2024
Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update.
Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber R, Restuccia E, Im Y, Huang C, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez H, Bliss J, Viale G, Bines J, Piccart M, Aebi S, Andersson M, Bergh J, Bines J, Bliss J, Bonnefoi H, Caballero C, Cameron D, Cardoso F, Clark E, de Azambuja E, de Haas S, Dent S, Fein L, Frank E, Gelber R, Gnant M, Gomez Moreno H, Im S, Jackisch C, Janni W, Jassem J, Krop I, Kümmel S, Liu T, Loi S, Loibl S, Masuda N, Nili Gam-Yal E, Nyawira B, Pascual T, Piccart M, Pienkowski T, Procter M, Restuccia E, Rodríguez-Lescure Á, Suter T, Thomssen C, Tjan-Heijnen V, Tomasello G, Torres Ulloa M, Twelves C, Viale G, Walshe J, Wilcken N, Winer E. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. Journal Of Clinical Oncology 2024, jco2302505. PMID: 39259927, DOI: 10.1200/jco.23.02505.Peer-Reviewed Original ResearchInvasive disease-free survivalNode-negative cohortNode-positive cohortOverall survivalBreast cancerAPHINITY trialHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveInvasive disease-free survival benefitHER2+) breast cancerHuman epidermal growth factor receptor 2-positive breast cancerInterim overall survival analysisYears of median follow-upIntent-to-treat populationInterim analysisHormone receptor-negativeDisease-free survivalMedian follow-upPrimary end pointOverall survival analysisAdjuvant pertuzumabAdjuvant trastuzumabReceptor-negativePlacebo groupClinical trial update
2019
Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapy
2016
Treatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab
Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii J, Burstein HJ, Winer EP, Freedman RA. Treatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab. Breast Cancer Research And Treatment 2016, 159: 151-162. PMID: 27484879, DOI: 10.1007/s10549-016-3927-4.Peer-Reviewed Original ResearchConceptsAdjuvant trastuzumabOlder patientsSystemic treatmentBreast cancerHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2HER2-positive diseaseStage III diseaseCongestive heart failureGrowth factor receptor 2Positive breast cancerFactor receptor 2Treatment omissionEndocrine therapyClinical characteristicsSystemic therapyHeart failureBlack patientsTreatment disparitiesTreatment patternsHuman epidermal growth factorEpidermal growth factorMedicare dataPatients
2015
Genomic 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
Duration and Toxicity of Adjuvant Trastuzumab in Older Patients With Early-Stage Breast Cancer: A Population-Based Study
Vaz-Luis I, Keating NL, Lin NU, Lii H, Winer EP, Freedman RA. Duration and Toxicity of Adjuvant Trastuzumab in Older Patients With Early-Stage Breast Cancer: A Population-Based Study. Journal Of Clinical Oncology 2014, 32: 927-934. PMID: 24516021, PMCID: PMC3948095, DOI: 10.1200/jco.2013.51.1261.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerCardiac eventsOlder patientsBreast cancerTrastuzumab completionAdjuvant trastuzumabTreatment completionOlder womenHuman epidermal growth factor receptorAdjuvant trastuzumab useAge 76 yearsDays of therapyMost older patientsSignificant cardiac eventsMultivariable logistic regressionEpidermal growth factor receptorGrowth factor receptorMore comorbiditiesTrastuzumab useComorbidity scorePatient ageHospital admissionOptimal treatmentLower oddsMedicare data
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 modelsCompletion of adjuvant trastuzumab for older patients with early-stage breast cancer (BC).
Freedman R, Luis I, Lin N, Lii J, Winer E, Keating N. Completion of adjuvant trastuzumab for older patients with early-stage breast cancer (BC). Journal Of Clinical Oncology 2013, 31: 616-616. DOI: 10.1200/jco.2013.31.15_suppl.616.Peer-Reviewed Original ResearchEarly-stage breast cancerBreast cancerAdjuvant trastuzumabCardiac eventsOlder womenTrastuzumab completionOlder patientsHospital admissionDays of therapyTaxane-based therapyMultivariable logistic regressionMore comorbiditiesLower oddsHispanic womenMedicare dataTrastuzumabPatientsTherapyLogistic regressionWomenComorbiditiesChemotherapyAdmissionOne-quarterTreatment
2008
Self-Reported Practices and Attitudes of US Oncologists Regarding Off-Protocol Therapy
Peppercorn J, Burstein H, Miller FG, Winer E, Joffe S. Self-Reported Practices and Attitudes of US Oncologists Regarding Off-Protocol Therapy. Journal Of Clinical Oncology 2008, 26: 5994-6000. PMID: 19029413, DOI: 10.1200/jco.2008.18.1420.Peer-Reviewed Original ResearchConceptsUS oncologistsInvestigational cancer therapiesUS medical oncologistsSelf-reported practicesAdjuvant trastuzumabCommunity oncologistsMedical oncologistsOpen trialAcademic oncologistsClinical trialsTrial recruitmentOncologistsClinical issuesDevelopment of guidelinesInformed consentLack of consensusAnonymous surveyCancer therapyTrialsPatientsTherapyDemographic factorsRandom sampleMonthsFurther definition