2024
Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆. Annals Of Oncology 2024, 35: 993-1002. PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatients6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)
Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro M, Bajpai J, Barrios C, Bergh J, Bergsten-Nordström E, Biganzoli L, Cardoso M, Carey L, Mac Gregor M, Chidebe R, Cortés J, Curigliano G, Dent R, Saghir N, Eniu A, Fallowfield L, Francis P, Millan S, Gilchrist J, Gligorov J, Gradishar W, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim S, Koppikar S, Kuper-Hommel M, Lecouvet F, Mason G, Mertz S, Mueller V, Myerson C, Neciosup S, Offersen B, Ohno S, Pagani O, Partridge A, Penault-Llorca F, Prat A, Rugo H, Senkus E, Sledge G, Swain S, Thomssen C, Vorobiof D, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, Winer E. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). The Breast 2024, 76: 103756. PMID: 38896983, PMCID: PMC11231614, DOI: 10.1016/j.breast.2024.103756.Peer-Reviewed Original ResearchAdvanced breast cancerLevel of evidenceInternational consensus guidelinesBreast cancerConsensus guidelinesGrading of RecommendationsConsensus conferenceHighest level of evidenceManagement of advanced breast cancerBreast cancer subtypesInternational Consensus ConferencePercentage of consensusTreatment algorithmCancer subtypesSupportive careGuidelinesExpert opinionGlobal AllianceCancerPatientsManagement optionsRecommendationsCareHigher levelsConsensus
2023
Comprehensive genomic characterization of HER2-low and HER2-0 breast cancer
Tarantino P, Gupta H, Hughes M, Files J, Strauss S, Kirkner G, Feeney A, Li Y, Garrido-Castro A, Barroso-Sousa R, Bychkovsky B, DiLascio S, Sholl L, MacConaill L, Lindeman N, Johnson B, Meyerson M, Jeselsohn R, Qiu X, Li R, Long H, Winer E, Dillon D, Curigliano G, Cherniack A, Tolaney S, Lin N. Comprehensive genomic characterization of HER2-low and HER2-0 breast cancer. Nature Communications 2023, 14: 7496. PMID: 37980405, PMCID: PMC10657399, DOI: 10.1038/s41467-023-43324-w.Peer-Reviewed Original ResearchConceptsHER2-low tumorsBreast cancerHER2-negative metastatic breast cancerMetastatic breast cancerTumor mutational burdenHigh rateComprehensive genomic characterizationHER2 0Mutational burdenBreast tumorsTumorsHER2Genomic alterationsNext-generation sequencingSignificant differencesGenomic findingsCancerGenomic landscapeMolecular underpinningsHemideletionGenomic characterizationHigher numberPatientsCopy countsImpact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
Schmid P, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia J, Zhou X, Haiderali A, Nguyen A, Cortes J, Winer E. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. European Journal Of Cancer 2023, 195: 113393. PMID: 37976633, DOI: 10.1016/j.ejca.2023.113393.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerCombined positive scoreMetastatic triple-negative breast cancerPD-L1 combined positive scoreHealth-related qualityBreast cancerQLQ-C30 functional scalesTumor PD-L1 expressionGHS/QoLNausea/vomitingPD-L1 expressionStart of treatmentHRQoL resultsEligible patientsHRQoL analysisOverall survivalSystemic therapyClinical outcomesFunctional scalesPhysician's choicePatientsChemotherapyFirst onsetCountry guidelinesMedian TTDCirculating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆
Parsons H, Blewett T, Chu X, Sridhar S, Santos K, Xiong K, Abramson V, Patel A, Cheng J, Brufsky A, Rhoades J, Force J, Liu R, Traina T, Carey L, Rimawi M, Miller K, Stearns V, Specht J, Falkson C, Burstein H, Wolff A, Winer E, Tayob N, Krop I, Makrigiorgos G, Golub T, Mayer E, Adalsteinsson V. Circulating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆. Annals Of Oncology 2023, 34: 899-906. PMID: 37597579, PMCID: PMC10898256, DOI: 10.1016/j.annonc.2023.08.004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerResidual cancer burdenNeoadjuvant chemotherapyCancer burdenBreast cancerWeek 3Additional neoadjuvant chemotherapyPlasma samplesCase-control analysisCtDNA clearanceCtDNA positivityNeoadjuvant paclitaxelDisease recurrenceProspective studyWeek 12RCB 0CtDNA assaysPatientsSufficient tissueChemotherapyTumor fractionTumor DNARCB-3RespondersAdditional studiesEstimating mortality in women with triple-negative breast cancer: The ‘ESTIMATE triple-negative’ tool
Leone J, Graham N, Leone J, Tolaney S, Leone B, Freedman R, Hassett M, Vallejo C, Winer E, Lin N, Tayob N. Estimating mortality in women with triple-negative breast cancer: The ‘ESTIMATE triple-negative’ tool. European Journal Of Cancer 2023, 189: 112930. PMID: 37356327, DOI: 10.1016/j.ejca.2023.05.018.Peer-Reviewed Original ResearchConceptsBreast cancer-specific mortalityTriple-negative breast cancerRisk of BCSMTumor characteristicsBreast cancerCumulative riskNon-metastatic triple-negative breast cancerMost tumor characteristicsCancer-specific mortalityRisk of deathPopulation-based riskHigh-grade triple-negative breast cancerCause mortalityMost patientsPathologic variablesInitial diagnosisHigh riskNew diagnosisPatientsMortalityDiagnosisYear 0RiskCancerWomenRekindling Joy in Medicine Through Thoughtful Communication: A Practical Guide.
Sanft T, Winer E. Rekindling Joy in Medicine Through Thoughtful Communication: A Practical Guide. American Society Of Clinical Oncology Educational Book 2023, 43: e100034. PMID: 37267275, DOI: 10.1200/edbk_100034.Peer-Reviewed Original Research190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119
Cortés J, Lipatov O, Im S, Gonçalves A, Lee K, Schmid P, Tamura K, Testa L, Ohtani S, Harbeck N, Loi S, Salgado R, Lunceford J, Karantza V, Mejia J, Cristescu R, Nebozhyn M, Jelinic P, Huang L, Winer E. 190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119. ESMO Open 2023, 8: 101379. DOI: 10.1016/j.esmoop.2023.101379.Peer-Reviewed Original Research
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 differencesPatientsMenCorrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]. Annals Of Oncology 2022, 34: 630. PMID: 36564285, DOI: 10.1016/j.annonc.2022.12.005.Peer-Reviewed Original ResearchVP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up
Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber R, Restuccia E, Im Y, Huang C, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Moreno H, Bliss J, Viale G, Bines J, Piccart M. VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up. Annals Of Oncology 2022, 33: 986-987. DOI: 10.1016/j.annonc.2022.06.009.Peer-Reviewed Original ResearchASO Visual Abstract: Expanding Staging Criteria in T1–2N0 Hormone Receptor-Positive Breast Cancer Patients Enrolled in TAILORx
Kantor O, Burstein HJ, King TA, Shak S, Russell CA, Giuliano AE, Hortobagyi GN, Winer EP, Korde LA, Sparano JA, Mittendorf EA. ASO Visual Abstract: Expanding Staging Criteria in T1–2N0 Hormone Receptor-Positive Breast Cancer Patients Enrolled in TAILORx. Annals Of Surgical Oncology 2022, 29: 8024-8025. DOI: 10.1245/s10434-022-12294-6.Peer-Reviewed Original ResearchEstimating long-term mortality in women with hormone receptor-positive breast cancer: The ‘ESTIMATE’ tool
Leone JP, Graham N, Tolaney SM, Leone BA, Freedman RA, Hassett MJ, Leone J, Vallejo CT, Winer EP, Lin NU, Tayob N. Estimating long-term mortality in women with hormone receptor-positive breast cancer: The ‘ESTIMATE’ tool. European Journal Of Cancer 2022, 173: 20-29. PMID: 35841843, DOI: 10.1016/j.ejca.2022.06.029.Peer-Reviewed Original ResearchConceptsBreast cancer-specific mortalityHR-positive breast cancerBreast cancerCumulative riskCause mortalityTumor characteristicsRisk of BCSMHormone receptor-positive breast cancerReceptor-positive breast cancerCancer-specific mortalityEnd Results registryLong-term mortalityRisk of deathCancer patient subgroupsPopulation-based riskPathologic variablesInitial diagnosisPatient subgroupsSEER dataPatientsAge groupsCancerMortalityHormone receptorsDiagnosisp16INK4A-deficiency predicts response to combined HER2 and CDK4/6 inhibition in HER2+ breast cancer brain metastases
Ni J, Kabraji S, Xie S, Wang Y, Pan P, He X, Liu Z, Leone JP, Long HW, Brown MA, Winer EP, Dillon DAR, Lin NU, Zhao JJ. p16INK4A-deficiency predicts response to combined HER2 and CDK4/6 inhibition in HER2+ breast cancer brain metastases. Nature Communications 2022, 13: 1473. PMID: 35304445, PMCID: PMC8933392, DOI: 10.1038/s41467-022-29081-2.Peer-Reviewed Original ResearchConceptsPatient-derived xenograftsBrain metastasesMetastatic HER2-positive breast cancerBiomarker-driven clinical trialsBreast cancer brain metastasesHER2-positive breast cancerOrthotopic patient-derived xenograftsMajority of HER2Cancer brain metastasesCDK4/6 inhibitionProtein immunohistochemistryClinical trialsBreast cancerHER2Tumor suppressor p16INK4aPatientsMetastasisBCBMAbemaciclibTucatinibXenograftsImmunohistochemistryCancerCDK4/6TrialsPerceptions of patients and medical oncologists toward biospecimen donation in the setting of abnormal breast imaging findings
Seah DS, Tayob N, Leone JP, Hu J, Yin J, Hughes M, Scott SM, Lederman RI, Frank E, Sohl JJ, Stadler ZK, Erick TK, Peppercorn J, Winer EP, Silverman SG, Come SE, Lin NU. Perceptions of patients and medical oncologists toward biospecimen donation in the setting of abnormal breast imaging findings. Breast Cancer Research And Treatment 2022, 192: 201-210. PMID: 35066788, DOI: 10.1007/s10549-021-06494-z.Peer-Reviewed Original ResearchConceptsAdditional biospecimensMedical oncologistsBreast biopsyBreast tissueBiopsy resultsSingle academic medical centerBreast medical oncologistsPain/discomfortPerceptions of patientsMost medical oncologistsAbnormal breastDiagnostic breast biopsyAcademic medical centerPercutaneous breast biopsyNational Cancer InstituteDonation of bloodCancer CenterDiagnostic biopsyPercutaneous biopsyMedical CenterBiopsyCancer InstitutePatientsOncologistsProcedure riskThe Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast CancerNeratinib and Fulvestrant in HER2-Mutated Breast Cancer
X. C, Luo J, Freedman RA, Pluard TJ, Nangia JR, Lu J, Valdez-Albini F, Cobleigh M, Jones JM, Lin NU, Winer EP, Marcom PK, Thomas S, Anderson J, Haas B, Bucheit L, Bryce R, Lalani AS, Carey LA, Goetz MP, Gao F, Kimmick G, Pegram MD, Ellis MJ, Bose R. The Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast CancerNeratinib and Fulvestrant in HER2-Mutated Breast Cancer. Clinical Cancer Research 2022, 28: 1258-1267. PMID: 35046057, DOI: 10.1158/1078-0432.ccr-21-3418.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerER cohortEstrogen receptor-positive breast cancerReceptor-positive breast cancerClinical benefit rateDual HER2 blockadePhase II trialEfficacy of neratinibHER2 blockadeNeratinib monotherapyStable diseaseII trialHER2 mutationsLobular histologyPartial responseEndocrine resistanceBenefit ratePatientsFurther evaluationCancerFulvestrantHER2NeratinibProgression
2021
LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB)
Hortobagyi G, Stemmer S, Burris H, Yap Y, Sonke G, Hart L, Campone M, Petrakova K, Winer E, Janni W, Conte P, Cameron D, André F, Arteaga C, Zarate J, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Annals Of Oncology 2021, 32: s1290-s1291. DOI: 10.1016/j.annonc.2021.08.2090.Peer-Reviewed Original ResearchPD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer
Rugo HS, Loi S, Adams S, Schmid P, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Winer EP, Kockx MM, Peeters D, Chui SY, Lin JC, Nguyen-Duc A, Viale G, Molinero L, Emens LA. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer. Journal Of The National Cancer Institute 2021, 113: 1733-1743. PMID: 34097070, PMCID: PMC8634452, DOI: 10.1093/jnci/djab108.Peer-Reviewed Original ResearchConceptsNab-paclitaxelPD-L1Metastatic triple-negative breast cancer patientsAdvanced triple-negative breast cancerAnalytical concordanceTriple-negative breast cancer patientsTriple-negative breast cancerDouble-positive casesCombined positive scorePD-L1 statusPD-L1 assaysBreast cancer patientsSingle positive caseMore patientsSP263 assaysClinical outcomesClinical benefitCancer patientsClinical activityBreast cancerSP142SP263PatientsPhase IIIPositive scoreAdjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelFactors 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 5Patients