2024
Multi-platform biomarkers of response to an immune checkpoint inhibitor in the neoadjuvant I-SPY 2 trial for early-stage breast cancer
Campbell M, Wolf D, Yau C, Brown-Swigart L, Wulfkuhle J, Gallagher I, Zhu Z, Bolen J, Vandenberg S, Hoyt C, Mori H, Borowsky A, Sit L, Perlmutter J, Asare S, Investigators I, Nanda R, Liu M, Yee D, DeMichele A, Hylton N, Pusztai L, Berry D, Hirst G, Petricoin E, Veer L, Esserman L. Multi-platform biomarkers of response to an immune checkpoint inhibitor in the neoadjuvant I-SPY 2 trial for early-stage breast cancer. Cell Reports Medicine 2024, 101799. PMID: 39510069, DOI: 10.1016/j.xcrm.2024.101799.Peer-Reviewed Original ResearchImmune checkpoint blockadeI-SPY 2 TRIALPathological complete responseTumor microenvironmentBreast cancerAssociated with pathologic complete responseBreast cancer receptor subtypesNeoadjuvant immune checkpoint blockadePD-L1<sup>+</sup> cellsSpatial distribution of immune cellsDistribution of immune cellsEarly-stage breast cancerImmune checkpoint inhibitorsBiomarkers of responseImmune cell populationsImmune cell densityAssociated with responseImmune cell signalingCheckpoint blockadeCheckpoint inhibitorsComplete responsePretreatment biopsiesReceptor subtypesT cellsImmune cells
2019
Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial.
Wulfkuhle J, Yau C, Wolf D, Gallagher R, Brown Swigart L, Hirst G, Campbell M, Nanda R, Liu M, Pusztai L, Esserman L, Berry D, van 't Veer L, Petricoin E. Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial. Journal Of Clinical Oncology 2019, 37: 2631-2631. DOI: 10.1200/jco.2019.37.15_suppl.2631.Peer-Reviewed Original ResearchI-SPY 2 TRIALImmune checkpoint inhibitorsCheckpoint inhibitorsTumor epitheliumPD1 inhibitor pembrolizumabTumor antigen presentationHER2-negative subtypeMHC-II expressionTumor cell expressionPredictors of responseWilcoxon rank sum testPositive associationRank sum testProtein expression levelsImmune activationControl armAntigen presentationResponse predictorsHR subgroupsB cellsCell expressionPatientsSum testProtein expressionTumors
2016
Adaptive Randomization of Neratinib in Early Breast Cancer
Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA. Adaptive Randomization of Neratinib in Early Breast Cancer. New England Journal Of Medicine 2016, 375: 11-22. PMID: 27406346, PMCID: PMC5259558, DOI: 10.1056/nejmoa1513750.Peer-Reviewed Original ResearchConceptsPathological complete responseComplete responseBreast cancerNeoadjuvant therapyStandard chemotherapyHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusBiomarker signaturesSerial magnetic resonance imagingI-SPY 2 TRIALTyrosine kinase inhibitor neratinibClinical stage IIPrimary end pointHormone receptor statusPhase 2 trialPhase 3 trialStandard neoadjuvant chemotherapyEarly breast cancerMultiple new agentsAdaptive randomizationNegative breast cancerConfirmatory phase 3 trialPhase 3 testingExperimental groupMagnetic resonance imaging
2009
From the Lab to the Clinic: Gene-Expression Profiles That Are Associated with Mek-Inhibitor Sensitivity In Vitro Are Coordinately Co-Expressed in Breast Cancer Biopsy Samples from the I-SPY Trial (CALGB 150007/150012, ACRIN 6657).
Wolf D, Das D, Lenburg M, Paquette J, Spellman P, Gray J, Gray J, Pusztai L, Symmans F, Hatzis C, Esserman L, van 't Veer L, I-SPY Investigators .. From the Lab to the Clinic: Gene-Expression Profiles That Are Associated with Mek-Inhibitor Sensitivity In Vitro Are Coordinately Co-Expressed in Breast Cancer Biopsy Samples from the I-SPY Trial (CALGB 150007/150012, ACRIN 6657). Cancer Research 2009, 69: 2042-2042. DOI: 10.1158/0008-5472.sabcs-09-2042.Peer-Reviewed Original ResearchSensitive cell linesCancer cell linesOutcome dataCell linesI-SPY 2 TRIALI-SPY 1 TRIALInitial tumor responseNeo-adjuvant chemotherapyPre-treatment biopsiesThird of patientsBreast cancer biopsy samplesDrug response predictorsBreast cancer therapyBreast cancer cell linesMEK inhibitor sensitivityExpression of genesTumor responseTherapeutic responseResponse predictorsPatientsBiopsy samplesTumor samplesPatient samplesCancer ResDrug sensitivity