Abstract | BACKGROUND: METHODS: RESULTS: At the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab- chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo- chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab- chemotherapy group and 46 of 390 patients (11.8%) in the placebo- chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab- chemotherapy group and 73.0% in the placebo- chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. CONCLUSIONS:
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Authors | Peter Schmid, Javier Cortes, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Theodoros Foukakis, Peter A Fasching, Fatima Cardoso, Michael Untch, Liyi Jia, Vassiliki Karantza, Jing Zhao, Gursel Aktan, Rebecca Dent, Joyce O'Shaughnessy, KEYNOTE-522 Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 382
Issue 9
Pg. 810-821
(02 27 2020)
ISSN: 1533-4406 [Electronic] United States |
PMID | 32101663
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Massachusetts Medical Society. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Epirubicin
- Doxorubicin
- Cyclophosphamide
- Carboplatin
- pembrolizumab
- Paclitaxel
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Carboplatin
(administration & dosage)
- Cyclophosphamide
(administration & dosage)
- Doxorubicin
(administration & dosage)
- Epirubicin
(administration & dosage)
- Female
- Humans
- Intention to Treat Analysis
- Kaplan-Meier Estimate
- Middle Aged
- Neoadjuvant Therapy
- Neoplasm Staging
- Paclitaxel
(administration & dosage)
- Triple Negative Breast Neoplasms
(drug therapy, mortality, pathology)
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