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 diseaseCorrelation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial)
Hennessy M, Leal J, Huang C, Solnes L, Denbow R, Abramson V, Carey L, Liu M, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Cimino-Mathews A, Wahl R, Stearns V, Connolly R. Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial). Journal Of Nuclear Medicine 2023, 64: jnumed.123.265853. PMID: 37652539, DOI: 10.2967/jnumed.123.265853.Peer-Reviewed Original ResearchConceptsF-FDG PET/CTHER2-positive breast cancerRecurrence-free survivalPET/CTPathologic complete responseOverall survivalBreast cancerOperable HER2-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Growth factor receptor 2Kaplan-Meier methodStatistical significanceLean body massFactor receptor 2Imaging-based biomarkersCorrelation of SUVHER2 therapyNeoadjuvant trastuzumabNeoadjuvant therapyAdjuvant therapyComplete responsePhysician's discretionOS outcomesCox regressionAssessment 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
2022
Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effects
2021
Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021
Burstein HJ, Curigliano G, Thürlimann B, Weber WP, Poortmans P, Regan MM, Senn HJ, Winer EP, Gnant M, Conference P, Aebi S, André F, Barrios C, Bergh J, Bonnefoi H, Morales D, Brucker S, Burstein H, Cameron D, Cardoso F, Carey L, Chua B, Ciruelos E, Colleoni M, Curigliano G, Delaloge S, Denkert C, Dubsky P, Ejlertsen B, Fitzal F, Francis P, Galimberti V, Mahmoud H, Garber J, Gnant M, Gradishar W, Gulluoglu B, Harbeck N, Huang C, Huober J, Ilbawi A, Jiang Z, Johnston S, Lee E, Loibl S, Morrow M, Partridge A, Piccart M, Poortmans P, Prat A, Regan M, Rubio I, Rugo H, Rutgers E, Sedlmayer F, Semiglazov V, Senn H, Shao Z, Spanic T, Tesarova P, Thürlimann B, Tjulandin S, Toi M, Trudeau M, Turner N, Luis I, Viale G, Watanabe T, Weber W, Winer E, Xu B. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Annals Of Oncology 2021, 32: 1216-1235. PMID: 34242744, PMCID: PMC9906308, DOI: 10.1016/j.annonc.2021.06.023.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBreast cancerSystemic therapyEarly breast cancerTime of diagnosisBreast cancer patientsInternational consensus guidelinesBreast cancer riskRadiation oncology providersBreast cancer diagnosisNeoadjuvant therapyMultidisciplinary careOncology providersClinical featuresConsensus guidelinesCancer patientsPatient preferencesTreatment recommendationsTreatment responseCancer riskClinical careClinical informationConsensus conferenceEarly breast cancer diagnosisPatient experienceTemporal and spatial topography of cell proliferation in cancer.
Kabraji S, Gaglia G, Argyropoulou D, Dai Y, Wang S, Bergholz J, Coy S, Lin J, Jeselsohn R, Metzger O, Winer E, Dillon D, Zhao J, Sorger P, Santagata S. Temporal and spatial topography of cell proliferation in cancer. Journal Of Clinical Oncology 2021, 39: 3122-3122. DOI: 10.1200/jco.2021.39.15_suppl.3122.Peer-Reviewed Original ResearchCell cycle stateCancer cellsBreast cancerTumor-infiltrating immune cellsDisease-free survivalCell cycle protein expressionCell proliferationDormant cancer cellsCancer cell proliferationQuiescent cancer cellsCycle stateCancer stem cellsSame primary tumorNeoadjuvant therapyProliferative cancer cellsAdjuvant therapyClinical outcomesColorectal cancerPrimary tumorImmune cellsUntreated tumorsDiverse tumor typesUnique tumorProliferation indexProliferative index
2020
Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsResponse to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer.
Sella T, Gelber S, Poorvu P, Kim H, Guzman Arocho Y, Collins L, Ruddy K, Tamimi R, Peppercorn J, Schapira L, Borges V, Come S, Warner E, Snow C, Jakubowski D, Russell C, Winer E, Rosenberg S, Partridge A. Response to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer. Journal Of Clinical Oncology 2020, 38: 514-514. DOI: 10.1200/jco.2020.38.15_suppl.514.Peer-Reviewed Original ResearchPathologic complete responseBreast Recurrence ScoreNeoadjuvant chemotherapyBreast cancerRecurrence scoreBreast Cancer StudyYoung womenHER2- BCEstrogen receptor-positive early breast cancerHER-2 negative breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyNeoadjuvant endocrine therapyResidual invasive tumorEarly breast cancerPost-menopausal womenNegative breast cancerHigh gradeLogistic regression modelingAdjuvant chemotherapyDuctal histologyPgR negativityEndocrine therapyNeoadjuvant therapyProspective cohort
2019
SL 2.1 Adjuvant and neoadjuvant therapy in patients with early breast cancer: Principles and practical considerations
Winer E. SL 2.1 Adjuvant and neoadjuvant therapy in patients with early breast cancer: Principles and practical considerations. The Breast 2019, 44: s11. DOI: 10.1016/s0960-9776(19)30093-1.Peer-Reviewed Original Research
2017
De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017
Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, Colleoni M, Regan MM, Piccart-Gebhart M, Senn H, Thürlimann B, André F, Baselga J, Bergh J, Bonnefoi H, Brucker S, Cardoso F, Carey L, Ciruelos E, Cuzick J, Denkert C, Di Leo A, Ejlertsen B, Francis P, Galimberti V, Garber J, Gulluoglu B, Goodwin P, Harbeck N, Hayes D, Huang C, Huober J, Khaled H, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne K, Pagani O, Partridge A, Pritchard K, Ro J, Rutgers E, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Toi M, Tutt A, Viale G, Watanabe T, Whelan T, Xu B. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Annals Of Oncology 2017, 28: 1700-1712. PMID: 28838210, PMCID: PMC6246241, DOI: 10.1093/annonc/mdx308.Peer-Reviewed Original ResearchConceptsLow-risk patientsBreast cancerNeoadjuvant therapyPostmenopausal womenEarly-stage breast cancerER-positive breast cancerAvoidance of chemotherapyDe-escalate therapyAdjuvant endocrine treatmentRegional nodal irradiationHigh-risk patientsEarly breast cancerSentinel node biopsyHigh-risk tumorsPositive breast cancerBreast cancer recurrenceExpert consensus conferenceSubstantial new evidenceNodal irradiationBisphosphonate useEndocrine treatmentNeoadjuvant treatmentOvarian suppressionPremenopausal womenPrimary therapy
2016
Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance)
Golshan M, Cirrincione CT, Sikov WM, Carey LA, Berry DA, Overmoyer B, Henry NL, Somlo G, Port E, Burstein HJ, Hudis C, Winer E, Ollila DW, for the Alliance for Clinical Trials in Oncology. Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance). Breast Cancer Research And Treatment 2016, 160: 297-304. PMID: 27704226, PMCID: PMC5189982, DOI: 10.1007/s10549-016-4006-6.Peer-Reviewed Original ResearchConceptsNeoadjuvant systemic therapyBreast-conserving therapyBCT-eligible patientsPathologic complete responseSuccessful breast-conserving therapyHER2-positive breast cancerBCT eligibilityPCR rateBreast conservationSurgical assessmentBreast cancerStage IIHigh clinical response rateFinal surgical procedureClinical response rateSubset of patientsManagement of patientsPoor cosmetic outcomeSuccess rateCALGB 40601Converted patientsNeoadjuvant trialsNeoadjuvant therapyPrimary surgeryMulticentric disease
2015
Impact of neoadjuvant therapy on breast conservation rates in triple-negative and HER2-positive breast cancer: Combined results of CALGB 40603 and 40601 (Alliance).
Golshan M, Cirrincione C, Carey L, Sikov W, Berry D, Burstein H, Overmoyer B, Henry N, Somlo G, Port E, Winer E, Hudis C, Ollila D. Impact of neoadjuvant therapy on breast conservation rates in triple-negative and HER2-positive breast cancer: Combined results of CALGB 40603 and 40601 (Alliance). Journal Of Clinical Oncology 2015, 33: 1007-1007. DOI: 10.1200/jco.2015.33.15_suppl.1007.Peer-Reviewed Original Research
2013
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction
Kansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsFemaleHumansMammaplastyMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPostoperative ComplicationsTreatment OutcomeYoung AdultConceptsSurgical complicationsAC/TPostoperative complicationsComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerOverall complication rateRate of complicationsThird of patientsCohort of patientsSame healthcare systemSingle-arm trialFisher's exact testUse of BevTerms of demographicsNeoadjuvant bevacizumabNeoadjuvant therapyImplant reconstructionMastectomyNeoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.
Kansal K, Dominici L, Tolaney S, Isakoff S, Krop I, Smith B, Jiang W, Potler H, Brock J, Winer E, Golshan M. Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction. Journal Of Clinical Oncology 2013, 31: 1100-1100. DOI: 10.1200/jco.2013.31.15_suppl.1100.Peer-Reviewed Original ResearchSurgical complicationsAC/TNeoadjuvant bevacizumabNeoadjuvant therapyComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerUse of bevacizumabOverall complication rateRate of complicationsThird of patientsCohort of patientsSingle-arm trialSame healthcare systemFisher's exact testTerms of demographicsNon-randomized dataPostoperative complicationsImplant reconstructionImpact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance).
Ollila D, Berry D, Cirrincione C, Carey L, Amos K, Henry N, Winer E, Hudis C, Golshan M. Impact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance). Journal Of Clinical Oncology 2013, 31: 501-501. DOI: 10.1200/jco.2013.31.15_suppl.501.Peer-Reviewed Original ResearchNeoadjuvant therapyBCT candidatesCALGB 40601Neoadjuvant chemotherapySystemic therapySurgical resultsBreast surgeonsBreast cancerTumor-free surgical marginsBreast cancer ptsNeoadjuvant systemic therapyOperable breast cancerBreast conservation ratesPhase III trialsAnti-HER2 treatmentModern systemic therapyBreast cancer operationsBCT eligibilityCancer ptsEligible patientsNeoadjuvant trialsTherapy ratesIII trialsSurgical marginsCancer operations
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 entity
2010
Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery?
Golshan M, Garber JE, Gelman R, Tung N, Smith BL, Troyan S, Greenberg CC, Winer EP, Ryan P. Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery? Annals Of Surgical Oncology 2010, 18: 733-737. PMID: 20882415, DOI: 10.1245/s10434-010-1366-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsChemotherapy, AdjuvantCisplatinCombined Modality TherapyFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm StagingPostoperative ComplicationsReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSentinel Lymph Node BiopsySurvival RateTreatment OutcomeConceptsTriple-negative breast cancerSingle-arm trialNeoadjuvant cisplatinPostoperative complicationsBreast cancerTwo-sided Fisher's exact testExpander/implantsSafety of bevacizumabOperable breast cancerDefinitive local therapyBreast cancer surgeryNegative breast cancerFisher's exact testBackgroundNeoadjuvant chemotherapyNeoadjuvant settingNeoadjuvant therapyProtocol therapySurgical complicationsLocal therapyRelated complicationsCancer surgeryCisplatin therapyBreast surgeryComplicationsPatients
2009
Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assays
2007
Does MRI predict pathologic tumor response in women with breast cancer undergoing preoperative chemotherapy?
Segara D, Krop IE, Garber JE, Winer E, Harris L, Bellon JR, Birdwell R, Lester S, Lipsitz S, Iglehart JD, Golshan M. Does MRI predict pathologic tumor response in women with breast cancer undergoing preoperative chemotherapy? Journal Of Surgical Oncology 2007, 96: 474-480. PMID: 17640031, DOI: 10.1002/jso.20856.Peer-Reviewed Original ResearchConceptsNeoadjuvant therapyNeoadjuvant chemotherapyPreoperative chemotherapyTumor sizePhysical examBreast cancerFinal pathologic tumor sizePathologic tumor sizeStart of therapyInvasive breast cancerBreast cancer patientsPathologic tumor responseCorrelation of ultrasoundUse of MRIPhysical exam dataComplete respondersBreast conservationPathologic sizeCancer patientsPathology sizeTumor responseUS assessmentPathologic measurementsPathology responsePatients