2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
2015
Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance)
Ligibel JA, Cirrincione CT, Liu M, Citron M, Ingle JN, Gradishar W, Martino S, Sikov W, Michaelson R, Mardis E, Perou CM, Ellis M, Winer E, Hudis CA, Berry D, Barry WT. Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance). Journal Of The National Cancer Institute 2015, 107: djv179. PMID: 26113580, PMCID: PMC4651106, DOI: 10.1093/jnci/djv179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBody Mass IndexBreast NeoplasmsCyclophosphamideDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPaclitaxelReceptors, EstrogenTreatment OutcomeConceptsBody mass indexBaseline body mass indexNode-positive breast cancerBreast cancerCALGB 9741Prognostic factorsMass indexMedian baseline body mass indexSignificant prognostic factorsIndependent prognostic factorBreast cancer outcomesGroup of patientsSequence of chemotherapyEstrogen receptor statusProportional hazards regressionActual body weightDose densityDosed chemotherapyMenopausal statusOverall survivalReceptor statusRandomized trialsHazards regressionPoor prognosisTumor size
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
2007
HER2 and Response to Paclitaxel in Node-Positive Breast Cancer
Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA. HER2 and Response to Paclitaxel in Node-Positive Breast Cancer. New England Journal Of Medicine 2007, 357: 1496-1506. PMID: 17928597, DOI: 10.1056/nejmoa071167.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor type 2Node-positive breast cancerAddition of paclitaxelEstrogen receptor statusHER2 positivityBreast cancerAdjuvant chemotherapyDoxorubicin dosesAdjuvant anthracycline-based chemotherapyEpidermal growth factor receptor type 2HER2-positive breast cancerFactor receptor type 2CB11 monoclonal antibodyCycles of paclitaxelAnthracycline-based chemotherapyAdministration of paclitaxelReceptor type 2Breast cancer cellsAdjuvant treatmentHazard ratioClinical outcomesPositive cancersHER2 amplificationImmunohistochemical analysisCyclophosphamidePredictors of Resistance to Preoperative Trastuzumab and Vinorelbine for HER2-Positive Early Breast Cancer
Harris LN, You F, Schnitt SJ, Witkiewicz A, Lu X, Sgroi D, Ryan PD, Come SE, Burstein HJ, Lesnikoski BA, Kamma M, Friedman PN, Gelman R, Iglehart JD, Winer EP. Predictors of Resistance to Preoperative Trastuzumab and Vinorelbine for HER2-Positive Early Breast Cancer. Clinical Cancer Research 2007, 13: 1198-1207. PMID: 17317830, DOI: 10.1158/1078-0432.ccr-06-1304.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Resistance, NeoplasmFemaleGenes, erbB-2HumansMalePredictive Value of TestsPreoperative CareReceptor, ErbB-2TrastuzumabVinblastineVinorelbineConceptsPathologic complete responsePreoperative trastuzumabBreast cancerClinical responseComplete responseStage II/III breast cancerHER2-positive early breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical complete responseEarly breast cancerGrowth factor receptor 2Estrogen receptor statusPositive breast cancerPredictors of responseBasal-like phenotypeInsulin-like growthFactor receptor 2Predictors of resistanceReceptor membrane expressionExtremes of responseGrowth factor pathwaysLow response rateGrowth factor receptorPreoperative treatment
2006
Estrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer
Berry D, Cirrincione C, Henderson I, Citron M, Budman D, Goldstein L, Martino S, Perez E, Muss H, Norton L, Hudis C, Winer E. Estrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer. Obstetrical & Gynecological Survey 2006, 61: 584-585. DOI: 10.1097/01.ogx.0000234789.05150.7c.Peer-Reviewed Original ResearchER-negative patientsER-positive patientsER-positive tumorsER-negative tumorsNode-positive breast cancerER-negative womenEstrogen receptor statusBreast cancerOverall survivalER statusLymph node-positive breast cancerER-positive breast cancerModern intensive chemotherapyWeak prognostic factorER-positive diseaseLeukemia Group BDisease-free survivalER-negative diseaseOverall survival ratePatterns of riskAdjuvant chemotherapyChemotherapy trialsEndocrine treatmentIntensive chemotherapyRecurrent diseaseEstrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer
Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ, Martino S, Perez EA, Muss HB, Norton L, Hudis C, Winer EP. Estrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer. JAMA 2006, 295: 1658-1667. PMID: 16609087, PMCID: PMC1459540, DOI: 10.1001/jama.295.14.1658.Peer-Reviewed Original ResearchConceptsER-positive tumorsER-positive patientsEstrogen receptor statusAdjuvant chemotherapyOverall survivalBreast cancerBreast cancer estrogen receptor statusNode-positive breast cancer patientsNode-positive breast cancerER-negative breast cancerDoxorubicin/cyclophosphamideRegimens of cyclophosphamideER-negative patientsLeukemia Group BLow-dose cyclophosphamideNode-positive tumorsBreast cancer patientsRate of recurrenceRelative risk reductionER-negative tumorsMortality rate reductionAdjuvant treatmentEndocrine therapyER statusRandomized trials
2003
Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer.
Buzdar A, O’Shaughnessy J, Booser DJ, Pippen JE, Jones SE, Munster PN, Peterson P, Melemed AS, Winer E, Hudis C. Phase II, randomized, double-blind study of two dose levels of arzoxifene in patients with locally advanced or metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 1007-14. PMID: 12637464, DOI: 10.1200/jco.2003.06.108.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Resistance, NeoplasmEndometriumEstrogen Receptor ModulatorsFemaleHumansMiddle AgedPatient SelectionPiperidinesReceptors, EstrogenSurvival AnalysisTamoxifenThiophenesTreatment OutcomeConceptsMetastatic breast cancerClinical benefit rateBreast cancerTamoxifen refractoryTR patientsResponse rateDose levelsEnd pointSelective estrogen receptor modulatorsPhase II studyPrimary end pointSecondary end pointsTumor response rateDouble-blind studyEstrogen receptor statusMetastatic disease sitesEstrogen receptor modulatorsTreatment of TSSimilar TTPTamoxifen therapyII studyDaily doseLonger TTPReceptor statusDose-dependent toxicity
1999
Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis.
Parmigiani G, Berry D, Winer E, Tebaldi C, Iglehart J, Prosnitz L. Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis. Journal Of Clinical Oncology 1999, 17: 1465-73. PMID: 10334532, DOI: 10.1200/jco.1999.17.5.1465.Peer-Reviewed Original ResearchConceptsAxillary lymph node dissectionBenefits of ALNDLymph node dissectionQuality of lifeAdjuvant chemotherapyAdjuvant therapyNode dissectionBreast cancerLeukemia Group B StudyEarly-stage breast cancerRoutine useAxillary radiation therapyER-negative womenER-positive womenAdjuvant systemic therapySmall primary tumorsBreast-conserving therapyBreast cancer patientsEstrogen receptor statusNegative axillaOxford OverviewAdjuvant treatmentChemotherapy combinationsSurvival benefitSystemic therapy