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
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 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
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 practicePatientsTamoxifen
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 testTamoxifenCancer
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 monotherapy
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 therapy