2019
Olaparib and α-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial
Konstantinopoulos PA, Barry WT, Birrer M, Westin SN, Cadoo KA, Shapiro GI, Mayer EL, O'Cearbhaill RE, Coleman RL, Kochupurakkal B, Whalen C, Curtis J, Farooq S, Luo W, Eismann J, Buss MK, Aghajanian C, Mills GB, Palakurthi S, Kirschmeier P, Liu J, Cantley LC, Kaufmann SH, Swisher EM, D'Andrea AD, Winer E, Wulf GM, Matulonis UA. Olaparib and α-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial. The Lancet Oncology 2019, 20: 570-580. PMID: 30880072, PMCID: PMC7025391, DOI: 10.1016/s1470-2045(18)30905-7.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleGenome, HumanHumansMaximum Tolerated DoseMiddle AgedMutationOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsThiazolesTreatment OutcomeConceptsEpithelial ovarian cancerPhase 2 dosePI3K inhibitor alpelisibPrimary peritoneal cancerPhase 1b trialRecurrent breast cancerGermline BRCA mutationsOvarian cancerBreast cancerDose levelsPeritoneal cancerBRCA mutationsFallopian tubeCommon treatment-related grade 3High-grade serous histologyTreatment-related grade 3Breast Cancer Research FoundationDecreased neutrophil countDose-escalation cohortsDose-expansion cohortsTreatment-related deathsTriple negative histologyResponse Evaluation CriteriaSolid Tumors 1.1Key eligibility criteria
2018
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer
Schöffski P, Cresta S, Mayer IA, Wildiers H, Damian S, Gendreau S, Rooney I, Morrissey KM, Spoerke JM, Ng VW, Singel SM, Winer E. A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer. Breast Cancer Research 2018, 20: 109. PMID: 30185228, PMCID: PMC6125885, DOI: 10.1186/s13058-018-1015-x.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase Ib studyMetastatic breast cancerAdverse eventsBreast cancerIb studyResultsSixty-nine patientsAntitumor activityManageable safety profileAdvanced breast cancerSerious adverse eventsPreliminary antitumor activityDrug-drug interactionsEvaluation of safetySecondary endpointsPartial responseComplete responseDose escalationRandomized studySafety profilePatientsBevacizumabTrastuzumabPictilisibLetrozole
2017
Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance)
Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). The AAPS Journal 2017, 19: 1411-1423. PMID: 28620884, PMCID: PMC5711539, DOI: 10.1208/s12248-017-0101-9.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAntineoplastic AgentsBreast NeoplasmsDose-Response Relationship, DrugEpothilonesFemaleHumansModels, BiologicalNeoplasm MetastasisPaclitaxelPeripheral Nervous System DiseasesConceptsChemotherapy-induced peripheral neuropathyProportion of patientsMetastatic breast cancerKinetic-pharmacodynamic modelIndirect response modelNab-paclitaxelDose modificationPeripheral neuropathyBreast cancerDrug effectsRandomized phase III trialLinear drug effectFirst-line chemotherapyPhase III trialsTime pointsDose-limiting toxicityLater time pointsEarly time pointsCALGB 40502Neurotoxicity ScaleIII trialsFunctional assessmentChemotherapeutic agentsPatientsCancer18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials
Wang Y, Ayres KL, Goldman DA, Dickler MN, Bardia A, Mayer IA, Winer E, Fredrickson J, Arteaga CL, Baselga J, Manning HC, Mahmood U, Ulaner GA. 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials. Clinical Cancer Research 2017, 23: 3053-3060. PMID: 28011460, PMCID: PMC5474190, DOI: 10.1158/1078-0432.ccr-16-2197.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkers, PharmacologicalBreast NeoplasmsCinnamatesDose-Response Relationship, DrugEstradiolEstrogen Receptor alphaFemaleFulvestrantHumansIndazolesMiddle AgedMolecular ImagingMolecular Targeted TherapyPositron Emission Tomography Computed TomographyReceptors, EstrogenTamoxifenConceptsFES-PET/CTPET/CTClinical trialsER-positive metastatic breast cancerPhase IPhase I clinical trialEstrogen receptor occupancyPhase II trialMetastatic breast cancerSubsequent clinical trialsClin Cancer ResER downregulationFulvestrant therapyAntagonist/Escalation trialII trialTarget lesionsBreast cancerER occupancyUseful biomarkerPatientsReceptor occupancyDay 3Uptake valueDrug dosagePhase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer
Matulonis U, Wulf G, Barry W, Birrer M, Westin S, Farooq S, Bell-McGuinn K, Obermayer E, Whalen C, Spagnoletti T, Luo W, Liu H, Hok R, Aghajanian C, Solit D, Mills G, Taylor B, Won H, Berger M, Palakurthi S, Liu J, Cantley L, Winer E. Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer. Annals Of Oncology 2017, 28: 512-518. PMID: 27993796, PMCID: PMC5834157, DOI: 10.1093/annonc/mdw672.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsDose-Response Relationship, DrugFemaleGerm-Line MutationHumansMiddle AgedMorpholinesNeoplasm GradingNeoplasm Recurrence, LocalOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesConceptsGermline BRCA mutationsOvarian cancerStudy treatmentPARP inhibitorsRandomized phase II studyDose-expansion cohortsPhase II studyPhase I trialDose-escalation designWild-type patientsBiomarkers of responsePARP inhibitor combinationsCombination of BKM120Polymerase inhibitor olaparibPoly (ADP-ribose) polymerase (PARP) inhibitor olaparibPI3K inhibitorsAdditional DLTsOlaparib 300Preclinical synergyRecurrent breastEscalation studyII studyI trialClinical benefitBRCA mutations
2015
Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancer
Tolaney SM, Tan S, Guo H, Barry W, Van Allen E, Wagle N, Brock J, Larrabee K, Paweletz C, Ivanova E, Janne P, Overmoyer B, Wright JJ, Shapiro GI, Winer EP, Krop IE. Phase II study of tivantinib (ARQ 197) in patients with metastatic triple-negative breast cancer. Investigational New Drugs 2015, 33: 1108-1114. PMID: 26123926, PMCID: PMC4608248, DOI: 10.1007/s10637-015-0269-8.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerPhase 2 studyProgression-free survivalBreast cancerPartial responseSingle-arm phase 2 studyResults 22 patientsPhase II studyDaily oral dosingOverall response rateRecent preclinical dataMechanism of actionTivantinib monotherapyMetastatic settingAdverse eventsII studyMethods PatientsPrior linesPreclinical dataOral dosingTivantinibPatientsMET expressionResponse rate
2014
Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer
Tolaney S, Burris H, Gartner E, Mayer IA, Saura C, Maurer M, Ciruelos E, Garcia AA, Campana F, Wu B, Xu Y, Jiang J, Winer E, Krop I. Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2014, 149: 151-161. PMID: 25537644, DOI: 10.1007/s10549-014-3248-4.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerAdverse eventsBreast cancerArm 2Arm 1Phase I/II dose-escalation studyMetastatic HER2-positive breast cancerPhase I/II studyTreatment-related adverse eventsHER2-positive breast cancerTreatment-related gradeAcceptable safety profileDose-escalation studyDose-limiting toxicityDose-escalation designPan-class IEvaluable patientsPaclitaxel armPrior taxanePrior trastuzumabErythematous rashII studyPartial responsePeripheral neuropathyCombination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study
Liu JF, Barry WT, Birrer M, Lee JM, Buckanovich RJ, Fleming GF, Rimel B, Buss MK, Nattam S, Hurteau J, Luo W, Quy P, Whalen C, Obermayer L, Lee H, Winer EP, Kohn EC, Ivy SP, Matulonis UA. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study. The Lancet Oncology 2014, 15: 1207-1214. PMID: 25218906, PMCID: PMC4294183, DOI: 10.1016/s1470-2045(14)70391-2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinConfidence IntervalsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesQuinazolinesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsProgression-free survivalRecurrent platinum-sensitive ovarian cancerPlatinum-sensitive ovarian cancerPhase 2 studyOvarian cancerOlaparib monotherapyMedian progression-free survivalGermline BRCA statusPhase 2 dosePrimary peritoneal cancerRecurrent ovarian cancerPhase 2 trialPhase 3 trialSide effect profilePhase 1 trialUS academic medical centersPatient-reported outcomesEndometrioid ovarian cancerGermline BRCA1/2 mutationsAnti-angiogenic therapyAnti-angiogenic agentsCombination of olaparibAcademic medical centerNational Cancer InstituteVEGF receptor 1Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance). Journal Of Clinical Oncology 2014, 33: 13-21. PMID: 25092775, PMCID: PMC4268249, DOI: 10.1200/jco.2014.57.0572.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFatigueFemaleHumansHypertensionMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeutropeniaPaclitaxelRemission InductionThrombocytopeniaTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyBreast/axillaStage IIBreast cancerPathologic complete response rateRandomized phase II trialAddition of carboplatinDose-dense doxorubicinRole of carboplatinComplete response ratePhase II trialStandard neoadjuvant chemotherapyThird of patientsAdjuvant trialsConcurrent carboplatinSkipped dosesWeek paclitaxelEarly discontinuationII trialPostoperative complicationsThromboembolic eventsDose modificationOverall survivalStand Up to Cancer Phase Ib Study of Pan-Phosphoinositide-3-Kinase Inhibitor Buparlisib With Letrozole in Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer
Mayer IA, Abramson VG, Isakoff SJ, Forero A, Balko JM, Kuba MG, Sanders ME, Yap JT, Van den Abbeele AD, Li Y, Cantley LC, Winer E, Arteaga CL. Stand Up to Cancer Phase Ib Study of Pan-Phosphoinositide-3-Kinase Inhibitor Buparlisib With Letrozole in Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. Journal Of Clinical Oncology 2014, 32: 1202-1209. PMID: 24663045, PMCID: PMC3986383, DOI: 10.1200/jco.2013.54.0518.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell Line, TumorClass I Phosphatidylinositol 3-KinasesDose-Response Relationship, DrugDrug Administration ScheduleFemaleFluorodeoxyglucose F18HumansLetrozoleMiddle AgedMorpholinesMultimodal ImagingNitrilesPhosphoinositide-3 Kinase InhibitorsPositron-Emission TomographyProtein Kinase InhibitorsRadiopharmaceuticalsReceptor, ErbB-2Receptors, EstrogenTomography, X-Ray ComputedTriazolesConceptsMaximum-tolerated dosePhase Ib studyPET/CTEndocrine therapyDisease progressionBreast cancerIb studyCommon drug-related adverse eventsDrug-related adverse eventsPIK3CA hot spot mutationsPositive breast cancer cell linesER-positive breast cancerPositron emission tomography/Human epidermal growth factor receptorBreast cancer refractoryClinical benefit rateOral reversible inhibitorPIK3CA mutation statusPhase III trialsMetastatic breast cancerRapid disease progressionEmission tomography/Different administration schedulesBreast cancer cell linesMetabolic disease progression
2013
A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer
Mayer EL, Scheulen ME, Beckman J, Richly H, Duarte A, Cotreau MM, Strahs AL, Agarwal S, Steelman L, Winer EP, Dickler MN. A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer. Breast Cancer Research And Treatment 2013, 140: 331-339. PMID: 23868188, DOI: 10.1007/s10549-013-2632-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerTyrosine kinase inhibitorsWeekly paclitaxelPaclitaxel 90Breast cancerPhase I dose-escalation studyI dose-escalation studyVascular endothelial growth factor receptor 1Activity of tivozanibSafety/tolerabilityGrade 3/4 toxicitiesPeripheral sensory neuropathyPhase Ib studyDose-escalation studyResponse Evaluation CriteriaSelective tyrosine kinase inhibitorVEGFR-TKI treatmentSolid Tumors responseGrowth factor receptor 1Influence of paclitaxelFactor receptor 1Stable diseaseMBC patientsPartial responseProgressive diseaseA Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer
Liu JF, Tolaney SM, Birrer M, Fleming GF, Buss MK, Dahlberg SE, Lee H, Whalen C, Tyburski K, Winer E, Ivy P, Matulonis UA. A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer. European Journal Of Cancer 2013, 49: 2972-2978. PMID: 23810467, PMCID: PMC3956307, DOI: 10.1016/j.ejca.2013.05.020.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapsulesCarcinoma, Ovarian EpithelialDiarrheaDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHumansMiddle AgedNauseaNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneReceptors, Vascular Endothelial Growth FactorTabletsTreatment OutcomeConceptsTriple-negative breast cancerOvarian cancer patientsOverall response rateCombination of cediranibCancer patientsBreast cancerDose levelsMetastatic triple-negative breast cancerEvaluable breast cancer patientsPARP inhibitorsClinical benefit rateGrade 3 fatigueGrade 3 hypertensionPhase 2 dosingVascular endothelial growth factor receptorResponse Evaluation CriteriaSolid Tumors 1.1Endothelial growth factor receptorPhase 1 trialBreast cancer patientsDose-escalation designHighest dose levelPolymerase inhibitor olaparibCA125 criteriaGrowth factor receptor
2011
Troponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib
Morris PG, Chen C, Steingart R, Fleisher M, Lin N, Moy B, Come S, Sugarman S, Abbruzzi A, Lehman R, Patil S, Dickler M, McArthur HL, Winer E, Norton L, Hudis CA, Dang CT. Troponin I and C-Reactive Protein Are Commonly Detected in Patients with Breast Cancer Treated with Dose-Dense Chemotherapy Incorporating Trastuzumab and Lapatinib. Clinical Cancer Research 2011, 17: 3490-3499. PMID: 21372222, DOI: 10.1158/1078-0432.ccr-10-1359.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsC-Reactive ProteinCarcinomaDose-Response Relationship, DrugFeasibility StudiesFemaleHumansLapatinibMiddle AgedQuinazolinesStroke VolumeTrastuzumabTroponin IConceptsLeft ventricular ejection fractionC-reactive proteinMedian left ventricular ejection fractionTroponin IDetectable C-reactive proteinDose-dense doxorubicinAnthracycline-based chemotherapyDose-dense chemotherapyVentricular ejection fractionProspective feasibility studyCardiac troponin IDetectable cTnIWeekly paclitaxelMonth 6CTnI levelsEjection fractionMonth 3Months 0Month 2Breast cancerEarly biomarkersPatientsChemotherapyEarly detectionTrastuzumab
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 IInternational Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured?
Pagani O, Senkus E, Wood W, Colleoni M, Cufer T, Kyriakides S, Costa A, Winer EP, Cardoso F. International Guidelines for Management of Metastatic Breast Cancer: Can Metastatic Breast Cancer Be Cured? Journal Of The National Cancer Institute 2010, 102: 456-463. PMID: 20220104, PMCID: PMC3298957, DOI: 10.1093/jnci/djq029.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsBreast NeoplasmsCatheter AblationChemotherapy, AdjuvantClinical Trials as TopicCongresses as TopicConsensus Development Conferences as TopicDose-Response Relationship, DrugEarly Detection of CancerEuropeFemaleGene Expression ProfilingHumansImmunosuppressive AgentsInterdisciplinary CommunicationInternational CooperationLiver NeoplasmsLung NeoplasmsNeoplasm StagingNeoplastic Cells, CirculatingObserver VariationPatient Care TeamPatient SelectionPractice Guidelines as TopicRadiotherapy, AdjuvantSurvival RateConceptsMetastatic breast cancerOligometastatic diseaseBreast cancerMetastatic lesionsPrimary tumorEuropean Breast Cancer ConferenceFirst consensus recommendationsOptimal local treatmentRapid disease controlAvailable therapeutic optionsSubset of patientsLong-term outcomesLarge retrospective seriesDetectable metastatic lesionsAttractive therapeutic strategyChemotherapy optionsSurvival benefitSystemic therapyTreatment guidelinesRegional chemotherapyRetrospective seriesTask ForceLung metastasesTherapeutic optionsPatient population
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 weekBevacizumabTolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer
Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Research And Treatment 2009, 117: 615-623. PMID: 19294501, PMCID: PMC4578795, DOI: 10.1007/s10549-009-0366-5.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerStable diseaseValidation cohortBreast cancerSequential cohortsPhase ICombination oral therapyOral antineoplastic therapyDays on/7Primary endpointSecondary endpointsOral therapyPartial responseAntineoplastic therapySerious toxicityDose reductionDrug dosesM2/dayCohortSignificant toxicityPatientsTherapyMTDCycle 1Capecitabine
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
2005
Dose Density in Breast Cancer: A Simple Message?
Lin NU, Gelman R, Winer EP. Dose Density in Breast Cancer: A Simple Message? Journal Of The National Cancer Institute 2005, 97: 1712-1714. PMID: 16333021, DOI: 10.1093/jnci/dji438.Peer-Reviewed Original ResearchAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantClinical Trials, Phase III as TopicConfounding Factors, EpidemiologicCyclophosphamideDisease-Free SurvivalDose-Response Relationship, DrugEpirubicinFemaleFluorouracilHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignRisk FactorsSurvival AnalysisTreatment OutcomeQuality of life among patients with Stage II and III breast carcinoma randomized to receive high‐dose chemotherapy with autologous bone marrow support or intermediate‐dose chemotherapy
Peppercorn J, Herndon J, Kornblith AB, Peters W, Ahles T, Vredenburgh J, Schwartz G, Shpall E, Hurd DD, Holland J, Winer E, Group T. Quality of life among patients with Stage II and III breast carcinoma randomized to receive high‐dose chemotherapy with autologous bone marrow support or intermediate‐dose chemotherapy. Cancer 2005, 104: 1580-1589. PMID: 16118805, DOI: 10.1002/cncr.21363.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBone Marrow TransplantationBreast NeoplasmsCarmustineChemotherapy, AdjuvantCisplatinCombined Modality TherapyCyclophosphamideDose-Response Relationship, DrugFemaleHumansMiddle AgedNeoplasm StagingQuality of LifeSurvival RateTime FactorsTransplantation, AutologousConceptsQuality of lifeFunctional Living Index-CancerPositive lymph nodesHigh-dose chemotherapySymptom Distress ScaleBreast carcinomaHDC armLymph nodesQOL scoresAutologous bone marrow supportAutologous stem cell supportMcCorkle Symptom Distress ScaleMultiple positive lymph nodesAutologous bone marrow transplantationIntensive adjuvant therapyBone marrow supportHigh-dose cyclophosphamideStem cell supportTotal QOL scoreBone marrow transplantationAdjuvant chemotherapyAdjuvant settingAdjuvant therapyMarrow supportIndex cancer