2023
Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
Schmid P, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia J, Zhou X, Haiderali A, Nguyen A, Cortes J, Winer E. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. European Journal Of Cancer 2023, 195: 113393. PMID: 37976633, DOI: 10.1016/j.ejca.2023.113393.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerCombined positive scoreMetastatic triple-negative breast cancerPD-L1 combined positive scoreHealth-related qualityBreast cancerQLQ-C30 functional scalesTumor PD-L1 expressionGHS/QoLNausea/vomitingPD-L1 expressionStart of treatmentHRQoL resultsEligible patientsHRQoL analysisOverall survivalSystemic therapyClinical outcomesFunctional scalesPhysician's choicePatientsChemotherapyFirst onsetCountry guidelinesMedian TTDCirculating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆
Parsons H, Blewett T, Chu X, Sridhar S, Santos K, Xiong K, Abramson V, Patel A, Cheng J, Brufsky A, Rhoades J, Force J, Liu R, Traina T, Carey L, Rimawi M, Miller K, Stearns V, Specht J, Falkson C, Burstein H, Wolff A, Winer E, Tayob N, Krop I, Makrigiorgos G, Golub T, Mayer E, Adalsteinsson V. Circulating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆. Annals Of Oncology 2023, 34: 899-906. PMID: 37597579, PMCID: PMC10898256, DOI: 10.1016/j.annonc.2023.08.004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerResidual cancer burdenNeoadjuvant chemotherapyCancer burdenBreast cancerWeek 3Additional neoadjuvant chemotherapyPlasma samplesCase-control analysisCtDNA clearanceCtDNA positivityNeoadjuvant paclitaxelDisease recurrenceProspective studyWeek 12RCB 0CtDNA assaysPatientsSufficient tissueChemotherapyTumor fractionTumor DNARCB-3RespondersAdditional studies190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119
Cortés J, Lipatov O, Im S, Gonçalves A, Lee K, Schmid P, Tamura K, Testa L, Ohtani S, Harbeck N, Loi S, Salgado R, Lunceford J, Karantza V, Mejia J, Cristescu R, Nebozhyn M, Jelinic P, Huang L, Winer E. 190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119. ESMO Open 2023, 8: 101379. DOI: 10.1016/j.esmoop.2023.101379.Peer-Reviewed Original Research
2022
Erratum to “Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust” [Annals of Oncology 32 (2021) 1077–1082]
Piccart M, Kalinsky K, Gray R, Barlow W, Poncet C, Cardoso F, Winer E, Sparano J. Erratum to “Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust” [Annals of Oncology 32 (2021) 1077–1082]. Annals Of Oncology 2022, 33: 668. PMID: 35487836, DOI: 10.1016/j.annonc.2022.04.001.Peer-Reviewed Original Research
2021
Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust
Piccart M, Kalinsky K, Gray R, Barlow W, Poncet C, Cardoso F, Winer E, Sparano J. Gene expression signatures for tailoring adjuvant chemotherapy of luminal breast cancer: stronger evidence, greater trust. Annals Of Oncology 2021, 32: 1077-1082. PMID: 34082017, DOI: 10.1016/j.annonc.2021.05.804.Peer-Reviewed Original Research
2020
44O Pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-119 Asia-Pacific subpopulation
Im S, Cortes J, Lipatov O, Goncalves A, Lee K, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Zambelli S, Harbeck N, Andre F, Dent R, Lin J, Karantza V, Mejia J, Winer E. 44O Pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-119 Asia-Pacific subpopulation. Annals Of Oncology 2020, 31: s1258. DOI: 10.1016/j.annonc.2020.10.064.Peer-Reviewed Original Research141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer
Schmid P, Haiderali A, Mejia J, Guo Z, Zhou X, Martin-Nguyen A, Cortés J, Winer E. 141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer. Annals Of Oncology 2020, 31: s65-s66. DOI: 10.1016/j.annonc.2020.03.242.Peer-Reviewed Original Research
2019
TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.
Mayer E, Abramson V, Jankowitz R, Falkson C, Marcom P, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Perou C, Richardson A, Tung N, Barry W, Tan-Wasielewski Z, Timms K, Hartman A, Wolff A, Winer E. TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker. Journal Of Clinical Oncology 2019, 37: 507-507. DOI: 10.1200/jco.2019.37.15_suppl.507.Peer-Reviewed Original ResearchPhase II studyII studyPreoperative chemotherapyHRD scoreRandomized phase II studyOne-sided type I errorCo-primary objectivesNew safety signalsSimilar response ratesHomologous recombination deficiency biomarkersPreoperative cisplatinTNBC cohortPathologic responseRCB 0Evaluable specimensPredictive biomarkersAlternative chemotherapySpecific chemotherapySafety signalsArm CCT armChemotherapyStage IResponse rateBaseline tissue
2018
69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer
Waks A, Winer E. 69 Chemotherapy and HER2-Directed Therapy for Metastatic Breast Cancer. 2018, 885-906.e8. DOI: 10.1016/b978-0-323-35955-9.00069-6.Peer-Reviewed Original ResearchMetastatic breast cancerBreast cancerHER2-positive metastatic breast cancerTriple-negative breast cancerTriple-negative diseaseBRCA-deficient breast cancersUnderstanding of treatmentDistinct disease subtypesBrain metastasesOverall survivalSystemic therapyClinical efficacyNovel therapiesDisease subtypesTherapyCancerHER2ChemotherapyImportant advancesImmunotherapyPertuzumabPatientsMetastasisSubtypesDisease
2017
Lymphedema, musculoskeletal events and arm function in older patients receiving adjuvant chemotherapy for breast cancer (Alliance A171302)
Hopkins JO, Allred J, Hurria A, Jatoi A, Lafky JM, Cohen H, Hudis C, Winer E, Mandelblatt J, Partridge A, Carey L, Muss HB. Lymphedema, musculoskeletal events and arm function in older patients receiving adjuvant chemotherapy for breast cancer (Alliance A171302). Breast Cancer Research And Treatment 2017, 166: 793-808. PMID: 28825227, PMCID: PMC5771504, DOI: 10.1007/s10549-017-4454-7.Peer-Reviewed Original ResearchConceptsQuality of lifeArm functionBreast cancerAdjuvant chemotherapyMusculoskeletal eventsPhysician-reported adverse eventsIncidence of lymphedemaAxillary node dissectionType of chemotherapyEORTC QLQ-BR23Breast cancer treatmentImpact of treatmentDetection of lymphedemaCALGB 49907Node dissectionAdverse eventsOlder patientsQLQ-BR23Standard therapyStudy entryWomen 65Month 2Elderly womenPatientsChemotherapySurvival 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
2016
KEYNOTE-119: A randomized phase III study of single-agent pembrolizumab (MK-3475) vs single-agent chemotherapy per physician's choice for metastatic triple-negative breast cancer (mTNBC).
Winer E, Dang T, Karantza V, Su S. KEYNOTE-119: A randomized phase III study of single-agent pembrolizumab (MK-3475) vs single-agent chemotherapy per physician's choice for metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2016, 34: tps1102-tps1102. DOI: 10.1200/jco.2016.34.15_suppl.tps1102.Peer-Reviewed Original Research
2015
Tailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer
Stover DG, Winer EP. Tailoring adjuvant chemotherapy regimens for patients with triple negative breast cancer. The Breast 2015, 24: s132-s135. PMID: 26255198, DOI: 10.1016/j.breast.2015.07.032.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerAdjuvant chemotherapyHigh-risk triple negative breast cancerLong-term outcome dataAnthracycline-taxane combinationsBRCA mutation carriersStandard of careNegative breast cancerPoor prognosis subtypeAdjuvant settingStandard regimensToxic regimensMetastatic settingCytotoxic chemotherapySystemic therapyImmune infiltratesTumor characteristicsMutation carriersOutcome dataWarrants further considerationStage ISpecific subgroupsChemotherapyCancerStandard chemotherapy versus capcitabine for older women with early stage breast cancer: An update of CALGB/CTSU/Alliance 49907.
Muss H, Berry D, Cirrincione C, Theodoulou M, Hurria A, Cohen H, Partridge A, Norton L, Hudis C, Winer E. Standard chemotherapy versus capcitabine for older women with early stage breast cancer: An update of CALGB/CTSU/Alliance 49907. Journal Of Clinical Oncology 2015, 33: 1022-1022. DOI: 10.1200/jco.2015.33.15_suppl.1022.Peer-Reviewed Original ResearchGenomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, Eckel-Passow JE, Dueck AC, Tenner KS, Jen J, Fan JB, Geiger XJ, McCullough AE, Chen B, Jenkins RB, Sledge GW, Winer EP, Gralow JR, Reinholz MM. Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. Journal Of Clinical Oncology 2015, 33: 701-708. PMID: 25605861, PMCID: PMC4334774, DOI: 10.1200/jco.2014.57.6298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticGenomicsHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyProportional Hazards ModelsReceptor, ErbB-2TranscriptomeTrastuzumabConceptsRelapse-free survivalImmune function genesAdjuvant trastuzumab trialsArm BTrastuzumab trialsHazard ratioArm AHuman epidermal growth factor receptorClinicopathologic risk factorsProportional hazard ratiosEpidermal growth factor receptorGrowth factor receptorAdjuvant trastuzumabC patientsCombination chemotherapyClinical outcomesRisk factorsBreast cancerPatientsTrastuzumabPredictive signatureFunction genesChemotherapyGene enrichmentFactor receptor
2014
Adjuvant Chemotherapy in Breast Cancer
Lim E, Goel S, Winer E. Adjuvant Chemotherapy in Breast Cancer. 2014, 335-351. DOI: 10.1007/978-1-4939-1145-5_23.Peer-Reviewed Original ResearchAdjuvant chemotherapyAdjuvant chemotherapy regimenAdjuvant systemic therapyAdjuvant combination chemotherapyBreast cancer recurrenceYears of ageChemotherapy regimenPrognostic determinantsSystemic therapyCombination chemotherapyClinicians' estimationTumor stagePatient prognosisPatient outcomesCancer recurrenceBreast cancerMortality rateClinical practiceTumor biologyClinical settingChemotherapyBiological rationalePrognosisRecurrenceSignificant reductionPredicting response and survival in chemotherapy-treated triple-negative breast cancer
Prat A, Lluch A, Albanell J, Barry WT, Fan C, Chacón JI, Parker JS, Calvo L, Plazaola A, Arcusa A, Seguí-Palmer MA, Burgues O, Ribelles N, Rodriguez-Lescure A, Guerrero A, Ruiz-Borrego M, Munarriz B, López JA, Adamo B, Cheang MC, Li Y, Hu Z, Gulley ML, Vidal MJ, Pitcher BN, Liu MC, Citron ML, Ellis MJ, Mardis E, Vickery T, Hudis CA, Winer EP, Carey LA, Caballero R, Carrasco E, Martín M, Perou CM, Alba E. Predicting response and survival in chemotherapy-treated triple-negative breast cancer. British Journal Of Cancer 2014, 111: 1532-1541. PMID: 25101563, PMCID: PMC4200088, DOI: 10.1038/bjc.2014.444.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerChemotherapy responseClinical trialsProliferation signatureBreast cancerMultivariable logistic regression modelFuture clinical trialsBasal-like diseaseBasal-like subtypeIntrinsic molecular subtypesClinical pathological dataLogistic regression modelsBLBC subtypeIntrinsic subtypesSignificant interaction testMolecular subtypesCox modelIndependent cohortTNBC heterogeneityClinical implicationsSignificant associationBLBCChemotherapyPhenotypic subtypesLow expressionCirculating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500
Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500. Journal Of Clinical Oncology 2014, 32: 3483-3489. PMID: 24888818, PMCID: PMC4209100, DOI: 10.1200/jco.2014.56.2561.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerFirst-line chemotherapyMedian overall survivalDays of therapyOverall survivalInitial therapyBreast cancerTumor cellsTrial of patientsMore effective treatmentsEvaluable patientsStandard chemotherapyPrimary outcomeArm APoor prognosisPrognostic significanceCytotoxic therapyAlternative chemotherapyEffective treatmentChemotherapyPatientsTherapyEarly switchingPersistent increaseMonthsIdentification of biomarkers to predict response to single-agent platinum chemotherapy in metastatic triple-negative breast cancer (mTNBC): Correlative studies from TBCRC009.
Isakoff S, He L, Mayer E, Goss P, Traina T, Carey L, Krag K, Liu M, Rugo H, Stearns V, Come S, Ryan P, Finkelstein D, Hartman A, Garber J, Timms K, Winer E, Ellisen L. Identification of biomarkers to predict response to single-agent platinum chemotherapy in metastatic triple-negative breast cancer (mTNBC): Correlative studies from TBCRC009. Journal Of Clinical Oncology 2014, 32: 1020-1020. DOI: 10.1200/jco.2014.32.15_suppl.1020.Peer-Reviewed Original ResearchPhase III study evaluating safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy in subjects with early-stage triple-negative breast cancer (TNBC).
Von Minckwitz G, O'Shaughnessy J, Winer E, Wolmark N, Geyer C, Huober J, Loibl S, Sikov W, Untch M, McKee M, Giranda V, Rugo H. Phase III study evaluating safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy in subjects with early-stage triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2014, 32: tps1149-tps1149. DOI: 10.1200/jco.2014.32.15_suppl.tps1149.Peer-Reviewed Original Research