2024
Event-free survival by residual cancer burden with pembrolizumab in early-stage TNBC: exploratory analysis from KEYNOTE-522☆
Pusztai L, Denkert C, O’Shaughnessy J, Cortes J, Dent R, McArthur H, Kümmel S, Bergh J, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Zhu Y, Pan W, Tryfonidis K, Schmid P. Event-free survival by residual cancer burden with pembrolizumab in early-stage TNBC: exploratory analysis from KEYNOTE-522☆. Annals Of Oncology 2024, 35: 429-436. PMID: 38369015, DOI: 10.1016/j.annonc.2024.02.002.Peer-Reviewed Original ResearchTriple-negative breast cancerEvent-free survivalPathological complete responseResidual cancer burdenEarly-stage triple-negative breast cancerEvent-free survival eventsPembrolizumab groupRCB-2KEYNOTE-522Neoadjuvant pembrolizumabRCB-0Central nervous system recurrenceCancer burdenCycles of paclitaxelIncreased pCR ratePembrolizumab to chemotherapyCycles of doxorubicinCox regression modelsRCB-1Adjuvant pembrolizumabDistant recurrencePCR rateResidual diseaseSystemic recurrenceComplete response
2022
Event-free survival by residual cancer burden after neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy for early TNBC: Exploratory analysis from KEYNOTE-522.
Pusztai L, Denkert C, O'Shaughnessy J, Cortes J, Dent R, McArthur H, Kuemmel S, Bergh J, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Zhu Y, Pan W, Tryfonidis K, Schmid P. Event-free survival by residual cancer burden after neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy for early TNBC: Exploratory analysis from KEYNOTE-522. Journal Of Clinical Oncology 2022, 40: 503-503. DOI: 10.1200/jco.2022.40.16_suppl.503.Peer-Reviewed Original Research
2019
LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC)
Schmid P, Cortés J, Dent R, 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, Karantza V, Zhao J, Aktan G, O’Shaughnessy J. LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC). Annals Of Oncology 2019, 30: v853-v854. DOI: 10.1093/annonc/mdz394.003.Peer-Reviewed Original ResearchEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalSubsidiary of MerckGerman Study GroupBristol-Myers SquibbPD-L1Dohme Corp.Daiichi SankyoSeattle GeneticsChemo groupYpT0 ypN0Merck SharpGenomic HealthStudy groupFavorable trendF. Hoffmann-La Roche LtdCycles of paclitaxelDual primary endpointsI-SPY 2Cycles of doxorubicinPhase III studyWolters Kluwer HealthEli LillyKyowa Hakko Kirin
2007
Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen
Buzdar AU, Valero V, Ibrahim NK, Francis D, Broglio KR, Theriault RL, Pusztai L, Green MC, Singletary SE, Hunt KK, Sahin AA, Esteva F, Symmans WF, Ewer MS, Buchholz TA, Hortobagyi GN. Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen. Clinical Cancer Research 2007, 13: 228-233. PMID: 17200359, DOI: 10.1158/1078-0432.ccr-06-1345.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorPathologic CR rateEpidermal growth factor receptorConcurrent trastuzumabGrowth factor receptorCR rateEfficacy dataBreast cancerStudy populationHigher pathologic complete remission rateSecond cohortPathologic complete remission rateCardiac safety dataCycles of FECCycles of paclitaxelOperable breast cancerComplete remission rateDisease-free survivalFactor receptorBreast cancer patientsNew safety concernsSame chemotherapyWeekly trastuzumabCyclophosphamide chemotherapyNeoadjuvant therapy
2006
Kinetics of serum HER‐2/neu changes in patients with HER‐2‐positive primary breast cancer after initiation of primary chemotherapy
Mazouni C, Hall A, Broglio K, Fritsche H, Andre F, Esteva FJ, Hortobagyi GN, Buzdar AU, Pusztai L, Cristofanilli M. Kinetics of serum HER‐2/neu changes in patients with HER‐2‐positive primary breast cancer after initiation of primary chemotherapy. Cancer 2006, 109: 496-501. PMID: 17149760, DOI: 10.1002/cncr.22418.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularCyclophosphamideEpirubicinFemaleFluorouracilHumansKineticsMiddle AgedNeoadjuvant TherapyPrognosisProspective StudiesReceptor, ErbB-2TrastuzumabConceptsPrimary breast cancerPathological complete responseBreast cancerECD levelsPrimary chemotherapyNeoadjuvant therapyPathological responseWeek 6HER-2 extracellular domainWeek 3HER-2/neu receptorCycles of fluorouracilCycles of paclitaxelNeu extracellular domainTrastuzumab-based regimensUtility of quantitationInitiation of chemotherapyExtracellular domainSame chemotherapyWeekly trastuzumabInitial chemotherapyNeoadjuvant chemotherapyComplete responseTreatment regimenResidual disease
2005
Significantly Higher Pathologic Complete Remission Rate After Neoadjuvant Therapy With Trastuzumab, Paclitaxel, and Epirubicin Chemotherapy: Results of a Randomized Trial in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer
Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly Higher Pathologic Complete Remission Rate After Neoadjuvant Therapy With Trastuzumab, Paclitaxel, and Epirubicin Chemotherapy: Results of a Randomized Trial in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer. Journal Of Clinical Oncology 2005, 23: 3676-3685. PMID: 15738535, DOI: 10.1200/jco.2005.07.032.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDisease-Free SurvivalEpirubicinFemaleFluorouracilHumansMiddle AgedNeoadjuvant TherapyPaclitaxelProspective StudiesReceptor, ErbB-2Remission InductionTrastuzumabConceptsClinical congestive heart failureHuman epidermal growth factor receptorOperable breast cancerAddition of trastuzumabCongestive heart failureChemotherapy armData monitoring committeeEpidermal growth factor receptorGrowth factor receptorHeart failureBreast cancerHigher pathologic complete remission ratePathologic complete remission ratePathologic complete response rateCycles of fluorouracilCycles of paclitaxelHER2-positive diseaseComplete response rateComplete remission rateFactor receptorCardiac ejection fractionNeoadjuvant settingSame chemotherapyWeekly trastuzumabNeoadjuvant therapy