2021
Utility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer.
Laws A, Garrido-Castro A, Poorvu P, Winer E, Mittendorf E, King T. Utility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer. Oncology 2021, 35: 77-84. PMID: 33577165, DOI: 10.46883/onc.2021.3502.0077.Peer-Reviewed Original ResearchConceptsRecurrence scorePositive nodesClinical trialsBreast cancerHER2-negative breast cancerNode-positive breast cancerLarge population-based registryNode-positive populationAdjuvant chemotherapy useChemotherapy-treated patientsClinical practice guidelinesCurrent practice patternsPopulation-based registryMultiple clinical trialsPotential predictive valueADAPT trialAdjuvant chemotherapyChemotherapy useEndocrine therapyPostmenopausal patientsChemotherapy benefitExcellent outcomesPractice patternsPractice guidelinesRetrospective analysis
2020
Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center
Losk K, Freedman RA, Laws A, Kantor O, Mittendorf EA, Tan-Wasielewski Z, Trippa L, Lin NU, Winer EP, King TA. Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Breast Cancer Research And Treatment 2020, 185: 215-227. PMID: 32939592, DOI: 10.1007/s10549-020-05931-9.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalPN1 breast cancerRecurrence scoreChemotherapy useBreast cancerOverall survivalChemotherapy receiptPN1 patientsRS testingUse of RSNode-positive breast cancerOncotype DX recurrence scoreAdjuvant chemotherapy receiptLow genomic riskNode-positive diseaseAdjuvant treatment decisionsLow recurrence scoreShort-term outcomesMultivariate logistic regressionComprehensive cancer centerDX recurrence scoreOncotype DX testingChemotherapy omissionPT1-2N0Upfront surgery
2019
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer
Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AH. Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer. Journal Of Clinical Oncology 2019, 38: 725-733. PMID: 31809240, PMCID: PMC7048163, DOI: 10.1200/jco.19.01959.Peer-Reviewed Original ResearchConceptsNode-positive breast cancerDistant recurrence-free survivalRecurrence scoreBreast cancerBreast Cancer StudyN0 diseaseN1 diseaseYoung womenYoung Women's Breast Cancer StudyPositive/HER2-negative breast cancerHER2-negative breast cancerHuman epidermal growth factor receptorEarly distant recurrenceEarly-stage estrogenN0 breast cancerRS risk groupsNode-positive diseaseMinority of patientsRecurrence-free survivalYears of ageEpidermal growth factor receptorGrowth factor receptorDistant recurrenceAxillary nodesEligible womenP246 Breast cancer-specific survival (BCSS) in patients (pts) with nodenegative (N0) and node-positive (N+) breast cancer (BC) guided by the 21-gene assay: a SEER-genomic real-world evidence study
Winer E, Shak S, Sledge G, Albain K, Mamounas E, Jakubowski D, Petkov V, Wolmark N, Hortobagyi G. P246 Breast cancer-specific survival (BCSS) in patients (pts) with nodenegative (N0) and node-positive (N+) breast cancer (BC) guided by the 21-gene assay: a SEER-genomic real-world evidence study. The Breast 2019, 44: s100-s101. DOI: 10.1016/s0960-9776(19)30347-9.Peer-Reviewed Original Research
2018
Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update
Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KA, Giordano SH, Hudis CA, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. Journal Of Clinical Oncology 2018, 37: 423-438. PMID: 30452337, DOI: 10.1200/jco.18.01160.Peer-Reviewed Original ResearchConceptsAdjuvant endocrine treatmentASCO Clinical Practice GuidelineAdjuvant endocrine therapySecond breast cancerClinical practice guidelinesBreast cancer recurrenceBreast cancerEndocrine treatmentAI treatmentEndocrine therapyExtended therapyCancer recurrencePractice guidelinesHormone receptor-positive breast cancerNode-positive breast cancerNode-negative breast cancerReceptor-positive breast cancerAdjuvant AI therapyNode-positive cancersOverall survival advantageContralateral breast cancerYears of therapyRandomized clinical trialsAromatase inhibitor treatmentAI therapy
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
2013
Body mass index (BMI), tumor subtype, and relapse-free survival (RFS) in CALGB 9741 (Alliance).
Ligibel J, Cirrincione C, Liu M, Citron M, Ingle J, Gradishar W, Martino S, Sikov W, Michaelson R, Hudis C, Winer E, Barry W. Body mass index (BMI), tumor subtype, and relapse-free survival (RFS) in CALGB 9741 (Alliance). Journal Of Clinical Oncology 2013, 31: 1032-1032. DOI: 10.1200/jco.2013.31.15_suppl.1032.Peer-Reviewed Original ResearchRelapse-free survivalBody mass indexBreast cancerCALGB 9741Node-positive breast cancerEarly-stage breast cancerInteraction of BMIAggressive tumor histologyEarly breast cancerLuminal B tumorsNormal-weight individualsNon-obese individualsActual body weightDistribution of subtypesChi-squared testPrimary endpointBiologic subtypeMenopausal statusObese patientsB tumorsDose adjustmentIndependent predictorsLuminal tumorsMass indexTumor histology
2011
p53 Expression in Node-Positive Breast Cancer Patients: Results from the Cancer and Leukemia Group B 9344 Trial (159905)
Lara JF, Thor AD, Dressler LG, Broadwater G, Bleiweiss IJ, Edgerton S, Cowan D, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA, Hayes DF, B F. p53 Expression in Node-Positive Breast Cancer Patients: Results from the Cancer and Leukemia Group B 9344 Trial (159905). Clinical Cancer Research 2011, 17: 5170-5178. PMID: 21693655, PMCID: PMC3149770, DOI: 10.1158/1078-0432.ccr-11-0484.Peer-Reviewed Original ResearchConceptsAddition of paclitaxelDoses of doxorubicinOverall survivalP53 protein expressionAdjuvant doxorubicinDose escalationBreast cancerP53 expressionNode-positive breast cancer patientsNode-positive breast cancerEarly-stage breast cancerCycles of cyclophosphamideNode-positive patientsProtein expressionStage II patientsBreast cancer patientsRandomized clinical trialsWorse RFSWorse OSII patientsPredictive factorsWorse prognosisCancer patientsP53 positivityP53 staining
2009
Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148).
Berry D, Berry D, Thor A, Jewell S, Broadwater G, Edgerton S, Hayes D, Hudis C, Winer E, Nielsen T, Ellis M. Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148). Cancer Research 2009, 69: 606-606. DOI: 10.1158/0008-5472.sabcs-09-606.Peer-Reviewed Original ResearchAdjuvant doxorubicin/cyclophosphamideNode-positive breast cancerWhole section analysisTissue microarrayHazard ratioER statusBreast cancerAdjuvant phase III trialsDouble-negative tumorsDoxorubicin/cyclophosphamideNon-responding patientsPhase III trialsMajority of patientsMultivariate Cox modelConfidence intervalsTumor tissue microarraysSet of patientsTMA cohortHormonal therapyIII trialsSurvival benefitCentral pathologyPathology blocksKaplan-MeierClinical assessmentPrognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, America F. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology 2009, 11: 55-65. PMID: 20005174, PMCID: PMC3058239, DOI: 10.1016/s1470-2045(09)70314-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic TestingHumansKaplan-Meier EstimateLymphatic MetastasisMiddle AgedPatient SelectionPostmenopausePredictive Value of TestsProportional Hazards ModelsRandomized Controlled Trials as TopicReceptors, EstrogenRecurrenceRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRisk AssessmentTamoxifenTime FactorsTreatment OutcomeUnited StatesConceptsLow recurrence scorePositive breast cancerAnthracycline-based chemotherapyDisease-free survivalHigh recurrence scoreRecurrence scorePositive nodesBreast cancerPostmenopausal womenRetrospective analysisNode-positive breast cancerTamoxifen-alone groupTamoxifen-treated patientsPhase 3 trialNational Cancer InstituteEffect of recurrenceOverall survivalSpecific survivalSurvival benefitCox regressionHigh riskTreatment groupsCancer InstituteChemotherapyPredictive value
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 analysisCyclophosphamideToxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience
Muss HB, Berry DA, Cirrincione C, Budman DR, Henderson IC, Citron ML, Norton L, Winer EP, Hudis CA. Toxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience. Journal Of Clinical Oncology 2007, 25: 3699-3704. PMID: 17704418, DOI: 10.1200/jco.2007.10.9710.Peer-Reviewed Original ResearchConceptsAdjuvant chemotherapy regimensTreatment-related deathsYounger patientsAdjuvant chemotherapyHematologic toxicityNonhematologic toxicityChemotherapy regimensOlder patientsGrade 3Acute myeloid leukemia/myelodysplastic syndromeNational Cancer Institute grade 3Grade 4 hematologic toxicityLeukemia Group B experienceLeukemia/myelodysplastic syndromeNode-positive breast cancerComparison of cyclophosphamideNode-positive patientsPercent of patientsHealthy older patientsStrict eligibility criteriaRisk of toxicityCALGB 9741Patients 65Elderly patientsOverall survival
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 diseaseToxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience
Muss H, Berry D, Cirrincione C, Budman D, Henderson I, Citron M, Norton L, Winer E, Hudis C. Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience. Journal Of Clinical Oncology 2006, 24: 559-559. DOI: 10.1200/jco.2006.24.18_suppl.559.Peer-Reviewed Original ResearchAML/MDSNon-hematologic toxicitiesBreast cancerOlder ptsYounger ptsNode-positive breast cancerIntensive adjuvant chemotherapyAge-adjusted ratesStrict eligibility criteriaAdjuvant chemotherapyHematologic toxicityMajor toxicitySurvival benefitYounger patientsCardiac deathClinical trialsGrade 3Eligibility criteriaHigh incidenceNormal populationIncidenceDeathTrialsRegimensSignificant differencesEstrogen-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
2005
Adjuvant Chemotherapy in Older and Younger Women With Lymph Node–Positive Breast Cancer
Muss HB, Woolf S, Berry D, Cirrincione C, Weiss RB, Budman D, Wood WC, Henderson IC, Hudis C, Winer E, Cohen H, Wheeler J, Norton L, B F. Adjuvant Chemotherapy in Older and Younger Women With Lymph Node–Positive Breast Cancer. JAMA 2005, 293: 1073-1081. PMID: 15741529, DOI: 10.1001/jama.293.9.1073.Peer-Reviewed Original ResearchConceptsLymph node-positive breast cancerNode-positive breast cancerTreatment-related mortalityDisease-free survivalAdjuvant chemotherapyBreast cancerOverall survivalOlder womenMore chemotherapyOlder patientsHigh treatment-related mortalityAge groupsYoung womenPositive lymph nodesHealthy older patientsDuration of chemotherapyGood general healthSmaller tumor sizeBreast cancer mortalityBreast cancer patientsCommunity medical centerDifferent age groupsTamoxifen useLymph nodesRetrospective review
2003
Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741.
Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. Journal Of Clinical Oncology 2003, 21: 1431-9. PMID: 12668651, DOI: 10.1200/jco.2003.09.081.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Administration ScheduleFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedMultivariate AnalysisPaclitaxelProportional Hazards ModelsRecombinant ProteinsSurvival AnalysisTreatment OutcomeConceptsOverall survivalDose-dense regimensBreast cancerAxillary node-positive breast cancerNode-positive primary breast cancerNode-positive breast cancerConcurrent combination chemotherapyDose-dense treatmentProtocol-specified analysisPostoperative adjuvant treatmentPrimary end pointPrimary breast cancerDose densityAdjuvant chemotherapyConcurrent chemotherapyAdjuvant treatmentSequential chemotherapySevere neutropeniaCombination chemotherapyClinical outcomesFemale patientsTreatment failureSequential doxorubicinConcurrent doxorubicinChemotherapy