2022
Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.
Foldi J, Kahn A, Silber A, Qing T, Reisenbichler E, Fischbach N, Persico J, Adelson K, Katoch A, Chagpar A, Park T, Blanchard A, Blenman K, Rimm DL, Pusztai L. Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC. Clinical Cancer Research 2022, 28: 3720-3728. PMID: 35903931, PMCID: PMC9444984, DOI: 10.1158/1078-0432.ccr-22-0862.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkersBreast NeoplasmsFemaleHumansNeoadjuvant TherapyTriple Negative Breast NeoplasmsConceptsImmune-related adverse eventsTriple-negative breast cancerNon-AA patientsEvent-free survivalPhase I/II clinical trialsClinical trialsNeoadjuvant chemotherapyOverall survivalAA patientsEarly-stage triple-negative breast cancerIncidence of irAEsPathologic complete response rateSignificant associationMultivariate logistic regression analysisTumor-infiltrating lymphocyte countsComplete response ratePrimary efficacy endpointPD-L1 statusProportional hazards modelLogistic regression analysisAfrican American womenEFS ratesNeoadjuvant immunotherapyEfficacy endpointAdverse eventsPredictive Markers of Response to Neoadjuvant Durvalumab with Nab-Paclitaxel and Dose-Dense Doxorubicin/Cyclophosphamide in Basal-Like Triple-Negative Breast Cancer.
Blenman KRM, Marczyk M, Karn T, Qing T, Li X, Gunasekharan V, Yaghoobi V, Bai Y, Ibrahim EY, Park T, Silber A, Wolf DM, Reisenbichler E, Denkert C, Sinn BV, Rozenblit M, Foldi J, Rimm DL, Loibl S, Pusztai L. Predictive Markers of Response to Neoadjuvant Durvalumab with Nab-Paclitaxel and Dose-Dense Doxorubicin/Cyclophosphamide in Basal-Like Triple-Negative Breast Cancer. Clinical Cancer Research 2022, 28: 2587-2597. PMID: 35377948, PMCID: PMC9464605, DOI: 10.1158/1078-0432.ccr-21-3215.Peer-Reviewed Original ResearchConceptsBasal-like triple-negative breast cancerPathologic complete responseResidual diseaseNeoadjuvant durvalumabDNA damage repairSomatic mutationsBreast cancerWnt/β-cateninHigh expressionTriple-negative breast cancerBasal-Like TripleDoxorubicin/cyclophosphamideDNA repairTumor mutation burdenRNA sequencingEpithelial-mesenchymal transitionFive-gene signatureB-cell markersCancer driversEnrichment analysisNegative breast cancerDamage repairGene expressionJAK-STATCell cycle
2021
Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial
Pusztai L, Yau C, Wolf DM, Han HS, Du L, Wallace AM, String-Reasor E, Boughey JC, Chien AJ, Elias AD, Beckwith H, Nanda R, Albain KS, Clark AS, Kemmer K, Kalinsky K, Isaacs C, Thomas A, Shatsky R, Helsten TL, Forero-Torres A, Liu MC, Brown-Swigart L, Petricoin EF, Wulfkuhle JD, Asare SM, Wilson A, Singhrao R, Sit L, Hirst GL, Berry S, Sanil A, Asare AL, Matthews JB, Perlmutter J, Melisko M, Rugo HS, Schwab RB, Symmans WF, Yee D, Van't Veer LJ, Hylton NM, DeMichele AM, Berry DA, Esserman LJ. Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial. Cancer Cell 2021, 39: 989-998.e5. PMID: 34143979, PMCID: PMC11064785, DOI: 10.1016/j.ccell.2021.05.009.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerI-SPY2 trialBreast cancerNeoadjuvant chemotherapyStage II/III HER2-negative breast cancerStage II/III breast cancerGrade 3 adverse eventsPathologic complete response ratePD-L1 inhibitor durvalumabMast cell signaturePaclitaxel neoadjuvant chemotherapyComplete response rateHER2-negative patientsStandard neoadjuvant chemotherapyHER2-negative cancersPARP inhibitor olaparibAdverse eventsGene expression signaturesCare controlSuperior efficacyImmune responseResponse rateCancerInhibitor olaparib
2020
PD-L1 Protein Expression on Both Tumor Cells and Macrophages are Associated with Response to Neoadjuvant Durvalumab with Chemotherapy in Triple-negative Breast Cancer
Ahmed FS, Gaule P, McGuire J, Patel K, Blenman K, Pusztai L, Rimm DL. PD-L1 Protein Expression on Both Tumor Cells and Macrophages are Associated with Response to Neoadjuvant Durvalumab with Chemotherapy in Triple-negative Breast Cancer. Clinical Cancer Research 2020, 26: 5456-5461. PMID: 32709714, PMCID: PMC7572612, DOI: 10.1158/1078-0432.ccr-20-1303.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntigens, CDAntigens, Differentiation, MyelomonocyticAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorCell ProliferationFemaleGene Expression Regulation, NeoplasticHumansLymphocytes, Tumor-InfiltratingMacrophagesMiddle AgedNeoadjuvant TherapyProgrammed Cell Death 1 ReceptorTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPD-L1 expressionNeoadjuvant durvalumabTumor cellsImmune cellsBreast cancerPretreatment core-needle biopsiesPhase I/II clinical trialsPD-L1 protein expressionIMpassion 130 trialCore needle biopsyAmount of CD68Neoadjuvant settingMetastatic settingPD-L1Clinical trialsNeedle biopsyInsufficient tissuePatientsCD68Stromal compartmentQuantitative immunofluorescenceChemotherapyFinal analysisProtein expression
2016
New Strategies in Breast Cancer: Immunotherapy
Pusztai L, Karn T, Safonov A, Abu-Khalaf MM, Bianchini G. New Strategies in Breast Cancer: Immunotherapy. Clinical Cancer Research 2016, 22: 2105-2110. PMID: 26867935, PMCID: PMC9359478, DOI: 10.1158/1078-0432.ccr-15-1315.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalB7-H1 AntigenBreast NeoplasmsClinical Trials, Phase I as TopicFemaleHumansImmunotherapyPrognosisReceptor, ErbB-2ConceptsBreast cancerClinical trialsEffective immune checkpoint inhibitorsObjective tumor response rateEstrogen receptor-positive cancersLocal antitumor immune responsePhase I clinical trialImmune checkpoint inhibitorsTumor response rateAntitumor immune responseReceptor-positive cancersTriple-negative cancersLocal immune microenvironmentHER2-positive cancersMost breast cancersNew treatment modalitiesCheckpoint inhibitorsDurable responsesL1 antibodyLymphocytic infiltrationImmune microenvironmentImmune infiltrationTreatment modalitiesImmune responsePreclinical studies
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 Research
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 assessmentTrialsPatientsNeoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen
Buzdar AU, Valero V, Ibrahim NK, Francis D, Broglio KR, Theriault RL, Pusztai L, Green MC, Singletary SE, Hunt KK, Sahin AA, Esteva F, Symmans WF, Ewer MS, Buchholz TA, Hortobagyi GN. Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen. Clinical Cancer Research 2007, 13: 228-233. PMID: 17200359, DOI: 10.1158/1078-0432.ccr-06-1345.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorPathologic CR rateEpidermal growth factor receptorConcurrent trastuzumabGrowth factor receptorCR rateEfficacy dataBreast cancerStudy populationHigher pathologic complete remission rateSecond cohortPathologic complete remission rateCardiac safety dataCycles of FECCycles of paclitaxelOperable breast cancerComplete remission rateDisease-free survivalFactor receptorBreast cancer patientsNew safety concernsSame chemotherapyWeekly trastuzumabCyclophosphamide chemotherapyNeoadjuvant therapy
2006
Kinetics of serum HER‐2/neu changes in patients with HER‐2‐positive primary breast cancer after initiation of primary chemotherapy
Mazouni C, Hall A, Broglio K, Fritsche H, Andre F, Esteva FJ, Hortobagyi GN, Buzdar AU, Pusztai L, Cristofanilli M. Kinetics of serum HER‐2/neu changes in patients with HER‐2‐positive primary breast cancer after initiation of primary chemotherapy. Cancer 2006, 109: 496-501. PMID: 17149760, DOI: 10.1002/cncr.22418.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularCyclophosphamideEpirubicinFemaleFluorouracilHumansKineticsMiddle AgedNeoadjuvant TherapyPrognosisProspective StudiesReceptor, ErbB-2TrastuzumabConceptsPrimary breast cancerPathological complete responseBreast cancerECD levelsPrimary chemotherapyNeoadjuvant therapyPathological responseWeek 6HER-2 extracellular domainWeek 3HER-2/neu receptorCycles of fluorouracilCycles of paclitaxelNeu extracellular domainTrastuzumab-based regimensUtility of quantitationInitiation of chemotherapyExtracellular domainSame chemotherapyWeekly trastuzumabInitial chemotherapyNeoadjuvant chemotherapyComplete responseTreatment regimenResidual diseaseContinued Use of Trastuzumab (Herceptin) after Progression on Prior Trastuzumab Therapy in HER-2-Positive Metastatic Breast Cancer
Pusztai L, Esteva FJ. Continued Use of Trastuzumab (Herceptin) after Progression on Prior Trastuzumab Therapy in HER-2-Positive Metastatic Breast Cancer. Cancer Investigation 2006, 24: 187-191. PMID: 16619408, DOI: 10.1080/07357900500524629.Peer-Reviewed Original ResearchConceptsTrastuzumab therapyClinical trialsBreast cancerImportant unanswered clinical questionsLong-term side effectsContinuation of trastuzumabPrior trastuzumab therapyTrastuzumab-containing therapyUse of trastuzumabMetastatic breast cancerUnanswered clinical questionsPositive breast cancerRandomized clinical trialsTerm side effectsAccrue patientsMetastatic diseaseContinued administrationRandomized trialsControl armRegistry programDisease progressionClinical questionsSide effectsModest toxicityTrastuzumab
2005
Optimizing outcomes in HER2-positive breast cancer: the molecular rationale.
Esteva FJ, Pusztai L. Optimizing outcomes in HER2-positive breast cancer: the molecular rationale. Oncology 2005, 19: 5-16. PMID: 19364051.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsCell ProliferationCombined Modality TherapyDisease ProgressionDrug Resistance, NeoplasmErbB ReceptorsFemaleGenetic TherapyHSP90 Heat-Shock ProteinsHumansProtein Kinase InhibitorsReceptor, ErbB-2TrastuzumabConceptsAnti-HER2 therapyHER2-positive breast cancerBreast cancerEpidermal growth factor receptor HER2Small molecule tyrosine kinase inhibitorsGrowth factor receptor HER2Common chemotherapy regimensSuppression of HER2Anti-HER2 agentsHER2-positive cancersStandard of careOverexpression of HER2Use of therapiesTyrosine kinase inhibitorsHER2 blockersChemotherapy regimensSequential regimensRandomized trialsMaximum antitumor effectMechanisms of resistanceClinical trialsOptimizing outcomesAntitumor effectsReceptor HER2HER2 activitySignificantly Higher Pathologic Complete Remission Rate After Neoadjuvant Therapy With Trastuzumab, Paclitaxel, and Epirubicin Chemotherapy: Results of a Randomized Trial in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer
Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly Higher Pathologic Complete Remission Rate After Neoadjuvant Therapy With Trastuzumab, Paclitaxel, and Epirubicin Chemotherapy: Results of a Randomized Trial in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer. Journal Of Clinical Oncology 2005, 23: 3676-3685. PMID: 15738535, DOI: 10.1200/jco.2005.07.032.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDisease-Free SurvivalEpirubicinFemaleFluorouracilHumansMiddle AgedNeoadjuvant TherapyPaclitaxelProspective StudiesReceptor, ErbB-2Remission InductionTrastuzumabConceptsClinical congestive heart failureHuman epidermal growth factor receptorOperable breast cancerAddition of trastuzumabCongestive heart failureChemotherapy armData monitoring committeeEpidermal growth factor receptorGrowth factor receptorHeart failureBreast cancerHigher pathologic complete remission ratePathologic complete remission ratePathologic complete response rateCycles of fluorouracilCycles of paclitaxelHER2-positive diseaseComplete response rateComplete remission rateFactor receptorCardiac ejection fractionNeoadjuvant settingSame chemotherapyWeekly trastuzumabNeoadjuvant therapy
2004
Targeted Therapies for Cancer 2004
Ross JS, Schenkein DP, Pietrusko R, Rolfe M, Linette GP, Stec J, Stagliano NE, Ginsburg GS, Symmans WF, Pusztai L, Hortobagyi GN. Targeted Therapies for Cancer 2004. American Journal Of Clinical Pathology 2004, 122: 598-609. PMID: 15487459, DOI: 10.1309/5cwpu41afr1vym3f.Peer-Reviewed Original ResearchConceptsBcr/abl-positive chronic myelogenous leukemiaNon-small cell lung cancerEmergence of trastuzumabMetastatic colorectal cancerMetastatic breast cancerCell lung cancerRoute of administrationChronic myelogenous leukemiaProteasome inhibitor bortezomibEpidermal growth factor receptor (EGFR) geneNew therapeutic agentsEpidermal growth factor receptorSpecific genetic defectsTargeted anticancer therapiesGrowth factor receptorAgent bevacizumabGrowth factor receptor geneMolecular diagnosticsColorectal cancerCancer patientsLung cancerHematologic malignanciesImatinib mesylateTargeted therapyBreast cancer
2003
HER-2/neu testing in breast cancer.
Ross JS, Fletcher JA, Bloom KJ, Linette GP, Stec J, Clark E, Ayers M, Symmans WF, Pusztai L, Hortobagyi GN. HER-2/neu testing in breast cancer. American Journal Of Clinical Pathology 2003, 120 Suppl: s53-71. PMID: 15298144, DOI: 10.1309/949fpq1aq3p0rlc0.Peer-Reviewed Original ResearchConceptsBreast cancerNeu testingNeu statusProspective clinical outcome studyTrastuzumab-based therapyMajor clinical trialsEarly clinical stagePredictors of responseClinical outcome studiesBreast cancer specimensAdvanced diseaseClinical responseClinical stageClinical trialsStandards of practiceCancer specimensImmunohistochemical analysisOutcome studiesPotential efficacyCancerSitu hybridization techniqueRecent evidenceTherapySitu hybridization methodExcellent resultsBreast cancer biomarkers and molecular medicine
Ross JS, Linette GP, Stec J, Clark E, Ayers M, Leschly N, Symmans WF, Hortobagyi GN, Pusztai L. Breast cancer biomarkers and molecular medicine. Expert Review Of Molecular Diagnostics 2003, 3: 573-585. PMID: 14510178, DOI: 10.1586/14737159.3.5.573.Peer-Reviewed Original ResearchConceptsCell cycle regulatorsInvasion-associated proteinsTumor suppressor geneTranscription factorsTranscriptional profilingDNA repairGrowth factor receptorCell adhesion moleculeDrug resistance proteinsGenomic microarraysCycle regulatorsBreast cancer biomarkersPrognostic factorsApoptosis regulatorEpithelial growth factor receptorSuppressor geneHormone receptor proteinsBreast cancer predispositionCancer predispositionReceptor proteinCytogenetic markersResistance proteinBreast cancer prognostic factorsCancer biomarkersFactor receptorThe HER-2/neu Gene and Protein in Breast Cancer 2003: Biomarker and Target of Therapy
Ross JS, Fletcher JA, Linette GP, Stec J, Clark E, Ayers M, Symmans WF, Pusztai L, Bloom KJ. The HER-2/neu Gene and Protein in Breast Cancer 2003: Biomarker and Target of Therapy. The Oncologist 2003, 8: 307-325. PMID: 12897328, DOI: 10.1634/theoncologist.8-4-307.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge DistributionAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkers, TumorBreast NeoplasmsBreast Neoplasms, MaleCombined Modality TherapyEducation, Medical, ContinuingFemaleGene Expression Regulation, NeoplasticGenes, erbB-2Genetic Predisposition to DiseaseHumansIncidenceMaleMiddle AgedNeoplasm StagingPrognosisRisk AssessmentSensitivity and SpecificitySurvival AnalysisTrastuzumabTreatment OutcomeConceptsBreast cancerHER-2/neu statusHER-2/neu oncogeneNeu geneNew hormonal therapiesSerum-based testingMale breast cancerHER-2/neu geneTarget of therapyNeu gene amplificationEpidermal growth factor receptorTransmembrane tyrosine kinase receptorPrediction of responseGrowth factor receptorHormonal therapyTyrosine kinase receptorsTrastuzumab therapyDuctal carcinomaNeu overexpressionHER-2Disease outcomeTumor cytosolsTherapy responseNeu statusNeu testing
2002
Phase II Study of Weekly Docetaxel and Trastuzumab for Patients With HER-2–Overexpressing Metastatic Breast Cancer
Esteva FJ, Valero V, Booser D, Guerra LT, Murray JL, Pusztai L, Cristofanilli M, Arun B, Esmaeli B, Fritsche HA, Sneige N, Smith TL, Hortobagyi GN. Phase II Study of Weekly Docetaxel and Trastuzumab for Patients With HER-2–Overexpressing Metastatic Breast Cancer. Journal Of Clinical Oncology 2002, 20: 1800-1808. PMID: 11919237, DOI: 10.1200/jco.2002.07.058.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease ProgressionDocetaxelDrug Administration ScheduleFemaleGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceMiddle AgedPaclitaxelReceptor, ErbB-2TaxoidsTime FactorsTrastuzumabTreatment OutcomeUp-RegulationConceptsMetastatic breast cancerOverall response rateWeekly docetaxelBreast cancerPhase II studySecond-line therapyTrastuzumab-based therapyWeek of restExtracellular domain levelsII studyLoading doseMedian timeExcessive tearingFluid retentionECD concentrationsRepetitive dosingWeekly treatmentECD levelsPatientsTrastuzumabActive combinationResponse rateDocetaxelCancerAcute toxicity