2023
Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial
Tolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerInvasive disease-free survivalDisease-free survivalRecurrence-free intervalAdjuvant paclitaxelBreast cancerEastern Cooperative Oncology Group performance statusInvasive disease-free survival eventsDisease-free survival eventsHormone receptor-positive diseaseNew contralateral breast cancerBreast cancer-specific survivalProtocol-defined treatmentCancer-specific survivalReceptor-positive diseasePhase 2 studyContralateral breast cancerLong-term outcomesAPT trialCause deathEligible patientsIntravenous paclitaxelTrastuzumab weeklyDistant recurrenceIpsilateral recurrence
2022
Survival in male breast cancer over the past 3 decades
Leone J, Freedman R, Leone J, Tolaney S, Vallejo C, Leone B, Winer E, Lin N, Hassett M. Survival in male breast cancer over the past 3 decades. Journal Of The National Cancer Institute 2022, 115: 421-428. PMID: 36583555, PMCID: PMC10086618, DOI: 10.1093/jnci/djac241.Peer-Reviewed Original ResearchConceptsBreast cancer-specific survivalMale breast cancerOverall survivalBreast cancerMultivariable Cox regressionCancer-specific survivalEnd Results registryYear of diagnosisBreast cancer mortalityStage of diseaseLog-rank testCox regressionCancer mortalityKaplan-MeierIndependent associationCox modelSignificant improvementSignificant associationCancerLife expectancyDiagnosisSurvivalSignificant differencesPatientsMen
2021
Survival in male breast cancer (MaBC) over the past three decades.
Leone J, Freedman R, Leone J, Hassett M, Tolaney S, Vallejo C, Leone B, Winer E, Lin N. Survival in male breast cancer (MaBC) over the past three decades. Journal Of Clinical Oncology 2021, 39: 569-569. DOI: 10.1200/jco.2021.39.15_suppl.569.Peer-Reviewed Original ResearchBreast cancer-specific survivalOverall survivalBreast cancerCox modelWorse breast cancer-specific survivalHormone receptor-negative statusGrade 3 diseaseCancer-specific survivalEnd Results registryReceptor-negative statusYear of diagnosisMale breast cancerMultivariate Cox modelDecade of diagnosisPeriod of diagnosisBreast cancer mortalityProportional hazards regressionLog-rank testCause of deathPatient characteristicsMedian ageHazards regressionCancer mortalityKaplan-MeierBlack raceTumor subtypes and survival in male breast cancer
Leone J, Freedman RA, Lin NU, Tolaney SM, Vallejo CT, Leone BA, Winer EP, Leone JP. Tumor subtypes and survival in male breast cancer. Breast Cancer Research And Treatment 2021, 188: 695-702. PMID: 33770314, DOI: 10.1007/s10549-021-06182-y.Peer-Reviewed Original ResearchConceptsBreast cancer-specific survivalOverall survivalTumor subtypesBreast cancerHormone receptorsWorse breast cancer-specific survivalMultivariate Cox proportional hazards analysisCox proportional hazards analysisPurposeMale breast cancerTumor subtype distributionCancer-specific survivalProportional hazards analysisInvasive breast cancerMale breast cancerAggressive tumor biologyCox hazard ratiosPopulation-based informationTN diseaseAdvanced diseaseHazard ratioHR-/HER2Inferior survivalMedian agePatient characteristicsPrognostic factors
2019
Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPoisson DistributionPolymorphism, Single NucleotideReceptor, ErbB-2RecurrenceRiskTrastuzumabTreatment OutcomeConceptsDisease-free survivalRecurrence-free intervalSmall HER2-positive tumorsAdjuvant paclitaxelHER2-positive tumorsLong-term outcomesTrastuzumab trialsBreast cancerOverall survivalSmall human epidermal growth factor receptor 2Breast cancer-specific survivalPaclitaxel-induced peripheral neuropathyExcellent long-term outcomesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorPAM50 intrinsic subtypesCancer-specific survivalPhase II studyPrimary end pointGrowth factor receptor 2Positive breast cancerTreatment of patientsSeven-year followP246 Breast cancer-specific survival (BCSS) in patients (pts) with nodenegative (N0) and node-positive (N+) breast cancer (BC) guided by the 21-gene assay: a SEER-genomic real-world evidence study
Winer E, Shak S, Sledge G, Albain K, Mamounas E, Jakubowski D, Petkov V, Wolmark N, Hortobagyi G. P246 Breast cancer-specific survival (BCSS) in patients (pts) with nodenegative (N0) and node-positive (N+) breast cancer (BC) guided by the 21-gene assay: a SEER-genomic real-world evidence study. The Breast 2019, 44: s100-s101. DOI: 10.1016/s0960-9776(19)30347-9.Peer-Reviewed Original ResearchBreast cancer-specific survivalBreast cancerNode-positive breast cancerReal-world evidence studiesCancer-specific survivalEvidence studiesPatientsCancerBreast Cancer Treatment
Waks AG, Winer EP. Breast Cancer Treatment. JAMA 2019, 321: 288-300. PMID: 30667505, DOI: 10.1001/jama.2018.19323.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerNonmetastatic breast cancerTriple-negative tumorsBreast cancerSystemic therapyTumor subtypesMetastatic triple-negative breast cancerHormone receptor-positive tumorsBreast cancer-specific survivalHuman epidermal growth factor 2Epidermal growth factor 2Small-molecule inhibitor therapyMajor tumor subtypesCancer-specific survivalMedian overall survivalProgesterone receptor expressionMetastatic breast cancerTime of diagnosisReceptor-positive tumorsBreast cancer treatmentErbB2-positive tumorsPreoperative treatment responseERBB2 gene amplificationDistinct risk profilesPalliating symptoms
2017
Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).
Tolaney S, Barry W, Guo H, Dillon D, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Partridge A, Hudis C, Krop I, Burstein H, Winer E. Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Journal Of Clinical Oncology 2017, 35: 511-511. DOI: 10.1200/jco.2017.35.15_suppl.511.Peer-Reviewed Original ResearchBreast cancer-specific survivalDisease-free survivalRecurrence-free intervalBreast cancerDistant recurrenceOverall survivalTumor sizeNew contralateral breast cancerHER2-positive breast cancerNode-negative HER2Cancer-specific survivalPhase II studyContralateral breast cancerAdjuvant paclitaxelAPT trialNodal micrometastasisPrimary endpointProtocol therapyAdjuvant therapyDFS eventsII studyDisease recurrenceRegional recurrenceSpecific survivalClinical outcomes
2016
Subtype-Dependent Relationship Between Young Age at Diagnosis and Breast Cancer Survival
Partridge AH, Hughes ME, Warner ET, Ottesen RA, Wong YN, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Tamimi RM. Subtype-Dependent Relationship Between Young Age at Diagnosis and Breast Cancer Survival. Journal Of Clinical Oncology 2016, 34: 3308-3314. PMID: 27480155, DOI: 10.1200/jco.2015.65.8013.Peer-Reviewed Original ResearchConceptsMultivariable Cox proportional hazards modelsCox proportional hazards modelBreast cancer deathsProportional hazards modelBreast cancerYears of ageYounger ageCancer deathHazards modelHuman epidermal growth factor receptor 2 subtypeStage INational Comprehensive Cancer Network centersBreast cancer-specific survivalEarly-stage breast cancerYoung womenCancer-specific survivalSurvival of womenEarly breast cancerLuminal B tumorsBreast cancer mortalityTriple-negative tumorsBreast cancer survivalLuminal breast cancerBreast cancer recurrenceBreast cancer subtypes
2015
Racial differences in outcomes for patients with metastatic breast cancer by disease subtype
Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii H, Winer EP, Freedman RA. Racial differences in outcomes for patients with metastatic breast cancer by disease subtype. Breast Cancer Research And Treatment 2015, 151: 697-707. PMID: 26022349, DOI: 10.1007/s10549-015-3432-1.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerDe novo metastatic breast cancerNovo metastatic breast cancerBreast cancer-specific survivalCancer-specific survivalHER2-positive tumorsOverall survivalBreast cancerTreatment patternsBlack patientsRacial differencesDisease subgroupsMultivariate Cox proportional modelEnd Results-Medicare dataHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Impact of raceHER2-positive diseaseHR-negative diseaseHR-negative tumorsLonger median OSMedian overall survivalGrowth factor receptor 2Survival of womenCox proportional modelsRacial and Ethnic Differences in Breast Cancer Survival: Mediating Effect of Tumor Characteristics and Sociodemographic and Treatment Factors
Warner ET, Tamimi RM, Hughes ME, Ottesen RA, Wong YN, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Partridge AH. Racial and Ethnic Differences in Breast Cancer Survival: Mediating Effect of Tumor Characteristics and Sociodemographic and Treatment Factors. Journal Of Clinical Oncology 2015, 33: 2254-2261. PMID: 25964252, PMCID: PMC4486344, DOI: 10.1200/jco.2014.57.1349.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAsianBiomarkers, TumorBlack or African AmericanBody Mass IndexBreast NeoplasmsCause of DeathDisease-Free SurvivalEthnicityFemaleHealth Status DisparitiesHealthcare DisparitiesHispanic or LatinoHumansLogistic ModelsMiddle AgedMultivariate AnalysisNeoplasm GradingNeoplasm StagingProportional Hazards ModelsRacial GroupsRisk FactorsSocioeconomic FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesWhite PeopleConceptsBreast cancer-specific survivalEstrogen receptor-positive tumorsCancer-specific survivalReceptor-positive tumorsBreast cancer survivalTumor characteristicsCancer survivalBreast cancerNational Comprehensive Cancer Network centersBreast cancer-specific deathHuman epidermal growth factor receptorCancer-specific deathMultivariable adjusted modelsYear of diagnosisBody mass indexProportional hazards regressionEpidermal growth factor receptorRace/ethnicityGrowth factor receptorHazards regressionMass indexRisk factorsSurvival differencesLike tumorsHigh risk
2013
Lumpectomy Plus Tamoxifen With or Without Irradiation in Women Age 70 Years or Older With Early Breast Cancer: Long-Term Follow-Up of CALGB 9343
Hughes KS, Schnaper LA, Bellon JR, Cirrincione CT, Berry DA, McCormick B, Muss HB, Smith BL, Hudis CA, Winer EP, Wood WC. Lumpectomy Plus Tamoxifen With or Without Irradiation in Women Age 70 Years or Older With Early Breast Cancer: Long-Term Follow-Up of CALGB 9343. Journal Of Clinical Oncology 2013, 31: 2382-2387. PMID: 23690420, PMCID: PMC3691356, DOI: 10.1200/jco.2012.45.2615.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomy, SegmentalNeoplasm Recurrence, LocalNeoplasm StagingOdds RatioRadiotherapy, AdjuvantReceptors, EstrogenTamoxifenTime FactorsTreatment OutcomeConceptsBreast cancer-specific survivalEarly-stage breast cancerCancer-specific survivalOverall survivalBreast cancerRadiation therapyRegional recurrenceDistant metastasisER-positive early-stage breast cancerDistant disease-free survivalWomen age 70 yearsEstrogen receptor-positive breast carcinomasFrequency of mastectomyTen-year OSAdjuvant radiation therapyPrimary end pointDisease-free survivalEarly breast cancerAge 70 yearsBreast-conserving surgeryBreast preservationCALGB 9343Locoregional recurrenceTAM groupLocal recurrence
2011
P1-08-05: Age and Survival in Women with Early Stage Breast Cancer: An Analysis Controlling for Tumor Subtype.
Partridge A, Hughes M, Ottesen R, Wong Y, Edge S, Theriault R, Blayney D, Niland J, Winer E, Weeks J, Tamimi R. P1-08-05: Age and Survival in Women with Early Stage Breast Cancer: An Analysis Controlling for Tumor Subtype. Cancer Research 2011, 71: p1-08-05-p1-08-05. DOI: 10.1158/0008-5472.sabcs11-p1-08-05.Peer-Reviewed Original ResearchMultivariate Cox proportional hazards modelEarly-stage breast cancerCox proportional hazards modelStage breast cancerProportional hazards modelBreast cancerEstrogen receptorYoung womenProgesterone receptorStratified analysisOlder womenHazards modelTumor subtypesYounger ageBreast cancer-specific survivalHER-2/neu statusCancer-specific survivalER-positive diseaseIndependent risk factorEarly breast cancerER-negative diseaseAge 40 yearsBreast cancer recurrenceEfficacy of therapyBreast cancer biology
2009
Prediction of 10-Year Chemotherapy Benefit and Breast Cancer-Specific Survival by the 21-Gene Recurrence Score (RS) Assay in Node-Positive, ER-Positive Breast Cancer – An Update of SWOG-8814 (INT0100).
Albain K, Barlow W, Shak S, Hortobagyi G, Livingston R, Yeh I, Ravdin P, Bugarini R, Baehner F, Davidson N, Sledge G, Winer E, Hudis C, Ingle J, Perez E, Pritchard K, Shepherd L, Gralow J, Yoshizawa C, Allred D, Osborne C, Hayes D. Prediction of 10-Year Chemotherapy Benefit and Breast Cancer-Specific Survival by the 21-Gene Recurrence Score (RS) Assay in Node-Positive, ER-Positive Breast Cancer – An Update of SWOG-8814 (INT0100). Cancer Research 2009, 69: 112-112. DOI: 10.1158/0008-5472.sabcs-09-112.Peer-Reviewed Original ResearchBreast cancer-specific survivalDisease-free survivalER-positive breast cancerAnthracycline-based chemotherapyCancer-specific survivalBreast cancerRecurrence scoreRS categorySuperior breast cancer-specific survivalDFS analysisNew adjuvant treatment strategiesPositive axillary lymph nodesAdjuvant treatment strategiesAxillary lymph nodesHigh-risk patientsUse of chemotherapyLow recurrence scoreHigh recurrence scoreLow RS groupNational Cancer InstituteLack of improvementLog-rank p-valueCensoring deathsLast followChemotherapy benefit
2002
American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002.
Winer EP, Hudis C, Burstein HJ, Chlebowski RT, Ingle JN, Edge SB, Mamounas EP, Gralow J, Goldstein LJ, Pritchard KI, Braun S, Cobleigh MA, Langer AS, Perotti J, Powles TJ, Whelan TJ, Browman GP. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002. Journal Of Clinical Oncology 2002, 20: 3317-27. PMID: 12149306, DOI: 10.1200/jco.2002.06.020.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerAromatase inhibitorsBreast cancerASCO Health Services Research CommitteeAdjuvant breast cancer settingClinical Oncology technology assessmentEvidence-based technology assessmentsHealth Services Research CommitteeBreast cancer-specific survivalAdjuvant hormonal therapyBreast cancer settingCancer-specific survivalBreast cancer incidenceIndividual health care providersHealth care providersAmerican SocietyOutcomes of interestNet health benefitAdjuvant tamoxifenASCO panelAdjuvant therapyHormonal therapyOverall survivalStandard therapyAmerican Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition.
Chlebowski RT, Col N, Winer EP, Collyar DE, Cummings SR, Vogel VG, Burstein HJ, Eisen A, Lipkus I, Pfister DG. American Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition. Journal Of Clinical Oncology 2002, 20: 3328-43. PMID: 12149307, DOI: 10.1200/jco.2002.06.029.Peer-Reviewed Original ResearchConceptsBreast cancer risk reductionUse of tamoxifenCancer risk reductionBreast cancer riskCancer riskASCO Health Services Research CommitteeBreast cancer risk reduction strategiesAromatase inhibitionCancer risk reduction strategiesClinical Oncology technology assessmentEvidence-based technology assessmentsHealth Services Research CommitteeBreast cancer-specific survivalHigher breast cancer riskUse of raloxifeneCancer-specific survivalHormone replacement therapyBreast cancer incidenceHealth benefitsGreater clinical benefitOverall health benefitsAmerican SocietyOutcomes of interestNet health benefitRisk reduction