2021
Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial
Winer EP, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J, investigators K. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. The Lancet Oncology 2021, 22: 499-511. PMID: 33676601, DOI: 10.1016/s1470-2045(20)30754-3.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerCombined positive scoreMedian overall survivalPD-L1 combined positive scoreTreatment-related adverse eventsPhase 3 trialChemotherapy groupOverall survivalPembrolizumab groupBreast cancerAdverse eventsPrimary endpointMetastatic diseaseEastern Cooperative Oncology Group performance statusPD-L1 tumor statusCommon grade 3Durable antitumour activityInvestigator-choice chemotherapyPrevious systemic treatmentSerious adverse eventsThird-line treatmentSubpopulation of patientsTreatment of patientsSingle-drug chemotherapy
2019
Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPoisson DistributionPolymorphism, Single NucleotideReceptor, ErbB-2RecurrenceRiskTrastuzumabTreatment OutcomeConceptsDisease-free survivalRecurrence-free intervalSmall HER2-positive tumorsAdjuvant paclitaxelHER2-positive tumorsLong-term outcomesTrastuzumab trialsBreast cancerOverall survivalSmall human epidermal growth factor receptor 2Breast cancer-specific survivalPaclitaxel-induced peripheral neuropathyExcellent long-term outcomesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorPAM50 intrinsic subtypesCancer-specific survivalPhase II studyPrimary end pointGrowth factor receptor 2Positive breast cancerTreatment of patientsSeven-year follow
2015
Tailoring 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
2014
Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Saura C, Lowe E, Frewer P, Winer E, Baselga J, Garber J. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Annals Of Oncology 2014, 25: 1656-1663. PMID: 24827126, DOI: 10.1093/annonc/mdu187.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsBRCA1/2 mutationsDay 1Overall objective response rateBID days 1Grade 3 neutropeniaObjective response ratePhase I trialTreatment of patientsGermline BRCA1/2 mutationsColony-stimulating factorWarrants further investigationAdvanced breastHematologic supportMeasurable diseaseOral olaparibAdverse eventsI trialTreatment cohortsLipase elevationCisplatin dosesFrequent gradePreliminary efficacyStandard treatment
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
2006
Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer
Naughton M, Gu L, Wang X, Seidman A, Winer E, Kornblith A. Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2006, 24: 674-674. DOI: 10.1200/jco.2006.24.18_suppl.674.Peer-Reviewed Original ResearchNegative patientsQOL differencesGreater efficacyMain trial resultsPrior radiation therapyMetastatic breast cancerPhase III studyTreatment of patientsMain outcome measuresEORTC-C30Prior chemotherapyBreast symptomsIII studyPerformance statusPatient ageHour infusionTreatment armsBreast moduleGlobal QoLCancer symptomsBreast cancerClinical dataQoL dataOutcome measuresRadiation therapy
2003
Multicenter phase II study of oral bexarotene for patients with metastatic breast cancer.
Esteva FJ, Glaspy J, Baidas S, Laufman L, Hutchins L, Dickler M, Tripathy D, Cohen R, DeMichele A, Yocum RC, Osborne CK, Hayes DF, Hortobagyi GN, Winer E, Demetri GD. Multicenter phase II study of oral bexarotene for patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 999-1006. PMID: 12637463, DOI: 10.1200/jco.2003.05.068.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBexaroteneBreast NeoplasmsDisease ProgressionDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleEstrogen Receptor ModulatorsFemaleHumansMiddle AgedReceptors, EstrogenReceptors, ProgesteroneSurvival AnalysisTamoxifenTetrahydronaphthalenesThyroid HormonesToremifeneTreatment OutcomeConceptsMetastatic breast cancerTamoxifen-resistant patientsPartial responseStable diseaseBreast cancerOral bexaroteneAdverse eventsCommon drug-related adverse eventsDrug-related serious adverse eventsDrug-related adverse eventsMulticenter phase II studyRefractory metastatic breast cancerRetinoid X receptor-selective retinoidEfficacy of bexarotenePhase II studySerious adverse eventsChemotherapy-refractory patientsGroup of patientsReceptor-selective retinoidsHormone-refractory patientsTreatment of patientsCases of pancreatitisDrug-related deathsPreclinical antitumor activityOral agents
1999
Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642.
Costanza M, Weiss R, Henderson I, Norton L, Berry D, Cirrincione C, Winer E, Wood W, Frei III E, McIntyre O, Schilsky R. Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642. Journal Of Clinical Oncology 1999, 17: 1397-406. PMID: 10334524, DOI: 10.1200/jco.1999.17.5.1397.Peer-Reviewed Original ResearchMeSH KeywordsAdenineAdultAgedAminoglycosidesAnalysis of VarianceAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCyclophosphamideDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansImidesIsoquinolinesMelphalanMiddle AgedNaphthalimidesNeoplasm StagingOrganophosphonatesProspective StudiesSurvival AnalysisTrimetrexateConceptsPhase II agentMetastatic breast cancer patientsStandard combination chemotherapyMetastatic breast cancerBreast cancer patientsSingle agentResponse rateCombination chemotherapyCancer patientsBreast cancerUntreated metastatic breast cancer patientsMeasurable metastatic breast cancerRandomized phase III trialPhase III trialsDuration of responseSingle-agent drugsTreatment of patientsCumulative response rateSuggestion of benefitLow response rateImmediate chemotherapyIII trialsMetastatic diseaseVisceral diseaseRandomized studyQuality of life in patients surviving at least 12 months following high dose chemotherapy with autologous bone marrow support
Winer E, Lindley C, Hardee M, Sawyer W, Brunatti C, Borstelmann N, Peters W. Quality of life in patients surviving at least 12 months following high dose chemotherapy with autologous bone marrow support. Psycho-Oncology 1999, 8: 167-176. PMID: 10335560, DOI: 10.1002/(sici)1099-1611(199903/04)8:2<167::aid-pon354>3.0.co;2-s.Peer-Reviewed Original ResearchConceptsFunctional Living Index-CancerHigh-dose chemotherapyQuality of lifeAutologous bone marrow supportBone marrow supportSymptom Distress ScaleDose chemotherapyBreast cancerMarrow supportSexual functioningMajority of patientsBreast cancer patientsLong-term outcomesTreatment of patientsMore yearsFLIC scoresTransplant supportIndex cancerRecurrent diseaseAssessment of qualityMedian timeCancer patientsSexual functionClinical trialsSevere symptoms
1998
Oral 5-FU analogues in the treatment of breast cancer.
Bunnell CA, Winer EP. Oral 5-FU analogues in the treatment of breast cancer. Oncology 1998, 12: 39-43. PMID: 9830624.Peer-Reviewed Original ResearchConceptsPhase II trialBreast cancer patientsBreast cancerII trialCancer patientsResponse rateOpen-label phase II trialRandomized phase II studyCombination of UFTHand-foot syndromePartial response ratePhase II studyTreatment-related toxicityAdvanced breast cancerMetastatic breast cancerOverall response rateTreatment of patientsPreliminary response dataAnthracycline useCommon toxicitiesSalvage therapyMetastatic settingII studyTherapeutic armamentariumGrade 3
1997
Breast Cancer
Chu L, Winer E. Breast Cancer. 1997, 257-279. DOI: 10.1007/978-1-4757-2705-0_20.Peer-Reviewed Original ResearchBreast cancerOlder womenMost randomized studiesBreast cancer increasesWomen 65 yearsTreatment of patientsYears of ageOlder patientsRandomized studyIndolent diseaseCancer increasesFunctional statusGeriatric populationRelative survivalTumor biologyAge groupsCancerFemale populationYoung womenCommon diseaseWomenPatientsAgeDiseaseSocial support