the data-cutoff date (March 22, 2024), the median follow-up was 75.1 months (range, 65.9 to 84.0). The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as compared with 81.7% (95% CI, 77.5 to 85.2) in the placebo-chemotherapy group (...