2024
Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.
Albain K, Yau C, Petricoin E, Wolf D, Lang J, Chien A, Haddad T, Forero-Torres A, Wallace A, Kaplan H, Pusztai L, Euhus D, Nanda R, Elias A, Clark A, Godellas C, Boughey J, Isaacs C, Tripathy D, Lu J, Yung R, Gallagher R, Wulfkuhle J, Brown-Swigart L, Krings G, Chen Y, Potter D, Stringer-Reasor E, Blair S, Asare S, Wilson A, Hirst G, Singhrao R, Buxton M, Clennell J, Sanil A, Berry S, Asare A, Matthews J, DeMichele A, Hylton N, Melisko M, Perlmutter J, Rugo H, Symmans W, Van't Veer L, Yee D, Berry D, Esserman L. Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery. Clinical Cancer Research 2024, 30: 729-740. PMID: 38109213, PMCID: PMC10956403, DOI: 10.1158/1078-0432.ccr-22-2256.Peer-Reviewed Original ResearchPathological complete responseI-SPY2Breast cancerStage II/III breast cancerPhase II neoadjuvant trialTie2 receptorEarly-stage breast cancerT-cell gene signatureHormone receptorsDoxorubicin/cyclophosphamideHER2-negative diseaseHER2-positive diseaseStandard neoadjuvant therapyEvent-free survivalPhase III trialsPaclitaxel-based chemotherapyBreast cancer trialsPathway-specific biomarkersCell gene signatureNeoadjuvant trialsWeekly paclitaxelNeoadjuvant therapyPrimary endpointIII trialsPCR rate
2022
Impact of anti-HER2 therapy alone and in association with weekly paclitaxel on the ovarian reserve of young women with HER2-positive early breast cancer: Biomarker analysis of the NeoALTTO trial.
Lambertini M, Ceppi M, Anderson R, Cameron D, El-Abed S, Wang Y, Lecocq C, Nuciforo P, Rolyance R, Pusztai L, Sohn J, Arecco L, Del Mastro L, Partridge A, Saura C, Untch M, Piccart-Gebhart M, Di Cosimo S, de Azambuja E, Demeestere I. Impact of anti-HER2 therapy alone and in association with weekly paclitaxel on the ovarian reserve of young women with HER2-positive early breast cancer: Biomarker analysis of the NeoALTTO trial. Journal Of Clinical Oncology 2022, 40: 12084-12084. DOI: 10.1200/jco.2022.40.16_suppl.12084.Peer-Reviewed Original ResearchAnti-HER2 therapyAnti-Mullerian hormoneAMH levelsAnti-HER2 agentsOvarian reserveWeekly paclitaxelPrimary ovarian insufficiencyWeek 2NeoALTTO trialPremenopausal womenHER2-positive early breast cancerBaseline AMH levelsSubsequent ovarian functionLower AMH levelsBiomarker analysisEarly breast cancerMedian AMH levelsTime of surgeryHER2-positive BCSystemic anticancer treatmentBreast cancer patientsFrozen serum samplesNeoadjuvant trialsOncofertility counsellingPotential gonadotoxicity
2021
Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer
Symmans WF, Yau C, Chen YY, Balassanian R, Klein ME, Pusztai L, Nanda R, Parker BA, Datnow B, Krings G, Wei S, Feldman MD, Duan X, Chen B, Sattar H, Khazai L, Zeck JC, Sams S, Mhawech-Fauceglia P, Rendi M, Sahoo S, Ocal IT, Fan F, LeBeau LG, Vinh T, Troxell ML, Chien AJ, Wallace AM, Forero-Torres A, Ellis E, Albain KS, Murthy RK, Boughey JC, Liu MC, Haley BB, Elias AD, Clark AS, Kemmer K, Isaacs C, Lang JE, Han HS, Edmiston K, Viscusi RK, Northfelt DW, Khan QJ, Leyland-Jones B, Venters SJ, Shad S, Matthews JB, Asare SM, Buxton M, Asare AL, Rugo HS, Schwab RB, Helsten T, Hylton NM, van ’t Veer L, Perlmutter J, DeMichele AM, Yee D, Berry DA, Esserman LJ. Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer. JAMA Oncology 2021, 7: 1654-1663. PMID: 34529000, PMCID: PMC8446908, DOI: 10.1001/jamaoncol.2021.3690.Peer-Reviewed Original ResearchConceptsEvent-free survivalPathologic complete responseResidual cancer burdenInvestigational agentsInvestigational treatmentBreast cancerInterpretation of efficacyNeoadjuvant treatmentCancer burdenClinical trialsImproved event-free survivalNeoadjuvant breast cancer trialsStage 2/3 breast cancerHigh-risk breast cancerHormone receptorsI-SPY2 trialSecondary end pointsBreast cancer trialsEffective neoadjuvant treatmentI-SPY2Neoadjuvant paclitaxelNeoadjuvant trialsComplete responseEarly recurrencePrognostic significance
2018
Immune profiling of pre- and post-treatment breast cancer tissues from the S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide.
Li X, Warren S, Pelekanou V, Wali V, Cesano A, Liu M, Danaher P, Elliott N, Nahleh Z, Hayes D, Hortobagyi G, Barlow W, Hatzis C, Pusztai L. Immune profiling of pre- and post-treatment breast cancer tissues from the S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide. Journal Of Clinical Oncology 2018, 36: 578-578. DOI: 10.1200/jco.2018.36.15_suppl.578.Peer-Reviewed Original Research
2016
Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer
Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ. Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer. New England Journal Of Medicine 2016, 375: 23-34. PMID: 27406347, PMCID: PMC5259561, DOI: 10.1056/nejmoa1513749.Peer-Reviewed Original ResearchConceptsPathological complete responseHuman epidermal growth factor receptor 2Triple-negative breast cancerStandard therapyComplete responseBreast cancerBiomarker subtypesExperimental regimensEpidermal growth factor receptor 2I-SPY 2Triple-negative populationCompletion of chemotherapyPrimary end pointPhase 3 trialStandard neoadjuvant chemotherapyGrowth factor receptor 2HER2-negative tumorsAdaptive randomizationBiomarker signaturesTumor volume changesFactor receptor 2Phase 2Carboplatin groupNeoadjuvant trialsNeoadjuvant chemotherapyRelationship 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
2013
Genome-wide gene expression profiling to predict resistance to anthracyclines in breast cancer patients
Haibe-Kains B, Desmedt C, Di Leo A, Azambuja E, Larsimont D, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Genome-wide gene expression profiling to predict resistance to anthracyclines in breast cancer patients. Data In Brief 2013, 1: 7-10. PMID: 26484051, PMCID: PMC4608867, DOI: 10.1016/j.gdata.2013.09.001.Peer-Reviewed Original ResearchBreast cancer patientsResponse/resistanceAnthracycline monotherapyNeoadjuvant trialsGene expression signaturesNegative tumorsCancer patientsBreast cancerClinical dataEstrogen receptorClinical OncologyPredictive valuePatientsAnthracyclinesGene expressionII alphaExpression signaturesGenome-wide gene expressionMonotherapyExpressionTumorsCancerOncologyTrialsBiomarkersDeveloping 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
2011
Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types
Loi S, Symmans WF, Bartlett J, Fumagalli D, Veer L, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, Leyland-Jones BR. Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types. The Lancet Oncology 2011, 12: 1162-1168. PMID: 21684810, DOI: 10.1016/s1470-2045(11)70117-6.Peer-Reviewed Original ResearchConceptsNorth American Breast Cancer GroupBreast International GroupClinical trialsBiopsy procedureNeoadjuvant breast cancer trialsNeoadjuvant clinical trialsBreast cancer clinical trialsBreast cancer groupBreast cancer trialsStart of treatmentCancer clinical trialsNational Cancer InstituteNeoadjuvant trialsDefinitive surgeryNeoadjuvant treatmentCancer groupStudy protocolCancer trialsBreast cancerCancer InstituteUniform collectionTumor tissueBlood collectionTrialsSpecimen typesMultifactorial Approach to Predicting Resistance to Anthracyclines
Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial Approach to Predicting Resistance to Anthracyclines. Journal Of Clinical Oncology 2011, 29: 1578-1586. PMID: 21422418, DOI: 10.1200/jco.2010.31.2231.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntigens, NeoplasmBiomarkers, TumorBiopsyBreast NeoplasmsChemotherapy, AdjuvantDNA Topoisomerases, Type IIDNA-Binding ProteinsDrug Resistance, NeoplasmEpirubicinEuropeFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMiddle AgedNeoadjuvant TherapyOdds RatioPatient SelectionPoly-ADP-Ribose Binding ProteinsPredictive Value of TestsProspective StudiesReceptor, ErbB-2Receptors, EstrogenReproducibility of ResultsRisk AssessmentRisk FactorsTexasTreatment FailureConceptsPathologic complete responseHuman epidermal growth factor receptor 2Neoadjuvant trialsTOP trialPredictive valueEstrogen receptor-negative tumorsEpidermal growth factor receptor 2High negative predictive valuePrimary end pointGrowth factor receptor 2Receptor-negative tumorsResponse/resistanceFactor receptor 2Negative predictive valueUseful clinical toolER-negative samplesA scoresAnthracycline monotherapyEvaluable patientsGene expression signaturesComplete responseBreast cancerImmune responseReceptor 2Patients
2007
Differential response to primary chemotherapy and long-term survival in patients with triple-negative breast cancer
Liedtke C, Mazouni C, Hess K, Tordai A, André F, Symmans W, Gonzalez-Angulo A, Green M, Hortobagyi G, Pusztai L. Differential response to primary chemotherapy and long-term survival in patients with triple-negative breast cancer. Journal Of Clinical Oncology 2007, 25: 10519-10519. DOI: 10.1200/jco.2007.25.18_suppl.10519.Peer-Reviewed Original ResearchTriple-negative statusHigh nuclear gradeTriple-negative breast cancerTriple-negative tumorsLong-term survivalBreast cancerNuclear gradeNeoadjuvant chemotherapyOverall survivalNegative tumorsIndependent unfavorable prognostic factorHER2/neu expressionMD Anderson Cancer CenterComplete pathological responseProgesterone receptor expressionInvasive breast cancerPositive nodal statusTriple-negative groupUnfavorable prognostic factorAnderson Cancer CenterBasal-like subtypeRetrospective comparative analysisNegative control groupNeoadjuvant trialsRemainder patients
2006
A new measurement of residual cancer burden to predict survival after neoadjuvant chemotherapy
Symmans W, Peintinger F, Hatzis C, Kuerer H, Valero V, Hennessy B, Green M, Singletary E, Hortobagyi G, Pusztai L. A new measurement of residual cancer burden to predict survival after neoadjuvant chemotherapy. Journal Of Clinical Oncology 2006, 24: 536-536. DOI: 10.1200/jco.2006.24.18_suppl.536.Peer-Reviewed Original ResearchDistant relapse-free survivalResidual cancer burdenPathologic complete responseResidual diseaseComplete responsePathologic responseAJCC stageCancer burdenMultivariate Cox regression analysisRCB-3AJCC stage IIIHigh-risk patientsCox regression analysisNeoadjuvant chemotherapy trialsRelapse-free survivalDifferent prognostic groupsMedian followNeoadjuvant trialsPaclitaxel scheduleWeekly paclitaxelChemotherapy trialsNeoadjuvant chemotherapyPCR rateStrength of associationSurvival benefit