2024
Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502.
Gandhi S, Ballman K, Holmes M, Visvanathan K, Symington B, Carvan M, Matyka C, Weiss A, Winer E, Razaq W, Carey L, Partridge A, Chen W. Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502. Journal Of Clinical Oncology 2024, 42: 11016-11016. DOI: 10.1200/jco.2024.42.16_suppl.11016.Peer-Reviewed Original ResearchInvasive disease-free survivalBrief Pain InventoryPerceived Stress ScaleOverall survivalPittsburgh Sleep Quality IndexMultivariate Cox modelClinical outcomesBreast cancerCESD-RClinical trialsAssociated with worse clinical outcomesDouble-blind clinical trialCox modelBrief Pain Inventory scoresHormone receptor statusDisease-free survivalEpidemiologic Studies Depression Scale-RevisedCenter for Epidemiologic Studies Depression Scale-RevisedHigher Perceived Stress ScaleBody mass indexNonmetastatic breast cancerSleep qualityCESD-R scoresPerceived Stress Scale scoresPittsburgh Sleep Quality Index score
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
Efficacy 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 stageABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Openshaw T, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2020, 38: tps600-tps600. DOI: 10.1200/jco.2020.38.15_suppl.tps600.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsBlinded placebo-controlled trialHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirin
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 trialsABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2019, 37: tps599-tps599. DOI: 10.1200/jco.2019.37.15_suppl.tps599.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersTrial of aspirinDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirinIDFS events
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 status
2013
Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Levin J, Winer E. Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515). Journal Of Clinical Oncology 2013, 31: tps664-tps664. DOI: 10.1200/jco.2013.31.15_suppl.tps664.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBreast cancerOverall survivalMetastatic BCPFS eventsStage II/III breast cancerHigher pathologic complete response rateHER2-positive metastatic breast cancerMedian progression-free survivalPathologic complete response rateLonger progression-free survivalAssociated hazard ratiosClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateSecond-line treatmentHormone receptor statusPhase III studyAddition of lapatinibLine of treatmentChemotherapy discontinuationEligible patientsHER2 blockade
2012
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).
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 albuminHALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Nagarwala Y, Winer E. HALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515). Journal Of Clinical Oncology 2012, 30: tps658-tps658. DOI: 10.1200/jco.2012.30.15_suppl.tps658.Peer-Reviewed Original ResearchHER2-positive metastatic BCSecond-line treatmentMetastatic BCOverall survivalHigher pathologic complete response rateHER2-positive metastatic breast cancerBreast cancer preclinical modelsPathologic complete response rateClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateCombination of trastuzumabHormone receptor statusPhase III studyAddition of lapatinibKey eligibility criteriaMetastatic breast cancerLine of treatmentChemotherapy discontinuationHER2 blockadeITT populationMedian PFSStable diseaseBrain metastases
2011
OT1-02-02: HALT MBC: HER2 Suppression with the Addition of Lapatinib to Trastuzumab in HER2−Positive Metastatic Breast Cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Ellis C, DeSilvio M, Garofalo A, Nagarwala Y, Winer E. OT1-02-02: HALT MBC: HER2 Suppression with the Addition of Lapatinib to Trastuzumab in HER2−Positive Metastatic Breast Cancer (LPT112515). Cancer Research 2011, 71: ot1-02-02-ot1-02-02. DOI: 10.1158/0008-5472.sabcs11-ot1-02-02.Peer-Reviewed Original ResearchSecond-line treatmentAddition of lapatinibOverall survivalHigher pathological complete response rateBreast cancer preclinical modelsPathological complete response rateClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateHormone receptor statusPhase III studyMetastatic breast cancerLine of treatmentAnti-tumor activityHER2 blockadeMedian PFSStable diseaseBrain metastasesEfficacy endpointMaintenance therapyPreoperative treatmentAdverse eventsHazard ratioIII studyBreast 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
2008
VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy
Burstein HJ, Chen YH, Parker LM, Savoie J, Younger J, Kuter I, Ryan PD, Garber JE, Chen H, Campos SM, Shulman LN, Harris LN, Gelman R, Winer EP. VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy. Clinical Cancer Research 2008, 14: 7871-7877. PMID: 19047116, DOI: 10.1158/1078-0432.ccr-08-0593.Peer-Reviewed Original ResearchConceptsAdvanced breast cancer patientsRefractory breast cancerBreast cancer patientsBreast cancerPlasma VEGFCancer patientsTreatment outcomesSide effectsAnti-vascular endothelial growth factor therapyAdequate end-organ functionEndothelial growth factor therapyImportant new treatment modalityTumor hormone receptor statusMonoclonal anti-VEGF antibodyPrior chemotherapy regimensEnd-organ functionHormone receptor statusAnti-VEGF therapyMetastatic breast cancerGrowth factor therapyNew treatment modalitiesWarrants further evaluationAnti-VEGF antibodyBaseline VEGFEligible patientsDose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel
Liu MC, Demetri GD, Berry DA, Norton L, Broadwater G, Robert NJ, Duggan D, Hayes DF, Henderson IC, Lyss A, Hopkins J, Kaufman PA, Marcom PK, Younger J, Lin N, Tkaczuk K, Winer EP, Hudis CA, B F. Dose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel. Cancer Treatment Reviews 2008, 34: 223-230. PMID: 18234424, PMCID: PMC2651678, DOI: 10.1016/j.ctrv.2007.11.004.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFilgrastimFollow-Up StudiesGranulocyte Colony-Stimulating FactorHumansLymphatic MetastasisMiddle AgedPaclitaxelPilot ProjectsRecombinant ProteinsConceptsG-CSF supportGrowth factor supportRelapse-free survivalClinical outcomesDose levelsG-CSFFactor supportConventional doseClinical trialsBreast cancerNode-positive invasive breast cancerNode-positive breast cancer patientsAcute treatment-related toxicityHematopoietic growth factor supportOperable primary breast cancerAdjuvant chemotherapy regimenDose-intensified regimenDose-intensive regimensEarly study withdrawalNode-positive patientsTreatment-related toxicityHormone receptor statusInvasive breast cancerOverall survival ratePrimary breast cancer
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 reports