2021
A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor–positive Breast Cancer, SWOG S1222SWOG S1222
Moore HCF, Barlow WE, Somlo G, Gralow JR, Schott AF, Hayes DF, Kuhn P, Hicks JB, Welter L, Dy PA, Yeon CH, Conlin AK, Balcueva E, Lew DL, Tripathy D, Pusztai L, Hortobagyi GN. A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor–positive Breast Cancer, SWOG S1222SWOG S1222. Clinical Cancer Research 2021, 28: 611-617. PMID: 34844978, PMCID: PMC9782801, DOI: 10.1158/1078-0432.ccr-21-3131.Peer-Reviewed Original ResearchConceptsProgression-free survivalHER2-negative breast cancerFirst-line treatmentBreast cancerAdvanced hormone receptor-positive breast cancerAdvanced hormone-sensitive breast cancerHER2-negative advanced breast cancerHormone receptor-positive breast cancerHormone-sensitive breast cancerRandomized placebo-controlled trialReceptor-positive breast cancerCombination endocrine therapyMetastatic hormone receptorPlacebo-controlled trialAdvanced breast cancerMainstay of treatmentFront-line treatmentBaseline CTCsEndocrine therapyEndocrine treatmentPostmenopausal womenMetastatic diseaseOverall survivalPrognostic impactSystemic therapy
2020
Gene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer
Liedtke C, Pusztai L. Gene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer. 2020, 77-96. DOI: 10.1201/9780429137723-6.Peer-Reviewed Original ResearchBreast cancerEarly-stage breast cancerCombination chemotherapy regimensSubstantial tumor responseAdvanced breast cancerNeoadjuvant chemotherapy regimenStage breast cancerAdjuvant chemotherapyChemotherapy regimenNeoadjuvant therapyChemotherapy regimensPreoperative chemotherapyChemotherapy selectionOverall survivalInoperable cancerTumor responseStage ICancer tissuesCancerGene expression profilingChemotherapyDiagnostic toolCurrent standardSemiquantitative mannerExpression profiling
2018
Incorporating Genomics Into the Care of Patients With Advanced Breast Cancer
Kratz J, Burkard M, O'Meara T, Pusztai L, Veitch Z, Bedard PL. Incorporating Genomics Into the Care of Patients With Advanced Breast Cancer. American Society Of Clinical Oncology Educational Book 2018, 38: 56-64. PMID: 30231387, DOI: 10.1200/edbk_200731.Peer-Reviewed Original ResearchConceptsBreast cancerGenomic alterationsTumor genomic heterogeneityAdvanced breast cancerMetastatic breast cancerRecurrent genomic alterationsCare of patientsGenetic diversityMetastatic tumor sitesImproved clinical careGenomic sequencingLaboratory-developed testsClinical trialsGenomic heterogeneityDrug treatmentPatient tumorsClinical careSame patientBlood samplesHeterogeneous diseaseClinical relevanceTumor sitePatientsClonal evolutionCell populations
2016
SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer
Nahleh ZA, Barlow WE, Hayes DF, Schott AF, Gralow JR, Sikov WM, Perez EA, Chennuru S, Mirshahidi HR, Corso SW, Lew DL, Pusztai L, Livingston RB, Hortobagyi GN. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer. Breast Cancer Research And Treatment 2016, 158: 485-495. PMID: 27393622, PMCID: PMC4963434, DOI: 10.1007/s10549-016-3889-6.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerEvent-free survivalAddition of bevacizumabInflammatory breast cancerAdvanced breast cancerDose-dense doxorubicinNab-paclitaxelPathologic complete responseBreast cancerPCR rateOverall survivalOpen-label phase II clinical trialHormone receptor-positive diseaseImproved event-free survivalPathologic complete response ratePhase II clinical trialNeoadjuvant chemotherapy armNeoadjuvant nab-paclitaxelRole of bevacizumabWeekly nab-paclitaxelComplete response rateReceptor-positive diseaseHormone receptor statusSequence of administrationChemotherapy armA phase II study of the PI3K inhibitor taselisib (GDC-0032) combined with fulvestrant (F) in patients (pts) with HER2-negative (HER2-), hormone receptor-positive (HR+) advanced breast cancer (BC).
Dickler M, Saura C, Richards D, Krop I, Cervantes A, Bedard P, Patel M, Pusztai L, Oliveira M, Ware J, Jin H, Wilson T, Stout T, Wei M, Hsu J, Baselga J. A phase II study of the PI3K inhibitor taselisib (GDC-0032) combined with fulvestrant (F) in patients (pts) with HER2-negative (HER2-), hormone receptor-positive (HR+) advanced breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 520-520. DOI: 10.1200/jco.2016.34.15_suppl.520.Peer-Reviewed Original Research
2015
Use of neoadjuvant chemotherapy for patients with stage I to III breast cancer in the United States
Mougalian SS, Soulos PR, Killelea BK, Lannin DR, Abu-Khalaf MM, DiGiovanna MP, Sanft TB, Pusztai L, Gross CP, Chagpar AB. Use of neoadjuvant chemotherapy for patients with stage I to III breast cancer in the United States. Cancer 2015, 121: 2544-2552. PMID: 25902916, DOI: 10.1002/cncr.29348.Peer-Reviewed Original ResearchConceptsNeoadjuvant chemotherapyNAC useBreast cancerStage INational Cancer Data BaseStage III breast cancerStage IIIC cancerStage II diseaseStage III diseaseAdvanced breast cancerStandard of careLow-stage cancersLogistic regression analysisChi-square testIIIC cancersStage IIIAStage IIIBAdvanced cancerAfrican American individualsStage cancerPatterns of usePatientsAcademic centersClinical advantagesMultivariate analysis
2013
Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer.
James E, Chung G, Sowers N, Clark M, Lilian R, Abraham G, Chmael S, Cappiello M, DiGiovanna M, Hofstatter E, Sanft T, Israel G, Pusztai L, Harris L, Abu-Khalaf M. Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 154-154. DOI: 10.1200/jco.2013.31.26_suppl.154.Peer-Reviewed Original ResearchDose-expansion phaseGrade 3 non-hematological toxicityGrade 4 febrile neutropeniaCycle-1 DLTGrade 3 fatigueGrade 3/4 toxicitiesGrade 4 neutropeniaGrade 4 thrombocytopeniaMedian age 51Non-hematological toxicitiesObjective response rateAdvanced breast cancerDose-escalation phaseModest clinical activityHDAC inhibitor vorinostatClinical trial informationHistone deacetylase inhibitorsFebrile neutropeniaStable diseaseObjective responsePrior linesHematological toxicityTreatment delayClinical activityBreast cancerPhase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer.
James E, Chung G, DiGiovanna M, Sanft T, Hofstatter E, Sowers N, Clark M, Lilian R, Chmael S, Cappiello M, Abraham G, Israel G, Pusztai L, Harris L, Abu-Khalaf M. Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 2587-2587. DOI: 10.1200/jco.2013.31.15_suppl.2587.Peer-Reviewed Original ResearchDose-expansion phaseGrade 3 non-hematological toxicityTGFB pathwayGrade 4 febrile neutropeniaCycle-1 DLTGrade 3 fatigueGrade 3/4 toxicitiesGrade 4 neutropeniaGrade 4 thrombocytopeniaMedian age 51Non-hematological toxicitiesObjective response rateAdvanced breast cancerDose-escalation phaseModest clinical activityBiomarkers of responseHDAC inhibitor vorinostatClinical trial informationHistone deacetylase inhibitorsFebrile neutropeniaStable diseaseObjective responsePrior linesHematological toxicityTreatment delay
2010
Impact of Progression During Neoadjuvant Chemotherapy on Surgical Management of Breast Cancer
Caudle AS, Gonzalez-Angulo AM, Hunt KK, Pusztai L, Kuerer HM, Mittendorf EA, Hortobagyi GN, Meric-Bernstam F. Impact of Progression During Neoadjuvant Chemotherapy on Surgical Management of Breast Cancer. Annals Of Surgical Oncology 2010, 18: 932-938. PMID: 21061075, PMCID: PMC4347926, DOI: 10.1245/s10434-010-1390-8.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantCombined Modality TherapyFemaleFollow-Up StudiesHumansLymphatic MetastasisMastectomyMiddle AgedNeoadjuvant TherapyRetrospective StudiesSurvival RateTreatment OutcomeConceptsBreast conservation therapyNeoadjuvant chemotherapyBreast cancerSurgical managementDisease progressionStable diseaseImpact of progressionAdvanced breast cancerEarly-stage diseaseBCT candidatesClinical lymphadenopathyChemotherapy regimensProgressive diseaseStandard therapyComplete responseMedical oncologistsDistant metastasisClinicopathological dataFlap closurePatientsStage ITherapeutic interventionsOperative planEarly identificationMastectomy
2009
Impact of Progression during Neoadjuvant Chemotherapy on Operative Management of Breast Cancer.
Caudle A, Gonzalez-Angulo A, Hunt K, Kuerer H, Pusztai L, Kau S, Mittendorf E, Hortobagyi G, Meric-Bernstam F. Impact of Progression during Neoadjuvant Chemotherapy on Operative Management of Breast Cancer. Cancer Research 2009, 69: 1090-1090. DOI: 10.1158/0008-5472.sabcs-09-1090.Peer-Reviewed Original ResearchBreast-conserving therapyNeoadjuvant chemotherapyStable diseaseFirst regimenOperative managementDisease progressionBreast cancerSecond regimenMulti-disciplinary team membersImpact of progressionSecond chemotherapy regimenAdvanced breast cancerEarly-stage diseaseStandard of careBCT candidatesClinical lymphadenopathyUnderwent mastectomyChemotherapy regimenChemotherapy regimensLocal progressionStage diseaseFurther therapyClinicopathologic dataDistant metastasisMedical oncologistsEpstein-Barr virus (EBV) in fine needle aspirates containing inflammatory breast cancer cells.
Li C, Pusztai L, Cohen E, Symmans F, Wang B, Lee B, Hortobagyi G, Cristofanilli M, Reuben J. Epstein-Barr virus (EBV) in fine needle aspirates containing inflammatory breast cancer cells. Cancer Research 2009, 69: 3084. DOI: 10.1158/0008-5472.sabcs-3084.Peer-Reviewed Original ResearchInflammatory breast cancerEpstein-Barr virusFine needle aspiratesEBV DNABreast cancerEBV genomeQuantitative polymerase chain reactionLABC patientsNeedle aspiratesFNA samplesHuman herpes virus 8Findings warrants further investigationPotential viral oncogenesAdvanced breast cancerLatent EBV infectionHerpes virus 8Primary breast cancerBreast cancer patientsPossible viral etiologyEBV DNA sequencesQ-PCRInflammatory breast cancer cellsMouse mammary tumorsBreast cancer cellsWarrants further investigation
2008
Preoperative Systemic Chemotherapy and Pathologic Assessment of Response
Pusztai L. Preoperative Systemic Chemotherapy and Pathologic Assessment of Response. Pathology & Oncology Research 2008, 14: 169-171. PMID: 18553157, DOI: 10.1007/s12253-008-9070-8.Peer-Reviewed Original ResearchConceptsPathologic complete responsePreoperative systemic chemotherapyResidual cancer burdenResidual diseaseNeoadjuvant treatmentSystemic chemotherapyAxillary nodal burdenNeoadjuvant clinical trialsRoutine therapeutic modalityAdvanced breast cancerPrimary tumor dimensionsTranslational research modelRoutine diagnostic practiceNodal burdenPathologic responseComplete responsePathologic assessmentPrognostic distinctionResistant diseaseCancer burdenAdverse outcomesTumor bedClinical trialsPathologic informationBreast cancerBiomarkers as potential predictors of pathologic complete response (pCR) in the NOAH trial of neoadjuvant trastuzumab in patients (pts) with HER2-positive locally advanced breast cancer (LABC)
Gianni L, Eiermann W, Pusztai L, Semiglazov V, Hoegel B, Koehler A, Manikhas G, Bates M, Valagussa P, Baselga J. Biomarkers as potential predictors of pathologic complete response (pCR) in the NOAH trial of neoadjuvant trastuzumab in patients (pts) with HER2-positive locally advanced breast cancer (LABC). Journal Of Clinical Oncology 2008, 26: 504-504. DOI: 10.1200/jco.2008.26.15_suppl.504.Peer-Reviewed Original Research
2005
Gene Expression Profiles in Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Women With Locally Advanced Breast Cancer
Gianni L, Zambetti M, Clark K, Baker J, Cronin M, Wu J, Mariani G, Rodriguez J, Carcangiu M, Watson D, Valagussa P, Rouzier R, Symmans WF, Ross JS, Hortobagyi GN, Pusztai L, Shak S. Gene Expression Profiles in Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Women With Locally Advanced Breast Cancer. Journal Of Clinical Oncology 2005, 23: 7265-7277. PMID: 16145055, DOI: 10.1200/jco.2005.02.0818.Peer-Reviewed Original ResearchConceptsPathologic complete responseAdvanced breast cancerBreast cancerNeoadjuvant paclitaxelRecurrence scoreChemotherapy responseRecurrence riskLikelihood of pCRGreater recurrence riskReverse transcriptase-polymerase chain reactionTranscriptase-polymerase chain reactionCore biopsy tissueImmune-related genesNeoadjuvant anthracyclineNeoadjuvant studiesAssessable patientsReceptor-related genesChemotherapy benefitComplete responseCore biopsyPolymerase chain reactionUnivariate analysisProliferation-related genesIndependent patientsBiopsy tissue
2004
Expression of BAG-1 and BcL-2 Proteins Before and After Neoadjuvant Chemotherapy of Locally Advanced Breast Cancer
Pusztai L, Krishnamurti S, Cardona J, Sneige N, Esteva FJ, Volchenok M, Breitenfelder P, Kau SW, Takayama S, Krajewski S, Reed JC, Bast RC, Hortobagyi GN. Expression of BAG-1 and BcL-2 Proteins Before and After Neoadjuvant Chemotherapy of Locally Advanced Breast Cancer. Cancer Investigation 2004, 22: 248-256. PMID: 15199607, DOI: 10.1081/cnv-120030213.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarrier ProteinsCell DeathChemotherapy, AdjuvantDNA-Binding ProteinsDoxorubicinFemaleHumansImmunohistochemistryMiddle AgedNeoadjuvant TherapyPredictive Value of TestsPrognosisProto-Oncogene Proteins c-bcl-2Transcription FactorsTreatment OutcomeConceptsComplete pathological responsePathological responseBcl-2 expressionNeoplastic cellsBcl-2Breast cancerTissue specimensSubsequent pathological responsesAdvanced breast cancerBAG-1Breast epithelial cellsBAG-1 expressionExploratory pilot studyPrechemotherapy specimensNeoadjuvant chemotherapyClinical responseResidual tumorCytotoxic therapyPosttreatment specimensAnti-apoptotic proteinsPreoperative doxorubicinChemotherapyCytoplasmic stainingIndividual tumorsBreast tissue
2001
Chemotherapy of Metastatic Breast Cancer: What to Expect in 2001 and Beyond
Esteva F, Valero V, Pusztai L, Boehnke-Michaud L, Buzdar A, Hortobagyi G. Chemotherapy of Metastatic Breast Cancer: What to Expect in 2001 and Beyond. The Oncologist 2001, 6: 133-146. PMID: 11306725, DOI: 10.1634/theoncologist.6-2-133.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerHER-2/neu proteinAnthracycline/taxane combinationsDevelopment of anthracyclineAdvanced breast cancerHigh-dose chemotherapyPrimary breast cancerSingle-agent activityCombination chemotherapy treatmentsNovel biologic therapiesNovel treatment approachesMultidrug resistance inhibitorsTopoisomerase I inhibitorTaxane therapyBiologic therapyPalliative therapyTaxane combinationsProlong survivalTumor supressor geneChemotherapy treatmentTreatment approachesFluoropyrimidine analogsPatientsNeu protein