2021
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse events
2019
Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study
Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O’Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 397-404. PMID: 30475950, DOI: 10.1093/annonc/mdy517.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerDisease control ratePD-L1Positive populationPembrolizumab monotherapyMetastatic diseaseControl rateBreast cancerTreatment-related adverse eventsEnd pointManageable safety profileObjective response ratePrimary end pointSecondary end pointsProgression-free survivalSubset of patientsDurable antitumor activityDuration of responseLine of treatmentEligible patientsMedian OSMedian PFSAdverse eventsMedian duration
2016
Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511)
Freedman RA, Seisler DK, Foster JC, Sloan JA, Lafky JM, Kimmick GG, Hurria A, Cohen HJ, Winer EP, Hudis CA, Partridge AH, Carey LA, Jatoi A, Klepin HD, Citron M, Berry DA, Shulman LN, Buzdar AU, Suman VJ, Muss HB. Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511). Breast Cancer Research And Treatment 2016, 161: 363-373. PMID: 27866278, PMCID: PMC5226883, DOI: 10.1007/s10549-016-4051-1.Peer-Reviewed Original ResearchConceptsAML/MDSAcute myeloid leukemiaOlder patientsAdjuvant chemotherapyMyeloid leukemiaBreast cancerAnthracycline-based adjuvant chemotherapyMultivariable Cox regressionCooperative group trialsEffect of cyclophosphamideRace/ethnicityAnthracycline usePerformance statusCox regressionMyelodysplastic syndromeClinical trialsGroup trialsOlder womenOncology trialsPatientsStudy registrationOlder ageAnthracyclinesCancerAge
2015
Pneumocystis jiroveci pneumonia (PCP) in patients receiving neoadjuvant and adjuvant anthracycline-based chemotherapy for breast cancer: incidence and risk factors
Waks AG, Tolaney SM, Galar A, Arnaout A, Porter JB, Marty FM, Winer EP, Hammond SP, Baden LR. Pneumocystis jiroveci pneumonia (PCP) in patients receiving neoadjuvant and adjuvant anthracycline-based chemotherapy for breast cancer: incidence and risk factors. Breast Cancer Research And Treatment 2015, 154: 359-367. PMID: 26420402, DOI: 10.1007/s10549-015-3573-2.Peer-Reviewed Original ResearchConceptsPneumocystis jiroveci pneumoniaCases of PCPEarly-stage breast cancerBreast cancerJiroveci pneumoniaAC chemotherapyRisk factorsDana-Farber Cancer Institute/BrighamNon-metastatic breast cancer patientsAdjuvant anthracycline-based chemotherapyEarly-stage breast cancer treatmentAdriamycin/cyclophosphamideDose-dense ACAnthracycline-based chemotherapyDose-dense scheduleBreast cancer patientsBreast cancer treatmentEquivalents/dayCalculate incidenceCorticosteroid doseNausea prophylaxisSame chemotherapyOpportunistic infectionsOverall incidencePCP incidenceTailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015
Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thürlimann B, Senn H, Members P, André F, Baselga J, Bergh J, Bonnefoi H, Burstein H, Cardoso F, Castiglione-Gertsch M, Coates A, Colleoni M, Curigliano G, Davidson N, Di Leo A, Ejlertsen B, Forbes J, Galimberti V, Gelber R, Gnant M, Goldhirsch A, Goodwin P, Harbeck N, Hayes D, Huober J, Hudis C, Ingle J, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne C, Partridge A, de la Peña L, Piccart-Gebhart M, Pritchard K, Rutgers E, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Thürlimann B, Toi M, Tutt A, Viale G, von Minckwitz G, Watanabe T, Whelan T, Winer E, Xu B. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Annals Of Oncology 2015, 26: 1533-1546. PMID: 25939896, PMCID: PMC4511219, DOI: 10.1093/annonc/mdv221.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAxillaBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Intraductal, NoninfiltratingCarcinoma, LobularChemotherapy, AdjuvantFemaleHumansLymph Node ExcisionMastectomyMastectomy, SegmentalNeoplasm StagingPlatinum CompoundsPractice Guidelines as TopicRadiotherapy, AdjuvantReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTamoxifenTaxoidsTrastuzumabConceptsEarly breast cancerLuminal diseaseBreast cancerSt Gallen International Breast Cancer ConferenceSt Gallen International Expert ConsensusNew breast cancer casesPanel recommendationsEndocrine-responsive diseaseHER2-positive diseaseOvarian function suppressionNode-positive diseaseBreast cancer deathsER-negative diseaseTreatment of patientsAnnals of OncologyNode-negative cancersPremature ovarian failureBreast cancer casesSubstantial new evidenceInternational expert consensusPremenopausal patientsSimplified regimenAdjuvant therapyAxillary dissectionPremenopausal women
2013
A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901
Mandelblatt JS, Makgoeng SB, Luta G, Hurria A, Kimmick G, Isaacs C, Tallarico M, Barry WT, Pitcher B, Winer EP, Hudis C, Cohen HJ, Muss HB. A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901. Journal Of Geriatric Oncology 2013, 4: 353-361. PMID: 24472479, PMCID: PMC3910230, DOI: 10.1016/j.jgo.2013.05.004.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsOlder womenStandard chemotherapyClinical trialsProspective comparisonObservational studyBreast cancerNon-metastatic breast cancerOlder cancer populationPre-treatment QoLTherapy side effectsBreast cancer chemotherapyShort-term qualityAdjusted mean increaseQuality of lifeTumor factorsOlder patientsAnthracycline regimensQOL scoresGlobal QoLCancer populationSide effectsGroup physiciansChemotherapyLinear mixed effects models
2012
A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine
Krop IE, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. Journal Of Clinical Oncology 2012, 30: 3234-3241. PMID: 22649126, DOI: 10.1200/jco.2011.40.5902.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansImmunotoxinsLapatinibMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisQuinazolinesReceptor, ErbB-2TaxoidsTrastuzumabConceptsHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalOverall response rateMedian progression-free survivalPhase II studyT-DM1II studyTrastuzumab emtansineBreast cancerResponse rateSingle-arm phase II studyEpidermal growth factor receptor 2Human epidermal growth factor receptorClinical benefit rateHER2-directed therapiesMost adverse eventsGrowth factor receptor 2Single-agent activityHER2-positive tumorsMultiple chemotherapy agentsEffective new treatmentsFactor receptor 2Epidermal growth factor receptorChoosing the Best Trastuzumab-Based Adjuvant Chemotherapy Regimen: Should We Abandon Anthracyclines?
Burstein HJ, Piccart-Gebhart MJ, Perez EA, Hortobagyi GN, Wolmark N, Albain KS, Norton L, Winer EP, Hudis CA. Choosing the Best Trastuzumab-Based Adjuvant Chemotherapy Regimen: Should We Abandon Anthracyclines? Journal Of Clinical Oncology 2012, 30: 2179-2182. PMID: 22614986, PMCID: PMC6076002, DOI: 10.1200/jco.2012.42.0695.Peer-Reviewed Original Research
2011
CMF revisited in the 21st century
Munzone E, Curigliano G, Burstein HJ, Winer EP, Goldhirsch A. CMF revisited in the 21st century. Annals Of Oncology 2011, 23: 305-311. PMID: 21715566, DOI: 10.1093/annonc/mdr309.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerClassical CMFOptimal chemotherapy backboneRecent retrospective dataUse of CMFTreatment of patientsTriple negative cellsPoly (ADP-ribose) polymerase (PARP) inhibitorsMechanism of actionAdjuvant CMFChemotherapy backboneAdjuvant treatmentRetrospective dataSpecific subgroupsPolymerase inhibitorsCancerTrue effectivenessPatientsCMFPlatinum compoundsDrugsTreatmentPast yearYears
2009
International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy
Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ, Kyriakides S, Costa A, Cufer T, Albain KS, Force O. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy. Journal Of The National Cancer Institute 2009, 101: 1174-1181. PMID: 19657108, PMCID: PMC2736293, DOI: 10.1093/jnci/djp235.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAnthracyclinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCapecitabineComorbidityCongresses as TopicCross-Over StudiesDeoxycytidineDrug Administration ScheduleEuropeEvidence-Based MedicineFemaleFluorouracilHumansInternational CooperationKarnofsky Performance StatusMenopausePatient SelectionPractice Guidelines as TopicQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexSocioeconomic FactorsTaxoidsVinblastineVinorelbineConceptsMetastatic breast cancerSequential single-agent chemotherapySingle-agent chemotherapyBreast cancerEarly-stage breast cancerEuropean Breast Cancer ConferenceSequential single agentsPatient-rated qualityRapid clinical progressionDisease-related factorsImpact of therapySequential monotherapyAdvanced diseaseSequential therapyVisceral metastasesCytotoxic chemotherapyTask ForceClinical progressionPredictive factorsTreatment optionsCancer ConferenceRapid symptomsSingle agentChemotherapyInternational guidelinesTopoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013
Harris LN, Broadwater G, Abu-Khalaf M, Cowan D, Thor AD, Budman D, Cirrincione CT, Berry DA, Winer EP, Hudis CA, Hayes DF, Friedman P, Ellis M, Dressler L. Topoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013. Journal Of Clinical Oncology 2009, 27: 3430-3436. PMID: 19470942, PMCID: PMC4979079, DOI: 10.1200/jco.2008.18.4085.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntibiotics, AntineoplasticAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclophosphamideDNA Topoisomerases, Type IIDNA-Binding ProteinsDoxorubicinDrug InteractionsFluorouracilGene AmplificationHumansImmunohistochemistryReceptor, ErbB-2
2008
Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer
Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Research And Treatment 2008, 115: 115-121. PMID: 18496750, DOI: 10.1007/s10549-008-0055-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCohort StudiesDeoxycytidineDisease ProgressionErbB ReceptorsErlotinib HydrochlorideFemaleFluorouracilHumansMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsQuinazolinesTaxoidsConceptsAdvanced breast cancerSafety of erlotinibBreast cancerCohort 1 patientsCohort 2 patientsResults One patientCommon adverse eventsPhase II studyAdvanced stage diseaseMetastatic breast cancerBreast cancer patientsPrimary endpointSecondary endpointsAdverse eventsII studyPartial responseMedian timePredictive factorsCancer patientsErlotinib treatmentCohort 2Cohort 1Design MulticenterOne patientDry skin