2024
RNA-Seq based gene expression profiling of baseline and on-treatment breast tumors to predict response to HER2-directed therapy, without chemotherapy (TBCRC026).
Hennessy M, Fernández A, Huang C, Cimino-Mathews A, Denbow R, Abramson V, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Wahl R, Thompson E, Stearns V, Perou C, Carey L, Connolly R. RNA-Seq based gene expression profiling of baseline and on-treatment breast tumors to predict response to HER2-directed therapy, without chemotherapy (TBCRC026). Journal Of Clinical Oncology 2024, 42: 530-530. DOI: 10.1200/jco.2024.42.16_suppl.530.Peer-Reviewed Original ResearchRelapse-free survivalB cell signaturesGene expression signaturesHER2-directed therapyPET/CT parametersER-negativeHER2 subtypeClinical outcomesEarly stage HER2-positive breast cancerResponse to HER2-directed therapyAssociated with lack of responseHER2-positive breast cancerGene expression changesUnivariate logistic regression analysisHER2-positive cohortIncreased immune signalingMetabolic changesAssociated with pCRNatural killer cellsNested Cox modelsLogistic regression analysisWilcoxon signed-rank testHER2 ampliconFDG-PET/CTHER2- tumors
2020
Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.
Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. Journal Of Clinical Oncology 2020, 38: 4184-4193. PMID: 33095682, PMCID: PMC7723687, DOI: 10.1200/jco.20.01276.Peer-Reviewed Original ResearchConceptsPathologic complete responseRelapse-free survivalHuman epidermal growth factor receptor 2HER2-positive breast cancerBetter relapse-free survivalOverall survivalCALGB 40601Breast cancerImmune signaturesGene expression signaturesDe-escalation treatment strategiesPrediction of pCREnd pointEpidermal growth factor receptor 2Shorter relapse-free survivalPrimary end pointResidual disease groupSecondary end pointsUntreated stage IIGood prognostic factorGrowth factor receptor 2Phase III trialsExpression signaturesFactor receptor 2OS benefit
2015
Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, Eckel-Passow JE, Dueck AC, Tenner KS, Jen J, Fan JB, Geiger XJ, McCullough AE, Chen B, Jenkins RB, Sledge GW, Winer EP, Gralow JR, Reinholz MM. Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. Journal Of Clinical Oncology 2015, 33: 701-708. PMID: 25605861, PMCID: PMC4334774, DOI: 10.1200/jco.2014.57.6298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticGenomicsHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyProportional Hazards ModelsReceptor, ErbB-2TranscriptomeTrastuzumabConceptsRelapse-free survivalImmune function genesAdjuvant trastuzumab trialsArm BTrastuzumab trialsHazard ratioArm AHuman epidermal growth factor receptorClinicopathologic risk factorsProportional hazard ratiosEpidermal growth factor receptorGrowth factor receptorAdjuvant trastuzumabC patientsCombination chemotherapyClinical outcomesRisk factorsBreast cancerPatientsTrastuzumabPredictive signatureFunction genesChemotherapyGene enrichmentFactor receptor
2014
Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)
Shulman LN, Berry DA, Cirrincione CT, Becker HP, Perez EA, O'Regan R, Martino S, Shapiro CL, Schneider CJ, Kimmick G, Burstein HJ, Norton L, Muss H, Hudis CA, Winer EP. Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance). Journal Of Clinical Oncology 2014, 32: 2311-2317. PMID: 24934787, PMCID: PMC4105484, DOI: 10.1200/jco.2013.53.7142.Peer-Reviewed Original ResearchConceptsRelapse-free survivalSingle-agent paclitaxelOverall survivalHazard ratioBreast cancerTreatment-related deathsCycles of therapyOperable breast cancerPositive axillary nodesPrimary end pointDuration of therapyOptimal adjuvant chemotherapyComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Median followAdjuvant therapyHematologic toxicityPositive nodesAxillary nodesPatient deathBalance efficacyPatientsEnd pointTherapyOutcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study
Vaz-Luis I, Ottesen RA, Hughes ME, Mamet R, Burstein HJ, Edge SB, Gonzalez-Angulo AM, Moy B, Rugo HS, Theriault RL, Weeks JC, Winer EP, Lin NU. Outcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study. Journal Of Clinical Oncology 2014, 32: 2142-2150. PMID: 24888816, PMCID: PMC4076026, DOI: 10.1200/jco.2013.53.1608.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansMastectomy, SegmentalMiddle AgedNeoplasm StagingPrognosisProspective StudiesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTrastuzumabTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsDistant relapse-free survivalBN0M0 breast cancerHER2-negative tumorsBreast cancerT1a tumorsCohort studyT1b tumorsSurvival outcomesHR-positive/HER2-negative tumorsTumor subtypesNational Comprehensive Cancer Network databaseHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusHER2-negative breast cancerNode-negative breast cancerHormone receptorsConsideration of chemotherapyHER2-negative diseasePercent of patientsReceipt of chemotherapyNonrandomized cohort studyProspective cohort studyRelapse-free survivalRate of recurrenceMulti-institutional study
2013
Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101.
Shulman L, Berry D, Cirrincione C, Becker H, Perez E, O'Regan R, Martino S, Shapiro C, Atkins J, Schneider C, Kimmick G, Burstein H, Norton L, Muss H, Hudis C, Winer E. Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101. Journal Of Clinical Oncology 2013, 31: 1007-1007. DOI: 10.1200/jco.2013.31.15_suppl.1007.Peer-Reviewed Original ResearchRelapse-free survivalHazard ratioOverall survivalBreast cancerEarly-stage breast cancerCycles of therapyNon-hematologic toxicitiesOperable breast cancerPositive axillary nodesSingle-agent paclitaxelTreatment-related deathsOptimal adjuvant chemotherapyStage breast cancerConfidence intervalsComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Hematologic toxicityAdjuvant therapyPositive nodesPrimary endpointAxillary nodesVs. 4Conclusion of equivalenceGrade 3Body 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
2012
Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101
Shulman LN, Cirrincione CT, Berry DA, Becker HP, Perez EA, O'Regan R, Martino S, Atkins JN, Mayer E, Schneider CJ, Kimmick G, Norton L, Muss H, Winer EP, Hudis C. Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101. Journal Of Clinical Oncology 2012, 30: 4071-4076. PMID: 22826271, PMCID: PMC3494835, DOI: 10.1200/jco.2011.40.6405.Peer-Reviewed Original ResearchConceptsRelapse-free survivalHuman epidermal growth factor receptor 2Primary breast cancerPositive nodesBreast cancerHazard ratioAdjuvant chemotherapyChemotherapy regimenEstrogen receptor/progesterone receptorPrimary efficacy end pointEpidermal growth factor receptor 2Dose-dense fashionDoxorubicin/cyclophosphamideAdjusted hazard ratioCycles of doxorubicinEfficacy end pointOperable breast cancerPositive axillary nodesER/PgRGrowth factor receptor 2Factor receptor 2Chemotherapy regimensAxillary nodesMenopausal statusClinical outcomes
2010
Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104
Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104. Journal Of Clinical Oncology 2010, 28: 2418-2422. PMID: 20368559, PMCID: PMC2881723, DOI: 10.1200/jco.2009.26.4671.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAge FactorsAgedAged, 80 and overAntimetabolites, AntineoplasticBreast NeoplasmsCanadaCapecitabineChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleDrug MonitoringFemaleFluorouracilHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMastectomyMedication AdherenceMicro-Electrical-Mechanical SystemsNeoplasm StagingRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerBreast cancerCALGB 49907Oral chemotherapyClinical trialsOlder womenPatients age 65 yearsOral adjuvant chemotherapyPill bottle openingsNode-negative diseaseHormone receptor statusRelapse-free survivalRandomized clinical trialsAge 65 yearsMulticenter clinical trialNumber of dosesPercent of participantsLogistic regression modelsAdjuvant chemotherapyProtocol therapyOral therapyStandard chemotherapyMedian ageReceptor statusPatient adherence
2009
Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer
Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP. Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer. New England Journal Of Medicine 2009, 360: 2055-2065. PMID: 19439741, PMCID: PMC3082436, DOI: 10.1056/nejmoa0810266.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantCisplatinCyclophosphamideDeoxycytidineDoxorubicinFemaleFluorouracilHumansKaplan-Meier EstimateMaleMethotrexateNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingReceptors, EstrogenSurvival AnalysisConceptsEarly-stage breast cancerRelapse-free survivalStandard chemotherapyBreast cancerCapecitabine groupAdjuvant chemotherapyYears of ageOlder womenIIIB breast cancerStandard chemotherapy groupPrimary end pointStandard adjuvant chemotherapyTreatment-related complicationsOverall survival rateSevere toxic effectsCapecitabine therapyEndocrine therapyHazard ratioDisease recurrenceSuch patientsLong followPositive tumorsClinical trialsChemotherapyPatients
2008
Dose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel
Liu MC, Demetri GD, Berry DA, Norton L, Broadwater G, Robert NJ, Duggan D, Hayes DF, Henderson IC, Lyss A, Hopkins J, Kaufman PA, Marcom PK, Younger J, Lin N, Tkaczuk K, Winer EP, Hudis CA, B F. Dose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel. Cancer Treatment Reviews 2008, 34: 223-230. PMID: 18234424, PMCID: PMC2651678, DOI: 10.1016/j.ctrv.2007.11.004.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFilgrastimFollow-Up StudiesGranulocyte Colony-Stimulating FactorHumansLymphatic MetastasisMiddle AgedPaclitaxelPilot ProjectsRecombinant ProteinsConceptsG-CSF supportGrowth factor supportRelapse-free survivalClinical outcomesDose levelsG-CSFFactor supportConventional doseClinical trialsBreast cancerNode-positive invasive breast cancerNode-positive breast cancer patientsAcute treatment-related toxicityHematopoietic growth factor supportOperable primary breast cancerAdjuvant chemotherapy regimenDose-intensified regimenDose-intensive regimensEarly study withdrawalNode-positive patientsTreatment-related toxicityHormone receptor statusInvasive breast cancerOverall survival ratePrimary breast cancer
2003
The aromatase inhibitors as adjuvant therapy for hormone receptor-positive breast cancer.
Ligibel JA, Winer EP. The aromatase inhibitors as adjuvant therapy for hormone receptor-positive breast cancer. Journal Of The National Comprehensive Cancer Network 2003, 1: 215-21. PMID: 19768880, DOI: 10.6004/jnccn.2003.0020.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerAdjuvant hormonal therapyAromatase inhibitorsAdjuvant settingBreast cancerATAC trialHormonal therapyThird-generation aromatase inhibitor anastrozoleMost postmenopausal womenNew hormonal agentsAromatase inhibitor anastrozoleEarly breast cancerMetastatic breast cancerUse of tamoxifenRelapse-free survivalBreast cancer recurrenceAdjuvant therapyPostmenopausal patientsPostmenopausal womenThromboembolic eventsOverall mortalityHormonal agentsPatient populationUterine cancer