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- Publisher Website: 10.1056/NEJMoa2112651
- Scopus: eid_2-s2.0-85124776620
- PMID: 35139274
- WOS: WOS:000753100900011
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Article: Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
Title | Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer |
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Authors | Schmid, PeterCortes, JavierDent, RebeccaPusztai, LajosMcArthur, HeatherKümmel, SherkoBergh, JonasDenkert, CarstenPark, Yeon HeeHui, RinaHarbeck, NadiaTakahashi, MasatoUntch, MichaelFasching, Peter A.Cardoso, FatimaAndersen, JayPatt, DebraDanso, MichaelFerreira, MartaMouret-Reynier, Marie AngeIm, Seock AhAhn, Jin HeeGion, MariaBaron-Hay, SallyBoileau, Jean FrançoisDing, YuTryfonidis, KonstantinosAktan, GurselKarantza, VassilikiO'Shaughnessy, Joyce |
Issue Date | 2022 |
Citation | New England Journal of Medicine, 2022, v. 386, n. 6, p. 556-567 How to Cite? |
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. |
Persistent Identifier | http://hdl.handle.net/10722/326515 |
ISSN | 2023 Impact Factor: 96.2 2023 SCImago Journal Rankings: 20.544 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Schmid, Peter | - |
dc.contributor.author | Cortes, Javier | - |
dc.contributor.author | Dent, Rebecca | - |
dc.contributor.author | Pusztai, Lajos | - |
dc.contributor.author | McArthur, Heather | - |
dc.contributor.author | Kümmel, Sherko | - |
dc.contributor.author | Bergh, Jonas | - |
dc.contributor.author | Denkert, Carsten | - |
dc.contributor.author | Park, Yeon Hee | - |
dc.contributor.author | Hui, Rina | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.contributor.author | Takahashi, Masato | - |
dc.contributor.author | Untch, Michael | - |
dc.contributor.author | Fasching, Peter A. | - |
dc.contributor.author | Cardoso, Fatima | - |
dc.contributor.author | Andersen, Jay | - |
dc.contributor.author | Patt, Debra | - |
dc.contributor.author | Danso, Michael | - |
dc.contributor.author | Ferreira, Marta | - |
dc.contributor.author | Mouret-Reynier, Marie Ange | - |
dc.contributor.author | Im, Seock Ah | - |
dc.contributor.author | Ahn, Jin Hee | - |
dc.contributor.author | Gion, Maria | - |
dc.contributor.author | Baron-Hay, Sally | - |
dc.contributor.author | Boileau, Jean François | - |
dc.contributor.author | Ding, Yu | - |
dc.contributor.author | Tryfonidis, Konstantinos | - |
dc.contributor.author | Aktan, Gursel | - |
dc.contributor.author | Karantza, Vassiliki | - |
dc.contributor.author | O'Shaughnessy, Joyce | - |
dc.date.accessioned | 2023-03-10T02:19:49Z | - |
dc.date.available | 2023-03-10T02:19:49Z | - |
dc.date.issued | 2022 | - |
dc.identifier.citation | New England Journal of Medicine, 2022, v. 386, n. 6, p. 556-567 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/10722/326515 | - |
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 | eng | - |
dc.relation.ispartof | New England Journal of Medicine | - |
dc.title | Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer | - |
dc.type | Article | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.doi | 10.1056/NEJMoa2112651 | - |
dc.identifier.pmid | 35139274 | - |
dc.identifier.scopus | eid_2-s2.0-85124776620 | - |
dc.identifier.volume | 386 | - |
dc.identifier.issue | 6 | - |
dc.identifier.spage | 556 | - |
dc.identifier.epage | 567 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.isi | WOS:000753100900011 | - |