2022
Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersBreast NeoplasmsDisease-Free SurvivalDrug ApprovalFemaleHumansNeoadjuvant TherapyConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effects
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
2020
Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial
Brown JC, Zhang S, Ligibel JA, Irwin ML, Jones LW, Campbell N, Pollak MN, Sorrentino A, Cartmel B, Harrigan M, Tolaney SM, Winer EP, Ng K, Abrams TA, Sanft T, Douglas PS, Hu FB, Fuchs CS, Meyerhardt JA. Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial. Cancer Prevention Research 2020, 13: 1055-1062. PMID: 32859615, PMCID: PMC7718298, DOI: 10.1158/1940-6207.capr-20-0188.Peer-Reviewed Original ResearchConceptsHs-CRPColorectal cancerPhysical activityHigh-sensitivity C-reactive proteinLow baseline physical activitySurvivors of breastTrial product estimandBaseline physical activityBiomarkers of inflammationC-reactive proteinMeasures of inflammationImproved clinical outcomesEffects of exerciseType 2 diabetesCombination of exerciseStandard therapyClinical outcomesCancer recurrenceObservational studyTreatment groupsInflammation outcomesMetforminIL6Factorial trialInflammationTBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker
Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Annals Of Oncology 2020, 31: 1518-1525. PMID: 32798689, PMCID: PMC8437015, DOI: 10.1016/j.annonc.2020.08.2064.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerHomologous recombination deficiencyPhase II studyPathologic responsePreoperative cisplatinII studyBreast cancerProspective phase II studyEffective predictive biomarkersInadequate clinical responsePreoperative chemotherapy regimenSingle-agent cisplatinHomologous recombination deficiency biomarkersGermline BRCA1/2Preoperative paclitaxelChemotherapy regimenClinical responseCisplatin chemotherapyPredictive biomarkersAlternative chemotherapyPreoperative trialInadequate responseHRD scoreStage IBaseline tissue
2019
Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation
Xing Y, Lin NU, Maurer MA, Chen H, Mahvash A, Sahin A, Akcakanat A, Li Y, Abramson V, Litton J, Chavez-MacGregor M, Valero V, Piha-Paul SA, Hong D, Do KA, Tarco E, Riall D, Eterovic AK, Wulf GM, Cantley LC, Mills GB, Doyle LA, Winer E, Hortobagyi GN, Gonzalez-Angulo AM, Meric-Bernstam F. Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation. Breast Cancer Research 2019, 21: 78. PMID: 31277699, PMCID: PMC6612080, DOI: 10.1186/s13058-019-1154-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkersBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDrug MonitoringFemaleHeterocyclic Compounds, 3-RingHigh-Throughput Nucleotide SequencingHumansImmunohistochemistryMiddle AgedMutationNeoplasm MetastasisNeoplasm StagingProtein Kinase InhibitorsProto-Oncogene Proteins c-aktTreatment OutcomeConceptsObjective response ratePeripheral blood mononuclear cellsPlatelet-rich plasmaAdvanced breast cancerPhase II trialPre-treatment biopsiesBreast cancerAKT inhibitor MKAKT1 mutationsPTEN lossII trialPIK3CA mutationsPIK3CA/AKT1 mutationsAdvanced breast cancer patientsInhibitor MKTriple-negative breast cancerMethodsThe primary endpointPIK3CA/AKT1Common adverse eventsPre-treated patientsProgression-free survivalResultsTwenty-seven patientsBreast cancer patientsBlood mononuclear cellsPTEN mutations
2011
Adjuvant chemotherapy in luminal breast cancers
Lim E, Winer EP. Adjuvant chemotherapy in luminal breast cancers. The Breast 2011, 20: s128-s131. PMID: 22015279, DOI: 10.1016/s0960-9776(11)70309-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Agents, HormonalBiomarkersBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansMiddle AgedNeoplasm StagingNeoplasms, Hormone-DependentPrognosisRandomized Controlled Trials as TopicReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsAdjuvant endocrine therapyLuminal breast cancerEndocrine therapyBreast cancerEstrogen receptorAdjuvant chemotherapyProgesterone receptorHER2-negative breast cancerER-positive breast tumorsAddition of chemotherapyER-positive diseaseER-positive tumorsUse of chemotherapySubset of patientsSubgroup of patientsER-negative tumorsAdditional therapyCytotoxic chemotherapyEndocrine sensitivityClinicians' estimationTherapeutic responseFavorable outcomeCurrent biomarkersChemotherapyBreast tumors
2008
Impact of a Mixed Strength and Endurance Exercise Intervention on Insulin Levels in Breast Cancer Survivors
Ligibel JA, Campbell N, Partridge A, Chen WY, Salinardi T, Chen H, Adloff K, Keshaviah A, Winer EP. Impact of a Mixed Strength and Endurance Exercise Intervention on Insulin Levels in Breast Cancer Survivors. Journal Of Clinical Oncology 2008, 26: 907-912. PMID: 18281663, DOI: 10.1200/jco.2007.12.7357.Peer-Reviewed Original ResearchConceptsBreast cancer survivorsExercise groupCancer survivorsInsulin levelsExercise interventionInsulin concentrationsGlucose levelsBody compositionControl groupOverweight breast cancer survivorsUsual care control groupEndurance exercise interventionCare control groupMicroU/mLSignificant decreaseBreast cancer recurrenceBreast cancer riskBreast cancer prognosisInsulin resistanceHip circumferenceCancer recurrenceBody fatHip measurementsPhysical activityCancer risk
2005
Assessment of a Dietary Questionnaire in Cancer Patients Receiving Cytotoxic Chemotherapy
Meyerhardt JA, Heseltine D, Campos H, Holmes MD, Willett WC, Winer EP, Enzinger PC, Bunnell CA, Kulke MH, Fuchs CS. Assessment of a Dietary Questionnaire in Cancer Patients Receiving Cytotoxic Chemotherapy. Journal Of Clinical Oncology 2005, 23: 8453-8460. PMID: 16293876, DOI: 10.1200/jco.2005.02.5460.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsBiomarkersBreast NeoplasmsCarotenoidsColorectal NeoplasmsFatty AcidsFeeding BehaviorFemaleHumansMaleMiddle AgedMultivariate AnalysisNeuroendocrine TumorsNutrition AssessmentNutrition SurveysReproducibility of ResultsSurveys and QuestionnairesTocopherolsConceptsDietary questionnaireCytotoxic chemotherapyCancer patientsPlasma specimensInfluence of dietHealthy populationTotal vitamin E intakeSemiquantitative food frequency questionnaireComprehensive dietary questionnairesFood frequency questionnaireVitamin E intakeBody mass indexTotal energy intakeTotal plasma cholesterolChemotherapy-associated toxicitySelf-reported dietFrequency questionnaireE intakeMass indexSmoking statusNeuroendocrine cancerDietary factorsDietary intakePlasma cholesterolPatients