2016
Immune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast Cancer
Varadan V, Gilmore H, Miskimen KL, Tuck D, Parsai S, Awadallah A, Krop IE, Winer EP, Bossuyt V, Somlo G, Abu-Khalaf MM, Fenton MA, Sikov W, Harris L. Immune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast Cancer. Clinical Cancer Research 2016, 22: 3249-3259. PMID: 26842237, PMCID: PMC5439498, DOI: 10.1158/1078-0432.ccr-15-2021.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAntineoplastic Agents, ImmunologicalBiomarkers, TumorB-LymphocytesBreast NeoplasmsFemaleGene Expression ProfilingHumansImmunity, InnateLymphocyte ActivationMacrophagesMiddle AgedNeoadjuvant TherapyPaclitaxelProgrammed Cell Death 1 ReceptorReceptor, ErbB-2T-Lymphocytes, Helper-InducerTrastuzumabTreatment OutcomeConceptsPathologic complete responseBreast cancerImmune indicesBrief exposureFollicular helper T (Tfh) cell signatureHER2-positive breast cancerPD-1 positivitySingle-agent trastuzumabTrastuzumab-based therapyT cell activityT-cell signatureImmune cell infiltrationTumor core biopsiesImmune cell activationPreoperative trastuzumabNab-paclitaxelAntitumor immunityImmune signaturesPCR rateComplete responseMulticenter trialPD-1Cell infiltrationCore biopsyIntrinsic subtypes
2014
Patterns of chemotherapy, toxicity, and short-term outcomes for older women receiving adjuvant trastuzumab-based therapy
Freedman RA, Vaz-Luis I, Barry WT, Lii H, Lin NU, Winer EP, Keating NL. Patterns of chemotherapy, toxicity, and short-term outcomes for older women receiving adjuvant trastuzumab-based therapy. Breast Cancer Research And Treatment 2014, 145: 491-501. PMID: 24756187, DOI: 10.1007/s10549-014-2968-9.Peer-Reviewed Original ResearchConceptsNon-standard chemotherapyTrastuzumab-based therapyAdjuvant trastuzumab-based therapyOlder womenChemotherapy receiptHazard ratioBreast cancerHER2-positive breast cancerPattern of chemotherapyPropensity-weighted cohortsToxicity-related hospitalizationAdjusted hazard ratioTreatment-related toxicityMonths of chemotherapyShort-term outcomesMultivariable logistic regressionPopulation-based cohortPropensity score adjustmentAssociation of ageShort-term survivalComorbidity scoreOlder patientsTreatment toxicityWorse survivalHospital events
2013
Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study
Vaz-Luis I, Seah D, Olson EM, Wagle N, Metzger-Filho O, Sohl J, Litsas G, Burstein HJ, Krop IE, Winer EP, Lin NU. Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study. Clinical Breast Cancer 2013, 13: 254-263. PMID: 23829891, PMCID: PMC4084778, DOI: 10.1016/j.clbc.2013.02.010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingPractice Patterns, Physicians'PrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRetrospective StudiesSurvival RateTamoxifenYoung AdultConceptsTrastuzumab-based therapyFirst-line trastuzumab-based therapyAdvanced HER2-positive breast cancerHER2-positive breast cancerAdjuvant trastuzumabBreast cancerClinicopathological featuresClinical benefitC-statisticHuman epidermal growth factor-2-positive breast cancerTreatment durationPredictive valueHormone receptor-positive tumorsLong-term clinical benefitPrevious adjuvant trastuzumabTreatment duration groupsRetrospective cohort studyDisease-free intervalHormone receptor positivityReceptor-positive tumorsDuration of treatmentMagnitude of benefitLow predictive valueLogistic regression modelsDifferent logistic regression modelsClinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era
Olson EM, Najita JS, Sohl J, Arnaout A, Burstein HJ, Winer EP, Lin NU. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. The Breast 2013, 22: 525-531. PMID: 23352568, PMCID: PMC3713786, DOI: 10.1016/j.breast.2012.12.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCohort StudiesDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLiver NeoplasmsLung NeoplasmsMiddle AgedPractice Patterns, Physicians'PrognosisProportional Hazards ModelsReceptor, ErbB-2Retrospective StudiesTrastuzumabTreatment OutcomeConceptsHER2-positive metastatic breast cancerMetastatic breast cancerMedian overall survivalTrastuzumab-based therapyOverall survivalHazard ratioMedian durationBreast cancerCox proportional hazards modelCentral nervous system diseasePost-trastuzumab eraTreatment practice patternsHER2-positive patientsKaplan-Meier methodologyLog-rank testPatterns of careLine of treatmentNervous system diseasesProportional hazards modelTime of deathCNS metastasesCNS progressionMetastatic settingFirst recurrenceShorter OS
2011
Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based Therapy
Morrow PK, Wulf GM, Ensor J, Booser DJ, Moore JA, Flores PR, Xiong Y, Zhang S, Krop IE, Winer EP, Kindelberger DW, Coviello J, Sahin AA, Nuñez R, Hortobagyi GN, Yu D, Esteva FJ. Phase I/II Study of Trastuzumab in Combination With Everolimus (RAD001) in Patients With HER2-Overexpressing Metastatic Breast Cancer Who Progressed on Trastuzumab-Based Therapy. Journal Of Clinical Oncology 2011, 29: 3126-3132. PMID: 21730275, PMCID: PMC3157979, DOI: 10.1200/jco.2010.32.2321.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease-Free SurvivalEverolimusFemaleHumansImmunohistochemistryKaplan-Meier EstimateMiddle AgedNeoplasm MetastasisPTEN PhosphohydrolaseReceptor, ErbB-2Salvage TherapySirolimusTOR Serine-Threonine KinasesTrastuzumabConceptsHER2-overexpressing metastatic breast cancerMetastatic breast cancerProgression-free survivalCombination of everolimusTrastuzumab-based therapyPTEN lossBreast cancerPhase I/II studyMedian progression-free survivalDana-Farber Cancer InstituteTexas MD Anderson Cancer CenterMD Anderson Cancer CenterBeth Israel Deaconess Medical CenterClinical benefit ratePersistent stable diseaseAnderson Cancer CenterDownstream mammalian targetDaily everolimusNonhematologic toxicityStable diseaseII studyOverall survivalPartial responseHER2 overexpressingClinical benefit
2005
Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy
Burstein HJ, Lieberman G, Slamon DJ, Winer EP, Klein P. Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy. Annals Of Oncology 2005, 16: 1772-1777. PMID: 16150805, DOI: 10.1093/annonc/mdi371.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCentral Nervous System NeoplasmsCyclophosphamideDisease ProgressionDoxorubicinFemaleFollow-Up StudiesGene AmplificationHumansIn Situ Hybridization, FluorescencePaclitaxelPrevalenceReceptor, ErbB-2Survival RateTime FactorsTrastuzumabVinblastineVinorelbineConceptsTrastuzumab-based therapyMetastatic breast cancerHER2-overexpressing metastatic breast cancerCentral nervous system metastasesNervous system metastasesBreast cancerCNS progressionCNS metastasesFirst-line trastuzumab-based therapyHER2-positive metastatic breast cancerMulticenter phase II trialAdvanced breast cancerFirst-line treatmentPhase II trialPhase III studyTrastuzumab-based treatmentPrimary breast cancerHER2 gene amplificationGene amplificationMeasurable diseaseCNS recurrenceII trialIII studyMetastatic diseasePatient survival
2003
Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.
Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. Journal Of Clinical Oncology 2003, 21: 2889-95. PMID: 12885806, DOI: 10.1200/jco.2003.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHeart DiseasesHumansInfusions, IntravenousMiddle AgedPredictive Value of TestsReceptor, ErbB-2ROC CurveSurvival AnalysisTrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsLeft ventricular ejection fractionMetastatic breast cancerHER2-positive metastatic breast cancerBreast cancerHER2 extracellular domainResponse rateEjection fractionTumor markersNormal left ventricular ejection fractionMulticenter phase II studyMulticenter phase II trialPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Prior adjuvant chemotherapySafety of trastuzumabFirst-line chemotherapyPhase II studySymptomatic heart failureAdvanced breast cancerBaseline ejection fractionFirst-line therapyFirst-line treatmentPhase II trialTrastuzumab-based therapyCentral nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma. Cancer 2003, 97: 2972-2977. PMID: 12784331, DOI: 10.1002/cncr.11436.Peer-Reviewed Original ResearchConceptsPercent of patientsMetastatic breast carcinomaTrastuzumab-based therapyCentral nervous system metastasesCentral nervous system diseaseNervous system metastasesCNS diseaseNervous system diseasesBreast carcinomaBrain metastasesCNS metastasesLeptomeningeal involvementSystem diseasesDisease sitesMore brain metastasesParenchymal brain metastasesProgressive CNS diseaseFirst-line therapyTime of diagnosisMedian survival periodBlood-brain barrierNew treatment strategiesStable diseaseMetastatic diseasePharmacy records