2023
Biomarkers predicting response to 5 immunotherapy arms in the neoadjuvant I-SPY2 trial for early-stage breast cancer (BC): Evaluation of immune subtyping in the response predictive subtypes (RPS).
Wolf D, Yau C, Campbell M, Glas A, Mittempergher L, Kuilman M, Barcaru A, Brown Swigart L, Nanda R, Chien A, Pusztai L, Stringer-Reasor E, Shatsky R, Isaacs C, Perlmutter J, DeMichele A, Yee D, Esserman L, van 't Veer L. Biomarkers predicting response to 5 immunotherapy arms in the neoadjuvant I-SPY2 trial for early-stage breast cancer (BC): Evaluation of immune subtyping in the response predictive subtypes (RPS). Journal Of Clinical Oncology 2023, 41: 102-102. DOI: 10.1200/jco.2023.41.16_suppl.102.Peer-Reviewed Original ResearchPCR rateBreast cancerImmune markersSerious immune-related adverse eventsImmune-related adverse eventsHER2-negative breast cancerEarly-stage breast cancerI-SPY2 trialLower mast cellTumor immune signatureChemokines/cytokinesSingle-sample classifierImmune subtypingImmunotherapy armI-SPY2Therapy armAdverse eventsReceptor statusControl armDrug classesMast cellsLogistic regressionBenjamini-Hochberg methodHR subsetTumor 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
2018
Tumor infiltrating lymphocytes and PD-L1 expression in pre- and post-treatment breast cancers in the SWOG S0800 Phase II neoadjuvant chemotherapy trial
Pelekanou V, Barlow WE, Nahleh Z, Wasserman B, Lo YC, von Wahlde MK, Hayes D, Hortobagyi GN, Gralow J, Tripathy D, Porter P, Szekely B, Hatzis C, Rimm DL, Pusztai L. Tumor infiltrating lymphocytes and PD-L1 expression in pre- and post-treatment breast cancers in the SWOG S0800 Phase II neoadjuvant chemotherapy trial. Molecular Cancer Therapeutics 2018, 17: molcanther.1005.2017. PMID: 29588392, PMCID: PMC6548451, DOI: 10.1158/1535-7163.mct-17-1005.Peer-Reviewed Original ResearchConceptsPD-L1 expressionPathologic complete responseTIL countPosttreatment tissuePD-L1Estrogen receptorImmune checkpoint inhibitor therapyPD-L1 positivity rateTumor-infiltrating lymphocyte countsDoxorubicin/cyclophosphamideCheckpoint inhibitor therapyPD-L1 levelsMol Cancer TherNab-paclitaxelLymphocyte countResidual cancerComplete responseER statusImmune changesInhibitor therapyCox regressionPatient populationControl armClinical trialsPositivity rateComparison 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
2016
Relationship between Complete Pathologic Response to Neoadjuvant Chemotherapy and Survival in Triple-Negative Breast Cancer
Hatzis C, Symmans WF, Zhang Y, Gould RE, Moulder SL, Hunt KK, Abu-Khalaf M, Hofstatter EW, Lannin D, Chagpar AB, Pusztai L. Relationship between Complete Pathologic Response to Neoadjuvant Chemotherapy and Survival in Triple-Negative Breast Cancer. Clinical Cancer Research 2016, 22: 26-33. PMID: 26286912, DOI: 10.1158/1078-0432.ccr-14-3304.Peer-Reviewed Original ResearchConceptsPathologic complete responseRecurrence-free survivalTriple-negative breast cancerSurvival benefitNeoadjuvant trialsNeoadjuvant chemotherapyTrial populationBaseline prognosisBreast cancerOverall survival benefitComplete pathologic responseSignificant survival benefitPostneoadjuvant therapyPCR rateComplete responseImproved survivalPathologic responseSurvival improvementTreatment armsPatient survivalResidual diseaseControl armPrognostic variablesPatientsTrials
2006
Continued Use of Trastuzumab (Herceptin) after Progression on Prior Trastuzumab Therapy in HER-2-Positive Metastatic Breast Cancer
Pusztai L, Esteva FJ. Continued Use of Trastuzumab (Herceptin) after Progression on Prior Trastuzumab Therapy in HER-2-Positive Metastatic Breast Cancer. Cancer Investigation 2006, 24: 187-191. PMID: 16619408, DOI: 10.1080/07357900500524629.Peer-Reviewed Original ResearchConceptsTrastuzumab therapyClinical trialsBreast cancerImportant unanswered clinical questionsLong-term side effectsContinuation of trastuzumabPrior trastuzumab therapyTrastuzumab-containing therapyUse of trastuzumabMetastatic breast cancerUnanswered clinical questionsPositive breast cancerRandomized clinical trialsTerm side effectsAccrue patientsMetastatic diseaseContinued administrationRandomized trialsControl armRegistry programDisease progressionClinical questionsSide effectsModest toxicityTrastuzumab