2018
Comparison of Residual Risk–Based Eligibility vs Tumor Size and Nodal Status for Power Estimates in Adjuvant Trials of Breast Cancer Therapies
Wei W, Kurita T, Hess KR, Sanft T, Szekely B, Hatzis C, Pusztai L. Comparison of Residual Risk–Based Eligibility vs Tumor Size and Nodal Status for Power Estimates in Adjuvant Trials of Breast Cancer Therapies. JAMA Oncology 2018, 4: e175092-e175092. PMID: 29372234, PMCID: PMC5885272, DOI: 10.1001/jamaoncol.2017.5092.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantEligibility DeterminationFemaleHumansLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalNeoplasm, ResidualPatient SelectionPrognosisRandomized Controlled Trials as TopicReproducibility of ResultsResearch DesignRetrospective StudiesRisk FactorsSurvival AnalysisTrastuzumabTumor BurdenWatchful WaitingYoung AdultConceptsTumor sizeAdjuvant trialsEligibility criteriaNodal statusClinical trialsResidual riskEarly-stage breast cancerAdjuvant clinical trialsBaseline prognostic riskFuture adjuvant trialsResidual risk estimatesRisk of recurrenceBreast cancer therapyRisk thresholdTrial powerClinical trial powerTrial eligibilityAdjuvant therapyCare therapyConsecutive patientsPrognostic riskPatient eligibilityTrial populationPatient cohortControl arm
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