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Article: Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer

TitleEvent-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
Authors
Issue Date2022
Citation
New England Journal of Medicine, 2022, v. 386, n. 6, p. 556-567 How to Cite?
AbstractBACKGROUND 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 Identifierhttp://hdl.handle.net/10722/326515
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSchmid, Peter-
dc.contributor.authorCortes, Javier-
dc.contributor.authorDent, Rebecca-
dc.contributor.authorPusztai, Lajos-
dc.contributor.authorMcArthur, Heather-
dc.contributor.authorKümmel, Sherko-
dc.contributor.authorBergh, Jonas-
dc.contributor.authorDenkert, Carsten-
dc.contributor.authorPark, Yeon Hee-
dc.contributor.authorHui, Rina-
dc.contributor.authorHarbeck, Nadia-
dc.contributor.authorTakahashi, Masato-
dc.contributor.authorUntch, Michael-
dc.contributor.authorFasching, Peter A.-
dc.contributor.authorCardoso, Fatima-
dc.contributor.authorAndersen, Jay-
dc.contributor.authorPatt, Debra-
dc.contributor.authorDanso, Michael-
dc.contributor.authorFerreira, Marta-
dc.contributor.authorMouret-Reynier, Marie Ange-
dc.contributor.authorIm, Seock Ah-
dc.contributor.authorAhn, Jin Hee-
dc.contributor.authorGion, Maria-
dc.contributor.authorBaron-Hay, Sally-
dc.contributor.authorBoileau, Jean François-
dc.contributor.authorDing, Yu-
dc.contributor.authorTryfonidis, Konstantinos-
dc.contributor.authorAktan, Gursel-
dc.contributor.authorKarantza, Vassiliki-
dc.contributor.authorO'Shaughnessy, Joyce-
dc.date.accessioned2023-03-10T02:19:49Z-
dc.date.available2023-03-10T02:19:49Z-
dc.date.issued2022-
dc.identifier.citationNew England Journal of Medicine, 2022, v. 386, n. 6, p. 556-567-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/326515-
dc.description.abstractBACKGROUND 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.languageeng-
dc.relation.ispartofNew England Journal of Medicine-
dc.titleEvent-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa2112651-
dc.identifier.pmid35139274-
dc.identifier.scopuseid_2-s2.0-85124776620-
dc.identifier.volume386-
dc.identifier.issue6-
dc.identifier.spage556-
dc.identifier.epage567-
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000753100900011-

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