2016
Treatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab
Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii J, Burstein HJ, Winer EP, Freedman RA. Treatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab. Breast Cancer Research And Treatment 2016, 159: 151-162. PMID: 27484879, DOI: 10.1007/s10549-016-3927-4.Peer-Reviewed Original ResearchConceptsAdjuvant trastuzumabOlder patientsSystemic treatmentBreast cancerHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2HER2-positive diseaseStage III diseaseCongestive heart failureGrowth factor receptor 2Positive breast cancerFactor receptor 2Treatment omissionEndocrine therapyClinical characteristicsSystemic therapyHeart failureBlack patientsTreatment disparitiesTreatment patternsHuman epidermal growth factorEpidermal growth factorMedicare dataPatients
2013
Long‐term cardiac safety and outcomes of dose‐dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer
Morris PG, Iyengar NM, Patil S, Chen C, Abbruzzi A, Lehman R, Steingart R, Oeffinger KC, Lin N, Moy B, Come SE, Winer EP, Norton L, Hudis CA, Dang CT. Long‐term cardiac safety and outcomes of dose‐dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer. Cancer 2013, 119: 3943-3951. PMID: 24037735, DOI: 10.1002/cncr.28284.Peer-Reviewed Original ResearchConceptsDistant disease-free survivalCongestive heart failureEarly breast cancerHuman epidermal growth factor receptor 2Breast cancerTrial ALong-term cardiac safetyEpidermal growth factor receptor 2Dose-dense doxorubicinDose-dense chemotherapyAnti-HER2 therapyDisease-free survivalPhase 2 trialGrowth factor receptor 2Long-term incidenceFactor receptor 2Previous hypertensionCumulative incidenceHeart failureAdditional patientsCardiac safetyLower riskReceptor 2PatientsTrial B.
2011
P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA).
Dang C, Tolaney S, Najita J, Gelman R, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff A, Carey L, Vahdat L, Burdette-Radoux S, Budd T, Krop I, Burstein H, Hudis C, Winer E. P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA). Cancer Research 2011, 71: p2-18-02-p2-18-02. DOI: 10.1158/0008-5472.sabcs11-p2-18-02.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureHER2-positive breast cancerBenefit of chemotherapyPositive breast cancerBreast cancerHeart failureHigh-risk node-negative breast cancerIncidence of CHFSerial left ventricular ejection fractionSymptomatic congestive heart failureNode-negative breast cancerAdjuvant weekly paclitaxelAnthracycline-based treatmentNode-negative groupNode-negative populationVentricular systolic dysfunctionPhase II studyDisease-free survivalVentricular ejection fractionLVEF monitoringLVEF recoveryWeekly paclitaxelPrimary endpointProtocol therapy
2010
Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea
Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea. Journal Of Clinical Oncology 2010, 28: 2982-2988. PMID: 20479410, PMCID: PMC3664034, DOI: 10.1200/jco.2009.26.5900.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDiarrheaDose-Response Relationship, DrugDoxorubicinFeasibility StudiesFemaleFilgrastimFollow-Up StudiesGene AmplificationGranulocyte Colony-Stimulating FactorHumansImmunoenzyme TechniquesIn Situ Hybridization, FluorescenceLapatinibMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPilot ProjectsPolyethylene GlycolsQuinazolinesReceptor, ErbB-2Recombinant ProteinsSurvival RateTrastuzumabTreatment OutcomeConceptsDose-dense ACDose-dense doxorubicinGrade 3 diarrheaBreast cancerDose reductionDose delay/reductionHER2-positive breast cancerHuman epidermal growth factor receptorAsymptomatic LVEF declineCardiac event ratePrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionDelays/reductionsEpidermal growth factor receptorExcessive diarrheaGrowth factor receptorLVEF declineWeekly paclitaxelEjection fractionHeart failureMedian agePatientsStage I
2009
Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity.
Morris P, Chen C, Lin N, Moy B, Come S, Abbruzzi A, Patil S, Winer E, Norton L, Hudis C, Dang C. Dose-Dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel (P) with Trastuzumab (T) and Lapatinib (L) in Early Breast Cancer (EBC); Troponin I and C-Reactive Protein as Biomarkers of Cardiotoxicity. Cancer Research 2009, 69: 3088-3088. DOI: 10.1158/0008-5472.sabcs-09-3088.Peer-Reviewed Original ResearchLeft ventricular ejection fractionCongestive heart failureC-reactive proteinEarly breast cancerBiomarkers of cardiotoxicityMinimal elevationEvidence of CHFElevated C-reactive proteinTroponin IDose-dense doxorubicinSensitive inflammatory markerAnti-HER2 agentsVentricular ejection fractionPre-planned analysisCardiac troponin IElevated TnIUncontrolled arrhythmiaWeekly paclitaxelInflammatory markersMUGA scanUnstable anginaEjection fractionHeart failureRecent MIProspective study
2001
Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.
Burstein H, Kuter I, Campos S, Gelman R, Tribou L, Parker L, Manola J, Younger J, Matulonis U, Bunnell C, Partridge A, Richardson P, Clarke K, Shulman L, Winer E. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2001, 19: 2722-30. PMID: 11352965, DOI: 10.1200/jco.2001.19.10.2722.Peer-Reviewed Original ResearchConceptsGrade 2 cardiac toxicityAdvanced breast cancerBreast cancerResponse rateCardiac toxicityHER2-overexpressing metastatic breast cancerOnly grade 4 toxicityHER2-positive breast cancerCumulative doxorubicin doseGrade 4 toxicityStudy of trastuzumabSymptomatic heart failureThird-line therapyFirst-line therapyType of chemotherapyMetastatic breast cancerPercent of womenHigh response rateConcurrent trastuzumabPrior chemotherapyWeekly vinorelbineMetastatic diseasePositive patientsHeart failureDoxorubicin dose