2021
Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB).
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Zhang C, Winer E. Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2021, 39: 1043-1043. DOI: 10.1200/jco.2021.39.15_suppl.1043.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesOverall survivalTyrosine kinase inhibitorsBreast cancerPlacebo armAnalysis of OSOral tyrosine kinase inhibitorECOG performance statusPlacebo-controlled trialTotal study populationKaplan-Meier timeHER2CLIMB trialMeaningful prolongationMetastatic HER2Study medicationTolerability assessmentsMetastatic settingAdverse eventsDose modificationHazard ratioLast patientPerformance statusDisease progressionStudy population
2020
Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer
Barroso-Sousa R, Keenan TE, Pernas S, Exman P, Jain E, Garrido-Castro AC, Hughes M, Bychkovsky B, Umeton R, Files JL, Lindeman NI, MacConaill LE, Hodi FS, Krop IE, Dillon D, Winer EP, Wagle N, Lin NU, Mittendorf EA, Van Allen EM, Tolaney SM. Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2020, 26: 2565-2572. PMID: 32019858, PMCID: PMC7269810, DOI: 10.1158/1078-0432.ccr-19-3507.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerHigh tumor mutational burdenProgression-free survivalTumor mutational burdenObjective response rateImmune checkpoint inhibitorsAnti-PD-1/L1 therapyTriple-negative breast cancerOverall survivalL1 therapyPD-L1Breast cancerMutational burdenLow objective response rateLonger progression-free survivalShorter progression-free survivalDana-Farber Cancer InstituteTumor genomic featuresShorter overall survivalMutations/megabaseCheckpoint inhibitorsVisceral metastasesL1 blockadePerformance statusPrior lines
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
2013
Prospective clinical experience with research biopsies in breast cancer patients
Vaz-Luis I, Zeghibe CA, Frank ES, Sohl J, Washington KE, Silverman SG, Fonte JM, Mayer EL, Overmoyer BA, Richardson AL, Krop IE, Winer EP, Lin NU. Prospective clinical experience with research biopsies in breast cancer patients. Breast Cancer Research And Treatment 2013, 142: 203-209. PMID: 24113744, PMCID: PMC3825285, DOI: 10.1007/s10549-013-2717-5.Peer-Reviewed Original ResearchConceptsResearch biopsiesAdverse eventsDisease courseMetastatic samplesDana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experiencePatient's disease courseSingle institution experienceBreast cancer patientsPerformance of biopsyHigh rateAnalytic cohortFirst recurrenceMetastatic diseaseMost patientsPerformance statusReceptor statusPrimary cancerProspective studyCancer patientsBreast cancerPatientsBiopsyProspective clinical experience with research biopsies in breast cancer patients.
Zeghibe C, Luis I, Frank E, Sohl J, Washington K, Silverman S, Fonte J, Mayer E, Overmoyer B, Richardson A, Krop I, Winer E, Lin N. Prospective clinical experience with research biopsies in breast cancer patients. Journal Of Clinical Oncology 2013, 31: e17574-e17574. DOI: 10.1200/jco.2013.31.15_suppl.e17574.Peer-Reviewed Original ResearchResearch biopsiesAdverse eventsBreast cancerCohort 1Cohort 2Grade 2Dana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experienceSingle institution experienceTime of diagnosisBreast cancer patientsOngoing prospective studyMajority of ptsAcademic medical centerWithdrew consentAnalytic cohortChart reviewFirst recurrenceMetastatic diseasePerformance statusSevere painInstitution experienceProspective studyCognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907
Freedman RA, Pitcher B, Keating NL, Ballman KV, Mandelblatt J, Kornblith AB, Kimmick GG, Hurria A, Winer EP, Hudis CA, Cohen HJ, Muss HB, for the Alliance for Clinical Trials in Oncology. Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907. Breast Cancer Research And Treatment 2013, 139: 607-616. PMID: 23681403, PMCID: PMC3920483, DOI: 10.1007/s10549-013-2562-6.Peer-Reviewed Original ResearchConceptsSelf-reported cognitive functionCognitive function scoresCognitive functionOlder womenAdjuvant chemotherapyBreast cancerTime pointsStandard adjuvant chemotherapyAverage baseline scoreBaseline cognitive functionCALGB 49907Life substudyCognitive changesPerformance statusStandard chemotherapyMedian agePatient characteristicsTreatment armsTreatment regimenFunction scoresHealthy groupBaseline depressionCognitive screeningChemotherapyKruskal-Wallis test
2011
Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H, B F. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Annals Of Oncology 2011, 23: 632-638. PMID: 21693770, PMCID: PMC3331731, DOI: 10.1093/annonc/mdr297.Peer-Reviewed Original ResearchConceptsProgression-free survivalGood performance statusFirst-line therapyMetastatic breast cancerOverall survivalPerformance statusBreast cancerOlder womenLeukemia Group B StudySecond-line therapyImproved overall survivalDoses of paclitaxelEstrogen receptor-positive statusTolerability of paclitaxelToxic effectsBilirubin elevationPaclitaxel efficacyWeekly paclitaxelOlder patientsMetastatic sitesTumor responseSimilar efficacyPositive statusSpecific toxic effectsPatients
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
2000
A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma
Dawson N, Conaway M, Halabi S, Winer E, Small E, Lake D, Vogelzang N. A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma. Cancer 2000, 88: 825-834. PMID: 10679652, DOI: 10.1002/(sici)1097-0142(20000215)88:4<825::aid-cncr13>3.0.co;2-n.Peer-Reviewed Original ResearchConceptsHormone-refractory prostate carcinomaMegestrol acetateProstate carcinomaStable diseasePartial responsePerformance statusDay doseHigh-dose megestrol acetateEnd pointPossible dose-response effectDose megestrol acetateHigher baseline PSAOral megestrol acetateHigh-dose therapyPoor performance statusPrimary end pointSecondary end pointsMedian survival timeAdvanced prostate carcinomaDose-response effectDose-response correlationEvaluable diseaseMeasurable diseaseDose therapyBaseline PSA