2023
LBA20 A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC)
Loi S, Curigliano G, Salgado R, Diaz R, Delaloge S, Rojas C, Kok M, Manich C, Harbeck N, Mittendorf E, Yardley D, Pusztai L, Zaizar A, Ungureanu A, Ades F, Chandra R, Nathani R, Pacius M, Wu J, McArthur H. LBA20 A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC). Annals Of Oncology 2023, 34: s1259-s1260. DOI: 10.1016/j.annonc.2023.10.010.Peer-Reviewed Original ResearchPersistence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor-positive (HR +) breast cancer
Foldi J, Tsagianni A, Salganik M, Schnabel C, Brufsky A, van Londen G, Pusztai L, Sanft T. Persistence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor-positive (HR +) breast cancer. BMC Cancer 2023, 23: 606. PMID: 37391697, PMCID: PMC10314405, DOI: 10.1186/s12885-023-11104-w.Peer-Reviewed Original ResearchConceptsAdjuvant endocrine therapyEarly-stage hormone receptor-positive breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerEndocrine therapyBreast cancerLate breast cancer recurrenceExtended endocrine therapyNon-persistence ratesIntolerable side effectsBone density scanBreast cancer recurrenceHigher likelihoodRate of persistenceElectronic health recordsConclusionsIn patientsMedication persistenceTreatment persistenceLow patientsMetastatic recurrenceCancer recurrenceCommon reasonSide effectsPatientsStage IEvaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial
Speers C, Symmans W, Barlow W, Trevarton A, The S, Du L, Rae J, Shak S, Baehner R, Sharma P, Pusztai L, Hortobagyi G, Hayes D, Albain K, Godwin A, Thompson A. Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial. Journal Of Clinical Oncology 2023, 41: 1841-1848. PMID: 36649570, PMCID: PMC10082279, DOI: 10.1200/jco.22.01499.Peer-Reviewed Original ResearchConceptsBreast Recurrence ScoreAnthracycline-based chemotherapyDisease-free survivalRecurrence scoreEndocrine therapyTherapy indexAdjuvant anthracycline-based chemotherapyNode-positive breast cancerAdjuvant endocrine therapyPrimary end pointSubset of patientsPostmenopausal patientsChemotherapy benefitTreatment armsPrognostic indexPrognostic informationBreast cancerPrognostic assessmentPrognostic performancePatientsEnd pointTumor samplesChemotherapyClinical validationProportional hazards assumption
2021
Predicted sensitivity to endocrine therapy for stage II-III hormone receptor-positive and HER2-negative (HR+/HER2−) breast cancer before chemo-endocrine therapy
Du L, Yau C, Brown-Swigart L, Gould R, Krings G, Hirst G, Bedrosian I, Layman R, Carter J, Klein M, Venters S, Shad S, van der Noordaa M, Chien A, Haddad T, Isaacs C, Pusztai L, Albain K, Nanda R, Tripathy D, Liu M, Boughey J, Schwab R, Hylton N, DeMichele A, Perlmutter J, Yee D, Berry D, Veer L, Valero V, Esserman L, Symmans W. Predicted sensitivity to endocrine therapy for stage II-III hormone receptor-positive and HER2-negative (HR+/HER2−) breast cancer before chemo-endocrine therapy. Annals Of Oncology 2021, 32: 642-651. PMID: 33617937, DOI: 10.1016/j.annonc.2021.02.011.Peer-Reviewed Original ResearchConceptsResidual cancer burdenI-SPY2 trialIndependent prognostic informationPrognostic informationBreast cancerPrognostic signaturePre-treatment tumor biopsiesHER2-negative breast cancerStage IIDistant relapse-free survivalMultivariate Cox regression modelHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Chemo-endocrine therapyEndocrine-based treatmentAdjuvant endocrine therapyGrowth factor receptor 2Primary outcome measureRelapse-free survivalSimilar prognostic informationCox regression modelMolecular prognostic signaturesNegative breast cancerFactor receptor 2MDACC cohort
2020
Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer
Pusztai L, Taylor R, Mougalian SS. Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer. Cancer Cell 2020, 38: 323-325. PMID: 32931742, DOI: 10.1016/j.ccell.2020.08.006.Peer-Reviewed Original ResearchA phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL.
Loi S, McArthur H, Harbeck N, Pusztai L, Delaloge S, Letrent K, Chen T, Li B, Tatsuoka K, Zardavas D, Curigliano G. A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL. Journal Of Clinical Oncology 2020, 38: tps604-tps604. DOI: 10.1200/jco.2020.38.15_suppl.tps604.Peer-Reviewed Original ResearchAdjuvant endocrine therapyPathologic complete responsePrimary breast cancerEndocrine therapyNeoadjuvant chemotherapyBreast cancerNeoadjuvant phaseER expressionGlobal phase 3 studyDeath ligand 1 (PD-L1) expressionLong-term clinical outcomesAdequate organ functionDeath-1 (PD-1) inhibitionLow ER expressionAxillary nodal statusDisease-free survivalEvent-free survivalLigand 1 expressionPhase III trialsResidual cancer burdenPhase 3 studyOverall response rateRisk of relapseValid surrogate endpointQuality of lifeAdherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers.
Foldi J, Schnabel C, Salganik M, Pusztai L, Sanft T. Adherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers. Journal Of Clinical Oncology 2020, 38: 527-527. DOI: 10.1200/jco.2020.38.15_suppl.527.Peer-Reviewed Original ResearchLate distant recurrenceAdjuvant endocrine therapyEndocrine therapyDistant recurrenceDXA scansBreast cancerHigh riskStage IEarly-stage hormone receptorExtended endocrine therapyIntolerable side effectsOsteopenia/osteoporosisPositive breast cancerRate of adherenceSerious adverse effectsBreast cancer recurrenceMajority of ptsHigher likelihoodElectronic health recordsLocal recurrenceMedian ageLate recurrenceMetastatic recurrenceTumor characteristicsMedication adherence134TiP A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2− primary breast cancer: CheckMate 7FL
Curigliano G, McArthur H, Harbeck N, Pusztai L, Delaloge S, Letrent K, Chen T, Li B, Tatsuoka K, Zardavas D, Loi S. 134TiP A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2− primary breast cancer: CheckMate 7FL. Annals Of Oncology 2020, 31: s60-s61. DOI: 10.1016/j.annonc.2020.03.236.Peer-Reviewed Original Research
2017
Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer
Mougalian SS, Epstein LN, Jhaveri AP, Han G, Abu-Khalaf M, Hofstatter EW, DiGiovanna MP, Silber ALM, Adelson K, Pusztai L, Gross CP. Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. JCO Clinical Cancer Informatics 2017, 1: 1-10. PMID: 30657377, DOI: 10.1200/cci.17.00015.Peer-Reviewed Original ResearchConceptsAdverse effectsEndocrine therapyClinical trialsBreast cancerFrequency of AEsMedication-related adverse effectsTherapy-related adverse effectsBidirectional Text MessagingEndocrine therapy adherenceAdjuvant endocrine therapyMajority of patientsMedical record reviewSevere adverse effectsText message systemConsecutive patientsVaginal symptomsRecord reviewHot flashesTherapy adherenceClinic nursesHistorical controlsPatient acceptanceProvider teamGeneral populationPatientsDuration of neoadjuvant endocrine therapy and breast cancer outcomes.
Mougalian S, Soulos P, Lannin D, Pusztai L, Gross C, Killelea B. Duration of neoadjuvant endocrine therapy and breast cancer outcomes. Journal Of Clinical Oncology 2017, 35: e12129-e12129. DOI: 10.1200/jco.2017.35.15_suppl.e12129.Peer-Reviewed Original ResearchNeoadjuvant endocrine therapyEndocrine therapyClinical stagePathologic stageNational Cancer Data BasePR-positive breast cancerHigher nodal stageNetwork cancer programsAdjuvant endocrine therapyMultiple comorbid conditionsBreast cancer outcomesPopulation of patientsType of surgeryPositive breast cancerSimilar response ratesNeoadjuvant chemotherapyUnderwent surgeryNodal stageComorbid conditionsCancer outcomesLarge tumorsCancer programsBreast cancerOlder womenPatientsHealth economic impact of breast cancer index (BCI) in patients with hormone responsive breast cancer (HRBC) considering extended adjuvant endocrine therapy (EET).
Sanft T, Berkowitz A, Schroeder B, Hatzis C, Schnabel C, Aktas B, Brufsky A, Pusztai L, Gustavsen G, Van Londen G. Health economic impact of breast cancer index (BCI) in patients with hormone responsive breast cancer (HRBC) considering extended adjuvant endocrine therapy (EET). Journal Of Clinical Oncology 2017, 35: 25-25. DOI: 10.1200/jco.2017.35.8_suppl.25.Peer-Reviewed Original ResearchHormone-responsive breast cancerBreast Cancer IndexAdjuvant endocrine therapyEndocrine therapyCancer indexBreast cancerEarly-stage hormone receptor-positive breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerYale Cancer CenterReal-world cohortResponsive breast cancerPopulation of patientsGene expression-based testsPositive breast cancerHealth economic impactHealth economic analysisLikelihood of benefitPittsburgh Medical CenterNet cost savingsYr of treatmentGross cost savingsAdverse eventsExtended therapyLate recurrence
2015
Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer
Sanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L. Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer. Breast Cancer Research And Treatment 2015, 154: 533-541. PMID: 26578401, PMCID: PMC4661200, DOI: 10.1007/s10549-015-3631-9.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Agents, HormonalAnxietyBreast NeoplasmsChemotherapy, AdjuvantDecision MakingFemaleGene Expression Regulation, NeoplasticGenetic TestingHumansMiddle AgedNeoplasm Recurrence, LocalPrognosisProspective StudiesReceptors, EstrogenSurveys and QuestionnairesTamoxifenConceptsBreast Cancer IndexExtended endocrine therapyER-positive breast cancerAdjuvant endocrine therapyEndocrine therapyDecisional Conflict ScaleBreast cancerCancer indexPhysician recommendationRisk/benefit discussionEarly-stage estrogen receptorEndocrine therapy trialsYale Cancer CenterPositive breast cancerState-Trait Anxiety Inventory FormMean STAIExtended therapyLate recurrenceAbsolute benefitCancer CenterPatient satisfactionPrognostic informationTreatment recommendationsPatient anxietyImproved outcomesMultigene prognostic tests in breast cancer: past, present, future
Győrffy B, Hatzis C, Sanft T, Hofstatter E, Aktas B, Pusztai L. Multigene prognostic tests in breast cancer: past, present, future. Breast Cancer Research 2015, 17: 11. PMID: 25848861, PMCID: PMC4307898, DOI: 10.1186/s13058-015-0514-2.BooksConceptsER-negative cancersPrognostic valuePredictive markerBreast cancerPrognostic signatureExtended adjuvant endocrine therapyPrognostic testAdjuvant endocrine therapyCandidate predictive markersImmune gene signaturesPositive breast cancerGood prognostic valueSignificant prognostic valueTreatment response predictorsNew predictive markers
2013
Estrogen receptor (ER) mRNA expression and molecular subtype distribution in ER-negative/progesterone receptor-positive breast cancers
Itoh M, Iwamoto T, Matsuoka J, Nogami T, Motoki T, Shien T, Taira N, Niikura N, Hayashi N, Ohtani S, Higaki K, Fujiwara T, Doihara H, Symmans WF, Pusztai L. Estrogen receptor (ER) mRNA expression and molecular subtype distribution in ER-negative/progesterone receptor-positive breast cancers. Breast Cancer Research And Treatment 2013, 143: 403-409. PMID: 24337596, DOI: 10.1007/s10549-013-2763-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsBridged-Ring CompoundsFemaleGene Expression ProfilingHumansKi-67 AntigenMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRNA, MessengerSurvival RateTaxoidsYoung AdultConceptsEstrogen receptor mRNA expressionPR-positive patientsTriple-negative cohortER-positive cancersTriple-negative cancersReceptor mRNA expressionProgesterone receptorBreast cancerMolecular subtypesER-negative/PR-positive tumorsProgesterone receptor-positive breast cancerReceptor-positive breast cancerRelapse-free survival rateMRNA expressionAdjuvant endocrine therapyMolecular subtype distributionPR-positive tumorsRoutine clinical assessmentSafe clinical approachLuminal-type cancersExpression of ESR1Adjuvant endocrineEndocrine therapyNeoadjuvant chemotherapyAffymetrix U133A gene chipsProliferation and estrogen signaling can distinguish patients at risk for early versus late relapse among estrogen receptor positive breast cancers
Bianchini G, Pusztai L, Karn T, Iwamoto T, Rody A, Kelly C, Müller V, Schmidt M, Qi Y, Holtrich U, Becker S, Santarpia L, Fasolo A, Del Conte G, Zambetti M, Sotiriou C, Haibe-Kains B, Symmans WF, Gianni L. Proliferation and estrogen signaling can distinguish patients at risk for early versus late relapse among estrogen receptor positive breast cancers. Breast Cancer Research 2013, 15: r86. PMID: 24060333, PMCID: PMC3978752, DOI: 10.1186/bcr3481.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsCell ProliferationChemoradiotherapy, AdjuvantEstrogensFemaleFollow-Up StudiesGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMiddle AgedMitosisNeoplasm GradingNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingPrognosisReceptors, EstrogenRiskSignal TransductionTamoxifenConceptsNode-negative tumorsLate relapseNeoadjuvant letrozoleEndocrine therapyEarly relapseNegative tumorsBreast cancerEstrogen receptor-positive breast cancerProliferation markersReceptor-positive breast cancerER-positive breast cancerAdjuvant endocrine therapyAffymetrix gene expression profilesExtended endocrine therapyTamoxifen-treated patientsER-positive patientsGenomic grade indexPositive breast cancerRisk of recurrenceRisk of relapseEstrogen receptor activitySmall independent cohortEstrogen-related genesAdjuvant tamoxifenSystemic therapy
2012
12O_PR Independent Blinded Validation of the Genomic Index of Sensitivity to Endocrine Therapy (Set)
Karn T, Hatzis C, Symmans W, Pusztai L, Ruckhäberle E, Schmidt M, Müller V, Holtrich U, Rody A, Kaufmann M. 12O_PR Independent Blinded Validation of the Genomic Index of Sensitivity to Endocrine Therapy (Set). Annals Of Oncology 2012, 23: ii18. DOI: 10.1016/s0923-7534(19)65684-x.Peer-Reviewed Original ResearchEndocrine therapyPositive patientsPrognostic valueTumor sizeER-positive primary breast cancerPositive primary breast cancerAdjuvant endocrine therapyNegative PgR statusNode-negative cohortPure prognostic valueNode-negative patientsStepwise Cox regressionER-positive patientsPrimary breast cancerBest independent predictorPgR statusAdjuvant treatmentRetrospective cohortIndependent predictorsLymph nodesNegative cohortSurvival benefitCox regressionClinical associationsHER2 statusEstrogen Receptor (ER) mRNA and ER-Related Gene Expression in Breast Cancers That Are 1% to 10% ER-Positive by Immunohistochemistry
Iwamoto T, Booser D, Valero V, Murray JL, Koenig K, Esteva FJ, Ueno NT, Zhang J, Shi W, Qi Y, Matsuoka J, Yang EJ, Hortobagyi GN, Hatzis C, Symmans WF, Pusztai L. Estrogen Receptor (ER) mRNA and ER-Related Gene Expression in Breast Cancers That Are 1% to 10% ER-Positive by Immunohistochemistry. Journal Of Clinical Oncology 2012, 30: 729-734. PMID: 22291085, DOI: 10.1200/jco.2011.36.2574.Peer-Reviewed Original ResearchConceptsER-positive patientsIHC-positive patientsER-positive cancersESR1 mRNA expressionGene signature scoreER statusBreast cancerSignature scoreEstrogen receptor-positive cancersMRNA expressionAdjuvant endocrine therapyEndocrine-sensitive tumorsER-negative cohortER-positive cohortER-negative groupER-positive tumorsOverall survival ratePrimary breast cancerER-negative cancersReceptor-positive cancersSafe clinical approachEstrogen receptor mRNAEndocrine therapyER-positiveAffymetrix U133A gene chips
2010
Genomic Index of Sensitivity to Endocrine Therapy for Breast Cancer
Symmans WF, Hatzis C, Sotiriou C, Andre F, Peintinger F, Regitnig P, Daxenbichler G, Desmedt C, Domont J, Marth C, Delaloge S, Bauernhofer T, Valero V, Booser DJ, Hortobagyi GN, Pusztai L. Genomic Index of Sensitivity to Endocrine Therapy for Breast Cancer. Journal Of Clinical Oncology 2010, 28: 4111-4119. PMID: 20697068, PMCID: PMC2953969, DOI: 10.1200/jco.2010.28.4273.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAromatase InhibitorsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantChi-Square DistributionDisease-Free SurvivalEstrogen Receptor alphaFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenomicsHumansMiddle AgedNeoplasm StagingOligonucleotide Array Sequence AnalysisPatient SelectionProportional Hazards ModelsRisk AssessmentRisk FactorsSurvival AnalysisTamoxifenTime FactorsTranscription, GeneticTreatment OutcomeConceptsAdjuvant endocrine therapyEndocrine therapyBreast cancerDistant relapseER-positive breast cancerChemo-endocrine therapyDistant relapse riskYears of tamoxifenAdjuvant systemic therapyEstrogen receptor αBreast cancer samplesPrior chemotherapyNeoadjuvant chemotherapyPathologic responseSurvival benefitSystemic therapyUntreated cohortRelapse riskDeath riskTherapy indexAromatase inhibitionESR1 levelsReceptor αTamoxifenTherapy
2009
Evaluation of Microtubule-Associated Protein-Tau Expression As a Prognostic and Predictive Marker in the NSABP-B 28 Randomized Clinical Trial
Pusztai L, Jeong JH, Gong Y, Ross JS, Kim C, Paik S, Rouzier R, Andre F, Hortobagyi GN, Wolmark N, Symmans WF. Evaluation of Microtubule-Associated Protein-Tau Expression As a Prognostic and Predictive Marker in the NSABP-B 28 Randomized Clinical Trial. Journal Of Clinical Oncology 2009, 27: 4287-4292. PMID: 19667268, PMCID: PMC2744271, DOI: 10.1200/jco.2008.21.6887.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinEstrogen Receptor alphaFemaleFollow-Up StudiesHumansImmunohistochemistryKaplan-Meier EstimateMaleMicrotubule-Associated ProteinsMiddle AgedMultivariate AnalysisPaclitaxelPredictive Value of TestsPrognosisProportional Hazards ModelsRandomized Controlled Trials as TopicReceptor, ErbB-2Tau ProteinsConceptsDisease-free survivalOverall survivalTau protein expressionTau expressionEndocrine therapyPaclitaxel chemotherapyClinical trialsHuman epidermal growth factor receptor 2 (HER2) expressionEpidermal growth factor receptor 2 expressionBetter disease-free survivalWorse disease-free survivalD. Anderson Cancer CenterPrimary breast cancer specimensCourses of doxorubicinHER2-positive statusHormone receptor positiveNational Surgical BreastAdjuvant endocrine therapyPercent of patientsProtein expressionGreater tumor sizeER-positive statusEstrogen receptor-positive statusLow histologic gradeAnderson Cancer Center
2008
Histopathologic and Molecular Markers of Prognosis and Response to Therapy
Pusztai L, Symmans W. Histopathologic and Molecular Markers of Prognosis and Response to Therapy. MD Anderson Cancer Care Series 2008, 323-343. DOI: 10.1007/978-0-387-34952-7_11.Peer-Reviewed Original ResearchLymph node-negative breast cancerNode-negative breast cancerBreast cancerEndocrine therapyMultigene assaysValuable additional prognostic informationAdditional adjuvant chemotherapyPrognosis of womenAdjuvant endocrine therapyLymph node statusSurgical margin statusAdditional prognostic informationRoutine pathologic evaluationPersonalized treatment recommendationsAppropriate treatment decisionsAdjuvant chemotherapyMargin statusPathologic evaluationTrastuzumab therapyBetter prognosisNode statusOncotype DXTumor sizeHistopathologic subtypeProgesterone receptor