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 accessAbstract
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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Bray, F., Laversanne, M., Sung, H., Ferlay, J., Siegel, R. L., Soerjomataram, I., & Jemal, A. (2024) · CA: a cancer journal for clinicians · doi:10.3322/caac.21834 · Cited by 27,064
Toxicity and response criteria of the Eastern Cooperative Oncology Group
Oken, M. M., Creech, R. H., Tormey, D. C., Horton, J., Davis, T. E., McFadden, E. T., & Carbone, P. P. (1982) · AMERICAN JOURNAL OF CLINICAL ONCOLOGY · doi:10.1097/00000421-198212000-00014 · Cited by 11,647
Edge, S. B., & Compton, C. C. (2010) · Annals of Surgical Oncology · doi:10.1245/s10434-010-0985-4 · Cited by 9,029
Triple-negative breast cancer: clinical features and patterns of recurrence
Dent, R., Trudeau, M., Pritchard, K. I., Hanna, W. M., Kahn, H. K., Sawka, C. A., Lickley, L. A., Rawlinson, E., Sun, P., & Narod, S. A. (2007) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-06-3045 · Cited by 5,091
Self-citationCortazar, P., Zhang, L., Untch, M., Mehta, K., Costantino, J. P., Wolmark, N., Bonnefoi, H., Cameron, D., Gianni, L., Valagussa, P., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62422-8 · Cited by 4,742
Self-citationWolff, A. C., Hammond, M. E. H., Schwartz, J. N., Hagerty, K. L., Allred, D. C., Cote, R. J., Dowsett, M., Fitzgibbons, P. L., Hanna, W. M., Langer, A., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.09.2775 · Cited by 4,434
Hammond, M. E. H., Hayes, D. F., Dowsett, M., Allred, D. C., Hagerty, K. L., Badve, S., Fitzgibbons, P. L., Francis, G., Goldstein, N. S., Hayes, M., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.25.6529 · Cited by 4,213
Foulkes, W. D., Smith, I. E., & Reis-Filho, J. S. (2010) · New England Journal of Medicine · doi:10.1056/nejmra1001389 · Cited by 4,157
Pembrolizumab for Early Triple-Negative Breast Cancer
Schmid, P., Cortes, J., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1910549 · Cited by 3,270
Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease
Bianchini, G., Balko, J. M., Mayer, I. A., Sanders, M. E., & Gianni, L. (2016) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2016.66 · Cited by 3,079
Cited by
Yuan, Z., Liu, Z., Zhou, M., Wen, H., & Li, B. (2026) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2025.105111 · Cited by 6
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
- Publisher
- Massachusetts Medical Society
- 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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- 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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