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Peter Schmid, Javier Cortés, Rebecca Dent, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas C. S. Bergh, Carsten Denkert, Yeon Hee Park, Rina Hui and 20 more
BACKGROUND: The addition of pembrolizumab to neoadjuvant chemotherapy led to a significantly higher percentage of patients with early triple-negative breast cancer having a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery in an earlier analysis of this phase 3 trial of neoadjuvant and adjuvant therapy. The primary results regarding event-free survival in this trial have not been reported. 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 (the results for which have been reported previously) and event-free survival, defined as the time from randomization to the date of disease progression that precluded definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause. Safety was also assessed. RESULTS: Of the 1174 patients who underwent randomization, 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group. The median follow-up at this fourth planned interim analysis (data cutoff, March 23, 2021) was 39.1 months. The estimated event-free survival at 36 months was 84.5% (95% confidence interval [CI], 81.7 to 86.9) in the pembrolizumab-chemotherapy group, as compared with 76.8% (95% CI, 72.2 to 80.7) in the placebo-chemotherapy group (hazard ratio for event or death, 0.63; 95% CI, 0.48 to 0.82; P<0.001). Adverse events occurred predominantly during the neoadjuvant phase and were consistent with the established safety profiles of pembrolizumab and chemotherapy. CONCLUSIONS: In patients with early triple-negative breast cancer, neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab after surgery, resulted in significantly longer event-free survival than neoadjuvant chemotherapy alone. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).
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Schmid, P., Cortés, J., Dent, R., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J. C. S., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., Takahashi, M., Untch, M., Fasching, P. A., Cardoso, F., Andersen, J., Patt, D., Danso, M., Ferreira, M., … O’Shaughnessy, J. (2022). Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. New England Journal of Medicine, 386(6), 556–567. https://doi.org/10.1056/nejmoa2112651
Schmid, Peter, et al. "Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer." New England Journal of Medicine, vol. 386, no. 6, 2022, pp. 556–567, https://doi.org/10.1056/nejmoa2112651.
Schmid, Peter, Javier Cortés, Rebecca Dent, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas C. S. Bergh, et al. "Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer." New England Journal of Medicine 386, no. 6 (2022): 556–567. https://doi.org/10.1056/nejmoa2112651.
Schmid P., Cortés J., Dent R. [и др.] Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer // New England Journal of Medicine. — 2022. — Vol. 386, № 6. — P. 556–567. — URL: https://doi.org/10.1056/nejmoa2112651
@article{schmid2022eventfree,
title = {{Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer}},
author = {Peter Schmid and Javier Cortés and Rebecca Dent and Lajos Pusztai and Heather McArthur and Sherko Kümmel and Jonas C. S. Bergh and Carsten Denkert and Yeon Hee Park and Rina Hui and Nadia Harbeck and Masato Takahashi and Michael Untch and Peter Andreas Fasching and Fatima Cardoso and Jay Andersen and Debra Patt and Michael Danso and Marta Ferreira and M-A Mouret-Reynier and Seock‐Ah Im and Jin-Hee Ahn and Maria Gion and Sally Baron-Hay and Jean-François Boileau and Yu Ding and Konstantinos Tryfonidis and Gursel Aktan and Vassiliki Karantza and Joyce O’Shaughnessy},
journal = {New England Journal of Medicine},
year = {2022},
volume = {386},
number = {6},
pages = {556--567},
doi = {10.1056/nejmoa2112651},
url = {https://doi.org/10.1056/nejmoa2112651}
}TY - JOUR AU - Schmid, Peter AU - Cortés, Javier AU - Dent, Rebecca AU - Pusztai, Lajos AU - McArthur, Heather AU - Kümmel, Sherko AU - Bergh, Jonas C. S. AU - Denkert, Carsten AU - Park, Yeon Hee AU - Hui, Rina AU - Harbeck, Nadia AU - Takahashi, Masato AU - Untch, Michael AU - Fasching, Peter Andreas AU - Cardoso, Fatima AU - Andersen, Jay AU - Patt, Debra AU - Danso, Michael AU - Ferreira, Marta AU - Mouret-Reynier, M-A AU - Im, Seock‐Ah AU - Ahn, Jin-Hee AU - Gion, Maria AU - Baron-Hay, Sally AU - Boileau, Jean-François AU - Ding, Yu AU - Tryfonidis, Konstantinos AU - Aktan, Gursel AU - Karantza, Vassiliki AU - O’Shaughnessy, Joyce TI - Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer JO - New England Journal of Medicine VL - 386 IS - 6 SP - 556 EP - 567 PY - 2022 DA - 2022/02/09 DO - 10.1056/nejmoa2112651 UR - https://doi.org/10.1056/nejmoa2112651 ER -
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