2024
Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus arm
2023
Correlation of HER2 low status in I-SPY2 with molecular subtype, response, and survival.
Rugo H, Wolf D, Yau C, Petricoin E, Pohlmann P, Pusztai L, Symmans W, Borowsky A, Finestone S, Yee D, Hylton N, van 't Veer L, Esserman L, DeMichele A. Correlation of HER2 low status in I-SPY2 with molecular subtype, response, and survival. Journal Of Clinical Oncology 2023, 41: 514-514. DOI: 10.1200/jco.2023.41.16_suppl.514.Peer-Reviewed Original ResearchDistant recurrence-free survivalPathologic complete responseBreast cancerFisher's exact testExact testMolecular subtypesHER2-negative breast cancerHigh-risk breast cancerRisk breast cancerMetastatic breast cancerRecurrence-free survivalTN breast cancerRecurrence-free survival dataCox proportional hazardsHER2 gene amplificationI-SPY2TN diseaseFree survivalOverall survivalComplete responseHazard ratioTrastuzumab deruxtecanEndocrine sensitivityT-DXdTreatment arms
2021
Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients
Yau C, Osdoit M, van der Noordaa M, Shad S, Wei J, de Croze D, Hamy AS, Laé M, Reyal F, Sonke GS, Steenbruggen TG, van Seijen M, Wesseling J, Martín M, del Monte-Millán M, López-Tarruella S, Consortium I, Adamson K, Albain K, Asare A, Asare S, Balassanian R, Beckwith H, Berry S, Berry D, Boughey J, Buxton M, Chen Y, Chen B, Chien A, Chui S, Clark A, Clennell J, Datnow B, DeMichele A, Duan X, Edmiston K, Elias A, Ellis E, Esserman L, Euhus D, Fadare O, Fan F, Feldman M, Forero-Torres A, Haley B, Han H, Harada S, Haugen P, Helsten T, Hirst G, Hylton N, Isaacs C, Kemmer K, Khan Q, Khazai L, Klein M, Krings G, Lang J, LeBeau L, Leyland-Jones B, Liu M, Lo S, Lu J, Magliocco A, Matthews J, Melisko M, Mhawech-Fauceglia P, Moulder S, Murthy R, Nanda R, Northfelt D, Ocal I, Olopade O, Pambuccian S, Paoloni M, Park J, Parker B, Perlmutter J, Peterson G, Pusztai L, Rendi M, Rugo H, Sahoo S, Sams S, Sanil A, Sattar H, Schwab R, Singhrao R, Steeg K, Stringer-Reasor E, Symmans W, Tawfik O, Tripathy D, Troxell M, Veer L, Venters S, Vinh T, Viscusi R, Wallace A, Wei S, Wilson A, Yau C, Yee D, Zeck J, Boughey J, Goetz M, Hoskin T, Gould R, Valero V, Edge S, Abraham J, Bartlett J, Caldas C, Dunn J, Earl H, Hayward L, Hiller L, Provenzano E, Sammut S, Thomas J, Cameron D, Graham A, Hall P, Mackintosh L, Fan F, Godwin A, Schwensen K, Sharma P, DeMichele A, Cole K, Pusztai L, Kim M, van 't Veer L, Esserman L, Symmans W. Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients. The Lancet Oncology 2021, 23: 149-160. PMID: 34902335, PMCID: PMC9455620, DOI: 10.1016/s1470-2045(21)00589-1.Peer-Reviewed Original ResearchConceptsResidual cancer burdenEvent-free survivalRCB scoreHER2-positive groupNeoadjuvant chemotherapyBreast cancer subtypesBreast cancerHazard ratioCancer subtypesNodal statusCancer burdenT categoryEvent-free survival eventsPooled patient-level analysisLong-term survival outcomesPractice settingsWorse event-free survivalClinical T categoryHigher RCB scoresStandard pathology reportingHER2-negative patientsHormone receptor statusHER2-negative groupLong-term prognosisPrimary stage I
2015
A network meta-analysis of everolimus plus exemestane versus chemotherapy in the first- and second-line treatment of estrogen receptor-positive metastatic breast cancer
Generali D, Venturini S, Rognoni C, Ciani O, Pusztai L, Loi S, Jerusalem G, Bottini A, Tarricone R. A network meta-analysis of everolimus plus exemestane versus chemotherapy in the first- and second-line treatment of estrogen receptor-positive metastatic breast cancer. Breast Cancer Research And Treatment 2015, 152: 95-117. PMID: 26044370, DOI: 10.1007/s10549-015-3453-9.Peer-Reviewed Original ResearchConceptsProgression-free survivalMetastatic breast cancerHazard ratioMegestrol acetateResponse rateBreast cancerEstrogen receptor-positive metastatic breast cancerPFS/TTPSecond-line therapySecond-line treatmentToxicity of chemotherapyOverall response rateBetter response rateCapecitabineStandard pairwiseTamoxifenSunitinibChemotherapyTTP differenceMultiple treatmentsNMAIndividual studiesEverolimusExemestaneCancer
2012
Evaluation of circulating biomarkers of bone metastasis in early-stage breast cancer.
Dean-Colomb W, Hess K, Young E, Gornet T, Handy B, Moulder S, Ibrahim N, Pusztai L, Booser D, Valero V, Hortobagyi G, Esteva F. Evaluation of circulating biomarkers of bone metastasis in early-stage breast cancer. Journal Of Clinical Oncology 2012, 30: 10613-10613. DOI: 10.1200/jco.2012.30.15_suppl.10613.Peer-Reviewed Original ResearchP1NP valuesInterleukin-6Breast cancerClinical factorsHazard ratioCox proportional hazards regression analysisCox proportional hazards regression modelElecsys 2010Proportional hazards regression analysisEarly-stage breast cancerProportional hazards regression modelsSerum P1NP levelsKaplan-Meier methodHazards regression analysisBone metastasis developmentHazards regression modelsProcollagen type 1Breast cancer recurrenceRoche Elecsys 2010Advanced diseaseP1NP levelsBone metastasesSerum levelsBone turnoverUnivariate analysisA dendritic metagene that predicts prognosis and endocrine resistance in breast cancer.
Giampaolo B, Pusztai L, Qi Y, Iwamoto T, Kelly C, Zambetti M, Symmans W, Gianni L. A dendritic metagene that predicts prognosis and endocrine resistance in breast cancer. Journal Of Clinical Oncology 2012, 30: 545-545. DOI: 10.1200/jco.2012.30.15_suppl.545.Peer-Reviewed Original ResearchHazard ratioEndocrine resistanceBreast cancerNeoadjuvant endocrine therapyProliferative breast cancersAdjuvant tamoxifenEndocrine therapyDistant relapseFree survivalUntreated patientsBetter prognosisDendritic cellsEarly relapseOncotype DXPoor prognosisClinical variablesPoor responseUntreated tumorsLower riskMetagene signaturePredictive valueMultivariate analysisTumorsRelapsePrognosisCentromere protein-A, an essential centromere protein, is a prognostic marker for relapse in estrogen receptor-positive breast cancer
McGovern SL, Qi Y, Pusztai L, Symmans WF, Buchholz TA. Centromere protein-A, an essential centromere protein, is a prognostic marker for relapse in estrogen receptor-positive breast cancer. Breast Cancer Research 2012, 14: r72. PMID: 22559056, PMCID: PMC3446334, DOI: 10.1186/bcr3181.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAutoantigensBiomarkers, TumorBreast NeoplasmsCentromere Protein ACentromere Protein BChromosomal Proteins, Non-HistoneDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansKi-67 AntigenMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalReceptors, EstrogenRNA, MessengerTamoxifenConceptsER-positive diseaseDistant relapse-free survivalSystemic therapyER-negative tumorsIndependent prognostic markerNeoadjuvant chemotherapyPrognostic markerBreast cancerChemotherapy responseKi-67Estrogen receptor-positive breast cancerReceptor-positive breast cancerER-positive breast cancerSignificant independent prognostic markerER-positive tumorsRelapse-free survivalBreast cancer patientsHigh-grade cancerSignificant independent predictorsKi-67 expressionFree survivalHazard ratioIndependent predictorsPrognostic factorsNegative tumors
2011
PD03-02: Prognostic and Predictive Predictors for Triple Negative Breast Cancer.
Karn T, Pusztai L, Ruckhäberle E, Liedtke C, Schmidt M, Müller V, Gätje R, Hanker L, Ahr A, Holtrich U, Rody A, Kaufmann M. PD03-02: Prognostic and Predictive Predictors for Triple Negative Breast Cancer. Cancer Research 2011, 71: pd03-02-pd03-02. DOI: 10.1158/0008-5472.sabcs11-pd03-02.Peer-Reviewed Original ResearchTriple-negative breast cancerNegative breast cancerPrognostic signatureBreast cancerResponse of TNBCER-positive cancersPrognostic gene signatureMolecular phenotypesTNBC cohortNeoadjuvant chemotherapyHazard ratioBetter prognosisPrognostic predictorTherapeutic optionsPoor prognosisIndependent cohortPredictive valuePrognostic gene expression profilesMultivariate analysisGene signatureCancer ResCohortCancerPrognosisROC analysis
2010
Molecular Anatomy of Breast Cancer Stroma and Its Prognostic Value in Estrogen Receptor–Positive and –Negative Cancers
Bianchini G, Qi Y, Alvarez RH, Iwamoto T, Coutant C, Ibrahim NK, Valero V, Cristofanilli M, Green MC, Radvanyi L, Hatzis C, Hortobagyi GN, Andre F, Gianni L, Symmans WF, Pusztai L. Molecular Anatomy of Breast Cancer Stroma and Its Prognostic Value in Estrogen Receptor–Positive and –Negative Cancers. Journal Of Clinical Oncology 2010, 28: 4316-4323. PMID: 20805453, DOI: 10.1200/jco.2009.27.2419.Peer-Reviewed Original ResearchMeSH KeywordsAmyloid beta-Protein PrecursorAntineoplastic Agents, HormonalBiopsy, Fine-NeedleB-LymphocytesBreast NeoplasmsChi-Square DistributionCollagen Type IVExtracellular Matrix ProteinsFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMetagenomeNeoplasm Recurrence, LocalPhospholipid Transfer ProteinsPrognosisProportional Hazards ModelsProspective StudiesProtease NexinsProtein Serine-Threonine KinasesReceptor, Transforming Growth Factor-beta Type IIReceptors, Cell SurfaceReceptors, EstrogenReceptors, Transforming Growth Factor betaSurvival AnalysisTamoxifenConceptsER-negative cancersBreast cancer stromaER-positive cancersPrognostic valueCancer stromaNegative cancersProliferative cancersSystemic adjuvant therapyTamoxifen-treated patientsNode-negative patientsEstrogen-receptor positiveStrong prognostic valueCore needle biopsySubset of tumorsLess prognostic valueDistant relapseAdjuvant therapyHazard ratioFavorable prognosisHighest tertilePrognostic scoreCore biopsyBreast cancerImmune functionMultivariate analysisEstrogen Receptor Expression and Docetaxel Efficacy in Patients with Metastatic Breast Cancer: A Pooled Analysis of Four Randomized Trials
Andre F, Broglio K, Pusztai L, Berrada N, Mackey JR, Nabholtz JM, Chan S, Hortobagyi GN. Estrogen Receptor Expression and Docetaxel Efficacy in Patients with Metastatic Breast Cancer: A Pooled Analysis of Four Randomized Trials. The Oncologist 2010, 15: 476-483. PMID: 20421265, PMCID: PMC3227977, DOI: 10.1634/theoncologist.2009-0150.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerEfficacy of docetaxelBreast cancerHigh response rateER expressionResponse rateEstrogen receptorHazard ratioRandomized trialsDisease progressionProgression-free survival timeCox proportional hazards modelDocetaxel-based regimenEstrogen receptor expressionProportional hazards modelEffect of docetaxelER- diseasePFS timeDocetaxel efficacyPooled analysisTumor responseReceptor expressionSurvival timeLower riskHazards model
2009
Estrogen receptor expression and docetaxel efficacy in patients with metastatic breast cancer: A pooled analysis of four randomized trials
Mazouni C, André F, Broglio K, Pusztai L, Hortobagyi G. Estrogen receptor expression and docetaxel efficacy in patients with metastatic breast cancer: A pooled analysis of four randomized trials. Journal Of Clinical Oncology 2009, 27: 1046-1046. DOI: 10.1200/jco.2009.27.15_suppl.1046.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalER-negative diseaseEfficacy of docetaxelBreast cancerER expressionResponse rateRandomized trialsDisease progressionEstrogen receptor-positive metastatic breast cancerPositive metastatic breast cancerCox proportional hazards modelTumor response rateER-positive patientsER-negative cancersEstrogen receptor expressionProportional hazards modelEffect of docetaxelHazard ratioDocetaxel efficacyPooled analysisTumor responseReceptor expressionHazards modelPatients
2007
Estrogen receptor expression and efficacy of docetaxel in early breast cancer: A pooled analysis of 3,490 patients included in two randomized trials
Andre F, Broglio K, Roche H, Martin M, Penault-Lorca F, Hortobagyi G, Berry D, Pusztai L. Estrogen receptor expression and efficacy of docetaxel in early breast cancer: A pooled analysis of 3,490 patients included in two randomized trials. Journal Of Clinical Oncology 2007, 25: 537-537. DOI: 10.1200/jco.2007.25.18_suppl.537.Peer-Reviewed Original ResearchEfficacy of docetaxelRisk of deathER-positive diseaseER-negative diseaseEstrogen receptor expressionER expressionER statusPooled analysisAdjuvant chemotherapyHazard ratioRandomized trialsReceptor expressionBreast cancerAxillary node-positive breast cancerNode-positive breast cancerDocetaxel-containing regimenEarly breast cancerSubset of patientsPositive breast cancerAdjuvant treatment trialsSignificant risk reductionAdjuvant settingClinical characteristicsDocetaxel therapyOverall survival
2004
Her2/neu-positive disease does not increase risk of locoregional recurrence for patients treated with neoadjuvant doxorubicin-based chemotherapy, mastectomy, and radiotherapy
Buchholz TA, Huang EH, Berry D, Pusztai L, Strom EA, McNeese MD, Perkins GH, Schechter NR, Kuerer HM, Buzdar AU, Valero V, Hunt KK, Hortobagyi GN, Sahin AA. Her2/neu-positive disease does not increase risk of locoregional recurrence for patients treated with neoadjuvant doxorubicin-based chemotherapy, mastectomy, and radiotherapy. International Journal Of Radiation Oncology • Biology • Physics 2004, 59: 1337-1342. PMID: 15275718, DOI: 10.1016/j.ijrobp.2004.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibiotics, AntineoplasticBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicConfidence IntervalsDoxorubicinDrug Resistance, NeoplasmFemaleHumansLymphatic MetastasisMastectomy, RadicalNeoadjuvant TherapyNeoplasm ProteinsNeoplasm Recurrence, LocalRadiation ToleranceReceptor, ErbB-2Receptors, EstrogenRegression AnalysisRetrospective StudiesConceptsHER2/neu-positive diseaseHER2/neu-positive tumorsLocoregional recurrenceHER2/neuNeoadjuvant doxorubicinHER2/neu-negative diseaseHER2/neu-negative tumorsEstrogen receptor-negative diseaseHER2/neu positivityHER2/neu overexpressionChest wall boostNeu-negative tumorsOverall LRR ratePositive lymph nodesReceptor-negative diseaseCox regression analysisEstrogen receptor statusLRR rateSupraclavicular diseaseHazard ratioLymph nodesReceptor statusPostmastectomy radiotherapyPreclinical dataNeu overexpression