2023
Pembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer
Takahashi M, Cortés J, Dent R, Pusztai L, McArthur H, Kümmel S, Denkert C, Park Y, Im S, Ahn J, Mukai H, Huang C, Chen S, Kim M, Jia L, Li X, Tryfonidis K, Karantza V, Iwata H, Schmid P. Pembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer. JAMA Network Open 2023, 6: e2342107. PMID: 37966841, PMCID: PMC10652156, DOI: 10.1001/jamanetworkopen.2023.42107.Peer-Reviewed Original ResearchMeSH KeywordsAdjuvants, ImmunologicAdultAntibodies, Monoclonal, HumanizedAsiaB7-H1 AntigenFemaleHumansMiddle AgedTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalPathologic complete responseChemotherapy groupNeoadjuvant chemotherapyBreast cancerNeoadjuvant pembrolizumabDefinitive surgeryComplete responseMAIN OUTCOMEEastern Cooperative Oncology Group performance statusCell death ligand 1 (PD-L1) statusDeath ligand 1 (PD-L1) statusTreatment-related adverse eventsNonmetastatic triple-negative breast cancerCycles of pembrolizumabPembrolizumab Plus ChemotherapyTumor PD-L1Unacceptable toxic effectsPD-L1 statusOverall survival analysisAdjuvant pembrolizumabEFS eventsEFS rates
2022
Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. New England Journal Of Medicine 2022, 386: 556-567. PMID: 35139274, DOI: 10.1056/nejmoa2112651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyProgression-Free SurvivalTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalCycles of pembrolizumabPathological complete responseDefinitive surgeryBreast cancerNeoadjuvant chemotherapyComplete responseLonger event-free survivalUntreated stage IIPrimary end pointPhase 3 trialSecond primary cancerDoxorubicin-cyclophosphamideNeoadjuvant pembrolizumabNeoadjuvant phaseAdjuvant therapyDistant recurrenceNeoadjuvant therapyAdverse eventsPrimary cancerSafety profileDisease progressionPembrolizumab
2020
Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer
Kunst N, Wang SY, Hood A, Mougalian SS, DiGiovanna MP, Adelson K, Pusztai L. Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer. JAMA Network Open 2020, 3: e2027074. PMID: 33226431, PMCID: PMC7684449, DOI: 10.1001/jamanetworkopen.2020.27074.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Agents, PhytogenicBreast NeoplasmsCase-Control StudiesCost-Benefit AnalysisCross-Linking ReagentsDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMiddle AgedNeoadjuvant TherapyPaclitaxelQuality-Adjusted Life YearsReceptor, ErbB-2TrastuzumabTubulin ModulatorsUnited StatesConceptsErbB2-positive breast cancerAdjuvant treatment strategiesAdjuvant T-DM1Pathologic complete responseT-DM1Treatment strategiesBreast cancerKATHERINE trialResidual diseaseNeoadjuvant regimenHigher health benefitsHealth care payer perspectiveAdjuvant trastuzumab emtansineAnthracycline/cyclophosphamideDifferent adjuvant therapiesFlatiron Health databaseIncremental cost-effectiveness ratioNeoadjuvant treatment optionsHealth benefitsPositive breast cancerCare payer perspectiveCost-effectiveness ratioBase-case analysisDecision analytic modelH. PatientsEffect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer
Nanda R, Liu MC, Yau C, Shatsky R, Pusztai L, Wallace A, Chien AJ, Forero-Torres A, Ellis E, Han H, Clark A, Albain K, Boughey JC, Jaskowiak NT, Elias A, Isaacs C, Kemmer K, Helsten T, Majure M, Stringer-Reasor E, Parker C, Lee MC, Haddad T, Cohen RN, Asare S, Wilson A, Hirst GL, Singhrao R, Steeg K, Asare A, Matthews JB, Berry S, Sanil A, Schwab R, Symmans WF, van ‘t Veer L, Yee D, DeMichele A, Hylton NM, Melisko M, Perlmutter J, Rugo HS, Berry DA, Esserman LJ. Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer. JAMA Oncology 2020, 6: 676-684. PMID: 32053137, PMCID: PMC7058271, DOI: 10.1001/jamaoncol.2019.6650.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedBreast NeoplasmsFemaleHumansNeoadjuvant TherapyNeoplasm StagingProgrammed Cell Death 1 ReceptorConceptsEarly-stage breast cancerPathologic complete responseNeoadjuvant chemotherapyPhase 3 trialResidual cancer burdenStandard neoadjuvant chemotherapyBreast cancerComplete responseInvestigational armStage II/III breast cancerHigher event-free survival rateERBB2-negative breast cancerEvent-free survival rateAnthracycline-based neoadjuvant chemotherapyDistant recurrence-free survivalEnd pointTriple-negative breast cancerCycles of pembrolizumabEffect of pembrolizumabImmune-related endocrinopathiesNeoadjuvant clinical trialsTriple-negative cohortPrimary end pointSecondary end pointsRecurrence-free survivalProspective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer
Reisenbichler ES, Han G, Bellizzi A, Bossuyt V, Brock J, Cole K, Fadare O, Hameed O, Hanley K, Harrison BT, Kuba MG, Ly A, Miller D, Podoll M, Roden AC, Singh K, Sanders MA, Wei S, Wen H, Pelekanou V, Yaghoobi V, Ahmed F, Pusztai L, Rimm DL. Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer. Modern Pathology 2020, 33: 1746-1752. PMID: 32300181, PMCID: PMC8366569, DOI: 10.1038/s41379-020-0544-x.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenBiomarkers, TumorFemaleHumansImmunohistochemistryPatient SelectionProspective StudiesReproducibility of ResultsTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerNegative breast cancerOverall percent agreementPD-L1Intraclass correlation coefficientBreast cancerAdvanced triple-negative breast cancerPD-L1 positive casesImmune cell stainingMultiple pathologistsPD-L1 scoringMulti-institutional evaluationLung cancer studiesAtezolizumab therapySP142 assaySP263 assaysPatient selectionSP263SP142US FoodDrug AdministrationPathologist's assessmentPositive casesReal-world settingPercent agreementPembrolizumab for Early Triple-Negative Breast Cancer
Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J. Pembrolizumab for Early Triple-Negative Breast Cancer. New England Journal Of Medicine 2020, 382: 810-821. PMID: 32101663, DOI: 10.1056/nejmoa1910549.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDoxorubicinEpirubicinFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerPathological complete responseCycles of pembrolizumabPercentage of patientsDefinitive surgeryComplete responseBreast cancerNeoadjuvant chemotherapyTreatment-related adverse eventsUntreated stage IIPrimary end pointAcceptable safety profileEvent-free survivalPhase 3 trialSecond primary tumorsFirst interim analysisAdjuvant pembrolizumabTreat populationDistant recurrenceNeoadjuvant therapyPromising antitumor activityAdverse eventsSafety profilePrimary tumor
2018
Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Burrello T, Abu-Khalaf M, Sabbath K, Sanft T, Brandt DS, Hofstatter EW, Hatzis C, DiGiovanna MP, Pusztai L. Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer. Breast Cancer Research And Treatment 2018, 169: 333-340. PMID: 29396664, DOI: 10.1007/s10549-017-4653-2.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerPhase II trialII trialNeoadjuvant chemotherapyPCR rateHormone receptorsBreast cancerGrade 3/4 adverse eventsPathologic complete response rateCyclophosphamide neoadjuvant chemotherapyComplete response rateSymptomatic heart failureAsymptomatic decreaseNeoadjuvant settingWeekly paclitaxelAdverse eventsHeart failureTherapeutic plateauCardiac functionInterim analysisStage IResponse ratePurposeThe purposePatientsNegative cases
2016
T-DM1 Activity in Metastatic Human Epidermal Growth Factor Receptor 2–Positive Breast Cancers That Received Prior Therapy With Trastuzumab and Pertuzumab
Dzimitrowicz H, Berger M, Vargo C, Hood A, Abdelghany O, Raghavendra AS, Tripathy D, Valero V, Hatzis C, Pusztai L, Murthy R. T-DM1 Activity in Metastatic Human Epidermal Growth Factor Receptor 2–Positive Breast Cancers That Received Prior Therapy With Trastuzumab and Pertuzumab. Journal Of Clinical Oncology 2016, 34: 3511-3517. PMID: 27298406, PMCID: PMC6075965, DOI: 10.1200/jco.2016.67.3624.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsDisease ProgressionHumansMaytansineMiddle AgedNeoplasm MetastasisReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsRetreatmentRetrospective StudiesTrastuzumabConceptsMetastatic breast cancerHER2-positive metastatic breast cancerTumor response rateT-DM1Prior pertuzumabCancer HospitalBreast cancerMetastatic human epidermal growth factor receptorResponse rateStandard first-line therapyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2MD Anderson Cancer CenterHuman epidermal growth factor receptorFourth-line treatmentSmilow Cancer HospitalT-DM1 activityFirst-line therapyThird of patientsGrowth factor receptor 2Contemporary patient populationJames Cancer HospitalResults of patientsAdo-trastuzumab emtansineElectronic pharmacy recordsPembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study
Nanda R, Chow LQ, Dees EC, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Aktan G, Cheng JD, Karantza V, Buisseret L. Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study. Journal Of Clinical Oncology 2016, 34: 2460-2467. PMID: 27138582, PMCID: PMC6816000, DOI: 10.1200/jco.2015.64.8931.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsFemaleHumansL-Lactate DehydrogenaseMiddle AgedTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerAdvanced triple-negative breast cancerPD-L1Antitumor activityBreast cancerCell death protein 1 (PD-1) inhibitorsSingle-agent phase II studyAdvanced PD-L1Single-agent pembrolizumabStudy of immunotherapyTreatment-related deathsImmune checkpoint inhibitionPhase Ib studyPhase Ib trialPhase II studyAcceptable safety profilePD-L1 expressionOverall response rateProtein 1 inhibitorCommon toxicitiesIb trialKEYNOTE-012TNBC cohortII studyMedian duration
2015
Immune modulation of pathologic complete response after neoadjuvant HER2-directed therapies in the NeoSphere trial
Bianchini G, Pusztai L, Pienkowski T, Im YH, Bianchi GV, Tseng LM, Liu MC, Lluch A, Galeota E, Magazzù D, de la Haba-Rodríguez J, Oh DY, Poirier B, Pedrini JL, Semiglazov V, Valagussa P, Gianni L. Immune modulation of pathologic complete response after neoadjuvant HER2-directed therapies in the NeoSphere trial. Annals Of Oncology 2015, 26: 2429-2436. PMID: 26387142, DOI: 10.1093/annonc/mdv395.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 DFSHigh HER2 Expression Correlates with Response to the Combination of Lapatinib and Trastuzumab
Scaltriti M, Nuciforo P, Bradbury I, Sperinde J, Agbor-Tarh D, Campbell C, Chenna A, Winslow J, Serra V, Parra JL, Prudkin L, Jimenez J, Aura C, Harbeck N, Pusztai L, Ellis C, Eidtmann H, Arribas J, Cortes J, de Azambuja E, Piccart M, Baselga J. High HER2 Expression Correlates with Response to the Combination of Lapatinib and Trastuzumab. Clinical Cancer Research 2015, 21: 569-576. PMID: 25467182, DOI: 10.1158/1078-0432.ccr-14-1824.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiopsyBreast NeoplasmsFemaleGene ExpressionHumansLapatinibNeoadjuvant TherapyQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsProgression-free survivalPathologic complete responseAnti-HER2 therapyHER2 expressionBreast cancerLonger progression-free survivalCombination of lapatinibExpression of p95HER2Trastuzumab-based therapyHigh HER2 expressionMetastatic breast cancerHER2 protein expressionComplete responseHR statusClinical benefitPrimary tumorHER2 levelsCox modelP95HER2PatientsPositive subsetTrastuzumabLapatinibHER2Expression correlates
2012
Seventeen-gene signature from enriched Her2/Neu mammary tumor-initiating cells predicts clinical outcome for human HER2+:ERα− breast cancer
Liu JC, Voisin V, Bader GD, Deng T, Pusztai L, Symmans WF, Esteva FJ, Egan SE, Zacksenhaus E. Seventeen-gene signature from enriched Her2/Neu mammary tumor-initiating cells predicts clinical outcome for human HER2+:ERα− breast cancer. Proceedings Of The National Academy Of Sciences Of The United States Of America 2012, 109: 5832-5837. PMID: 22460789, PMCID: PMC3326451, DOI: 10.1073/pnas.1201105109.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsCalcium-Binding ProteinsCD24 AntigenCell DifferentiationCell DivisionEstrogen Receptor alphaFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenes, NeoplasmHumansIntercellular Signaling Peptides and ProteinsJagged-1 ProteinMembrane ProteinsMiceNeoadjuvant TherapyNeoplastic Stem CellsPrognosisReceptor, ErbB-2Serrate-Jagged ProteinsSignal TransductionTrastuzumabTreatment OutcomeConceptsTumor-initiating cellsMammary tumor-initiating cellsBreast cancerClinical outcomesPrognostic signatureHuman epidermal growth factor receptorAnti-HER2 drugsAnti-HER2 therapyHigh-risk patientsHigh-risk subgroupsEpidermal growth factor receptorGrowth factor receptorBC cohortRisk patientsAggressive diseaseBC patientsRetrospective analysisImmune responsePrognostic powerTumor growthPatientsChemotherapyFactor receptorCancerFraction of cellsLapatinib 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
2011
Plasma microRNA 210 levels correlate with sensitivity to trastuzumab and tumor presence in breast cancer patients
Jung E, Santarpia L, Kim J, Esteva FJ, Moretti E, Buzdar AU, Di Leo A, Le X, Bast RC, Park S, Pusztai L, Calin GA. Plasma microRNA 210 levels correlate with sensitivity to trastuzumab and tumor presence in breast cancer patients. Cancer 2011, 118: 2603-2614. PMID: 22370716, PMCID: PMC3864019, DOI: 10.1002/cncr.26565.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsDrug Resistance, NeoplasmFemaleHumansLymphatic MetastasisMicroRNAsMiddle AgedTrastuzumabConceptsBreast cancer patientsPositive breast cancerMiR-210 levelsBreast cancerMiR-210Cancer patientsMicroRNA expression levelsTumor presenceExpression levelsPlasma samplesBT474 cellsNeoadjuvant trastuzumab-based chemotherapyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Trastuzumab-resistant breast cancer cellsMiR expression levelsTrastuzumab-based chemotherapyPathologic complete responseGrowth factor receptor 2Cancer cellsPostoperative plasma samplesPreoperative plasma samplesReverse transcriptase-polymerase chain reactionQuantitative reverse transcriptase-polymerase chain reactionMiR-210 expressionCoping with uncertainty: T1a,bN0M0 HER2-positive breast cancer, do we have a treatment threshold?
Kelly CM, Pritchard KI, Trudeau M, Andreopoulou E, Hess K, Pusztai L. Coping with uncertainty: T1a,bN0M0 HER2-positive breast cancer, do we have a treatment threshold? Annals Of Oncology 2011, 22: 2387-2393. PMID: 21406473, DOI: 10.1093/annonc/mdq786.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBreast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Baseline risk estimatesBN0M0 breast cancerHER2-positive cohortNode-negative T1aStudy end pointDisease-free survivalRisks of therapyGrowth factor receptor 2Subset of patientsPositive breast cancerRetrospective database analysisHER2-negative cancersRecent retrospective studiesHER2-positive cancersFactor receptor 2Small cohort sizeAdjuvant therapyAdjuvant trastuzumabComorbid illnessesCardiac eventsAbsolute benefit
2009
The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine
Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine. The Oncologist 2009, 14: 320-368. PMID: 19346299, DOI: 10.1634/theoncologist.2008-0230.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorBreast NeoplasmsEverolimusEvidence-Based MedicineFemaleGene Expression Regulation, NeoplasticHumansImmunohistochemistryIn Situ HybridizationLapatinibNeoplasm StagingPolymerase Chain ReactionPractice Guidelines as TopicPrognosisPyrazolesPyrimidinesQuinazolinesReceptor, ErbB-2RNA, MessengerSirolimusSurvival AnalysisTaxoidsTrastuzumabTreatment OutcomeUp-RegulationConceptsBreast cancerOverall survivalInsulin-like growth factor receptor pathwayClinical Oncology-CollegeMetastatic breast cancerInvasive breast cancerAmerican Pathologists guidelinesHER-2 receptorTyrosine kinase inhibitorsTarget of therapyGrowth factor receptor pathwayKinase inhibitor lapatinibMean relative riskReal-time polymerase chain reactionTransmembrane tyrosine kinase receptorPrediction of responseChromosome 17 polysomyHormonal therapyTyrosine kinase receptorsTherapy toxicitySitu hybridizationPrognostic significancePolymerase chain reactionPathologists guidelinesRelative risk
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 rate
2007
CD40 signaling predicts response to preoperative trastuzumab and concomitant paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide in HER-2-overexpressing breast cancer
Esteva FJ, Wang J, Lin F, Mejia JA, Yan K, Altundag K, Valero V, Buzdar AU, Hortobagyi GN, Symmans WF, Pusztai L. CD40 signaling predicts response to preoperative trastuzumab and concomitant paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide in HER-2-overexpressing breast cancer. Breast Cancer Research 2007, 9: r87. PMID: 18086299, PMCID: PMC2246190, DOI: 10.1186/bcr1836.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBiopsy, Fine-NeedleBreast NeoplasmsCD40 AntigensCyclophosphamideEpirubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMastectomyMastectomy, Modified RadicalMastectomy, SegmentalMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeoplasm, ResidualPaclitaxelPredictive Value of TestsReceptor, ErbB-2RNA, MessengerSignal TransductionTranscription, GeneticTrastuzumabTreatment OutcomeUp-RegulationConceptsPathologic complete responseBreast cancerIIIA breast cancerFine-needle aspirationConcomitant paclitaxelConcomitant trastuzumabFEC therapyPreoperative trastuzumabPreoperative chemotherapyPrimary endpointComplete responseNodal statusResidual cancerTumor sizeTumor responseNuclear gradeReceptor mRNAMolecular predictorsTrastuzumabStage IIGreater riskLow expressionCancerCyclophosphamidePatientsPharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Pusztai L, Anderson K, Hess KR. Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer. Clinical Cancer Research 2007, 13: 6080-6086. PMID: 17947471, DOI: 10.1158/1078-0432.ccr-07-0809.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase II as TopicGene Expression ProfilingGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceOligonucleotide Array Sequence AnalysisPharmacogeneticsProbabilityRNA, MessengerTissue DistributionTrastuzumabConceptsPhase II studyPhase II trialII trialII studyBreast cancerTwo-stage phase II trialPhase II clinical trialPhase II trial designPredictors of responseMarker-positive patientsPhase II designUnselected patientsPatient populationClinical trialsTrastuzumab responseInsufficient responseTrial designResponse markersSame drugResponse rateMarker testingPotential predictorsMarker assessmentTrialsPatients