2024
Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023
Mariani M, Viale G, Galbardi B, Licata L, Bosi C, Dugo M, Notini G, Naldini M, Callari M, Criscitiello C, Pusztai L, Bianchini G. Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023. JAMA Network Open 2024, 7: e2423390. PMID: 39028669, PMCID: PMC11259908, DOI: 10.1001/jamanetworkopen.2024.23390.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsClinical Trials as TopicCross-Sectional StudiesFemaleHumansImmunotherapyConceptsCross-sectional studyPhase III trialsIII trialsBreast cancerImmunotherapy trialsLandscape of breast cancerPhase II studyPhase II trialPhase I trialSingle-center studySingle-center trialCancer immunotherapy trialsBreast cancer trialsPatient confidenceMain OutcomesFisher's exact testImmuno-oncology trialsTrial featuresProportion of trialsCompletion ratesAdjuvant settingPhase IIReport outcomesII trialPositive results
2023
Tumor-Derived Extracellular Vesicles as Complementary Prognostic Factors to Circulating Tumor Cells in Metastatic Breast Cancer
Nanou A, Miao J, Coumans F, Dolce E, Darga E, Barlow W, Smerage J, Paoletti C, Godwin A, Pusztai L, Sharma P, Thompson A, Hortobagyi G, Terstappen L, Hayes D. Tumor-Derived Extracellular Vesicles as Complementary Prognostic Factors to Circulating Tumor Cells in Metastatic Breast Cancer. JCO Precision Oncology 2023, 7: e2200372. PMID: 36634296, PMCID: PMC9928629, DOI: 10.1200/po.22.00372.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicFemaleHumansNeoplastic Cells, CirculatingPrognosisProspective StudiesConceptsCycles of chemotherapyMetastatic breast cancerTumor-derived extracellular vesiclesOverall survivalBreast cancerTumor cellsExtracellular vesiclesComplementary prognostic factorComplementary prognostic valuePoor overall survivalAdditional prognostic biomarkerLonger OSPrognostic factorsPrognostic significanceCTC countPrognostic valuePrognostic biomarkerChemotherapyCancerPatientsCTCsCellsBiomarkers
2022
Risk-adapted modulation through de-intensification of cancer treatments: an ESMO classification
Trapani D, Franzoi M, Burstein H, Carey L, Delaloge S, Harbeck N, Hayes D, Kalinsky K, Pusztai L, Regan M, Sestak I, Spanic T, Sparano J, Jezdic S, Cherny N, Curigliano G, Andre F. Risk-adapted modulation through de-intensification of cancer treatments: an ESMO classification. Annals Of Oncology 2022, 33: 702-712. PMID: 35550723, DOI: 10.1016/j.annonc.2022.03.273.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHumansMedical OncologyNeoplasmsProspective StudiesQuality of LifeRetrospective StudiesConceptsNon-inferiority clinical trialClinical trialsESMO classificationCancer treatmentPrecision Medicine Working GroupSingle-arm studyHealth system burdenOngoing clinical trialsShorter treatment durationLevel of evidenceEvidence-based criteriaQuality of lifePublic health expertsMedicine Working GroupStandard regimensCohort investigationWorking GroupCumulative doseTreatment modalitiesTreatment modulationPatient representativesTreatment durationIntermittent scheduleFinancial toxicityEvidence of reductionImpact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors
Kasi PM, Fehringer G, Taniguchi H, Starling N, Nakamura Y, Kotani D, Powles T, Li BT, Pusztai L, Aushev VN, Kalashnikova E, Sharma S, Malhotra M, Demko ZP, Aleshin A, Rodriguez A, Billings PR, Grothey A, Taieb J, Cunningham D, Yoshino T, Kopetz S. Impact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors. JCO Precision Oncology 2022, 6: e2100181. PMID: 35263168, PMCID: PMC8926064, DOI: 10.1200/po.21.00181.Peer-Reviewed Original ResearchMeSH KeywordsCirculating Tumor DNAClinical Trials as TopicDisease ProgressionHumansNeoplasm Recurrence, LocalNeoplasm, ResidualConceptsMolecular residual diseaseSurrogate end pointsCtDNA testingMRD detectionResidual diseaseClinical trialsCancer recurrenceTumor DNAEnd pointMRD-positive patientsUse of ctDNAHigh-risk categoryCtDNA dynamicsTrial enrichmentAccelerated approvalDifferent cancer typesCancer managementClinical utilityHigh riskClinical practiceSmall cohortSolid tumorsRecurrenceTrial durationTreatment assignment
2021
Evaluating Serum Thymidine Kinase 1 in Hormone Receptor Positive Metastatic Breast Cancer Patients Receiving First Line Endocrine Therapy in the SWOG S0226 Trial
Paoletti C, Barlow WE, Cobain EF, Bergqvist M, Mehta RS, Gralow JR, Hortobagyi GN, Albain KS, Pusztai L, Sharma P, Godwin AK, Thompson AM, Hayes DF, Rae JM. Evaluating Serum Thymidine Kinase 1 in Hormone Receptor Positive Metastatic Breast Cancer Patients Receiving First Line Endocrine Therapy in the SWOG S0226 Trial. Clinical Cancer Research 2021, 27: clincanres.1562.2021. PMID: 34521624, PMCID: PMC8595696, DOI: 10.1158/1078-0432.ccr-21-1562.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials as TopicFemaleHumansKaplan-Meier EstimateMiddle AgedPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRetrospective StudiesThymidine KinaseTreatment OutcomeConceptsProgression-free survivalMetastatic breast cancerFirst-line endocrine therapyOverall survivalEndocrine therapyHormone receptor-positive metastatic breast cancer patientsHormone receptor-positive metastatic breast cancerPositive metastatic breast cancer patientsSubsequent progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalCombination endocrine therapySerum thymidine kinase 1Trial of anastrozoleThymidine kinase 1 activityBreast cancer patientsLog-rank testLine endocrine therapyDu/LAdjuvant tamoxifenPrognostic effectCox regressionPoor prognosisWorse prognosisKaplan-MeierOptimal Management for Residual Disease Following Neoadjuvant Systemic Therapy
Foldi J, Rozenblit M, Park TS, Knowlton CA, Golshan M, Moran M, Pusztai L. Optimal Management for Residual Disease Following Neoadjuvant Systemic Therapy. Current Treatment Options In Oncology 2021, 22: 79. PMID: 34213636, DOI: 10.1007/s11864-021-00879-4.Peer-Reviewed Original ResearchConceptsPathologic complete responseResidual cancerClinical trialsAdjuvant therapyExcellent long-term disease-free survivalLong-term disease-free survivalAxillary lymph node dissectionHuman epidermal growth factor receptor 2Early-stage breast cancerEpidermal growth factor receptor 2Post-mastectomy breastSystemic adjuvant therapyInternal mammary nodesLymph node dissectionNeoadjuvant systemic therapyDisease-free survivalGrowth factor receptor 2Minimal residual disease monitoringRecurrence-free survivalType of surgeryPivotal clinical trialsOngoing clinical trialsFactor receptor 2Residual disease monitoringAccurate prognostic estimatesExpected Medium- and Long-Term Impact of the COVID-19 Outbreak in Oncology
Onesti CE, Tagliamento M, Curigliano G, Harbeck N, Bartsch R, Wildiers H, Tjan-Heijnen V, Martin M, Rottey S, Generali D, Campone M, Cristofanilli M, Pusztai L, Peeters M, Berchem G, Cortes J, Ruhstaller T, Ciruelos E, Rugo HS, Jerusalem G. Expected Medium- and Long-Term Impact of the COVID-19 Outbreak in Oncology. JCO Global Oncology 2021, 7: go.20.00589. PMID: 33529077, PMCID: PMC8081548, DOI: 10.1200/go.20.00589.Peer-Reviewed Original ResearchConceptsMedical oncologistsCOVID-19 positive patientsCOVID-19 outbreakUse of telemedicineClinical trial activityAffected modalityPalliative treatmentOncology unitLong-term impactNational registryPostacute phaseClinical activityMultidisciplinary meetingOncologic activityLocal registryHealthcare staffTreatment adaptationPatientsEarly cessationTrial activityHealthcare systemCOVID-19 pandemicOncologistsRegistrySignificant reduction
2018
Incorporating Genomics Into the Care of Patients With Advanced Breast Cancer
Kratz J, Burkard M, O'Meara T, Pusztai L, Veitch Z, Bedard PL. Incorporating Genomics Into the Care of Patients With Advanced Breast Cancer. American Society Of Clinical Oncology Educational Book 2018, 38: 56-64. PMID: 30231387, DOI: 10.1200/edbk_200731.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsClinical Decision-MakingClinical Trials as TopicDisease ManagementFemaleGenomicsGerm CellsHumansNeoplasm StagingTreatment OutcomeConceptsBreast cancerGenomic alterationsTumor genomic heterogeneityAdvanced breast cancerMetastatic breast cancerRecurrent genomic alterationsCare of patientsGenetic diversityMetastatic tumor sitesImproved clinical careGenomic sequencingLaboratory-developed testsClinical trialsGenomic heterogeneityDrug treatmentPatient tumorsClinical careSame patientBlood samplesHeterogeneous diseaseClinical relevanceTumor sitePatientsClonal evolutionCell populations
2015
Predictive and Prognostic Value of the TauProtein in Breast Cancer.
Bonneau C, Gurard-Levin ZA, Andre F, Pusztai L, Rouzier R. Predictive and Prognostic Value of the TauProtein in Breast Cancer. Anticancer Research 2015, 35: 5179-84. PMID: 26408675.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBiomarkers, TumorBreast NeoplasmsBridged-Ring CompoundsClinical Trials as TopicDrug Resistance, NeoplasmFemaleHumansPrognosisTau ProteinsTaxoidsConceptsBreast cancerTau protein expressionTau proteinPrognostic valueTau expressionHuman epidermal growth factor receptor 2 (HER2) expressionEpidermal growth factor receptor 2 expressionLow tau expressionProtein expressionSubset of patientsReceptor 2 expressionIncreased response rateEffects of taxanesNodal statusBetter prognosisPredictive markerTaxane resistanceChemotherapy sensitivityPredictive valueResponse ratePubMed databaseDrug resistanceCancerHormone receptorsTaxanesMeasurement 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 DFS
2013
Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials
DeMichele A, Berry DA, Zujewski J, Hunsberger S, Rubinstein L, Tomaszewski JE, Kelloff G, Perlmutter J, Buxton M, Lyandres J, Albain KS, Benz C, Chien AJ, Haluska P, Leyland-Jones B, Liu MC, Munster P, Olopade O, Park JW, Parker BA, Pusztai L, Tripathy D, Rugo H, Yee D, Esserman L. Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials. Clinical Cancer Research 2013, 19: 2817-2823. PMID: 23470967, PMCID: PMC4096560, DOI: 10.1158/1078-0432.ccr-12-2620.Peer-Reviewed Original ResearchConceptsNeoadjuvant trialsNeoadjuvant settingStandard therapyInvestigational agentsDrug developmentPhase II neoadjuvant trialI-SPY2 trialSafe drug developmentShort-term endpointsNeoadjuvant studiesCurable patientsPathologic responsePoor prognosisNovel therapiesBreast cancerNovel agentsSafety dataStudy populationDisease processEfficacious drugsNew agentsDrug AdministrationPatient exposurePatient safetyStudy design
2012
Cell Line Derived Multi-Gene Predictor of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer: A Validation Study on US Oncology 02-103 Clinical Trial
Shen K, Qi Y, Song N, Tian C, Rice SD, Gabrin MJ, Brower SL, Symmans WF, O’Shaughnessy J, Holmes FA, Asmar L, Pusztai L. Cell Line Derived Multi-Gene Predictor of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer: A Validation Study on US Oncology 02-103 Clinical Trial. BMC Medical Genomics 2012, 5: 51. PMID: 23158478, PMCID: PMC3536618, DOI: 10.1186/1755-8794-5-51.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveBreast NeoplasmsCell Line, TumorClinical Trials as TopicDemographyFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenes, NeoplasmHumansMiddle AgedMultivariate AnalysisNeoadjuvant TherapyReproducibility of ResultsTreatment OutcomeUnited StatesConceptsMulti-gene predictorsBreast cancerNeoadjuvant chemotherapyCombination chemotherapyCyclophosphamide combination chemotherapyDocetaxel/capecitabineEpirubicin/cyclophosphamideER-negative patientsPathologic complete responseER-positive cancersReceiver-operating characteristic curveAU-ROCCell linesBlinded validation studyNeoadjuvant treatmentMost patientsComplete responseER statusPathologic responseClinical outcomesValidation studyResidual diseaseTx groupClinical trialsEstrogen receptor
2011
Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types
Loi S, Symmans WF, Bartlett J, Fumagalli D, Veer L, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, Leyland-Jones BR. Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types. The Lancet Oncology 2011, 12: 1162-1168. PMID: 21684810, DOI: 10.1016/s1470-2045(11)70117-6.Peer-Reviewed Original ResearchConceptsNorth American Breast Cancer GroupBreast International GroupClinical trialsBiopsy procedureNeoadjuvant breast cancer trialsNeoadjuvant clinical trialsBreast cancer clinical trialsBreast cancer groupBreast cancer trialsStart of treatmentCancer clinical trialsNational Cancer InstituteNeoadjuvant trialsDefinitive surgeryNeoadjuvant treatmentCancer groupStudy protocolCancer trialsBreast cancerCancer InstituteUniform collectionTumor tissueBlood collectionTrialsSpecimen types
2010
Use of standard markers and incorporation of molecular markers into breast cancer therapy
Kaufmann M, Pusztai L, Members T. Use of standard markers and incorporation of molecular markers into breast cancer therapy. Cancer 2010, 117: 1575-1582. PMID: 21472705, DOI: 10.1002/cncr.25660.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicGene Expression ProfilingHumansPrognosisConceptsFuture clinical trialsClinical trialsBreast cancerRoutine pathological evaluationBreast cancer managementCancer Research GroupBreast cancer therapyRoutine clinical decisionImportant therapeutic targetPredictive gene signaturesPathological evaluationPatient selectionConsensus recommendationsCancer managementHeterogeneous diseaseTherapeutic targetPredictive valueBreast pathologyClinical decisionDifferent subtypesGene signatureGenomic profilingClinical levelNew molecular markersOutcome prediction
2008
Hormone receptor status and pathologic response of HER2-positive breast cancer treated with neoadjuvant chemotherapy and trastuzumab
Peintinger F, Buzdar AU, Kuerer HM, Mejia JA, Hatzis C, Gonzalez-Angulo AM, Pusztai L, Esteva FJ, Dawood SS, Green MC, Hortobagyi GN, Symmans WF. Hormone receptor status and pathologic response of HER2-positive breast cancer treated with neoadjuvant chemotherapy and trastuzumab. Annals Of Oncology 2008, 19: 2020-2025. PMID: 18667396, PMCID: PMC2733116, DOI: 10.1093/annonc/mdn427.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials as TopicCyclophosphamideDoxorubicinEpirubicinFemaleFluorouracilHumansMiddle AgedNeoadjuvant TherapyNeoplasm, ResidualNeoplasms, Hormone-DependentPaclitaxelRandomized Controlled Trials as TopicReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTrastuzumabConceptsHER2-positive breast cancerHormone receptor statusPathologic complete responseResidual cancer burdenPathologic responseBreast cancerNeoadjuvant chemotherapyReceptor statusExtensive residual diseaseHR-negative cancerHR-positive cancersPathologic response rateAddition of trastuzumabNeo-adjuvant chemotherapyStandard neoadjuvant chemotherapyFEC chemotherapyHR-/HER2Pathologic reviewComplete responseLymph nodesCancer burdenResidual diseasePrimary tumorChemotherapyResponse rateCurrent Status of Prognostic Profiling in Breast Cancer
Pusztai L. Current Status of Prognostic Profiling in Breast Cancer. The Oncologist 2008, 13: 350-360. PMID: 18448548, DOI: 10.1634/theoncologist.2007-0216.Peer-Reviewed Original ResearchMeSH KeywordsAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicDNA Topoisomerases, Type IIDNA-Binding ProteinsFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansOligonucleotide Array Sequence AnalysisOncogenesPredictive Value of TestsPrognosisReceptor, ErbB-2Receptors, EstrogenResearch DesignTamoxifenTaxoidsTreatment OutcomeConceptsBreast cancerClinical-pathological variablesClinical trial planningClinical courseClinical outcomesPathological variablesTreatment armsPrognostic informationClinical trialsTreatment strategiesClinicopathologic parametersHeterogeneous diseaseSpecific treatmentTherapeutic targetPrognostic profilingClinical heterogeneityGene expression fingerprintProspective tissue collectionAbnormal gene expressionIndividual tumorsPrognostic testTumorsPredictive indicatorIndividual diseasesTrial planning
2007
Markers predicting clinical benefit in breast cancer from microtubule-targeting agents
Pusztai L. Markers predicting clinical benefit in breast cancer from microtubule-targeting agents. Annals Of Oncology 2007, 18: xii15-xii20. PMID: 18083698, DOI: 10.1093/annonc/mdm534.Peer-Reviewed Original ResearchConceptsMicrotubule-targeting agentsSubset of patientsEstrogen receptor negativityBreast cancer patientsNon-cross resistanceMicrotubule-associated protein tauMechanism of actionReceptor negativityClinical benefitPatient groupCancer patientsClinical trialsPoor responseHER2 amplificationClinical dataClinical studiesBreast cancerTaxane resistanceBetaIII-tubulinProtein tauP-glycoproteinPharmacogenomic analysisTaxanesLow expressionPatientsThe use of microarray technology in the management of breast cancer.
Pusztai L. The use of microarray technology in the management of breast cancer. Clinical Advances In Hematology And Oncology 2007, 5: 193-4, 197. PMID: 17519880.Peer-Reviewed Original ResearchPrimary 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 ResearchMeSH KeywordsAntineoplastic AgentsBreast NeoplasmsCarcinoma, LobularChemotherapy, AdjuvantClinical Trials as TopicFemaleHumansIncidenceNeoplasm InvasivenessConceptsInvasive 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 ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicDecision MakingFemaleHumansNeoplasm StagingPatient SelectionPrognosisConceptsAdjuvant chemotherapyMolecular classificationBreast cancerER-positive tumorsEarly-stage diseaseNew molecular classificationRoutine clinical useAdjuvant therapyNegative diseaseEstrogen receptorIndividual patientsChemotherapyClinical usePatientsCancerDiseaseMolecular characteristicsFuture promiseTherapyTumorsReceptors