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.
2009
Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction
Morris PG, Dickler M, McArthur HL, Traina T, Sugarman S, Lin N, Moy B, Come S, Godfrey L, Nulsen B, Chen C, Steingart R, Rugo H, Norton L, Winer E, Hudis CA, Dang CT. Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction. Journal Of Clinical Oncology 2009, 27: 6117-6123. PMID: 19901120, PMCID: PMC3664032, DOI: 10.1200/jco.2008.20.2952.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCardiac ElectrophysiologyChemotherapy, AdjuvantCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHeart DiseasesHumansMiddle AgedPaclitaxelPolyethylene GlycolsRecombinant ProteinsStroke VolumeTrastuzumabTreatment OutcomeVentricular Function, LeftConceptsLeft ventricular ejection fractionMedian left ventricular ejection fractionDose-dense ACVentricular ejection fractionEjection fractionBreast cancerHER2-normal breast cancerHER2-positive breast cancerTargeted biologic therapiesAdjuvant doxorubicinConcurrent bevacizumabSame regimenBiologic therapyAsymptomatic declineMedian ageMonth 6Cardiac dysfunctionCardiac safetyLVEF measurementsAngiography scansPatientsEarly riskSequential studyThird weekBevacizumabPhase I Study of Nonpegylated Liposomal Doxorubicin plus Trastuzumab in Patients with HER2-Positive Breast Cancer
Theodoulou M, Batist G, Campos S, Winer E, Welles L, Hudis C. Phase I Study of Nonpegylated Liposomal Doxorubicin plus Trastuzumab in Patients with HER2-Positive Breast Cancer. Clinical Breast Cancer 2009, 9: 101-107. PMID: 19433391, DOI: 10.3816/cbc.2009.n.019.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerCardiac toxicityBreast cancerLiposomal doxorubicinTreatment cyclesCardiac safetyLeft ventricular ejection fraction reductionHER2/neu 2Median progression-free survivalVentricular ejection fraction reductionHER2-positive breast cancerClinical cardiac assessmentCumulative anthracycline dosesEjection fraction reductionNonpegylated Liposomal DoxorubicinGrade 3/4 neutropeniaObjective tumor responseHER2-positive patientsProgression-free survivalPhase I trialClinical cardiac toxicityAnthracycline dosesCytotoxic regimensFebrile neutropeniaTrastuzumab regimenDose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results.
Dang C, Lin N, Moy B, Come S, Lake D, Theodoulou M, Troso-Sandoval T, Dickler M, Gorsky M, D'Andrea G, Modi S, Seidman A, Drullinsky P, Partridge A, Schapira L, Wulf G, Gilewski T, Atieh D, Mayer E, Isakoff S, Sugarman S, Fornier M, Traina T, Bromberg J, Currie V, Robson M, Burstein H, Overmoyer B, Ryan P, Kuter I, Younger J, Schumer S, Tung N, Zarwan C, Schnipper L, Chen C, Winer E, Norton L, Hudis C. Dose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results. Cancer Research 2009, 69: 2108. DOI: 10.1158/0008-5472.sabcs-2108.Peer-Reviewed Original ResearchDd ACHER2- BCLVEF declineDose reductionHER2/neu-positive breast cancerCongestive heart failure ratesNeu-positive breast cancerAsymptomatic LVEF declineCardiac event rateDose-dense doxorubicinHeart failure ratesDose delaysExcessive diarrheaWeekly paclitaxelMedian ageCardiac safetyMonth 2Breast cancerEvent ratesCancer ResDiarrheaPilot studyLVEFLapatinibBaseline
2008
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
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