2018
Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade
Metzger‐Filho O, Ferreira AR, Jeselsohn R, Barry WT, Dillon DA, Brock JE, Vaz‐Luis I, Hughes ME, Winer EP, Lin NU. Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade. The Oncologist 2018, 24: e441-e449. PMID: 30518616, PMCID: PMC6656459, DOI: 10.1634/theoncologist.2018-0363.Peer-Reviewed Original ResearchConceptsInvasive lobular carcinomaDisease-free survivalHistologic gradeLobular carcinomaPostmenopausal womenSystemic therapyBetter prognosisAromatase inhibitorsPrognostic powerDisease-free survival advantageEarly-stage breast cancerFavorable disease-free survivalCox proportional hazards modelAdjuvant aromatase inhibitorsBaseline clinicopathologic characteristicsDetailed clinical databaseHER2-negative diseaseRetrospective cohort studyImportant prognostic factorKaplan-Meier methodProportional hazards modelIntermediate histologic gradeDistinct disease subtypesCohort studyOverall prognosisUnraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer
Kuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, Hughes ME, Wagle N, Kirschmeier P, Jänne PA, Paweletz CP, Lin NU, Krop IE, Barry WT, Winer EP, Brown M, Jeselsohn R. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. Npj Breast Cancer 2018, 4: 22. PMID: 30083595, PMCID: PMC6072793, DOI: 10.1038/s41523-018-0075-5.Peer-Reviewed Original ResearchMetastatic breast cancerESR1 mutationsBreast cancerMetastatic settingClinicopathological featuresPIK3CA mutationsAromatase inhibitorsER-positive metastatic breast cancerDetailed clinical dataSpecific systemic treatmentMetastatic treatmentDistant recurrenceMetastatic diseaseSystemic treatmentPrimary diseaseEndocrine resistanceCDK4/6 inhibitorsPathological featuresFulvestrant treatmentClinical dataPrior treatmentSignificant associationPatientsCancerPrevalence
2016
Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years
Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. New England Journal Of Medicine 2016, 375: 209-219. PMID: 27264120, PMCID: PMC5024713, DOI: 10.1056/nejmoa1604700.Peer-Reviewed Original ResearchConceptsContralateral breast cancerDisease-free survivalAromatase inhibitorsBreast cancerOverall survivalDisease-free survival ratesPositive early breast cancerAdjuvant aromatase inhibitorsNew-onset osteoporosisPlacebo-controlled trialPrimary end pointEarly breast cancerAnnual incidence rateTreatment of choiceBreast cancer recurrenceExtension of treatmentQuality of lifeBone painLetrozole groupAdjuvant therapyPlacebo groupPostmenopausal womenDisease recurrenceIncidence rateLower incidenceAdjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression
Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. Journal Of Clinical Oncology 2016, 34: 1689-1701. PMID: 26884586, DOI: 10.1200/jco.2015.65.9573.Peer-Reviewed Original ResearchConceptsReceptor-positive breast cancerAdjuvant endocrine therapyOvarian suppressionStandard adjuvant therapyEndocrine therapyBreast cancerAdjuvant chemotherapyAdjuvant therapyAromatase inhibitorsClinical Oncology Clinical Practice Guideline UpdateHormone receptor-positive breast cancerEstrogen receptor-positive breast cancerClinical Practice Guideline UpdateStage I breast cancerDisease-free survivalHigh-risk patientsLow-risk patientsI breast cancerSubset of patientsOverall clinical benefitRandomized clinical trialsNode-negative cancersQuality of lifeDistant recurrencePremenopausal women
2014
Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen
Ruddy KJ, DeSantis SD, Barry W, Guo H, Block CC, Borges V, Winer EP, Partridge AH. Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen. Clinical Breast Cancer 2014, 14: 413-416. PMID: 24970714, DOI: 10.1016/j.clbc.2014.04.007.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantFeasibility StudiesFemaleFollow-Up StudiesGonadotropin-Releasing HormoneHumansLetrozoleMiddle AgedNeoplasm GradingNeoplasm StagingNitrilesOvariectomyPremenopausePrognosisSurvival RateTamoxifenTriazolesConceptsPremenopausal womenAdjuvant tamoxifenEndocrine therapyExtended therapyAromatase inhibitorsBreast cancerStandard adjuvant endocrine therapyGonadotropin-releasing hormone agonistSingle-arm clinical trialPhase II single-arm clinical trialsEarly study closureYears of tamoxifenAdjuvant endocrine therapySubstantial side effectsProtocol-directed therapyCommon toxicitiesLengthier coursesPremenopausal patientsOvarian suppressionPoor accrualPostmenopausal patientsVaginal drynessHormone agonistStudy closureBone lossAdjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Láng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA. Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 371: 107-118. PMID: 24881463, PMCID: PMC4175521, DOI: 10.1056/nejmoa1404037.Peer-Reviewed Original ResearchMeSH KeywordsAdultAndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedOsteoporosisPremenopauseQuality of LifeTamoxifenTriptorelin PamoateConceptsPositive early breast cancerEarly breast cancerOvarian suppressionBreast cancerPostmenopausal womenPremenopausal womenTamoxifen plus ovarian suppressionSuppression groupRate of freedomDisease-free survivalPhase 3 trialPremenopausal breast cancerOvarian estrogen productionPositive breast cancerAromatase inhibitor exemestaneAdjuvant exemestaneOvarian irradiationAdjuvant therapyAdjuvant treatmentAdverse eventsOverall survivalEstrogen productionAromatase inhibitorsGrade 3Primary analysisAdjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update
Burstein HJ, Temin S, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Rowden D, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. Journal Of Clinical Oncology 2014, 32: 2255-2269. PMID: 24868023, PMCID: PMC4876310, DOI: 10.1200/jco.2013.54.2258.Peer-Reviewed Original ResearchConceptsAdjuvant endocrine therapyHormone receptor-positive breast cancerReceptor-positive breast cancerClinical practice guidelinesAdjuvant tamoxifenEndocrine therapyAromatase inhibitorsBreast cancerPractice guidelinesClinical Oncology Clinical Practice GuidelineOncology Clinical Practice GuidelineASCO Clinical Practice GuidelineYears of tamoxifenContralateral breast cancerYears of therapyRandomized clinical trialsBreast cancer recurrenceTreatment of womenOutcomes of interestTamoxifen useAdjuvant therapyASCO guidelinesAdverse eventsTamoxifen treatmentDisease recurrence
2012
Patterns of bone density evaluation in a community population treated with aromatase inhibitors
Ligibel JA, O’Malley A, Fisher M, Daniel GW, Winer EP, Keating NL. Patterns of bone density evaluation in a community population treated with aromatase inhibitors. Breast Cancer Research And Treatment 2012, 134: 1305-1313. PMID: 22791365, PMCID: PMC3449001, DOI: 10.1007/s10549-012-2151-0.Peer-Reviewed Original ResearchConceptsBone density testingBreast cancer patientsAromatase inhibitorsBone density evaluationAI therapyHealth maintenance organizationDensity testingCancer patientsHealthCore Integrated Research DatabaseMaintenance organizationYears of therapyCommunity-based populationLong-term therapyCommunity-based cohortMultivariable logistic regressionProton pump inhibitorsLow education levelRate of testingTamoxifen therapyTamoxifen useBone lossPharmacy dataPump inhibitorsBreast cancerBone density
2011
P2-17-06: Patterns of Bone Density Evaluation in a Community Population Treated with Aromatase Inhibitors.
Ligibel J, O'Malley A, Fisher M, Daniel G, Winer E, Keating N. P2-17-06: Patterns of Bone Density Evaluation in a Community Population Treated with Aromatase Inhibitors. Cancer Research 2011, 71: p2-17-06-p2-17-06. DOI: 10.1158/0008-5472.sabcs11-p2-17-06.Peer-Reviewed Original ResearchBone density testingBone density evaluationBaseline bone densityAI therapyBone densityDensity testingBone lossAromatase inhibitorsOlder womenHealthCore Integrated Research DatabaseLogistic regressionCommunity-based populationLong-term therapyBreast cancer patientsCommunity-based cohortBone density lossProton pump inhibitorsRisk of fractureLow education levelClinical characteristicsPharmacy dataPump inhibitorsCancer patientsDiagnosis codesAI initiationPD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC).
Mayer I, Balko J, Kuba M, Sanders M, Yap J, Li Y, Winer E, Arteaga C. PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC). Cancer Research 2011, 71: pd09-05-pd09-05. DOI: 10.1158/0008-5472.sabcs11-pd09-05.Peer-Reviewed Original ResearchPan-PI3K inhibitor BKM120Metastatic breast cancerFDG-PET imagingAromatase inhibitorsBreast cancerSafe side effect profilePhase Ib clinical trialAlternative administration schedulesDiagnostic tumor biopsiesGrade 3 transaminitisMost common toxicitiesPI3K-targeted therapiesSafety/tolerabilityPhase Ib studyMetastatic bone diseaseSide effect profileMonths of initiationPost-menopausal patientsWeeks of treatmentPI3K pathway inhibitionMost breast cancersAromatase inhibitor letrozoleProgression of diseasePI3K/AktCommon toxicitiesPL1-1: How To Use Endocrine Therapy for Breast Cancer: Beyond the Basics.
Winer E. PL1-1: How To Use Endocrine Therapy for Breast Cancer: Beyond the Basics. Cancer Research 2011, 71: pl1-1-pl1-1. DOI: 10.1158/0008-5472.sabcs11-pl1-1.Peer-Reviewed Original ResearchHormone receptor-positive diseaseReceptor-positive diseaseEndocrine therapyPositive diseaseBreast cancerClinical practiceExtended adjuvant therapyAdjuvant endocrine therapyBreast cancer patientsAdjuvant therapyHormonal therapyMore treatment choicesPremenopausal womenSufficient therapyLate recurrenceCancer patientsAromatase inhibitorsTreatment choiceHigh riskPatientsTherapyDrug resistanceCancer ResHormone receptorsTumorsRisk of myocardial infarction, stroke, and fracture in a cohort of community-based breast cancer patients
Ligibel JA, James O’Malley A, Fisher M, Daniel GW, Winer EP, Keating NL. Risk of myocardial infarction, stroke, and fracture in a cohort of community-based breast cancer patients. Breast Cancer Research And Treatment 2011, 131: 589-597. PMID: 21881937, DOI: 10.1007/s10549-011-1754-1.Peer-Reviewed Original ResearchConceptsAdjuvant aromatase inhibitorsBreast cancer patientsCommunity-based populationCancer patientsSerious side effectsMyocardial infarctionHormonal therapyClinical trialsSide effectsOnly serious side effectTime-varying treatment variablesHealthCore Integrated Research DatabaseCox proportional hazards modelNon-trial populationSide effect profileRisk of osteoporosisProportional hazards modelHip fractureEffect profileDiagnosis codesAromatase inhibitorsHigh riskPropensity score methodsLower riskHazards model
2010
American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer
Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Malin J, Mamounas EP, Rowden D, Solky AJ, Sowers MR, Stearns V, Winer EP, Somerfield MR, Griggs JJ. American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer. Journal Of Clinical Oncology 2010, 28: 3784-3796. PMID: 20625130, PMCID: PMC5569672, DOI: 10.1200/jco.2009.26.3756.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerSan Antonio Breast Cancer SymposiumYears of tamoxifenAdverse effect profileAromatase inhibitorsBreast cancerAI therapyEndocrine therapyPostmenopausal womenEffect profileClinical Oncology Clinical Practice GuidelineOncology Clinical Practice GuidelineAdjuvant treatment strategiesAdjuvant endocrine therapyDisease-free survivalContralateral breast cancerClinical practice guidelinesEvidence-based guidelinesCochrane Collaboration LibraryBreast cancer recurrenceUpdate CommitteeAmerican SocietyQuality of lifeSequential treatment
2008
Pharmacogenomic Variation of CYP2D6 and the Choice of Optimal Adjuvant Endocrine Therapy for Postmenopausal Breast Cancer: A Modeling Analysis
Punglia RS, Burstein HJ, Winer EP, Weeks JC. Pharmacogenomic Variation of CYP2D6 and the Choice of Optimal Adjuvant Endocrine Therapy for Postmenopausal Breast Cancer: A Modeling Analysis. Journal Of The National Cancer Institute 2008, 100: 642-648. PMID: 18445827, PMCID: PMC2864146, DOI: 10.1093/jnci/djn100.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCytochrome P-450 CYP2D6Decision Support TechniquesDisease-Free SurvivalEstrogen Receptor ModulatorsFemaleGenotypeHumansMarkov ChainsMiddle AgedMutationNeoplasms, Hormone-DependentOdds RatioPostmenopauseReceptors, EstrogenSelective Estrogen Receptor ModulatorsTamoxifenConceptsDisease-free survivalWt/wt patientsAromatase inhibitorsBreast cancerCYP2D6 genotypeEndocrine therapyWT patientsNorth Central Cancer Treatment Group trialsEstrogen receptor-positive breast cancerBreast International Group (BIG) 1Optimal adjuvant endocrine therapyReceptor-positive breast cancerDisease-free survival outcomesAromatase inhibitor monotherapyAdjuvant endocrine therapyAdjuvant endocrine treatmentPostmenopausal breast cancerActive tamoxifen metabolitesBreast cancer patientsCytochrome P450 2D6Adjuvant tamoxifenEndocrine treatmentPostmenopausal womenHazard ratioInhibitor monotherapyAdvances in Adjuvant Endocrine Therapy for Postmenopausal Women
Lin NU, Winer EP. Advances in Adjuvant Endocrine Therapy for Postmenopausal Women. Journal Of Clinical Oncology 2008, 26: 798-805. PMID: 18258989, DOI: 10.1200/jco.2007.15.0946.Peer-Reviewed Original ResearchConceptsPostmenopausal womenAromatase inhibitorsEndocrine therapyBreast cancerHormone receptor-positive breast cancerHormone receptor-positive cancersInitial breast cancer diagnosisReceptor-positive breast cancerMost postmenopausal womenUpfront aromatase inhibitorsYears of tamoxifenAdjuvant endocrine therapyDisease-free survivalReceptor-positive cancersCommon tumor subtypeBreast cancer diagnosisPostmenopausal settingEndocrine treatmentOverall survivalDisease recurrenceRandomized trialsAvailable trialsIndividual patientsHigh riskTumor subtypesSummary of aromatase inhibitor clinical trials in postmenopausal women with early breast cancer
Buzdar AU, Coombes RC, Goss PE, Winer EP. Summary of aromatase inhibitor clinical trials in postmenopausal women with early breast cancer. Cancer 2008, 112: 700-709. PMID: 18072256, DOI: 10.1002/cncr.23193.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsEndocrine therapyAdjuvant therapyPostmenopausal womenClinical trialsBreast cancerEstrogen receptor-positive breast cancerEfficacy of AIsReceptor-positive breast cancerInitial adjuvant therapyEarly breast cancerEnd-organ effectsGold standard treatmentYears of treatmentAI therapyThrombolic eventsNight sweatsSkeletal eventsVaginal bleedingEndometrial cancerHot flashesBone resorptionEfficacy dataDisease outcomeOptimal durationAdherence to Initial Adjuvant Anastrozole Therapy Among Women With Early-Stage Breast Cancer
Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A. Adherence to Initial Adjuvant Anastrozole Therapy Among Women With Early-Stage Breast Cancer. Journal Of Clinical Oncology 2008, 26: 556-562. PMID: 18180462, DOI: 10.1200/jco.2007.11.5451.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerAdjuvant anastrozole therapyBreast cancerAnastrozole therapyProgram data setHealth programsAdjuvant aromatase inhibitorsOral hormonal therapyMonths of therapyEarly-stage diseaseIdentification of patientsProportion of daysLongitudinal claims dataHormonal therapyMean adherenceDevelopment of interventionsAdherence estimatesContinuous eligibilityPrescription claimsAromatase inhibitorsClaims dataTherapyCancerObservation periodWomen
2007
Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer
Thompson D, Taylor DC, Montoya EL, Winer EP, Jones SE, Weinstein MC. Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer. Value In Health 2007, 10: 367-376. PMID: 17888101, DOI: 10.1111/j.1524-4733.2007.00190.x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAndrostadienesAntineoplastic ProtocolsAromatase InhibitorsBreast NeoplasmsCost-Benefit AnalysisDrug Administration ScheduleFemaleForecastingHumansMarkov ChainsMiddle AgedNeoplasm Recurrence, LocalPostmenopauseQuality-Adjusted Life YearsSEER ProgramSelective Estrogen Receptor ModulatorsTamoxifenConceptsIntergroup Exemestane StudyDisease-free survivalDisease-related eventsTreatment strategiesEarly-stage breast cancer patientsEarly-stage breast cancerProlongs disease-free survivalCost-effective treatment strategyIncremental cost-effectiveness ratioYears of tamoxifenYears of therapyBreast cancer patientsSEER-Medicare dataBreast cancer statusLifetime medical care costsMedical care costsCost-effectiveness ratioTamoxifen therapyPostmenopausal womenRecurrence rateCancer careCancer patientsPatient transitionsAromatase inhibitorsBreast cancerCould treatment with tamoxifen be superior to aromatase inhibitors in early-stage breast cancer after pharmacogenomic testing? A modeling analysis
Punglia R, Winer E, Weeks J, Burstein H. Could treatment with tamoxifen be superior to aromatase inhibitors in early-stage breast cancer after pharmacogenomic testing? A modeling analysis. Journal Of Clinical Oncology 2007, 25: 502-502. DOI: 10.1200/jco.2007.25.18_suppl.502.Peer-Reviewed Original ResearchDisease-free survivalOptimal treatment strategyAromatase inhibitorsHazard ratioUnselected womenTreatment strategiesBreast cancerEstrogen receptor-positive breast cancerWt/wt patientsReceptor-positive breast cancerEarly-stage breast cancerAnnual recurrence riskAdjuvant endocrine treatmentEfficacy of tamoxifenPercent of patientsActive tamoxifen metabolitesWT cohortsEndocrine treatmentBIG 1Initial treatmentTamoxifen metabolitesCancer recurrenceUnselected groupMutation carriersPharmacogenomic testing
2006
Menopausal-type symptoms in young breast cancer survivors
Leining M, Gelber S, Rosenberg R, Przypyszny M, Winer E, Partridge A. Menopausal-type symptoms in young breast cancer survivors. Annals Of Oncology 2006, 17: 1777-1782. PMID: 16971671, DOI: 10.1093/annonc/mdl299.Peer-Reviewed Original ResearchConceptsYoung breast cancer survivorsBreast cancer survivorsOvarian suppressionCancer survivorsBreast cancerBreast Cancer Prevention Trial Symptom ChecklistBothersome menopausal symptomsAge 40 yearsTreatment decision makingLong-term qualityTime of surveyPrior chemotherapyPostmenopausal statusBothersome symptomsSymptom scoresHot flashesMenopausal symptomsAromatase inhibitorsInternet-based surveyBaseline anxietySymptom ChecklistSymptomsYoung womenSurvivorsWomen