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The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.

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

Open access
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·2024·New England Journal of Medicine

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.).

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Metadata

Authors
Schmid, P., Cortes, J., Dent, R., McArthur, H., Pusztai, L., Kümmel, S., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., Takahashi, M., Im, S.-A., Untch, M., Fasching, P. A., Mouret-Reynier, M.-A., Foukakis, T., Ferreira, M., Cardoso, F., Zhou, X., Karantza, V., Tryfonidis, K., Aktan, G., & O’Shaughnessy, J.
Venue
New England Journal of Medicine
Published
2024-11-28
Volume
391
Issue
21
Pages
1981-1991
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W4402551965
Cited by
561
References
34
FWCI
85.83
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. https://app.cochat.ai/papers/10.1056/nejmoa2409932
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Schmid, P., Cortes, J., Dent, R., McArthur, H., Pusztai, L., Kümmel, S., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., Takahashi, M., Im, S.-A., Untch, M., Fasching, P. A., Mouret-Reynier, M.-A., Foukakis, T., Ferreira, M., Cardoso, F., Zhou, X., . . . O’Shaughnessy, J. (2024). Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2409932

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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