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Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | Schmid, P. | - |
dc.contributor.author | Cortes, J. | - |
dc.contributor.author | Dent, R. | - |
dc.contributor.author | Pusztai, L. | - |
dc.contributor.author | McArthur, H. | - |
dc.contributor.author | Kummel, S. | - |
dc.contributor.author | Bergh, J. | - |
dc.contributor.author | Denkert, C. | - |
dc.contributor.author | Park, Y. H. | - |
dc.contributor.author | Hui, R. | - |
dc.contributor.author | Harbeck, N. | - |
dc.contributor.author | Takahashi, M. | - |
dc.contributor.author | Untch, M. | - |
dc.contributor.author | Fasching, P. A. | - |
dc.contributor.author | Cardoso, F. | - |
dc.contributor.author | Andersen, J. | - |
dc.contributor.author | Patt, D. | - |
dc.contributor.author | Danso, M. | - |
dc.contributor.author | Ferreira, M. | - |
dc.contributor.author | Mouret-Reynier, M-A | - |
dc.contributor.author | Im, S-A | - |
dc.contributor.author | Ahn, J-H | - |
dc.contributor.author | Gion, M. | - |
dc.contributor.author | Baron-Hay, S. | - |
dc.contributor.author | Boileau, J-F | - |
dc.contributor.author | Ding, Y. | - |
dc.contributor.author | Tryfonidis, K. | - |
dc.contributor.author | Aktan, G. | - |
dc.contributor.author | Karantza, V | - |
dc.contributor.author | O'Shaughnessy, J. | - |
dc.date.accessioned | 2022-04-26T07:12:22Z | - |
dc.date.available | 2022-04-26T07:12:22Z | - |
dc.date.created | 2022-03-03 | - |
dc.date.created | 2022-03-03 | - |
dc.date.created | 2022-03-03 | - |
dc.date.created | 2022-03-03 | - |
dc.date.created | 2022-03-03 | - |
dc.date.issued | 2022-02 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.386 No.6, pp.556-567 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.other | 155307 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179237 | - |
dc.description.abstract | 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. | - |
dc.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1056/NEJMoa2112651 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 000753100900011 | - |
dc.identifier.scopusid | 2-s2.0-85124776620 | - |
dc.citation.endpage | 567 | - |
dc.citation.number | 6 | - |
dc.citation.startpage | 556 | - |
dc.citation.volume | 386 | - |
dc.identifier.sci | 000753100900011 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, S-A | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CLINICAL-FEATURES | - |
dc.subject.keywordPlus | PLUS CHEMOTHERAPY | - |
dc.subject.keywordPlus | PRIMARY THERAPY | - |
dc.subject.keywordPlus | ADVERSE EVENTS | - |
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