2024
Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer
Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kümmel S, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Im S, Untch M, Fasching P, Mouret-Reynier M, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. New England Journal Of Medicine 2024 PMID: 39282906, DOI: 10.1056/nejmoa2409932.Peer-Reviewed Original ResearchEarly-stage triple-negative breast cancerTriple-negative breast cancerPembrolizumab-chemotherapy groupPlacebo-chemotherapy groupCycles of pembrolizumabPathological complete responseEvent-free survivalOverall survivalBreast cancerAdjuvant pembrolizumabComplete responseSafety profile of pembrolizumabData cutoff dateUntreated stage IIPlatinum-containing chemotherapyMedian follow-upEstimate overall survivalSecondary end pointsEpirubicin-cyclophosphamideNeoadjuvant pembrolizumabNeoadjuvant therapyDoxorubicin-cyclophosphamideNeoadjuvant chemotherapyDefinitive surgeryPembrolizumabLBA4 Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study
Schmid P, Cortés J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Im S, Untch M, Fasching P, Cardoso F, Zhao J, Zhou X, Tryfonidis K, Aktan G, O'Shaughnessy J. LBA4 Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. Annals Of Oncology 2024, 35: s1204-s1205. DOI: 10.1016/j.annonc.2024.08.2247.Peer-Reviewed Original ResearchNeoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study
Dent R, Cortés J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Haiderali A, Jia L, Nguyen A, Pan W, O'Shaughnessy J, Schmid P. Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study. Journal Of The National Cancer Institute 2024, 116: 1654-1663. PMID: 38913881, PMCID: PMC11461162, DOI: 10.1093/jnci/djae129.Peer-Reviewed Original ResearchEarly-stage triple-negative breast cancerTriple-negative breast cancerLS mean changeBaseline to weekPatient-reported outcomesAdjuvant pembrolizumabBetween-group differencesKEYNOTE-522Neoadjuvant phaseAdjuvant phaseBreast cancerMean changePathological complete responseEvent-free survivalQuality-of-life resultsNeoadjuvant pembrolizumabPatient-reported outcome assessmentsComplete responseNeoadjuvant chemotherapyEORTC QLQ-30PembrolizumabQuality-of-lifeSecondary objectivesQLQ-30Placebo
2023
LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis
Park Y, Im S, Ahn J, Kim M, Cortés J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, O'Shaughnessy J, Mouret-Reynier M, Ferreira M, Cortes M, Boileau J, Hui R, Zhu Y, Pan W, Karantza V, Schmid P. LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis. Annals Of Oncology 2023, 34: s1467-s1468. DOI: 10.1016/j.annonc.2023.10.132.Peer-Reviewed Original ResearchLBA18 Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase III KEYNOTE-522 study
Schmid P, Cortés J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Reynier M, Ferreira M, Im S, Cardoso F, Ding Y, Pan W, Tryfonidis K, O'Shaughnessy J. LBA18 Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase III KEYNOTE-522 study. Annals Of Oncology 2023, 34: s1257. DOI: 10.1016/j.annonc.2023.10.008.Peer-Reviewed Original ResearchP125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study
Kümmel S, Schmid P, Harbeck N, Takahashi M, Untch M, Boileau J, Cortes J, McArthur H, Dent R, O’Shaughnessy J, Pusztai L, Foukakis T, Park Y, Hui R, Cardoso F, Denkert C, Zhu Y, Pan W, Karantza V, Fasching P. P125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study. The Breast 2023, 68: s63-s64. DOI: 10.1016/s0960-9776(23)00242-4.Peer-Reviewed Original Research
2022
135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522
Dent R, Cortés J, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Haiderali A, Jia L, Nguyen A, Pan W, O'Shaughnessy J, Schmid P. 135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522. Annals Of Oncology 2022, 33: s600-s601. DOI: 10.1016/j.annonc.2022.07.170.Peer-Reviewed Original ResearchPathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial.
Huppert L, Rugo H, Pusztai L, Mukhtar R, Chien A, Yau C, Wolf D, Berry D, van 't Veer L, Yee D, DeMichele A, Esserman L, Consortium I. Pathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial. Journal Of Clinical Oncology 2022, 40: 504-504. DOI: 10.1200/jco.2022.40.16_suppl.504.Peer-Reviewed Original ResearchI-SPY2 trialInvestigational agentsMolecular subtypesNodal statusPathologic complete response rateMultiple investigational agentsComplete response ratePhase 3 trialHER2- breast cancerLuminal statusNeoadjuvant therapyPrimary endpointImmune signaturesPCR rateTreatment armsHeterogenous diseaseBC therapySubtype 5Breast cancerImmune biologyResponse ratePembrolizumabHormone receptorsDiseaseTrialsEvent-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. New England Journal Of Medicine 2022, 386: 556-567. PMID: 35139274, DOI: 10.1056/nejmoa2112651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyProgression-Free SurvivalTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalCycles of pembrolizumabPathological complete responseDefinitive surgeryBreast cancerNeoadjuvant chemotherapyComplete responseLonger event-free survivalUntreated stage IIPrimary end pointPhase 3 trialSecond primary cancerDoxorubicin-cyclophosphamideNeoadjuvant pembrolizumabNeoadjuvant phaseAdjuvant therapyDistant recurrenceNeoadjuvant therapyAdverse eventsPrimary cancerSafety profileDisease progressionPembrolizumabPembrolizumab vs placebo + chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as adjuvant treatment for early triple-negative breast cancer (TNBC): Phase 3 KEYNOTE-522 study
Kümmel S, Cortés J, Dent R, Pusztai L, McArthur H, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Ding Y, Tryfonidis K, Aktan G, Karantza V, O’Shaughnessy J, Schmid P. Pembrolizumab vs placebo + chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as adjuvant treatment for early triple-negative breast cancer (TNBC): Phase 3 KEYNOTE-522 study. European Journal Of Surgical Oncology 2022, 48: e30-e31. DOI: 10.1016/j.ejso.2021.12.430.Peer-Reviewed Original Research
2021
VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Ding Y, Tryfonidis K, Aktan G, Karantza V, O’Shaughnessy J. VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC. Annals Of Oncology 2021, 32: 1198-1200. DOI: 10.1016/j.annonc.2021.06.014.Peer-Reviewed Original Research
2020
1O KEYNOTE-522 Asian subgroup: Phase III study of neoadjuvant pembrolizumab (pembro) vs placebo (pbo) + chemotherapy (chemo) followed by adjuvant pembro vs pbo for early triple-negative breast cancer (TNBC)
Dent R, Cortes J, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching P, Cardoso F, Jia L, Jensen E, Karantza V, Aktan G, O'Shaughnessy J, Schmid P. 1O KEYNOTE-522 Asian subgroup: Phase III study of neoadjuvant pembrolizumab (pembro) vs placebo (pbo) + chemotherapy (chemo) followed by adjuvant pembro vs pbo for early triple-negative breast cancer (TNBC). Annals Of Oncology 2020, 31: s1241-s1242. DOI: 10.1016/j.annonc.2020.10.021.Peer-Reviewed Original Research
2018
KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo + chemo as neoadjuvant therapy followed by pembro vs placebo as adjuvant therapy for triple-negative breast cancer (TNBC).
Schmid P, Cortes J, Bergh J, Pusztai L, Denkert C, Verma S, McArthur H, Kummel S, Ding Y, Karantza V, Dang T, Dent R. KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo + chemo as neoadjuvant therapy followed by pembro vs placebo as adjuvant therapy for triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2018, 36: tps602-tps602. DOI: 10.1200/jco.2018.36.15_suppl.tps602.Peer-Reviewed Original Research
2017
233TiP KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo + chemo as neoadjuvant followed by pembro vs placebo as adjuvant therapy for triple-negative breast cancer (TNBC)
Schmid P, Castan J, Bergh J, Pusztai L, Denkert C, Verma S, McArthur H, Zhao J, Aktan G, Dang T, Dent R. 233TiP KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo + chemo as neoadjuvant followed by pembro vs placebo as adjuvant therapy for triple-negative breast cancer (TNBC). Annals Of Oncology 2017, 28: v72. DOI: 10.1093/annonc/mdx364.015.Peer-Reviewed Original Research