2016
I-SPY 2 — Toward More Rapid Progress in Breast Cancer Treatment
Carey LA, Winer EP. I-SPY 2 — Toward More Rapid Progress in Breast Cancer Treatment. New England Journal Of Medicine 2016, 375: 83-84. PMID: 27406352, DOI: 10.1056/nejme1603691.Peer-Reviewed Original Research
2014
Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831
Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. Journal Of Clinical Oncology 2014, 32: 3744-3752. PMID: 25332249, PMCID: PMC4226805, DOI: 10.1200/jco.2014.55.5730.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorOverall survivalBreast cancerEpidermal growth factor receptorGrowth factor receptorNCCTG N9831NSABP BEarly-Stage Human Epidermal Growth Factor ReceptorHER2-positive operable breast cancerNational Surgical Adjuvant BreastLarge adjuvant trialsOperable breast cancerAddition of trastuzumabAnti-HER2 agentsFactor receptorSurvival end pointsBreast cancer resultsDFS ratesOverall DFSAdjuvant BreastAdjuvant chemotherapyAdjuvant trialsOS ratesMedian timePatient subgroupsComparison 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 pointTherapyA phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer
Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Medicine 2014, 3: 293-299. PMID: 24464780, PMCID: PMC3987079, DOI: 10.1002/cam4.164.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerPathological complete responsePositive breast cancerBreast cancerPreoperative capecitabineClinical responseHER2-negative operable breast cancerDihydropyrimidine dehydrogenaseOnly grade 3 toxicityOverall clinical response rateThymidine phosphorylaseGrade 3 responsePartial clinical responsePathological response assessmentsPreoperative chemotherapy regimensClinical response rateComplete clinical responseGrade 3 toxicityOperable breast cancerPhase II studyPalmar-plantar erythrodysesthesiaMetastatic breast cancerTime of surgeryMiller-Payne
2013
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction
Kansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsFemaleHumansMammaplastyMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPostoperative ComplicationsTreatment OutcomeYoung AdultConceptsSurgical complicationsAC/TPostoperative complicationsComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerOverall complication rateRate of complicationsThird of patientsCohort of patientsSame healthcare systemSingle-arm trialFisher's exact testUse of BevTerms of demographicsNeoadjuvant bevacizumabNeoadjuvant therapyImplant reconstructionMastectomyComparison 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 3Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.
Kansal K, Dominici L, Tolaney S, Isakoff S, Krop I, Smith B, Jiang W, Potler H, Brock J, Winer E, Golshan M. Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction. Journal Of Clinical Oncology 2013, 31: 1100-1100. DOI: 10.1200/jco.2013.31.15_suppl.1100.Peer-Reviewed Original ResearchSurgical complicationsAC/TNeoadjuvant bevacizumabNeoadjuvant therapyComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerUse of bevacizumabOverall complication rateRate of complicationsThird of patientsCohort of patientsSingle-arm trialSame healthcare systemFisher's exact testTerms of demographicsNon-randomized dataPostoperative complicationsImplant reconstructionImpact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance).
Ollila D, Berry D, Cirrincione C, Carey L, Amos K, Henry N, Winer E, Hudis C, Golshan M. Impact of neoadjuvant chemotherapy plus HER2-targeting on breast conservation rates: Surgical results from CALGB 40601 (Alliance). Journal Of Clinical Oncology 2013, 31: 501-501. DOI: 10.1200/jco.2013.31.15_suppl.501.Peer-Reviewed Original ResearchNeoadjuvant therapyBCT candidatesCALGB 40601Neoadjuvant chemotherapySystemic therapySurgical resultsBreast surgeonsBreast cancerTumor-free surgical marginsBreast cancer ptsNeoadjuvant systemic therapyOperable breast cancerBreast conservation ratesPhase III trialsAnti-HER2 treatmentModern systemic therapyBreast cancer operationsBCT eligibilityCancer ptsEligible patientsNeoadjuvant trialsTherapy ratesIII trialsSurgical marginsCancer operationsPAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer
Martín M, Prat A, Rodríguez-Lescure Á, Caballero R, Ebbert MT, Munárriz B, Ruiz-Borrego M, Bastien RR, Crespo C, Davis C, Rodríguez CA, López-Vega JM, Furió V, García AM, Casas M, Ellis MJ, Berry DA, Pitcher BN, Harris L, Ruiz A, Winer E, Hudis C, Stijleman IJ, Tuck DP, Carrasco E, Perou CM, Bernard PS. PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer. Breast Cancer Research And Treatment 2013, 138: 457-466. PMID: 23423445, PMCID: PMC3608881, DOI: 10.1007/s10549-013-2416-2.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell ProliferationClinical Trials, Phase III as TopicCyclophosphamideEpirubicinFemaleFluorouracilHumansKaplan-Meier EstimateKi-67 AntigenMiddle AgedMulticenter Studies as TopicMultivariate AnalysisPaclitaxelProportional Hazards ModelsProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeConceptsGroup of patientsWeekly paclitaxelOverall survivalPAM50 subtypesProliferation scoreBreast cancerNode-positive operable breast cancerMultivariable Cox regression analysisLow proliferation statusAnthracycline-containing chemotherapyOperable breast cancerPhase III trialsSubset of patientsCox regression analysisClinical-pathological variablesFEC armMedian followAdjuvant therapySecondary endpointsIII trialsPathological variablesHistologic gradeClinical trialsAdjuvant FECKi-67
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 outcomesA phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC).
Tolaney S, Duda D, Boucher Y, Goel S, Martin J, Ancukiewicz M, Potler H, Incio J, Ligibel J, Isakoff S, Fukumura D, Winer E, Krop I, Jain R. A phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC). Journal Of Clinical Oncology 2012, 30: 1026-1026. DOI: 10.1200/jco.2012.30.15_suppl.1026.Peer-Reviewed Original ResearchTN breast cancerBreast cancerInterstitial fluid pressureMiller-PayneTN tumorsHER2-negative operable breast cancerMean interstitial fluid pressureHormone receptorsMP responseAddition of BevAxillary LN involvementDose-dense doxorubicinTriple-negative cohortOperable breast cancerPhase II studyPredictors of responseMean vascular densityPreoperative bevacizumabLN involvementII studyOverall cohortPathologic responseBiomarker predictorsNegative cohortPharmacodynamic effects
2011
Will preoperative trials change future clinical practice?
Lim E, Winer E. Will preoperative trials change future clinical practice? Clinical Investigation 2011, 1: 59-73. DOI: 10.4155/cli.10.3.Peer-Reviewed Original ResearchPreoperative systemic therapySystemic therapyBreast cancerOperable breast cancerManagement of patientsPST trialsPost-treatment tissuesFuture clinical practiceAdjuvant trialsBreast cancePredictive biomarkersPreoperative trialBiomarker discovery programsBiologic mechanismsClinical practiceTherapyVivo studiesTrialsOff-target effectsIdentification of pathwaysCorrelative studiesDrug developmentCancerPatientsDiscovery programs
2010
Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery?
Golshan M, Garber JE, Gelman R, Tung N, Smith BL, Troyan S, Greenberg CC, Winer EP, Ryan P. Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery? Annals Of Surgical Oncology 2010, 18: 733-737. PMID: 20882415, DOI: 10.1245/s10434-010-1366-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsChemotherapy, AdjuvantCisplatinCombined Modality TherapyFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm StagingPostoperative ComplicationsReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSentinel Lymph Node BiopsySurvival RateTreatment OutcomeConceptsTriple-negative breast cancerSingle-arm trialNeoadjuvant cisplatinPostoperative complicationsBreast cancerTwo-sided Fisher's exact testExpander/implantsSafety of bevacizumabOperable breast cancerDefinitive local therapyBreast cancer surgeryNegative breast cancerFisher's exact testBackgroundNeoadjuvant chemotherapyNeoadjuvant settingNeoadjuvant therapyProtocol therapySurgical complicationsLocal therapyRelated complicationsCancer surgeryCisplatin therapyBreast surgeryComplicationsPatients
2009
Surgical Complications and the Use of Neoadjuvant Bevacizumab.
Golshan M, Garber J, Gelman R, Tung N, Smith B, Troyan S, Greenberg C, Winer E, Ryan P. Surgical Complications and the Use of Neoadjuvant Bevacizumab. Cancer Research 2009, 69: 43-43. DOI: 10.1158/0008-5472.sabcs-09-43.Peer-Reviewed Original ResearchTriple-negative breast cancerDefinitive local therapyPhase II trialPostoperative complicationsNeoadjuvant cisplatinDefinitive surgeryII trialWound breakdownLocal therapyMedian ageBreast cancerSingle-arm phase II trialArm phase II trialTwo-sided Fisher's exact testClinical stage IIDose-dense ACSafety of bevacizumabOperable breast cancerBreast cancer surgerySingle-arm trialNegative breast cancerFisher's exact testCycles cisplatinNeoadjuvant bevacizumabNeoadjuvant setting
2008
Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease
Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease. Journal Of Clinical Oncology 2008, 26: 814-819. PMID: 18258991, DOI: 10.1200/jco.2007.15.3510.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsCongresses as TopicFemaleHumansMastectomy, SegmentalNational Cancer Institute (U.S.)Neoadjuvant TherapyNeoplasm, ResidualPatient Care TeamPatient SelectionPreoperative CareReceptor, ErbB-2Remission InductionUnited StatesConceptsOperable breast cancerPreoperative systemic therapyBreast conservation ratesSystemic therapyInvasive breast cancerBreast cancerTumor responsePreoperative therapyPathologic assessmentNational Cancer Institute StatePostoperative adjuvant systemic therapyInitial tumor responseAdjuvant systemic therapyPathologic complete responseSurrogate end pointsStandard of careMultimodality treatment programBreast cancer biologyAdjuvant settingOperable diseaseOverall survivalPreoperative chemotherapySystemic treatmentComplete responseLymph nodesCardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial
Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. Journal Of Clinical Oncology 2008, 26: 1231-1238. PMID: 18250349, PMCID: PMC4048960, DOI: 10.1200/jco.2007.13.5467.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFluorouracilHeartHeart FailureHumansPrognosisReceptor, ErbB-2Risk FactorsSurvival RateTamoxifenTrastuzumabVentricular Dysfunction, LeftConceptsLeft ventricular ejection fractionAdjuvant breast cancer trialsBreast cancer trialsCardiac eventsLVEF decreaseCumulative incidenceArm BCancer trialsHER2-positive operable breast cancerPotential cardiac risk factorsOlder ageTrastuzumab-containing armsCardiac risk factorsOperable breast cancerVentricular ejection fractionAntihypertensive medicationsTrastuzumab discontinuationWeekly paclitaxelCardiac medicationsEjection fractionAntihypertensive agentsCardiac dysfunctionCardiac safetyCardiac functionControl arm