2024
Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus arm
2023
MammaPrint Index as a predictive biomarker for neoadjuvant chemotherapy response and outcome in patients with HR+HER2- breast cancer in NBRST.
Beitsch P, Pellicane J, Pusztai L, Baron P, Cobain E, Murray M, Ashikari A, Kelemen P, Mislowsky A, Barone J, Cowan K, Layeequr Rahman R, Dooley W, Menicucci A, Finn C, Audeh M, Whitworth P. MammaPrint Index as a predictive biomarker for neoadjuvant chemotherapy response and outcome in patients with HR+HER2- breast cancer in NBRST. Journal Of Clinical Oncology 2023, 41: 521-521. DOI: 10.1200/jco.2023.41.16_suppl.521.Peer-Reviewed Original ResearchDistant metastasis-free survivalPathological complete responseNeoadjuvant chemotherapyHigh riskGrade 3 tumorsLymph node statusObservational prospective studyHigh-risk tumorsKaplan-Meier analysisStage breast cancerLog-rank testPrediction of chemosensitivityESBC patientsMammaPrint testSYMPHONY trialsFree survivalNeoadjuvant therapyClinicopathologic subtypesComplete responseDistant metastasisImmune therapyMeier analysisRisk tumorsNode statusProspective study
2022
Vitamin D insufficiency as a peripheral neuropathy risk factor in white and black patients in SWOG 0221.
Chen C, Zirpoli G, McCann S, Barlow W, Budd G, Pusztai L, Hortobagyi G, Godwin A, Thompson A, Ambrosone C, Stringer K, Hertz D. Vitamin D insufficiency as a peripheral neuropathy risk factor in white and black patients in SWOG 0221. Journal Of Clinical Oncology 2022, 40: 12023-12023. DOI: 10.1200/jco.2022.40.16_suppl.12023.Peer-Reviewed Original ResearchVitamin D insufficiencyPaclitaxel-induced peripheral neuropathyD insufficiencyPeripheral neuropathyBlack patientsPaclitaxel scheduleIncrease riskHigh riskEarly-stage breast cancerNeuropathy risk factorsPaclitaxel-containing chemotherapyVitamin D supplementationSensory peripheral neuropathyTreatment-limiting toxicityBody mass indexRetrospective validation studySelf-reported raceD supplementationProspective trialWhite patientsFemale patientsMass indexBlack raceRisk factorsTreatment outcomesImpact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors
Kasi PM, Fehringer G, Taniguchi H, Starling N, Nakamura Y, Kotani D, Powles T, Li BT, Pusztai L, Aushev VN, Kalashnikova E, Sharma S, Malhotra M, Demko ZP, Aleshin A, Rodriguez A, Billings PR, Grothey A, Taieb J, Cunningham D, Yoshino T, Kopetz S. Impact of Circulating Tumor DNA–Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors. JCO Precision Oncology 2022, 6: e2100181. PMID: 35263168, PMCID: PMC8926064, DOI: 10.1200/po.21.00181.Peer-Reviewed Original ResearchConceptsMolecular residual diseaseSurrogate end pointsCtDNA testingMRD detectionResidual diseaseClinical trialsCancer recurrenceTumor DNAEnd pointMRD-positive patientsUse of ctDNAHigh-risk categoryCtDNA dynamicsTrial enrichmentAccelerated approvalDifferent cancer typesCancer managementClinical utilityHigh riskClinical practiceSmall cohortSolid tumorsRecurrenceTrial durationTreatment assignment
2021
How did the COVID crisis affect use of neoadjuvant therapy for patients with breast cancer?
Chagpar A, Lannin D, Mougalian S, Berger E, Gross C, Horowitz N, Sanft T, DiGiovanna M, Golshan M, Pusztai L. How did the COVID crisis affect use of neoadjuvant therapy for patients with breast cancer? Journal Of Clinical Oncology 2021, 39: e18708-e18708. DOI: 10.1200/jco.2021.39.15_suppl.e18708.Peer-Reviewed Original ResearchUse of NTNeoadjuvant therapyEarly pandemic periodBreast cancerNon-metastatic breast cancerPractice settingsEarly pandemicFlatiron Health databaseNeoadjuvant endocrine therapyTechnology-enabled abstractionSame period one yearSimilar clinicopathologic featuresLongitudinal electronic health recordsPeriod one yearElectronic health recordsTNBC subsetEndocrine therapyPatient ageTN patientsClinicopathologic featuresContemporary cohortClinical stageCancer clinicCancer managementHigh risk
2020
Adherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers.
Foldi J, Schnabel C, Salganik M, Pusztai L, Sanft T. Adherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers. Journal Of Clinical Oncology 2020, 38: 527-527. DOI: 10.1200/jco.2020.38.15_suppl.527.Peer-Reviewed Original ResearchLate distant recurrenceAdjuvant endocrine therapyEndocrine therapyDistant recurrenceDXA scansBreast cancerHigh riskStage IEarly-stage hormone receptorExtended endocrine therapyIntolerable side effectsOsteopenia/osteoporosisPositive breast cancerRate of adherenceSerious adverse effectsBreast cancer recurrenceMajority of ptsHigher likelihoodElectronic health recordsLocal recurrenceMedian ageLate recurrenceMetastatic recurrenceTumor characteristicsMedication adherence
2017
Comparison of epigenetic aging in normal breast tissue from women with and without breast cancer.
Hofstatter E, Horvath S, Chagpar A, Wali V, Bossuyt V, Storniolo A, Patwardhan G, Von Wahlde M, Pusztai L. Comparison of epigenetic aging in normal breast tissue from women with and without breast cancer. Journal Of Clinical Oncology 2017, 35: 1522-1522. DOI: 10.1200/jco.2017.35.15_suppl.1522.Peer-Reviewed Original ResearchNormal breast tissueBreast cancerBreast tissueHealthy peersSusan G. Komen Tissue BankIU Simon Cancer CenterNormal breast tissue samplesBreast cancer preventionCohort of womenImportant risk factorKomen Tissue BankLifetime of womenBreast tissue samplesCurrent medicationsTumor characteristicsCancer CenterRisk factorsCancer preventionClinical dataFamily historyReduction mammoplastyHigh riskChronologic ageReproductive historyCancerNew Therapeutic Strategies for Triple-Negative Breast Cancer.
Székely B, Silber AL, Pusztai L. New Therapeutic Strategies for Triple-Negative Breast Cancer. Oncology 2017, 31: 130-7. PMID: 28205193.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerResidual cancerBreast cancerEarly-stage triple-negative breast cancerUnselected triple negative breast cancerIntroduction of taxanesOngoing adjuvant trialsImmune checkpoint inhibitorsSurvival of patientsImportant clinical trialsImportant therapeutic advanceBRCA-mutant cancersNew therapeutic strategiesAntibody-drug conjugatesAdjuvant trialsNeoadjuvant chemotherapyAdjuvant therapyCheckpoint inhibitorsIdentifies patientsTherapeutic advancesClinical trialsHigh riskTherapeutic strategiesCancerTrials
2015
Genomic predictor of residual risk of recurrence after adjuvant chemotherapy and endocrine therapy in high risk estrogen receptor-positive breast cancers
Khan SS, Karn T, Symmans WF, Rody A, Müller V, Holtrich U, Becker S, Pusztai L, Hatzis C. Genomic predictor of residual risk of recurrence after adjuvant chemotherapy and endocrine therapy in high risk estrogen receptor-positive breast cancers. Breast Cancer Research And Treatment 2015, 149: 789-797. PMID: 25651779, DOI: 10.1007/s10549-015-3277-7.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalAdjuvant chemotherapyEndocrine therapyHigh riskOncotype DXBreast cancerEstrogen receptor-positive breast cancerReceptor-positive breast cancerRisk categoriesEarly-stage estrogen receptorEndocrine therapy sensitivityGood prognosis patientsER-positive patientsHigh-risk patientsPoor prognosis groupPositive breast cancerLow-risk groupAdjuvant endocrineMultimodality therapyPrognosis patientsRisk patientsEndocrine sensitivityIndependent predictorsPrognosis groupT stage
2013
USP-11 as a Predictive and Prognostic Factor Following Neoadjuvant Therapy in Women With Breast Cancer
Bayraktar S, Barrera A, Liu D, Pusztai L, Litton J, Valero V, Hunt K, Hortobagyi GN, Wu Y, Symmans F, Arun B. USP-11 as a Predictive and Prognostic Factor Following Neoadjuvant Therapy in Women With Breast Cancer. The Cancer Journal 2013, 19: 10-17. PMID: 23337751, PMCID: PMC3568679, DOI: 10.1097/ppo.0b013e3182801b3a.Peer-Reviewed Original ResearchConceptsNeoadjuvant systemic therapyPathological complete responseBreast cancerKaplan-Meier product-limit methodBetter survival outcomesDisease-free survivalOverall survival rateRisk of recurrenceProduct-limit methodLogistic regression modelsNeoadjuvant therapyComplete responsePrognostic factorsSystemic therapyDisease recurrencePrognostic relevanceSurvival outcomesHigh riskPatientsSurvival rateTumorsCancerRecurrencePolymerase inhibitionUbiquitin-specific protease family
2011
P2-12-06: Nomogram To Predict Subsequent Bone Metastasis in Patients with Non Metastatic Breast Carcinomas.
Lousquy R, Delpech Y, Rouzier R, Gligorov J, Hsu L, Barranger E, Pusztai L, Uzan S, Hortobagyi G, Coutant C, Ibrahim N. P2-12-06: Nomogram To Predict Subsequent Bone Metastasis in Patients with Non Metastatic Breast Carcinomas. Cancer Research 2011, 71: p2-12-06-p2-12-06. DOI: 10.1158/0008-5472.sabcs11-p2-12-06.Peer-Reviewed Original ResearchNon-metastatic breast cancerMetastatic breast cancerBreast cancerBone metastasesConcordance indexHigh riskCox proportional hazards regression modelNon-metastatic breast carcinomaMultivariate logistic regression analysisProportional hazards regression modelsM.D. Anderson Cancer CenterBreast cancer molecular subtypesMethods Medical recordsSubsequent bone metastasesLymph node statusLymphovascular space invasionSelection of patientsTime of diagnosisMetastatic breast carcinomaHazards regression modelsAnderson Cancer CenterCancer molecular subtypesLogistic regression analysisDesign of trialsAdjuvant hormonotherapyS1-7: Molecular Tumor Characteristics Influence Adjuvant Endocrine Treatment Outcome.
Bianchini G, Pusztai L, Iwamoto T, Kelly C, Zambetti M, Fasolo A, Del Conte G, Santarpia L, Symmans W, Gianni L. S1-7: Molecular Tumor Characteristics Influence Adjuvant Endocrine Treatment Outcome. Cancer Research 2011, 71: s1-7-s1-7. DOI: 10.1158/0008-5472.sabcs11-s1-7.Peer-Reviewed Original ResearchDistant relapse ratesPatterns of relapseAromatase inhibitorsLate relapseRelapse rateHigh riskTime cohortsEstrogen receptor-positive casesOncotype DX recurrence scoreAdjuvant clinical trialsEndocrine-sensitive cancersEndocrine-sensitive tumorsLow-proliferation tumorYears of tamoxifenNode-negative tumorsReceptor-positive casesUse of tamoxifenDX recurrence scoreBiomarker groupsEndocrine therapyEndocrine drugsEarly relapseEndocrine resistanceLate recurrenceRisk stratification
2009
CXCR4 Expression in Early Breast Cancer and Risk of Distant Recurrence
Andre F, Xia W, Conforti R, Wei Y, Boulet T, Tomasic G, Spielmann M, Zoubir M, Berrada N, Arriagada R, Hortobagyi GN, Hung M, Pusztai L, Delaloge S, Michiels S, Cristofanilli M. CXCR4 Expression in Early Breast Cancer and Risk of Distant Recurrence. The Oncologist 2009, 14: 1182-1188. PMID: 19939894, DOI: 10.1634/theoncologist.2009-0161.Peer-Reviewed Original ResearchConceptsPrimary breast tumorsCXCR4 expressionBone metastasesBreast tumorsClinical characteristicsDistant metastasisPrognostic valueHigh riskLigand stromal cell-derived factor-1Stromal cell-derived factor-1Cell-derived factor-1Bone-targeted agentsEarly breast cancerProspective clinical trialsCox regression modelNovel adjuvant strategyExpression of CXCR4Chemokine receptor 4Early metastatic processOccurrence of metastasesSpecific organ sitesCXCR4 tumorsDistant recurrenceOverall survivalAdjuvant strategies