2022
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2
2021
Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study
Emens LA, Molinero L, Loi S, Rugo HS, Schneeweiss A, Diéras V, Iwata H, Barrios CH, Nechaeva M, Nguyen-Duc A, Chui SY, Husain A, Winer EP, Adams S, Schmid P. Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study. Journal Of The National Cancer Institute 2021, 113: 1005-1016. PMID: 33523233, PMCID: PMC8328980, DOI: 10.1093/jnci/djab004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerMetastatic triple-negative breast cancerProgression-free survivalPD-L1Tumor immune microenvironmentBreast cancerIntratumoral CD8Nab-paclitaxelClinical benefitImmune microenvironmentImmune cellsBRCA1/2 mutationsAdvanced triple-negative breast cancerStromal tumor-infiltrating lymphocytesNab-paclitaxel 100Immune checkpoint inhibitorsOverall survival benefitTumor-infiltrating lymphocytesMetastatic tumor tissueBRCA1/2 mutation statusCheckpoint inhibitorsOverall survivalSurvival benefitImmune biomarkersClinical activity
2018
Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study
Li D, McCall LM, Hahn OM, Hudis CA, Cohen HJ, Muss HB, Jatoi A, Lafky JM, Ballman KV, Winer EP, Tripathy D, Schneider B, Barry W, Dickler MN, Hurria A. Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Research And Treatment 2018, 171: 325-334. PMID: 29789969, PMCID: PMC6076849, DOI: 10.1007/s10549-018-4828-5.Peer-Reviewed Original ResearchConceptsHormone receptor-positive advanced breast cancerAdvanced breast cancerIncidence of gradeAdverse eventsBreast cancerPhysical functionProgression-free survival benefitMultivariable logistic regression modelAddition of bevacizumabPhase III trialsPhysical function measuresAdverse event dataFunctional Assessment MeasureIncidence of toxicityFlight of stairsLogistic regression modelsHemorrhagic eventsIII trialsSurvival benefitMedian ageThrombosis eventsRisk factorsUnivariate analysisAssessment measuresBevacizumab
2017
T-DM1 — an important agent in the history of breast cancer management
Metzger-Filho O, Winer EP. T-DM1 — an important agent in the history of breast cancer management. Nature Reviews Clinical Oncology 2017, 14: 651-652. PMID: 28786416, DOI: 10.1038/nrclinonc.2017.123.Peer-Reviewed Original ResearchConceptsT-DM1HER2-positive breast cancerOverall survival benefitFavorable safety profileBreast cancer managementRelevant therapeutic targetTH3RESA trialProlonged followSurvival benefitSafety profileBreast cancerCancer managementTherapeutic targetLater linesImportant agentsPatientsHER2FollowCancerDiseaseTrialsSurvival benefit needed to undergo chemotherapy: Patient and physician preferences
Vaz‐Luis I, O'Neill A, Sepucha K, Miller KD, Baker E, Dang CT, Northfelt DW, Winer EP, Sledge GW, Schneider B, Partridge AH. Survival benefit needed to undergo chemotherapy: Patient and physician preferences. Cancer 2017, 123: 2821-2828. PMID: 28323331, PMCID: PMC5517352, DOI: 10.1002/cncr.30671.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAttitude of Health PersonnelAttitude to HealthBevacizumabBreast NeoplasmsChemotherapy, AdjuvantClinical Trials, Phase III as TopicCyclophosphamideDoxorubicinFemaleHumansMastectomyMastectomy, SegmentalMiddle AgedPaclitaxelPatient PreferencePhysiciansQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentSurveys and QuestionnairesSurvival RateTumor BurdenConceptsMonths of chemotherapyModest survival benefitSurvival benefitAdjuvant chemotherapyEarly-stage breast cancerContemporary adjuvant chemotherapyPhase 3 trialBreast cancer patientsStage breast cancerQuality of lifeMonths of benefitsAdjuvant cyclophosphamideAdjuvant doxorubicinChemotherapy regimenMost patientsUndergoing ChemotherapyCancer patientsPatient preferencesBreast cancerModest benefitOld regimenChemotherapyPatientsPhysician's choiceSerial surveys
2014
Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profile
2010
International 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
Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148).
Berry D, Berry D, Thor A, Jewell S, Broadwater G, Edgerton S, Hayes D, Hudis C, Winer E, Nielsen T, Ellis M. Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148). Cancer Research 2009, 69: 606-606. DOI: 10.1158/0008-5472.sabcs-09-606.Peer-Reviewed Original ResearchAdjuvant doxorubicin/cyclophosphamideNode-positive breast cancerWhole section analysisTissue microarrayHazard ratioER statusBreast cancerAdjuvant phase III trialsDouble-negative tumorsDoxorubicin/cyclophosphamideNon-responding patientsPhase III trialsMajority of patientsMultivariate Cox modelConfidence intervalsTumor tissue microarraysSet of patientsTMA cohortHormonal therapyIII trialsSurvival benefitCentral pathologyPathology blocksKaplan-MeierClinical assessmentPrognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, America F. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology 2009, 11: 55-65. PMID: 20005174, PMCID: PMC3058239, DOI: 10.1016/s1470-2045(09)70314-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic TestingHumansKaplan-Meier EstimateLymphatic MetastasisMiddle AgedPatient SelectionPostmenopausePredictive Value of TestsProportional Hazards ModelsRandomized Controlled Trials as TopicReceptors, EstrogenRecurrenceRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRisk AssessmentTamoxifenTime FactorsTreatment OutcomeUnited StatesConceptsLow recurrence scorePositive breast cancerAnthracycline-based chemotherapyDisease-free survivalHigh recurrence scoreRecurrence scorePositive nodesBreast cancerPostmenopausal womenRetrospective analysisNode-positive breast cancerTamoxifen-alone groupTamoxifen-treated patientsPhase 3 trialNational Cancer InstituteEffect of recurrenceOverall survivalSpecific survivalSurvival benefitCox regressionHigh riskTreatment groupsCancer InstituteChemotherapyPredictive value
2006
Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience
Muss H, Berry D, Cirrincione C, Budman D, Henderson I, Citron M, Norton L, Winer E, Hudis C. Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience. Journal Of Clinical Oncology 2006, 24: 559-559. DOI: 10.1200/jco.2006.24.18_suppl.559.Peer-Reviewed Original ResearchAML/MDSNon-hematologic toxicitiesBreast cancerOlder ptsYounger ptsNode-positive breast cancerIntensive adjuvant chemotherapyAge-adjusted ratesStrict eligibility criteriaAdjuvant chemotherapyHematologic toxicityMajor toxicitySurvival benefitYounger patientsCardiac deathClinical trialsGrade 3Eligibility criteriaHigh incidenceNormal populationIncidenceDeathTrialsRegimensSignificant differences
1999
Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis.
Parmigiani G, Berry D, Winer E, Tebaldi C, Iglehart J, Prosnitz L. Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis. Journal Of Clinical Oncology 1999, 17: 1465-73. PMID: 10334532, DOI: 10.1200/jco.1999.17.5.1465.Peer-Reviewed Original ResearchConceptsAxillary lymph node dissectionBenefits of ALNDLymph node dissectionQuality of lifeAdjuvant chemotherapyAdjuvant therapyNode dissectionBreast cancerLeukemia Group B StudyEarly-stage breast cancerRoutine useAxillary radiation therapyER-negative womenER-positive womenAdjuvant systemic therapySmall primary tumorsBreast-conserving therapyBreast cancer patientsEstrogen receptor statusNegative axillaOxford OverviewAdjuvant treatmentChemotherapy combinationsSurvival benefitSystemic therapy
1995
Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer.
Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, Lembersky B, Budman D, Bigley J, Hohneker J. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. Journal Of Clinical Oncology 1995, 13: 2567-74. PMID: 7595708, DOI: 10.1200/jco.1995.13.10.2567.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic AgentsBreast NeoplasmsDisease ProgressionDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematologic DiseasesHumansInjections, IntravenousMelphalanMiddle AgedProportional Hazards ModelsProspective StudiesQuality of LifeSurvival RateVinblastineVinorelbineConceptsQuality of lifeAdvanced breast cancerCancer-related symptomsTreatment failureBreast cancerALK patientsSurvival rateStabilization of diseaseEfficacy end pointTumor response ratePopulation of patientsMedian survival rateCommon toxicitiesProspective multicenterObjective responseSeptic deathSurvival benefitRandomized comparisonPatient populationPatientsIntergroup differencesTreatment centersResponse rateEnd pointVinorelbine tartrate