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

Cited 0 time in Web of Science Cited 14 time in Scopus
Authors

Schmid, Peter; Cortes, Javier; Dent, Rebecca; Mcarthur, Heather; Pusztai, Lajos; Kümmel, Sherko; Denkert, Carsten; Park, Yeon Hee; Hui, Rina; Harbeck, Nadia; Takahashi, Masato; Im, Seock-Ah; Untch, Michael; Fasching, Peter A.; Mouret-Reynier, Marie-Ange; Foukakis, Theodoros; Ferreira, Marta; Cardoso, Fatima; Zhou, Xuan; Karantza, Vassiliki; Tryfonidis, Konstantinos; Aktan, Gursel; O'shaughnessy, Joyce

Issue Date
2024-11
Publisher
Massachusetts Medical Society
Citation
New England Journal of Medicine, Vol.391 No.21, pp.1981-1991
Abstract
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 (P=0.002). Adverse events were consistent with the established safety profiles of pembrolizumab and chemotherapy. Conclusions Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab resulted in a significant improvement, as compared with neoadjuvant chemotherapy alone, in overall survival among patients with early-stage triple-negative breast cancer. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488).
ISSN
0028-4793
URI
https://hdl.handle.net/10371/216497
DOI
https://doi.org/10.1056/NEJMoa2409932
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  • College of Medicine
  • Department of Medicine
Research Area Clinical Medicine

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