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
Adaptive Trials in the Neoadjuvant Setting: A Model to Safely Tailor Care While Accelerating Drug Development
Yee D, Haddad T, Albain K, Barker A, Benz C, Boughey J, Buxton M, Chien AJ, DeMichele A, Dilts D, Elias A, Haluska P, Hogarth M, Hu A, Hytlon N, Kaplan HG, Kelloff GG, Khan Q, Lang J, Leyland-Jones B, Liu M, Nanda R, Northfelt D, Olopade OI, Park J, Parker B, Parkinson D, Pearson-White S, Perlmutter J, Pusztai L, Symmans F, Rugo H, Tripathy D, Wallace A, Wholley D, Veer L, Berry DA, Esserman L. Adaptive Trials in the Neoadjuvant Setting: A Model to Safely Tailor Care While Accelerating Drug Development. Journal Of Clinical Oncology 2012, 30: 4584-4586. PMID: 23169510, DOI: 10.1200/jco.2012.44.1022.Peer-Reviewed Original Research
2011
The Value of Genomic Analysis of Breast Cancer in Drug Development
Szekely B, Pusztai L. The Value of Genomic Analysis of Breast Cancer in Drug Development. JNCI Monographs 2011, 2011: 60-62. PMID: 22043042, DOI: 10.1093/jncimonographs/lgr039.Peer-Reviewed Original Research
2008
Molecular Pathology and Transcriptional Profiling in Early Drug Development
Liedtke C, Pusztai L, Symmans W. Molecular Pathology and Transcriptional Profiling in Early Drug Development. 2008, 47-84. DOI: 10.1002/9780470475959.ch3.Peer-Reviewed Original ResearchNeoadjuvant chemotherapyClinical settingMultigene predictorsBiomarker developmentClinical drugsIntroduction BiomarkersTranscriptional profilingEarly drug developmentMolecular pathologyBiomarkersChanging ParadigmChemotherapyDrug developmentNovel toolDrugsIntriguing modelPredictorsSettingPathologyProfiling
2007
Limitations of pharmacogenomic predictor discovery in Phase II clinical trials
Pusztai L. Limitations of pharmacogenomic predictor discovery in Phase II clinical trials. Pharmacogenomics 2007, 8: 1443-1448. PMID: 17979517, DOI: 10.2217/14622416.8.10.1443.Peer-Reviewed Original Research
2003
Clinical Application of cDNA Microarrays in Oncology
Pusztai L, Ayers M, Stec J, Hortobágyi GN. Clinical Application of cDNA Microarrays in Oncology. The Oncologist 2003, 8: 252-258. PMID: 12773747, DOI: 10.1634/theoncologist.8-3-252.Peer-Reviewed Original ResearchConceptsHundreds of genesGene expression patternsSingle-gene markersIndividual genesTranscriptional profilingCDNA microarrayMRNA speciesDNA microarraysExpression patternsComplex biologyNovel targetImportant new toolMicroarrayClinical outcomesGenesHuman tissuesImportant clinical outcomesDiseased tissuesDrug developmentTrue clinical utilityClinical utilityClinical OncologyNew toolBiologyExciting new technology
1999
Chemo-signal therapy, an emerging new approach to modify drug resistance in breast cancer
Pusztai L, Esteva F, Cristofanilli M, Hung M, Hortobagyi G. Chemo-signal therapy, an emerging new approach to modify drug resistance in breast cancer. Cancer Treatment Reviews 1999, 25: 271-277. PMID: 10544071, DOI: 10.1053/ctrv.1999.0132.Peer-Reviewed Original ResearchConceptsBreast cancerResponse modifiersPromising new treatment modalityNew treatment modalitiesCombination of chemotherapyNon-cytotoxic agentsCurrent clinical researchClinical drug developmentTreatment modalitiesClinical trialsClinical experienceChemotherapyCytotoxic drugsDrug resistanceClinical researchCancerOncogene expressionGrowth factor signalingDrug developmentSelect groupTherapyDevelopment of novelEarly phaseDrugsFactor signaling