2013
Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing
Frampton GM, Fichtenholtz A, Otto GA, Wang K, Downing SR, He J, Schnall-Levin M, White J, Sanford EM, An P, Sun J, Juhn F, Brennan K, Iwanik K, Maillet A, Buell J, White E, Zhao M, Balasubramanian S, Terzic S, Richards T, Banning V, Garcia L, Mahoney K, Zwirko Z, Donahue A, Beltran H, Mosquera JM, Rubin MA, Dogan S, Hedvat CV, Berger MF, Pusztai L, Lechner M, Boshoff C, Jarosz M, Vietz C, Parker A, Miller VA, Ross JS, Curran J, Cronin MT, Stephens PJ, Lipson D, Yelensky R. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nature Biotechnology 2013, 31: 1023-1031. PMID: 24142049, PMCID: PMC5710001, DOI: 10.1038/nbt.2696.Peer-Reviewed Original ResearchMeSH KeywordsDNA Copy Number VariationsDNA Mutational AnalysisGene FrequencyHumansMolecular Diagnostic TechniquesNeoplasmsReproducibility of ResultsSensitivity and SpecificitySequence Analysis, DNA
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
Molecular profiling contributes more than routine histology and immonohistochemistry to breast cancer diagnostics
Shiang C, Pusztai L. Molecular profiling contributes more than routine histology and immonohistochemistry to breast cancer diagnostics. Breast Cancer Research 2010, 12: s6. PMID: 21172090, PMCID: PMC3005726, DOI: 10.1186/bcr2735.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsDNA FingerprintingFemaleGene Expression ProfilingGenomicsHigh-Throughput Nucleotide SequencingHumansImmunohistochemistryMolecular Diagnostic TechniquesReceptors, Estrogen
2008
Commercialized Multigene Predictors of Clinical Outcome for Breast Cancer
Ross JS, Hatzis C, Symmans WF, Pusztai L, Hortobágyi GN. Commercialized Multigene Predictors of Clinical Outcome for Breast Cancer. The Oncologist 2008, 13: 477-493. PMID: 18515733, DOI: 10.1634/theoncologist.2007-0248.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsCost-Benefit AnalysisDevice ApprovalFemaleGene Expression ProfilingHumansMolecular Diagnostic TechniquesParaffin EmbeddingPredictive Value of TestsPrognosisReceptors, EstrogenReverse Transcriptase Polymerase Chain ReactionUnited StatesUnited States Food and Drug AdministrationConceptsQuantitative multiplex real-time polymerase chain reactionLymph node positiveValidation clinical trialEfficacy of tamoxifenER-positive patientsPredictive testRegulatory approval statusOncotype DX testCurrent clinical utilityReal-time polymerase chain reactionCytochrome P450 CYP2D6High accrual rateMultiplex real-time polymerase chain reactionParaffin-embedded tissuesThird-party payorsProspective trialYounger patientsNode positiveClinical outcomesOncotype DXPatient eligibilityMultigene assaysPolymerase chain reactionClinical trialsBreast cancer
2006
Chips to Bedside: Incorporation of Microarray Data into Clinical Practice
Pusztai L. Chips to Bedside: Incorporation of Microarray Data into Clinical Practice. Clinical Cancer Research 2006, 12: 7209-7214. PMID: 17189391, DOI: 10.1158/1078-0432.ccr-06-2649.Peer-Reviewed Original Research
2004
Improving patient care through molecular diagnostics
Perez EA, Pusztai L, van De Vijver M. Improving patient care through molecular diagnostics. Seminars In Oncology 2004, 31: 14-20. PMID: 15490370, DOI: 10.1053/j.seminoncol.2004.07.017.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsDihydrouracil Dehydrogenase (NADP)Gene Expression ProfilingGenes, erbB-2HumansImmunohistochemistryIn Situ Hybridization, FluorescenceMolecular Diagnostic TechniquesOligonucleotide Array Sequence AnalysisProteomicsReceptor, ErbB-2Reverse Transcriptase Polymerase Chain ReactionThymidine PhosphorylaseConceptsLymph node statusPresence of metastasesSpecific tumor subtypesSingle tumor markerAdverse eventsMolecular diagnosticsNode statusSpecific therapyBreast cancerEstrogen receptorHistologic appearanceTumor gradingTumor markersTumor subtypesPatient careDiagnostic testsInitial evaluationParticular molecular defectsPatientsTherapyCancerParticular treatmentTreatmentSimultaneous assessmentDiagnostic techniques
2003
Breast 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 receptor