2023
Metastatic breast cancer (MBC) with ultra-high tumor mutational burden (UHTMB): A comprehensive genomic profiling (CGP) study.
Fanucci K, Lustberg M, Fischbach N, Pelletier M, Sivapiragasam A, Ashok Kumar P, Kallem M, Danziger N, Sokol E, Sivakumar S, Pavlick D, Ross J, Pusztai L. Metastatic breast cancer (MBC) with ultra-high tumor mutational burden (UHTMB): A comprehensive genomic profiling (CGP) study. Journal Of Clinical Oncology 2023, 41: 1036-1036. DOI: 10.1200/jco.2023.41.16_suppl.1036.Peer-Reviewed Original ResearchMetastatic breast cancerLobular histologyBreast cancerHER2 IHCGenomic alterationsComprehensive genomic profiling studyPD-L1 gene amplificationImmune checkpoint inhibitor treatmentMicrosatellite instabilityAxillary LN metastasisMetastatic site biopsySubset of ptsStage IV diseaseCheckpoint inhibitor treatmentPD-L1 expressionTumor mutational burdenMutations/MbMSI-high statusHER2 IHC resultsGenomic profiling studiesSite biopsiesSP142 assayLN metastasisMetastatic diseaseHigh TMBCisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial
Rodler E, Sharma P, Barlow W, Gralow J, Puhalla S, Anders C, Goldstein L, Tripathy D, Brown-Glaberman U, Huynh T, Szyarto C, Godwin A, Pathak H, Swisher E, Radke M, Timms K, Lew D, Miao J, Pusztai L, Hayes D, Hortobagyi G. Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2023, 24: 162-174. PMID: 36623515, PMCID: PMC9924094, DOI: 10.1016/s1470-2045(22)00739-2.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerMedian progression-free survivalProgression-free survivalMetastatic breast cancerMetastatic triple-negative breast cancerGermline BRCA1/2Phase 2 trialVeliparib groupPlacebo groupPlatinum-based chemotherapyBreast cancerHomologous recombination deficiencyAdverse eventsPARP inhibitorsEligible patientsMetastatic diseaseEastern Cooperative Oncology Group performance statusBRCA mutation-associated breast cancerInvestigator-assessed progression-free survivalTreatment-related adverse eventsRecurrent triple-negative breast cancerAcademic clinical sitesAddition of veliparibCommon grade 3Lines of chemotherapy
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
2019
Changing frameworks in treatment sequencing of triple-negative and HER2-positive, early-stage breast cancers
Pusztai L, Foldi J, Dhawan A, DiGiovanna MP, Mamounas EP. Changing frameworks in treatment sequencing of triple-negative and HER2-positive, early-stage breast cancers. The Lancet Oncology 2019, 20: e390-e396. PMID: 31267973, DOI: 10.1016/s1470-2045(19)30158-5.Commentaries, Editorials and LettersConceptsEarly-stage breast cancerHER2-positive breast cancerBreast cancerClinical trialsNeoadjuvant chemotherapyEstrogen receptor-negative breast cancerImproved disease-free survivalReceptor-negative breast cancerParticular chemotherapy regimenResidual invasive cancerNeoadjuvant systemic therapyDisease-free survivalImportant clinical trialsAdo-trastuzumab emtansineNegative breast cancerAdjuvant settingKATHERINE trialOperable diseasePostoperative capecitabineChemotherapy regimenMetastatic diseaseSystemic therapyResidual diseaseInvasive cancerTreatment sequencing
2017
Hybrid capture-based genomic profiling of circulating tumor DNA from patients with estrogen receptor-positive metastatic breast cancer
Chung JH, Pavlick D, Hartmaier R, Schrock AB, Young L, Forcier B, Ye P, Levin MK, Goldberg M, Burris H, Gay LM, Hoffman AD, Stephens PJ, Frampton GM, Lipson DM, Nguyen DM, Ganesan S, Park BH, Vahdat LT, Leyland-Jones B, Mughal TI, Pusztai L, O’Shaughnessy J, Miller VA, Ross JS, Ali SM. Hybrid capture-based genomic profiling of circulating tumor DNA from patients with estrogen receptor-positive metastatic breast cancer. Annals Of Oncology 2017, 28: 2866-2873. PMID: 28945887, PMCID: PMC5834148, DOI: 10.1093/annonc/mdx490.Peer-Reviewed Original ResearchConceptsEstrogen receptor-positive metastatic breast cancerMetastatic breast cancerBreast cancerGenomic profilingGenomic alterationsEstrogen receptor-positive breast cancerMetastatic breast cancer managementReceptor-positive breast cancerTumor DNACo-occurring genomic alterationsMetastatic tissue biopsiesTissue samplesRoutine clinical careBreast cancer managementCourse of diseasePeripheral blood samplesMetastatic tumor tissueMetastatic diseaseFemale patientsInvasive alternativeCtDNA fractionCancer managementClinical careBlood samplesPatients
2014
Emergence of Constitutively Active Estrogen Receptor-α Mutations in Pretreated Advanced Estrogen Receptor–Positive Breast Cancer
Jeselsohn R, Yelensky R, Buchwalter G, Frampton G, Meric-Bernstam F, Gonzalez-Angulo AM, Ferrer-Lozano J, Perez-Fidalgo JA, Cristofanilli M, Gómez H, Arteaga CL, Giltnane J, Balko JM, Cronin MT, Jarosz M, Sun J, Hawryluk M, Lipson D, Otto G, Ross JS, Dvir A, Soussan-Gutman L, Wolf I, Rubinek T, Gilmore L, Schnitt S, Come SE, Pusztai L, Stephens P, Brown M, Miller VA. Emergence of Constitutively Active Estrogen Receptor-α Mutations in Pretreated Advanced Estrogen Receptor–Positive Breast Cancer. Clinical Cancer Research 2014, 20: 1757-1767. PMID: 24398047, PMCID: PMC3998833, DOI: 10.1158/1078-0432.ccr-13-2332.Peer-Reviewed Original ResearchConceptsEstrogen receptor α mutationBreast cancerAdvanced estrogen receptor-positive breast cancerEstrogen receptor-positive breast cancerReceptor-positive breast cancerHormone-dependent breast cancerPrimary breast cancerSubgroup of patientsER-negative tumorsLine of treatmentCodon 537ER- diseaseEndocrine treatmentTreatment-naïveESR1 mutationsMetastatic diseaseCell line modelsEndocrine resistanceMetastatic tumorsReceptor constitutive activityEstrogen receptorMetastatic samplesTumor specimensCancer-related genesNatural history
2012
Evaluation of circulating biomarkers of bone metastases in early-stage breast cancer.
Dean-Colomb W, Hess K, Young E, Gornet T, Handy B, Moulder S, Ibrahim N, Pusztai L, Booser D, Valero V, Hortobagyi G, Esteva F. Evaluation of circulating biomarkers of bone metastases in early-stage breast cancer. Journal Of Clinical Oncology 2012, 30: 10-10. DOI: 10.1200/jco.2012.30.30_suppl.10.Peer-Reviewed Original ResearchP1NP levelsBreast cancerStage IInterleukin-6Cox proportional hazards regression analysisStage IV breast cancerElecsys 2010Proportional hazards regression analysisKaplan-Meier methodTime of diagnosisHazards regression analysisWorse overall survivalBone metastasis developmentProcollagen type 1Breast cancer recurrenceRoche Elecsys 2010Advanced diseaseMetastatic diseaseOverall survivalBone metastasesClinical factorsSerum levelsSerum P1NPBone turnoverBiomarker levelsKi67 expression in the primary tumor predicts for clinical benefit and time to progression on first-line endocrine therapy in estrogen receptor-positive metastatic breast cancer
Delpech Y, Wu Y, Hess KR, Hsu L, Ayers M, Natowicz R, Coutant C, Rouzier R, Barranger E, Hortobagyi GN, Mauro D, Pusztai L. Ki67 expression in the primary tumor predicts for clinical benefit and time to progression on first-line endocrine therapy in estrogen receptor-positive metastatic breast cancer. Breast Cancer Research And Treatment 2012, 135: 619-627. PMID: 22890751, DOI: 10.1007/s10549-012-2194-2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsBreast Neoplasms, MaleCarcinoma, Ductal, BreastDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateKi-67 AntigenMaleMiddle AgedMultivariate AnalysisNeoplasm Recurrence, LocalNeoplasms, Hormone-DependentProportional Hazards ModelsReceptors, EstrogenRetrospective StudiesTreatment OutcomeConceptsFirst-line endocrine therapyEndocrine therapyMetastatic breast cancerMetastatic diseaseKi67 expressionClinical benefitPrimary tumorBreast cancerExpression groupEstrogen receptor-positive metastatic breast cancerIndependent adverse prognostic factorKaplan-Meier survival curvesClinical benefit rateKi67 expression levelsAdverse prognostic factorMedian survival timeLow Ki67 expressionBreast cancer correlatesHigh Ki67 expressionHigh clinical benefitPrognostic factorsMedian timeMetastatic recurrencePrimary cancerImmunohistochemical variables
2010
Estrogen and HER-2 Receptor Discordance Between Primary Breast Cancer and Metastasis
Pusztai L, Viale G, Kelly CM, Hudis CA. Estrogen and HER-2 Receptor Discordance Between Primary Breast Cancer and Metastasis. The Oncologist 2010, 15: 1164-1168. PMID: 21041379, PMCID: PMC3227913, DOI: 10.1634/theoncologist.2010-0059.Peer-Reviewed Original ResearchConceptsReceptors resultsBreast cancerHuman epidermal growth factor receptor 2 receptor statusRepeat tumor biopsiesRoutine repeat biopsyPrimary breast cancerReceptor-positive cancersReceptor-negative cancersEndocrine therapyFalse-negative resultsReceptor discordanceMetastatic diseaseReceptor statusRepeat biopsyClinical courseRecurrent cancerClinical groundsPrimary tumorTumor nestsEstrogen receptorTumor biopsiesHormone responsivenessReceptor assayCancerDiscordant resultsNomogram to Predict Subsequent Brain Metastasis in Patients With Metastatic Breast Cancer
Graesslin O, Abdulkarim BS, Coutant C, Huguet F, Gabos Z, Hsu L, Marpeau O, Uzan S, Pusztai L, Strom EA, Hortobagyi GN, Rouzier R, Ibrahim NK. Nomogram to Predict Subsequent Brain Metastasis in Patients With Metastatic Breast Cancer. Journal Of Clinical Oncology 2010, 28: 2032-2037. PMID: 20308667, DOI: 10.1200/jco.2009.24.6314.Peer-Reviewed Original ResearchConceptsSubsequent brain metastasesBrain metastasesMetastatic breast cancerBreast cancerPatient populationMethods Electronic medical recordsStage IV breast cancerHuman epidermal growth factor receptor 2Shorter disease-free survivalEpidermal growth factor receptor 2Multivariate logistic regression analysisDisease-free survivalGrowth factor receptor 2Logistic regression analysisDesign of trialsFactor receptor 2Cross Cancer InstituteElectronic medical recordsInstitutional review boardMetastatic diseaseMetastatic sitesPrevention trialsPrognostic featuresClinical nomogramMedical records
2009
A specific nomogram to predict subsequent brain metastasis in metastatic triple-negative breast cancer patients
Pusztai L, Rouzier R, Pusztai L, Ibrahim N. A specific nomogram to predict subsequent brain metastasis in metastatic triple-negative breast cancer patients. Journal Of Clinical Oncology 2009, 27: 1028-1028. DOI: 10.1200/jco.2009.27.15_suppl.1028.Peer-Reviewed Original ResearchSubsequent brain metastasesBrain metastasesBreast cancer patientsTN tumorsSpecific nomogramCancer patientsBreast cancerMetastatic triple-negative breast cancer patientsTriple-negative breast cancer patientsD. Anderson Cancer CenterTN breast cancerMetastatic breast cancerAnderson Cancer CenterBM occurrenceMetastatic diseaseMetastatic nodesMetastatic BCInitial diagnosisMetastatic sitesNegative tumorsCancer CenterPreventive treatmentRetrospective analysisFatal eventsHistological characteristics
2008
Paclitaxel-induced sickle cell crisis
Wilson NM, Espirito JL, Valero V, Pusztai L. Paclitaxel-induced sickle cell crisis. American Journal Of Health-System Pharmacy 2008, 65: 1333-1336. PMID: 18593679, DOI: 10.2146/ajhp070432.Peer-Reviewed Original ResearchConceptsSickle cell diseaseHemoglobin sickle cell diseaseSickle cell crisisMetastatic diseasePainful crisesCell crisisBreast cancerAxillary lymph node dissectionPostmenopausal African-American womenLiver function test valuesLow-dose oxycodoneLymph node dissectionAxillary lymph nodesShortness of breathHistory of cancerSickle cell traitAfrican American womenRib painWeekly paclitaxelChemotherapy regimenNode dissectionSegmental mastectomyBone scanLeft breastLymph nodes
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
1999
Relapse after complete response to anthracycline‐based combination chemotherapy in metastatic breast cancer
Pusztai L, Asmar L, Smith T, Hortobagyi G. Relapse after complete response to anthracycline‐based combination chemotherapy in metastatic breast cancer. Breast Cancer Research And Treatment 1999, 55: 1-8. PMID: 10472774, DOI: 10.1023/a:1006161906667.Peer-Reviewed Original ResearchConceptsAnthracycline-based combination chemotherapyComplete clinical responseDisease-free intervalMetastatic breast cancerInitial disease-free intervalSecond relapseFirst relapseCombination chemotherapyCR durationMedian survivalBreast cancerShorter CR durationSite of recurrenceLength of survivalMore frequent recurrenceClinical characteristicsClinical responseFirst recurrenceMetastatic diseaseVisceral sitesComplete responseClinical featuresMetastatic sitesSubsequent therapySecond recurrencePhase II study of mitoxantrone by 14-day continuous infusion with granulocyte colony-stimulating factor (GCSF) support in patients with metastatic breast cancer and limited prior therapy
Pusztai L, Holmes F, Fraschini G, Hortobagyi G. Phase II study of mitoxantrone by 14-day continuous infusion with granulocyte colony-stimulating factor (GCSF) support in patients with metastatic breast cancer and limited prior therapy. Cancer Chemotherapy And Pharmacology 1999, 43: 86-91. PMID: 9923546, DOI: 10.1007/s002800050867.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerGranulocyte colony-stimulating factor supportColony-stimulating factor supportObjective response ratePhase II studyContinuous infusionBreast cancerII studyFactor supportSide effectsResponse rateMajor dose-limiting side effectDose-limiting side effectDiscontinuation of therapySecond-line chemotherapySecond-line regimensPhase II evaluationComplete tumor responseContinuous intravenous infusionMaximal cytotoxic effectLimited antitumor activityAsymptomatic cardiotoxicityPrevious therapyStable diseaseMetastatic disease