2022
Impact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors
Kasi PM, Fehringer G, Taniguchi H, Starling N, Nakamura Y, Kotani D, Powles T, Li BT, Pusztai L, Aushev VN, Kalashnikova E, Sharma S, Malhotra M, Demko ZP, Aleshin A, Rodriguez A, Billings PR, Grothey A, Taieb J, Cunningham D, Yoshino T, Kopetz S. Impact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors. JCO Precision Oncology 2022, 6: e2100181. PMID: 35263168, PMCID: PMC8926064, DOI: 10.1200/po.21.00181.Peer-Reviewed Original ResearchConceptsMolecular residual diseaseSurrogate end pointsCtDNA testingMRD detectionResidual diseaseClinical trialsCancer recurrenceTumor DNAEnd pointMRD-positive patientsUse of ctDNAHigh-risk categoryCtDNA dynamicsTrial enrichmentAccelerated approvalDifferent cancer typesCancer managementClinical utilityHigh riskClinical practiceSmall cohortSolid tumorsRecurrenceTrial durationTreatment assignment
2020
EV-202: A phase II study of enfortumab vedotin in patients with select previously treated locally advanced or metastatic solid tumors.
Bruce J, Pusztai L, Braiteh F, Gorla S, Wu C, Baranda J. EV-202: A phase II study of enfortumab vedotin in patients with select previously treated locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2020, 38: tps3647-tps3647. DOI: 10.1200/jco.2020.38.15_suppl.tps3647.Peer-Reviewed Original ResearchNon-small cell lung cancerSafety/tolerabilityUrothelial carcinomaNectin-4Gastroesophageal cancerBreast cancerOpen-label phase 2 studySolid tumorsDose reduction/interruptionMonoclonal antibody-drug conjugatesActive CNS metastasesHigh-dose steroidsReduction/interruptionTumor-specific cohortsUncontrolled diabetes mellitusDisease control rateMetastatic urothelial carcinomaObjective response ratePhase II studyPlatinum-containing chemotherapyPhase 2 studyMetastatic solid tumorsPD-L1 inhibitorsTreatment of adultsCell lung cancer
2013
Cancer heterogeneity: implications for targeted therapeutics
Fisher R, Pusztai L, Swanton C. Cancer heterogeneity: implications for targeted therapeutics. British Journal Of Cancer 2013, 108: 479-485. PMID: 23299535, PMCID: PMC3593543, DOI: 10.1038/bjc.2012.581.Peer-Reviewed Original ResearchConceptsIntra-tumoural heterogeneityIntra-tumor heterogeneityClinical trial designCancer therapeuticsDistinct genomic alterationsClinical outcomesMalignant tumorsCurrent evidenceTrial designSolid tumorsSubpopulation of cellsSame tumorTumorsTissue collectionGenomic alterationsTherapeuticsBiomarker discoveryWidespread implementationEvidence
2012
Intratumor Heterogeneity: Seeing the Wood for the Trees
Yap TA, Gerlinger M, Futreal PA, Pusztai L, Swanton C. Intratumor Heterogeneity: Seeing the Wood for the Trees. Science Translational Medicine 2012, 4: 127ps10. PMID: 22461637, DOI: 10.1126/scitranslmed.3003854.Peer-Reviewed Original Research
2002
Global Gene Expression Changes During Neoadjuvant Chemotherapy for Human Breast Cancer
Buchholz TA, Stivers DN, Stec J, Ayers M, Clark E, Bolt A, Sahin AA, Symmans WF, Hess KR, Kuerer HM, Valero V, Hortobagyi GN, Pusztai L. Global Gene Expression Changes During Neoadjuvant Chemotherapy for Human Breast Cancer. The Cancer Journal 2002, 8: 461-468. PMID: 12500855, DOI: 10.1097/00130404-200211000-00010.Peer-Reviewed Original ResearchConceptsCore biopsy specimensBiopsy specimensBreast cancerNeoadjuvant chemotherapyGlobal gene expression changesGene expression changesGood pathological responsePrimary breast cancerExpression changesHuman breast cancerHuman solid tumorsPoor respondersPosttreatment specimensPathological responseIndividual patientsChemotherapyPatientsSerial samplesSolid tumorsExpression profilesIndividual tumorsPretreatment samplesDifferent tumorsTumorsDifferent patients