2023
Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials
Rediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.Peer-Reviewed Original ResearchConceptsEvent-free survivalHER2-positive breast cancerPathological complete responseCALGB 40601Breast cancerBreast pathological complete responseStromal tumor-infiltrating lymphocytesHormone receptor statusPhase III trialsClinical nodal statusIndependent prognostic factorTumor-infiltrating lymphocytesIdentification of patientsBreast cancer prognosisT cell receptorNeoadjuvant paclitaxelNeoadjuvant therapyIII trialsNodal statusComplete responsePrognostic factorsPrognostic scoreReceptor statusClinicopathological featuresResidual diseaseAssessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab
Waks A, Ogayo E, Paré L, Marín-Aguilera M, Brasó-Maristany F, Galván P, Castillo O, Martínez-Sáez O, Vivancos A, Villagrasa P, Villacampa G, Tarantino P, Desai N, Guerriero J, Metzger O, Tung N, Krop I, Parker J, Perou C, Prat A, Winer E, Tolaney S, Mittendorf E. Assessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab. JAMA Oncology 2023, 9: 835-840. PMID: 37103927, PMCID: PMC10141272, DOI: 10.1001/jamaoncol.2023.0181.Peer-Reviewed Original ResearchConceptsPathologic complete responseNeoadjuvant therapyPCR scoresNeoadjuvant paclitaxelBreast cancerPrognostic studiesRisk scoreLikelihood of pCRPretreatment tumor biopsy samplesErbB2-positive breast cancerBaseline tumor samplesLimited clinical featuresFavorable survival outcomesHormone receptor statusPositive breast cancerPrognostic risk scoreTumor biopsy samplesPaclitaxel weeklyComplete responsePCR rateReceptor statusClinical featuresMean ageSurvival outcomesRecurrence events
2021
Factors associated with late risks of breast cancer-specific mortality in the SEER registry
Leone JP, Vallejo CT, Hassett MJ, Leone J, Graham N, Tayob N, Freedman RA, Tolaney SM, Leone BA, Winer EP, Lin NU. Factors associated with late risks of breast cancer-specific mortality in the SEER registry. Breast Cancer Research And Treatment 2021, 189: 203-212. PMID: 33893907, PMCID: PMC8302525, DOI: 10.1007/s10549-021-06233-4.Peer-Reviewed Original ResearchConceptsBC-specific mortalityHR-positive breast cancerHR-negative breast cancerBreast cancerHR statusCumulative riskBreast cancer-specific mortalityCancer-specific mortalityT1a/bHormone receptor statusYear of diagnosisKaplan-Meier analysisLong-term riskBC deathConclusionThe risksGray regressionN2 diseaseLate relapseReceptor statusLate recurrenceSEER registryLater riskClinical trialsYear 5PatientsTwenty-year risks of breast cancer-specific mortality for stage III breast cancer in the surveillance, epidemiology, and end results registry
Leone JP, Leone BA, Tayob N, Hassett MJ, Leone J, Freedman RA, Tolaney SM, Winer EP, Vallejo CT, Lin NU. Twenty-year risks of breast cancer-specific mortality for stage III breast cancer in the surveillance, epidemiology, and end results registry. Breast Cancer Research And Treatment 2021, 187: 843-852. PMID: 33590387, DOI: 10.1007/s10549-021-06121-x.Peer-Reviewed Original ResearchConceptsRisk of BCSMBreast cancer-specific mortalityStage III breast cancerHR-negative diseaseHR-positive diseaseCancer-specific mortalityBreast cancerLate deathsNodal statusTumor sizeUnknown hormone receptor statusHR-positive tumorsEnd Results registryHormone receptor statusEnd Results (SEER) dataTraditional clinicopathologic factorsCumulative incidence functionGray regressionMethodsUsing SurveillanceAxillary nodesClinicopathologic factorsReceptor statusStage subgroupsPrimary tumorTumor grade
2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trialsExpanding criteria for prognostic stage IA disease in HR+ breast cancer.
Kantor O, King T, Shak S, Russell C, Giuliano A, Hortobagyi G, Burstein H, Winer E, Sparano J, Mittendorf E. Expanding criteria for prognostic stage IA disease in HR+ breast cancer. Journal Of Clinical Oncology 2020, 38: 550-550. DOI: 10.1200/jco.2020.38.15_suppl.550.Peer-Reviewed Original ResearchStage IA diseaseRecurrence scoreIA diseaseN categoryOncotype DX recurrence scoreNode-positive diseaseAJCC staging systemDX recurrence scoreRS resultsRS 11Median followDSS ratesPositive diseaseSEER databaseReceptor statusStaging systemEvidence of utilityScore 11Breast cancerTrial dataDiseaseAdditional studiesPatientsStagingDSSEfficacy of neoadjuvant chemotherapy (NAC) in male breast cancer (MaBC) compared with female breast cancer (FBC): A National Cancer Database (NCDB) study.
Leone J, Freedman R, Hassett M, Leone J, Tolaney S, Vallejo C, Leone B, Winer E, Lin N. Efficacy of neoadjuvant chemotherapy (NAC) in male breast cancer (MaBC) compared with female breast cancer (FBC): A National Cancer Database (NCDB) study. Journal Of Clinical Oncology 2020, 38: 587-587. DOI: 10.1200/jco.2020.38.15_suppl.587.Peer-Reviewed Original ResearchFemale breast cancerPathologic complete responseNeoadjuvant chemotherapyOverall survivalClinical responseTumor subtypesBreast cancerWorse OSExact testHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusEfficacy of NACInitiation of NACNational Cancer Database studyComplete clinical responseHormone receptor statusMale breast cancerLog-rank testFisher's exact testHR-/HER2Complete responseMedian ageReceptor statusMedian timeClinical stage
2019
Factors associated with twenty-year (y) risks of breast cancer-specific mortality (BCSM) in the Surveillance, Epidemiology, and End Results (SEER) Registry.
Leone J, Vallejo C, Hassett M, Leone J, Freedman R, Tolaney S, Leone B, Lin N, Winer E. Factors associated with twenty-year (y) risks of breast cancer-specific mortality (BCSM) in the Surveillance, Epidemiology, and End Results (SEER) Registry. Journal Of Clinical Oncology 2019, 37: 540-540. DOI: 10.1200/jco.2019.37.15_suppl.540.Peer-Reviewed Original ResearchRisk of BCSMBreast cancer-specific mortalityHR- breast cancerBreast cancerAdjusted riskCumulative riskAnnual event rateCancer-specific mortalityHormone receptor statusBreast cancer deathsEnd Results registryBetter adjuvant therapyKaplan-Meier analysisLong-term riskLate deathsAdjuvant therapyLate relapseReceptor statusHR statusPrimary cancerCox regressionBaseline variablesBlack raceCancer deathClinical trials
2015
Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance)
Ligibel JA, Cirrincione CT, Liu M, Citron M, Ingle JN, Gradishar W, Martino S, Sikov W, Michaelson R, Mardis E, Perou CM, Ellis M, Winer E, Hudis CA, Berry D, Barry WT. Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance). Journal Of The National Cancer Institute 2015, 107: djv179. PMID: 26113580, PMCID: PMC4651106, DOI: 10.1093/jnci/djv179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBody Mass IndexBreast NeoplasmsCyclophosphamideDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPaclitaxelReceptors, EstrogenTreatment OutcomeConceptsBody mass indexBaseline body mass indexNode-positive breast cancerBreast cancerCALGB 9741Prognostic factorsMass indexMedian baseline body mass indexSignificant prognostic factorsIndependent prognostic factorBreast cancer outcomesGroup of patientsSequence of chemotherapyEstrogen receptor statusProportional hazards regressionActual body weightDose densityDosed chemotherapyMenopausal statusOverall survivalReceptor statusRandomized trialsHazards regressionPoor prognosisTumor size
2014
NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATION
Emblem K, Pinho M, Chandra V, Gerstner E, Stufflebeam S, Sorenson G, Harris G, Freedman R, Sohl J, Younger J, Krop I, Winer E, Lin N. NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATION. Neuro-Oncology 2014, 16: v143-v143. PMCID: PMC4218348, DOI: 10.1093/neuonc/nou264.22.Peer-Reviewed Original ResearchAnti-angiogenic therapyBreast cancerBrain metastasesVascular normalizationTumor perfusionBrain tumorsDay 1Largest contrast-enhancing lesionPerfusion MRIParenchymal brain metastasesMonths of therapyPhase II studyHormone receptor statusMetastatic breast cancerSubset of patientsContrast-enhancing lesionsPrimary brain tumorsAnti-angiogenic effectsOxygen saturation levelsPrior therapyBreast metastasisII studySystemic therapyImproved survivalReceptor statusComorbidity, Chemotherapy Toxicity, and Outcomes Among Older Women Receiving Adjuvant Chemotherapy for Breast Cancer on a Clinical Trial: CALGB 49907 and CALGB 361004 (Alliance)
Klepin HD, Pitcher BN, Ballman KV, Kornblith AB, Hurria A, Winer EP, Hudis C, Cohen HJ, Muss HB, Kimmick GG. Comorbidity, Chemotherapy Toxicity, and Outcomes Among Older Women Receiving Adjuvant Chemotherapy for Breast Cancer on a Clinical Trial: CALGB 49907 and CALGB 361004 (Alliance). JCO Oncology Practice 2014, 10: e285-e292. PMID: 25074878, PMCID: PMC4161730, DOI: 10.1200/jop.2014.001388.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantComorbidityDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansKaplan-Meier EstimateMultivariate AnalysisProportional Hazards ModelsQuality of LifeRegression AnalysisSurveys and QuestionnairesTreatment OutcomeConceptsOverall survivalAdjuvant chemotherapyBurden scoreBreast cancerOlder womenShorter OSClinical trialsEarly-stage breast cancerCox proportional hazards modelStandard adjuvant chemotherapyNumber of comorbiditiesHazard of deathPhysical health subscaleOlder Americans ResourcesProportional hazards modelCALGB 49907Chemotherapy toxicityReceptor statusComorbid conditionsTumor sizeHealth subscaleGrade 3ComorbiditiesCommon conditionHazards model
2013
Prospective clinical experience with research biopsies in breast cancer patients
Vaz-Luis I, Zeghibe CA, Frank ES, Sohl J, Washington KE, Silverman SG, Fonte JM, Mayer EL, Overmoyer BA, Richardson AL, Krop IE, Winer EP, Lin NU. Prospective clinical experience with research biopsies in breast cancer patients. Breast Cancer Research And Treatment 2013, 142: 203-209. PMID: 24113744, PMCID: PMC3825285, DOI: 10.1007/s10549-013-2717-5.Peer-Reviewed Original ResearchConceptsResearch biopsiesAdverse eventsDisease courseMetastatic samplesDana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experiencePatient's disease courseSingle institution experienceBreast cancer patientsPerformance of biopsyHigh rateAnalytic cohortFirst recurrenceMetastatic diseaseMost patientsPerformance statusReceptor statusPrimary cancerProspective studyCancer patientsBreast cancerPatientsBiopsy
2012
Human epidermal growth factor receptor-2-positive breast cancer: does estrogen receptor status define two distinct subtypes?
Vaz-Luis I, Winer EP, Lin NU. Human epidermal growth factor receptor-2-positive breast cancer: does estrogen receptor status define two distinct subtypes? Annals Of Oncology 2012, 24: 283-291. PMID: 23022997, PMCID: PMC3551479, DOI: 10.1093/annonc/mds286.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2-positive diseaseEstrogen receptor statusBreast cancerReceptor statusClinical outcomesEpidermal growth factor receptor 2 overexpressionHuman epidermal growth factor receptor 2 (HER2) overexpressionDistinct subtypesFuture clinical trialsEfficacy of therapyMetastatic settingNeoadjuvant therapyMetastatic diseaseER statusSurvival outcomesClinical trialsPatterns of disseminationTherapyCancerDiseaseSubstantial minorityOutcomesSubtypesHeterogeneous entityCALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.18_suppl.cra1002.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerNab-paclitaxelPhase III trialsSensory neuropathyHazard ratioIII trialsInterim analysisGrade 2 sensory neuropathyMedian progression-free survivalAlbumin-bound formulationWeekly nanoparticle albuminPrimary end pointFirst-line therapyHormone receptor statusCause deathMeasurable diseaseWeek dosingWeekly paclitaxelHematologic toxicityFree survivalReceptor statusTaxane useExperimental armNanoparticle albuminComorbidity, chemotherapy toxicity, and outcomes among older women receiving adjuvant chemotherapy for breast cancer (BC).
Klepin H, Pitcher B, Ballman K, Kimmick G, Kornblith A, Cohen H, Hurria A, Winer E, Hudis C, Muss H. Comorbidity, chemotherapy toxicity, and outcomes among older women receiving adjuvant chemotherapy for breast cancer (BC). Journal Of Clinical Oncology 2012, 30: 6015-6015. DOI: 10.1200/jco.2012.30.15_suppl.6015.Peer-Reviewed Original ResearchAdjuvant chemotherapyBreast cancerOverall survivalBurden scoreOlder womenShorter OSEarly-stage breast cancerAdditional comorbid conditionsLeukemia Group BStandard adjuvant chemotherapyBetter functional statusStage breast cancerHazard of deathProportional hazards modelComorbidity burdenChemotherapy toxicityPrimary outcomePulmonary diseaseReceptor statusClinical outcomesComorbid conditionsComorbidity measuresNode statusSurvival outcomesTumor size
2011
Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer
Collins LC, Marotti JD, Gelber S, Cole K, Ruddy K, Kereakoglow S, Brachtel EF, Schapira L, Come SE, Winer EP, Partridge AH. Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer. Breast Cancer Research And Treatment 2011, 131: 1061-1066. PMID: 22080245, DOI: 10.1007/s10549-011-1872-9.Peer-Reviewed Original ResearchConceptsBasal-like carcinomasBreast cancerPathologic featuresYoung womenPatient ageTumor stageMolecular phenotypesInvasive breast cancerLuminal B tumorsPoor prognostic featuresDifferent age groupsClinical characteristicsB tumorsReceptor statusPrognostic featuresCentral reviewMedical recordsTumor gradeHigh prevalenceLarge cohortGeneral populationAge groupsBiomarker expressionCancerHER2Breast Medical Oncologists' Use of Standard Prognostic Factors to Predict a 21‐Gene Recurrence Score
Kamal AH, Loprinzi CL, Reynolds C, Dueck AC, Geiger XJ, Ingle JN, Carlson RW, Hobday TJ, Winer EP, Goetz MP. Breast Medical Oncologists' Use of Standard Prognostic Factors to Predict a 21‐Gene Recurrence Score. The Oncologist 2011, 16: 1359-1366. PMID: 21934103, PMCID: PMC3228065, DOI: 10.1634/theoncologist.2011-0048.Peer-Reviewed Original ResearchConceptsRecurrence scorePrognostic criteriaRS riskTreatment recommendationsIntermediate-risk casesHormone receptor statusLymph node negativeProspective clinical trialsStandard prognostic factorsIntermediate recurrence scoreAbility of oncologistsChemotherapy useChemotherapy recommendationsChemotherapy benefitNode negativePrognostic factorsReceptor statusHistologic typeAcademic oncologistsOncologists' useTumor gradeClinical trialsBreast cancerRS categoryOncologist's ability
2010
Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104
Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104. Journal Of Clinical Oncology 2010, 28: 2418-2422. PMID: 20368559, PMCID: PMC2881723, DOI: 10.1200/jco.2009.26.4671.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAge FactorsAgedAged, 80 and overAntimetabolites, AntineoplasticBreast NeoplasmsCanadaCapecitabineChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleDrug MonitoringFemaleFluorouracilHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMastectomyMedication AdherenceMicro-Electrical-Mechanical SystemsNeoplasm StagingRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerBreast cancerCALGB 49907Oral chemotherapyClinical trialsOlder womenPatients age 65 yearsOral adjuvant chemotherapyPill bottle openingsNode-negative diseaseHormone receptor statusRelapse-free survivalRandomized clinical trialsAge 65 yearsMulticenter clinical trialNumber of dosesPercent of participantsLogistic regression modelsAdjuvant chemotherapyProtocol therapyOral therapyStandard chemotherapyMedian ageReceptor statusPatient adherence
2006
Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342
Harris LN, Broadwater G, Lin NU, Miron A, Schnitt SJ, Cowan D, Lara J, Bleiweiss I, Berry D, Ellis M, Hayes DF, Winer EP, Dressler L. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Research 2006, 8: r66. PMID: 17129383, PMCID: PMC1797029, DOI: 10.1186/bcr1622.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerTriple-negative tumorsOverall survivalBreast cancerP53 statusNegative tumorsHER2 statusHormone receptorsHormone receptor statusShorter median timeDoses of paclitaxelLonger overall survivalHER2-positive tumorsAfrican American patientsHormone receptor expressionPrimary tumor tissuesAdvanced diseaseMetastatic diseaseShorter OSReceptor statusMedian timeTreatment failureShorter survivalCaucasian patientsPathology reportsThe impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer
Punglia RS, Kuntz KM, Winer EP, Weeks JC, Burstein HJ. The impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer. Cancer 2006, 106: 2576-2582. PMID: 16703595, DOI: 10.1002/cncr.21919.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCross-Over StudiesDecision Support TechniquesDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMarkov ChainsMiddle AgedModels, StatisticalModels, TheoreticalNeoplasm StagingOdds RatioPostmenopauseRandomized Controlled Trials as TopicReceptors, ProgesteroneTamoxifenTime FactorsTreatment OutcomeConceptsDisease-free survivalAromatase inhibitorsProgesterone receptorEstrogen receptorOptimal adjuvant endocrine therapyEarly-stage breast cancerAdjuvant endocrine therapyNode-positive groupProgesterone receptor statusRandomized clinical trialsSequential treatmentBreast cancer tumorsAI monotherapyAI therapyBiologic subsetsDFS ratesAdjuvant therapyEndocrine therapyPostmenopausal patientsPostmenopausal womenSequential therapyUpfront treatmentLymph nodesReceptor statusPR expression