2022
Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT
Francis P, Fleming G, Láng I, Ciruelos E, Bonnefoi H, Bellet M, Bernardo A, Climent M, Martino S, Bermejo B, Burstein H, Davidson N, Geyer C, Walley B, Ingle J, Coleman R, Müller B, Le Du F, Loibl S, Winer E, Ruepp B, Loi S, Colleoni M, Coates A, Gelber R, Goldhirsch A, Regan M, Group F. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. Journal Of Clinical Oncology 2022, 41: 1370-1375. PMID: 36493334, PMCID: PMC10419521, DOI: 10.1200/jco.22.01065.Peer-Reviewed Original ResearchConceptsOvarian function suppressionDisease-free survivalAdjuvant endocrine therapyPrimary end pointOverall survivalAdjuvant tamoxifenEndocrine therapyEnd pointBreast cancerHuman epidermal growth factor receptor-2-negative tumoursTamoxifen plus ovarian function suppressionHormone receptor-positive breast cancerReceptor-positive breast cancerClinical trial updateOvarian Function TrialPremenopausal breast cancerHigher baseline riskPrior chemotherapyPremenopausal womenTrial updateClinical trialsBaseline riskMultiple end pointsTamoxifenExemestane
2018
Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies
Nayar U, Cohen O, Kapstad C, Cuoco MS, Waks AG, Wander SA, Painter C, Freeman S, Persky NS, Marini L, Helvie K, Oliver N, Rozenblatt-Rosen O, Ma CX, Regev A, Winer EP, Lin NU, Wagle N. Acquired HER2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor–directed therapies. Nature Genetics 2018, 51: 207-216. PMID: 30531871, DOI: 10.1038/s41588-018-0287-5.Peer-Reviewed Original ResearchConceptsHER2 mutationsEstrogen receptorBreast cancerClinical resistance mechanismsMainstay of treatmentMetastatic breast cancerReceptor-directed therapyCDK6 inhibitor palbociclibPre-existing mutationsMetastatic settingEstrogen independenceInhibitor palbociclibPrimary tumorMetastatic biopsiesInhibitor neratinibTherapyPatientsER mutationsCancerTamoxifenResistance mechanismsDistinct mechanismsMutationsConfer resistanceBiopsyTailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. New England Journal Of Medicine 2018, 379: 122-137. PMID: 29863451, PMCID: PMC6193457, DOI: 10.1056/nejmoa1803164.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionTamoxifen-alone groupOvarian suppressionPremenopausal womenBreast cancerAdverse eventsOverall survivalDisease-free survival ratesOvarian Function TrialYears of tamoxifenAdjuvant endocrine therapyHigher adverse eventsReceipt of chemotherapyPremenopausal breast cancerLow recurrence rateAromatase inhibitor exemestaneUse of exemestaneSuppression groupExemestane TrialDistant recurrenceEndocrine therapyRecurrence rateGrade 3ExemestaneTamoxifen
2016
A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
Goss P, Ingle J, Pritchard K, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff A, Winer E, Hudis C, Stopeck A, Beck J, Kaur J, Whelan K, Tu D, Parulekar W. A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Journal Of Clinical Oncology 2016, 34: lba1-lba1. DOI: 10.1200/jco.2016.34.15_suppl.lba1.Peer-Reviewed Original Research
2013
Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice
Ruddy KJ, Desantis SD, Gelman RS, Wu AH, Punglia RS, Mayer EL, Tolaney SM, Winer EP, Partridge AH, Burstein HJ. Personalized medicine in breast cancer: tamoxifen, endoxifen, and CYP2D6 in clinical practice. Breast Cancer Research And Treatment 2013, 141: 421-427. PMID: 24062210, DOI: 10.1007/s10549-013-2700-1.Peer-Reviewed Original ResearchConceptsEndoxifen levelsEndocrine therapyBreast cancerCYP2D6 genotypeAdjuvant tamoxifenTamoxifen metabolismOptimal adjuvant endocrine therapyAlternative endocrine therapyBaseline whole bloodAdjuvant endocrine therapyMedical record reviewActual treatment decisionsPoor metabolizer genotypeCytochrome P450 2D6Record reviewClinical evidenceTreatment recommendationsTherapy recommendationsTreatment decisionsEstrogen receptorHormonal treatmentStage IClinical practicePatientsTamoxifenRelative effectiveness of letrozole alone or in sequence with tamoxifen for patients diagnosed with invasive lobular carcinoma.
Metzger Filho O, Giobbie-Hurder A, Mallon E, Viale G, Winer E, Thurlimann B, Gelber R, Regan M, Colleoni M, Ejlertsen B, Bonnefoi H, Forbes J, Neven P, Wardley A, Lang I, Smith I, Price K, Coates A, Goldhirsch A. Relative effectiveness of letrozole alone or in sequence with tamoxifen for patients diagnosed with invasive lobular carcinoma. Journal Of Clinical Oncology 2013, 31: 529-529. DOI: 10.1200/jco.2013.31.15_suppl.529.Peer-Reviewed Original ResearchMagnitude of benefitMonotherapy armYears of tamoxifenPost-menopausal womenInvasive lobular carcinomaILC patientsBetter DFSBIG 1Early BCClinicopathological variablesHistological subtypesLobular carcinomaILC subsetsPatientsTreatment assignmentDFSSignificant predictorsTamoxifenHistologyIDCGreater magnitudeClassic ILCOSArmPrevious data
2010
Factor V Leiden Mutation and Thromboembolism Risk in Women Receiving Adjuvant Tamoxifen for Breast Cancer
Garber JE, Halabi S, Tolaney SM, Kaplan E, Archer L, Atkins JN, Edge S, Shapiro CL, Dressler L, Paskett E, Kimmick G, Orcutt J, Scalzo A, Winer E, Levine E, Shahab N, Berliner N, B F. Factor V Leiden Mutation and Thromboembolism Risk in Women Receiving Adjuvant Tamoxifen for Breast Cancer. Journal Of The National Cancer Institute 2010, 102: 942-949. PMID: 20554945, PMCID: PMC2897879, DOI: 10.1093/jnci/djq211.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, HormonalBreast NeoplasmsCase-Control StudiesChemotherapy, AdjuvantEstrogen Receptor ModulatorsFactor VFemaleHumansLogistic ModelsMiddle AgedMultivariate AnalysisMutationOdds RatioPrevalenceRisk FactorsSelective Estrogen Receptor ModulatorsSmokingTamoxifenThromboembolismConceptsFactor V LeidenEarly-stage breast cancerThromboembolic eventsAdjuvant tamoxifenFVL mutationBreast cancerTamoxifen useTE riskControl subjectsOdds ratioFactor V Leiden mutationCase-control studyConditional logistic regressionV Leiden mutationPostmenopausal womenThromboembolism riskThrombosis riskMultivariable modelTherapeutic decisionsV LeidenLeiden mutationHigh riskPositive testTamoxifenCancerLumpectomy plus tamoxifen with or without irradiation in women age 70 or older with early breast cancer.
Hughes K, Schnaper L, Cirrincione C, Berry D, McCormick B, Muss H, Shank B, Hudis C, Winer E, Smith B. Lumpectomy plus tamoxifen with or without irradiation in women age 70 or older with early breast cancer. Journal Of Clinical Oncology 2010, 28: 507-507. DOI: 10.1200/jco.2010.28.15_suppl.507.Peer-Reviewed Original Research
2006
Aromatase Inhibitors in the Adjuvant Treatment of Postmenopausal Women with Early Stage Breast Cancer
Ligibel JA, Winer EP. Aromatase Inhibitors in the Adjuvant Treatment of Postmenopausal Women with Early Stage Breast Cancer. Women's Health 2006, 2: 89-97. PMID: 19803930, DOI: 10.2217/17455057.2.1.89.Peer-Reviewed Original Research
2005
Aromatase inhibitors as adjuvant therapy for postmenopausal women: a therapeutic advance but many unresolved questions
Ligibel JA, Winer EP. Aromatase inhibitors as adjuvant therapy for postmenopausal women: a therapeutic advance but many unresolved questions. Breast Cancer Research 2005, 7: 255. PMID: 16457700, PMCID: PMC1410766, DOI: 10.1186/bcr1347.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsPostmenopausal womenEarly-stage breast cancerCourse of tamoxifenAdjuvant hormonal therapyStage breast cancerAdjuvant settingAdjuvant therapyHormonal therapyUpfront therapyOngoing trialsMajor trialsTherapeutic advancesBreast cancerTherapyInhibitorsTrialsWomenTamoxifenYearsCancer
2003
Clinical differences among the aromatase inhibitors.
Ligibel JA, Winer EP. Clinical differences among the aromatase inhibitors. Clinical Cancer Research 2003, 9: 473s-9s. PMID: 12538503.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsAdjuvant settingLarge phase III trialsThird-generation aromatase inhibitorsFirst-line settingSecond-line therapyDisease-free survivalPhase III trialsMetastatic breast cancerMegesterol acetateATAC trialIII trialsMetastatic diseaseClinical differencesNonsteroidal agentsClinical significanceBreast cancerAromatase activityAnastrozoleLetrozoleStudy designTamoxifenTrialsExemestaneInhibitors