2023
Molecular Characterization of HER2-Low Invasive Breast Carcinoma by Quantitative RT-PCR Using Oncotype DX Assay
Lin H, Can T, Kahn A, Flannery C, Hoag J, Akkunuri A, Bailey H, Baehner R, Pusztai L, Rozenblit M. Molecular Characterization of HER2-Low Invasive Breast Carcinoma by Quantitative RT-PCR Using Oncotype DX Assay. The Oncologist 2023, 28: e973-e976. PMID: 37656608, PMCID: PMC10546821, DOI: 10.1093/oncolo/oyad249.Peer-Reviewed Original ResearchConceptsHER2 mRNA levelsIHC 0MRNA levelsOncotype DX recurrence score resultsEstrogen receptor-positive breast cancerReceptor-positive breast cancerCurrent adjuvant chemotherapyOncotype DX assayRecurrence Score resultsPositive breast cancerInvasive breast carcinomaIHC score 0Adjuvant chemotherapyQuantitative RT-PCRBreast carcinomaPositive statusScore 0Breast cancerStage IYale cohortHigher mRNA levelsCancerRT-PCRPatientsHER2
2022
Molecular differences between younger versus older ER-positive and HER2-negative breast cancers
Qing T, Karn T, Rozenblit M, Foldi J, Marczyk M, Shan N, Blenman K, Holtrich U, Kalinsky K, Meric-Bernstam F, Pusztai L. Molecular differences between younger versus older ER-positive and HER2-negative breast cancers. Npj Breast Cancer 2022, 8: 119. PMID: 36344517, PMCID: PMC9640562, DOI: 10.1038/s41523-022-00492-0.Peer-Reviewed Original ResearchBreast cancerYounger patientsHER2-negative breast cancerNode-positive breast cancerNode-negative diseaseSame clinical featuresHigh mutation burdenLower mRNA expressionAdjuvant chemotherapyMicroarray cohortTAILORx trialOvarian suppressionOlder patientsPatient ageClinical featuresProliferation-related gene expressionScore 0Mutation burdenCopy number gainsOlder womenGATA3 mutationsAge groupsGene signatureMRNA expressionChemotherapy
2021
21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer
Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Martin M, Kelly CM, Ruiz-Borrego M, Gil-Gil M, Arce-Salinas CH, Brain EGC, Lee ES, Pierga JY, Bermejo B, Ramos-Vazquez M, Jung KH, Ferrero JM, Schott AF, Shak S, Sharma P, Lew DL, Miao J, Tripathy D, Pusztai L, Hortobagyi GN. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. New England Journal Of Medicine 2021, 385: 2336-2347. PMID: 34914339, PMCID: PMC9096864, DOI: 10.1056/nejmoa2108873.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleGene Expression ProfilingHumansLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPostmenopausePremenopauseProspective StudiesReceptor, ErbB-2Receptors, SteroidReverse Transcriptase Polymerase Chain ReactionConceptsInvasive disease-free survivalDistant relapse-free survivalDisease-free survivalRelapse-free survivalChemotherapy benefitRecurrence scoreBreast cancerChemoendocrine therapyAdjuvant chemotherapyPostmenopausal womenPremenopausal womenLymph nodesAxillary lymph node-negative breast cancerLymph node-negative breast cancerPositive axillary lymph nodesHER2-negative breast cancerNode-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Positive lymph node diseasePositive lymph nodesSecondary end pointsAxillary lymph nodesLymph node diseaseGrowth factor receptor 2
2020
Gene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer
Liedtke C, Pusztai L. Gene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer. 2020, 77-96. DOI: 10.1201/9780429137723-6.Peer-Reviewed Original ResearchBreast cancerEarly-stage breast cancerCombination chemotherapy regimensSubstantial tumor responseAdvanced breast cancerNeoadjuvant chemotherapy regimenStage breast cancerAdjuvant chemotherapyChemotherapy regimenNeoadjuvant therapyChemotherapy regimensPreoperative chemotherapyChemotherapy selectionOverall survivalInoperable cancerTumor responseStage ICancer tissuesCancerGene expression profilingChemotherapyDiagnostic toolCurrent standardSemiquantitative mannerExpression profiling
2017
Does lymph node status influence adjuvant therapy decision-making in women 70 years of age or older with clinically node negative hormone receptor positive breast cancer?
Chagpar AB, Horowitz N, Sanft T, Wilson LD, Silber A, Killelea B, Moran MS, DiGiovanna MP, Hofstatter E, Chung G, Pusztai L, Lannin DR. Does lymph node status influence adjuvant therapy decision-making in women 70 years of age or older with clinically node negative hormone receptor positive breast cancer? The American Journal Of Surgery 2017, 214: 1082-1088. PMID: 28939252, DOI: 10.1016/j.amjsurg.2017.07.036.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerPositive breast cancerLymph nodesRadiation therapyBreast cancerPost-lumpectomy radiation therapyPost-mastectomy radiation therapyNational Cancer DatabaseSentinel LN biopsyBreast cancer patientsWomen 70 yearsAdjuvant chemotherapyAdjuvant therapyHormonal therapyLN biopsyLN evaluationLN statusCancer patientsCancer DatabasePatientsTherapyCancerChemotherapyHr
2015
Chemotherapy and the recurrence score—results as expected?
Pusztai L. Chemotherapy and the recurrence score—results as expected? Nature Reviews Clinical Oncology 2015, 12: 690-692. PMID: 26552957, DOI: 10.1038/nrclinonc.2015.191.Peer-Reviewed Original ResearchMeasurement of Domain-Specific HER2 (ERBB2) Expression May Classify Benefit From Trastuzumab in Breast Cancer
Carvajal-Hausdorf DE, Schalper KA, Pusztai L, Psyrri A, Kalogeras KT, Kotoula V, Fountzilas G, Rimm DL. Measurement of Domain-Specific HER2 (ERBB2) Expression May Classify Benefit From Trastuzumab in Breast Cancer. Journal Of The National Cancer Institute 2015, 107: djv136. PMID: 25991002, PMCID: PMC4554192, DOI: 10.1093/jnci/djv136.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicDisease-Free SurvivalExtracellular SpaceFemaleFluorescent Antibody TechniqueGene Expression Regulation, NeoplasticHumansIntracellular SpaceKaplan-Meier EstimateMiddle AgedPredictive Value of TestsPrognosisReceptor, ErbB-2Sensitivity and SpecificityTissue Array AnalysisTrastuzumabTreatment OutcomeConceptsHuman epidermal growth factor receptor 2ECD expressionICD statusLonger DFSQuantitative immunofluorescenceTrastuzumab therapyPrognostic valueBreast cancerTissue microarrayEpidermal growth factor receptor 2Adjuvant trastuzumab therapyDisease-free survival analysisTrastuzumab-treated patientsGrowth factor receptor 2High positive predictive valueHER2-positive tumorsKaplan-Meier estimatesFactor receptor 2ERBB2 gene amplificationHER2 protein expressionPositive predictive valueExtracellular domainAdjuvant chemotherapyHER2-ICDBetter DFSNeoadjuvant Chemotherapy for Breast Cancer Increases the Rate of Breast Conservation: Results from the National Cancer Database
Killelea BK, Yang VQ, Mougalian S, Horowitz NR, Pusztai L, Chagpar AB, Lannin DR. Neoadjuvant Chemotherapy for Breast Cancer Increases the Rate of Breast Conservation: Results from the National Cancer Database. Journal Of The American College Of Surgeons 2015, 220: 1063-1069. PMID: 25868410, DOI: 10.1016/j.jamcollsurg.2015.02.011.Peer-Reviewed Original ResearchConceptsNational Cancer DatabaseNeoadjuvant chemotherapyBreast preservationBreast conservationTumor sizeCancer DatabaseDefinitive breast surgerySmall institutional seriesBreast cancer increasesAdvanced nodal diseaseInvasive breast cancerYounger patient ageBreast tumor sizeLarger tumor sizeMultivariate logistic regressionHigh tumor gradeAmerican Cancer SocietyAdjuvant chemotherapyNodal diseasePrimary surgeryT4 tumorsInstitutional seriesPatient ageRetrospective reviewDistant metastasisGenomic predictor of residual risk of recurrence after adjuvant chemotherapy and endocrine therapy in high risk estrogen receptor-positive breast cancers
Khan SS, Karn T, Symmans WF, Rody A, Müller V, Holtrich U, Becker S, Pusztai L, Hatzis C. Genomic predictor of residual risk of recurrence after adjuvant chemotherapy and endocrine therapy in high risk estrogen receptor-positive breast cancers. Breast Cancer Research And Treatment 2015, 149: 789-797. PMID: 25651779, DOI: 10.1007/s10549-015-3277-7.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalAdjuvant chemotherapyEndocrine therapyHigh riskOncotype DXBreast cancerEstrogen receptor-positive breast cancerReceptor-positive breast cancerRisk categoriesEarly-stage estrogen receptorEndocrine therapy sensitivityGood prognosis patientsER-positive patientsHigh-risk patientsPoor prognosis groupPositive breast cancerLow-risk groupAdjuvant endocrineMultimodality therapyPrognosis patientsRisk patientsEndocrine sensitivityIndependent predictorsPrognosis groupT stage
2012
Adjuvant therapy in stage I carcinoma of the breast
Schwartz GF, Reis‐Fihlo J, Pusztai L, Fentiman IS, Holland R, Bartelink H, Rutgers EJ, Solin LJ, Palazzo J, Committee A. Adjuvant therapy in stage I carcinoma of the breast. Cancer 2012, 118: 2031-2038. PMID: 22392361, DOI: 10.1002/cncr.27431.Peer-Reviewed Original ResearchConceptsStage I breast cancerI breast cancerBreast cancerAdjuvant therapyConsensus conferenceStage ILymph node-negative breast cancerNode-negative breast cancerKimmel Cancer CenterAdjuvant chemotherapyAdjuvant hormonesAdjuvant treatmentCancer CenterClinical trialsThomas Jefferson UniversityTreatment criteriaTreatment decisionsIndividual tumorsCancerGenetic factorsChemotherapyMolecular phenotypingTherapyHormoneCurrent dataLapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial
Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M, Team O. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. The Lancet 2012, 379: 633-640. PMID: 22257673, PMCID: PMC5705192, DOI: 10.1016/s0140-6736(11)61847-3.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDiarrheaDrug Administration ScheduleFemaleHumansInfusions, IntravenousLapatinibLiverMiddle AgedNeoadjuvant TherapyPaclitaxelQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsPathological complete responseBreast cancerHER2-positive early breast cancerHER2-positive primary breast cancerAnti-HER2 monoclonal antibody trastuzumabHER2-positive breast cancerHER2-overexpressing breast cancerTyrosine kinase inhibitor lapatinibGrade 3 diarrheaLiver enzyme alterationsAnti-HER2 agentsAnti-HER2 therapyPhase 3 studyPhase 3 trialEarly breast cancerPrimary breast cancerSingle-agent therapySynergistic antitumour activityMajor cardiac dysfunctionKinase inhibitor lapatinibMonoclonal antibody trastuzumabAdjuvant chemotherapyNeoadjuvant phaseNeoadjuvant settingOral lapatinib
2010
Utility of oncotype DX risk estimates in clinically intermediate risk hormone receptor‐positive, HER2‐normal, grade II, lymph node‐negative breast cancers
Kelly CM, Krishnamurthy S, Bianchini G, Litton JK, Gonzalez‐Angulo A, Hortobagyi GN, Pusztai L. Utility of oncotype DX risk estimates in clinically intermediate risk hormone receptor‐positive, HER2‐normal, grade II, lymph node‐negative breast cancers. Cancer 2010, 116: 5161-5167. PMID: 20665886, DOI: 10.1002/cncr.25269.Peer-Reviewed Original ResearchConceptsTrial Assigning Individualized OptionsRisk of recurrenceOncotype DXRecurrence scoreBreast cancerIntermediate riskGrade I/II tumorsLymph node-negative breast cancerNode-negative breast cancerStage I/IID. Anderson Cancer CenterOncotype DX breast cancerRisk estimatesIntermediate-risk populationEarly breast cancerRoutine clinical variablesHigh-risk groupOncotype DX testingAnderson Cancer CenterAdjuvant chemotherapyDistant recurrenceConsecutive patientsII tumorsClinicopathological variablesLobular carcinoma
2009
Evaluation of microtubule associated protein tau expression as prognostic and predictive marker in the NSABP-B 28 randomized clinical trial.
Pusztai L, Jeong J, Gong Y, Ross J, Kim C, Hortobagyi G, Paik S, Symmans W. Evaluation of microtubule associated protein tau expression as prognostic and predictive marker in the NSABP-B 28 randomized clinical trial. Cancer Research 2009, 69: 54. DOI: 10.1158/0008-5472.sabcs-54.Peer-Reviewed Original ResearchOverall survivalTau protein expressionTau expressionClinical trialsHormone receptor-positive tumorsMD Anderson Cancer CenterDoxorubicin/cyclophosphamideER-negative subsetNational Surgical BreastAdjuvant endocrine treatmentProtein expressionReceptor-positive tumorsPercent of tumorsAnderson Cancer CenterNormal breast epitheliumAdjuvant chemotherapyPaclitaxel efficacyBowel ProjectEndocrine therapyEndocrine treatmentPaclitaxel chemotherapyNodal statusBetter prognosisClinical outcomesPositive tumors
2008
Effect of Molecular Disease Subsets on Disease-Free Survival in Randomized Adjuvant Chemotherapy Trials for Estrogen Receptor–Positive Breast Cancer
Pusztai L, Broglio K, Andre F, Symmans WF, Hess KR, Hortobagyi GN. Effect of Molecular Disease Subsets on Disease-Free Survival in Randomized Adjuvant Chemotherapy Trials for Estrogen Receptor–Positive Breast Cancer. Journal Of Clinical Oncology 2008, 26: 4679-4683. PMID: 18662965, DOI: 10.1200/jco.2008.17.2544.Peer-Reviewed Original ResearchConceptsDisease-free survivalER-positive breast cancerAdjuvant chemotherapy trialsProportion of patientsBreast cancerChemotherapy trialsRS patientsEstrogen receptor-positive breast cancerRandomized adjuvant chemotherapy trialReceptor-positive breast cancerFuture adjuvant studiesProportion of casesTwo-arm clinical trialChemotherapy decreasesMolecular diagnostic testsAdjuvant chemotherapyEndocrine therapyAdjuvant studiesDisease subsetsPositive cancersClinical trialsDFS estimatesRisk groupsEstrogen receptorMolecular subtypesEstrogen Receptor Expression and Efficacy of Docetaxel-Containing Adjuvant Chemotherapy in Patients With Node-Positive Breast Cancer: Results From a Pooled Analysis
Andre F, Broglio K, Roche H, Martin M, Mackey JR, Penault-Llorca F, Hortobagyi GN, Pusztai L. Estrogen Receptor Expression and Efficacy of Docetaxel-Containing Adjuvant Chemotherapy in Patients With Node-Positive Breast Cancer: Results From a Pooled Analysis. Journal Of Clinical Oncology 2008, 26: 2636-2643. PMID: 18509176, DOI: 10.1200/jco.2007.14.9146.Peer-Reviewed Original ResearchConceptsER-negative patientsER-positive patientsRisk of recurrenceDocetaxel therapyER expressionER statusPooled analysisBreast cancerNode-positive breast cancerCox proportional hazards modelAdjuvant chemotherapy trialsDisease-free survivalEfficacy of docetaxelEstrogen receptor expressionPositive breast cancerRisk of deathRandomized clinical trialsProportional hazards modelAdjuvant chemotherapyAdjuvant docetaxelChemotherapy trialsOverall survivalDocetaxel efficacyRandomized trialsClinical variablesHistopathologic 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
2007
Expression patterns and predictive value of phosphorylated AKT in early-stage breast cancer
Andre F, Nahta R, Conforti R, Boulet T, Aziz M, Yuan LX, Meslin F, Spielmann M, Tomasic G, Pusztai L, Hortobagyi GN, Michiels S, Delaloge S, Esteva FJ. Expression patterns and predictive value of phosphorylated AKT in early-stage breast cancer. Annals Of Oncology 2007, 19: 315-320. PMID: 17804473, DOI: 10.1093/annonc/mdm429.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedBiomarkers, TumorBreast NeoplasmsChi-Square DistributionCohort StudiesCombined Modality TherapyDisease-Free SurvivalErbB ReceptorsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansImmunohistochemistryMiddle AgedNeoplasm StagingPredictive Value of TestsProbabilityProportional Hazards ModelsProto-Oncogene Proteins c-aktRandomized Controlled Trials as TopicReceptor, ErbB-2Risk AssessmentSurvival AnalysisTime FactorsTreatment OutcomeConceptsEarly breast cancerBreast cancerPredictive valuePhosphorylated AktAdjuvant chemotherapyPAkt expressionAnthracycline-based adjuvant chemotherapyEarly-stage breast cancerEpidermal growth factor receptor expressionGrowth factor receptor expressionAkt phosphorylationBreast cancer tissuesFactor receptor expressionGrowth factor receptorHER2 tumorsRandomized trialsAssessable tumorsHER2 expressionReceptor expressionPositive stainingCancer tissuesEGFR expressionHER2Tumor resistancePatientsEstrogen 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 survivalPrimary systemic chemotherapy of invasive lobular carcinoma of the breast
Katz A, Saad ED, Porter P, Pusztai L. Primary systemic chemotherapy of invasive lobular carcinoma of the breast. The Lancet Oncology 2007, 8: 55-62. PMID: 17196511, DOI: 10.1016/s1470-2045(06)71011-7.Peer-Reviewed Original ResearchConceptsInvasive lobular carcinomaInvasive ductal carcinomaLobular carcinomaSystemic chemotherapyDuctal carcinomaAdjuvant systemic chemotherapyPrimary systemic chemotherapyUse of chemotherapyFrequent histological typeProspective clinical trialsDistinct clinical entityAdjuvant chemotherapyRandomised trialsHistological typeClinical entityBreast diseaseClinical trialsBreast cancerEstrogen receptorChemotherapyInsufficient evidencePrevention strategiesCarcinomaBest treatmentLow grade
2006
Molecular classification of breast cancer: implications for selection of adjuvant chemotherapy
Andre F, Pusztai L. Molecular classification of breast cancer: implications for selection of adjuvant chemotherapy. Nature Reviews Clinical Oncology 2006, 3: 621-632. PMID: 17080180, DOI: 10.1038/ncponc0636.Peer-Reviewed Original ResearchConceptsAdjuvant chemotherapyMolecular classificationBreast cancerER-positive tumorsEarly-stage diseaseNew molecular classificationRoutine clinical useAdjuvant therapyNegative diseaseEstrogen receptorIndividual patientsChemotherapyClinical usePatientsCancerDiseaseMolecular characteristicsFuture promiseTherapyTumorsReceptors