2024
Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆. Annals Of Oncology 2024, 35: 993-1002. PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatientsAdjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT
Tarantino P, Tayob N, Villacampa G, Dang C, Yardley D, Isakoff S, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff A, Reeder-Hayes K, Rugo H, Ramaswamy B, Zuckerman D, Hart L, Gadi V, Constantine M, Cheng K, Garrett A, Marcom P, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz R, Rimawi M, Abramson V, Pohlmann P, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Waks A, DeMeo M, Burstein H, Partridge A, Dell'Orto P, Russo L, Krause E, Newhouse D, Kurt B, Mittendorf E, Schneider B, Prat A, Winer E, Krop I, Tolaney S, Investigators T, Barroso-Sousa R, Curigliano G, DiLullo M, Hui W, Kirkup C, Viale G, Zheng Y. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT. Journal Of Clinical Oncology 2024, 42: 3652-3665. PMID: 38935923, PMCID: PMC11527383, DOI: 10.1200/jco.23.02170.Peer-Reviewed Original ResearchInvasive disease-free survivalRecurrence-free intervalAdjuvant T-DM1T-DM1Long-term outcomesBreast cancerStage I HER2-positive breast cancerInvasive disease-free survival eventsLong-term outcomes of patientsBreast cancer-specific survivalHER2-positive breast cancerAdjuvant trastuzumab emtansinePredictors of thrombocytopeniaRisk scoreT-DM1 armCancer-specific survivalHormone receptor statusHigh-risk tumorsDisease-free survivalMedian follow-upClinically relevant toxicitiesRisk of recurrenceOutcomes of patientsHER2 immunohistochemical scoresTH armPhase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer
Grinshpun A, Ren S, Graham N, DeMeo M, Wrabel E, Carter J, Tayob N, Pereslete A, Hamilton E, Juric D, Mayer E, Tolaney S, Krop I, Metzger O. Phase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer. ESMO Open 2024, 9: 103465. PMID: 38833970, PMCID: PMC11179085, DOI: 10.1016/j.esmoop.2024.103465.Peer-Reviewed Original ResearchProgression-free survivalMaximal tolerated doseHER2+ breast cancerAdverse eventsBreast cancerT-DM1Cohort AHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveHER2+) breast cancerMedian progression-free survivalAll-grade adverse eventsAssociated with significant toxicityCirculating tumor DNA analysisDevelopment of acquired resistanceHER2-directed regimensHER2-directed therapyAnti-HER2 therapyHER2-targeted therapyPhase Ib studyTumor DNA analysisPI3KDose escalationImprove disease controlOral inhibitor182MO Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2+ metastatic breast cancer (mBC) previously treated with trastuzumab emtansine (T-DM1): Updated overall survival (OS) results of the randomized phase III DESTINY-breast (DB-)02 study
Kim S, André F, Takano T, Fehm T, Park Y, Lee J, Borges G, Kaplan M, Kaczmarek E, Guarneri V, Yonemori K, Pluard T, Prat A, Paterson F, Oakman C, Nakatani S, Ashfaque S, Lu W, Egorov A, Krop I. 182MO Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2+ metastatic breast cancer (mBC) previously treated with trastuzumab emtansine (T-DM1): Updated overall survival (OS) results of the randomized phase III DESTINY-breast (DB-)02 study. ESMO Open 2024, 9: 103204. DOI: 10.1016/j.esmoop.2024.103204.Peer-Reviewed Original ResearchHER2 heterogeneity and treatment response-associated profiles in HER2-positive breast cancer in the NCT02326974 clinical trial
Li Z, Filho O, Viale G, dell'Orto P, Russo L, Goyette M, Kamat A, Yardley D, Abramson V, Arteaga C, Spring L, Chiotti K, Halsey C, Waks A, King T, Lester S, Bellon J, Winer E, Spellman P, Krop I, Polyak K. HER2 heterogeneity and treatment response-associated profiles in HER2-positive breast cancer in the NCT02326974 clinical trial. Journal Of Clinical Investigation 2024, 134: e176454. PMID: 38300710, PMCID: PMC10977978, DOI: 10.1172/jci176454.Peer-Reviewed Original ResearchPathological complete responseHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-targeted therapyPre-treatment tumorsErbB signalingHER2-targeted antibodiesBasal-like featuresHER2 protein levelsStratification of patientsNational Cancer InstituteNeoadjuvant trialsComplete responseResidual tumorT-DM1Copy number heterogeneityTrastuzumab emtansineERBB2 mRNAImmune infiltrationDownstream pathway componentsClinical challengeClinical trialsTumor
2023
An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03.
Krop I, Wildiers H, Hurvitz S, Cortes J, Im S, Iwata H, Andre F, Saura C, Modi S, Kim S, Egorov A, Mathias E, Cathcart J, Cagnazzo A, Cheng Y, Park Y. An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03. Journal Of Clinical Oncology 2023, 41: 1006-1006. DOI: 10.1200/jco.2023.41.16_suppl.1006.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsMetastatic breast cancerT-DXdGrade treatment-emergent adverse eventsHER2-positive metastatic breast cancerInterstitial lung disease/pneumonitisFavorable benefit-risk profileAge-specific efficacyGrade 5 eventsPooled safety analysisBenefit-risk profileYears of ageKey efficacy dataOlder ptsSerious AEsAdverse eventsTrastuzumab deruxtecanAdditional efficacyPooled analysisT-DM1Trastuzumab emtansineEfficacy dataBreast cancerSafety dataSafety outcomes
2022
Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)
Sella T, Zheng Y, Tayob N, Ruddy K, Freedman R, Dang C, Yardley D, Isakoff S, Valero V, DeMeo M, Burstein H, Winer E, Wolff A, Krop I, Partridge A, Tolaney S. Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). Npj Breast Cancer 2022, 8: 127. PMID: 36450763, PMCID: PMC9712612, DOI: 10.1038/s41523-022-00495-x.Peer-Reviewed Original ResearchHER2-positive breast cancerPatient-reported toxicityPatient-reported outcomesT-DM1Treatment discontinuationTrastuzumab emtansineBreast cancerStage I HER2-positive breast cancerAdjuvant trastuzumab emtansineExcellent disease outcomesLess activity impairmentPaclitaxel/trastuzumabSocial/familyPositive breast cancerSuperior QoLOlder patientsTreatment toleranceTreatment armsTreatment regimensEligible participantsGlobal QoLTherapy optionsActivity impairmentMultivariable modelDisease outcomePhase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockadeCardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial
Barroso-Sousa R, Tarantino P, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy KJ, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I, Tolaney SM. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. Npj Breast Cancer 2022, 8: 18. PMID: 35173164, PMCID: PMC8850608, DOI: 10.1038/s41523-022-00385-2.Peer-Reviewed Original ResearchLeft ventricular ejection fractionHER2-positive breast cancerAdjuvant T-DM1Adjuvant trastuzumab emtansineT-DM1Adverse eventsCardiac outcomesTrastuzumab emtansineBreast cancerStage I HER2-positive breast cancerAsymptomatic left ventricular ejection fractionBaseline left ventricular ejection fractionAnthracycline-free regimensAsymptomatic LVEF declineResidual invasive diseaseT-DM1 armCardiac adverse eventsVentricular systolic dysfunctionSignificant adverse eventsVentricular ejection fractionBody mass indexFavorable toxicity profilePotential therapeutic optionBreast Cancer StudyAdjuvant paclitaxelLocal Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast Cancer
Bellon JR, Tayob N, Yang DD, Tralins J, Dang CT, Isakoff SJ, DeMeo M, Burstein HJ, Partridge AH, Winer EP, Krop IE, Tolaney SM. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2022, 113: 117-124. PMID: 34990776, DOI: 10.1016/j.ijrobp.2021.12.173.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBreast-conserving surgeryStage I HER2-positive breast cancerT-DM1 armBreast radiation therapyT-DM1Radiation therapySkin toxicityBreast cancerBCS patientsWBRT patientsInvasive disease-free survival eventsDisease-free survival eventsInvasive disease-free survivalHuman epidermal growth factor receptor 2Phase II Randomized TrialWhole breast radiation therapyEpidermal growth factor receptor 2Adjuvant T-DM1Adjuvant trastuzumab emtansineEfficacy of HER2RT-related toxicityWeeks of therapyAcute skin toxicityAnti-HER2 therapy
2021
Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast Cancer
Bellon J, Tayob N, Burstein H, Partridge A, Demeo M, Tralins J, Yang D, Dang C, Isakoff S, Yardley D, Valero V, Winer E, Krop I, Tolaney S. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: s34. DOI: 10.1016/j.ijrobp.2021.07.103.Peer-Reviewed Original ResearchT-DM1 armBreast conserving surgeryPartial breast irradiationT-DM1Radiation therapyBreast cancerLocal recurrenceSkin toxicityGrade 2 acute skin toxicityProspective randomized phase II studyGrade 3 skin toxicityHormone receptor-positive diseaseRandomized phase II studyPhase II Randomized TrialAdjuvant T-DM1Conclusions Radiation therapyGrade 2 pneumonitisGrade 3 pneumonitisIpsilateral rib fracturesPhase II studyReceptor-positive diseaseWeeks of therapyAcute skin toxicityAnti-HER2 therapyNodal radiation therapyAlliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer
O'Sullivan CC, Ballman KV, McCall L, Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM, Irvin WJ, Lee M, Goetz MP, Symmans WF, Borges VF, Krop I, Carey LA, Partridge AH. Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Future Oncology 2021, 17: 4665-4676. PMID: 34636255, PMCID: PMC8600597, DOI: 10.2217/fon-2021-0753.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreastBreast NeoplasmsChemoradiotherapy, AdjuvantChemotherapy, AdjuvantClinical Trials, Phase III as TopicDisease-Free SurvivalDouble-Blind MethodFemaleFollow-Up StudiesHumansMastectomyMiddle AgedMulticenter Studies as TopicNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm, ResidualOxazolesPlacebosProspective StudiesPyridinesQuinazolinesRandomized Controlled Trials as TopicReceptor, ErbB-2ConceptsInvasive disease-free survivalDisease-free survivalBrain metastasis-free survivalBreast cancer-free survivalDistant recurrence-free survivalT-DM1Overall survivalResidual diseaseHER2-positive invasive breast cancerAdjuvant T-DM1Cancer-free survivalRecurrence-free survivalInvasive breast cancerMetastasis-free survivalPharmacokinetic end pointsOutcomes of interestQuality of lifeEligible patientsAdjuvant radiotherapyEndocrine therapyNeoadjuvant chemotherapyCorrelative biomarkersCare guidelinesBreast cancerPlaceboChemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)
Ruddy KJ, Zheng Y, Tayob N, Hu J, Dang CT, Yardley DA, Isakoff SJ, Valero VV, Faggen MG, Mulvey TM, Bose R, Sella T, Weckstein DJ, Wolff AC, Reeder-Hayes KE, Rugo HS, Ramaswamy B, Zuckerman DS, Hart LL, Gadi VK, Constantine M, Cheng KL, Briccetti FM, Schneider BP, Merrill Garrett A, Kelly Marcom P, Albain KS, DeFusco PA, Tung NM, Ardman BM, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Rosenberg S, DeMeo MK, Burstein HJ, Winer EP, Krop IE, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial). Breast Cancer Research And Treatment 2021, 189: 103-110. PMID: 34120223, DOI: 10.1007/s10549-021-06267-8.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaEarly-stage breast cancerRisk of infertilityAdo-trastuzumab emtansineT-DM1Gonadotropin-releasing hormone agonistAdjuvant T-DM1T-DM1 3.6Amenorrhea ratesPermanent menopauseStandard HER2Chemotherapy regimensPrimary endpointProtocol therapyMedian ageOvarian toxicityPremature menopauseHormone agonistBreast cancerMenstrual dataMonthsAmenorrheaEmtansineMenopauseTrastuzumabAdjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelA011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer.
O'Sullivan C, Ballman K, McCall L, Zemla T, Weiss A, Mitchell M, Blinder V, Tung N, Irvin W, Lee M, Goetz M, Symmans W, Borges V, Krop I, Partridge A, Carey L. A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Journal Of Clinical Oncology 2021, 39: tps595-tps595. DOI: 10.1200/jco.2021.39.15_suppl.tps595.Peer-Reviewed Original ResearchInvasive disease-free survivalEarly breast cancerTyrosine kinase inhibitorsAdjuvant T-DM1Neoadjuvant therapyPathologic complete responseDisease-free survivalResidual diseaseT-DM1Postoperative chemotherapyAdjuvant radiationBreast cancerHER2-positive invasive breast cancerBrain metastasis-free survivalBreast cancer-free survivalPathologic lymph node statusDistant recurrence-free survivalClinical stage IIInvasive residual diseasePost-neoadjuvant therapyCancer-free survivalDe-escalation trialsLymph node statusRecurrence-free survivalSelective tyrosine kinase inhibitorImpact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab
Filho OM, Viale G, Stein S, Trippa L, Yardley DA, Mayer IA, Abramson VG, Arteaga CL, Spring LM, Waks AG, Wrabel E, DeMeo MK, Bardia A, Dell'Orto P, Russo L, King TA, Polyak K, Michor F, Winer EP, Krop IE. Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discovery 2021, 11: candisc.1557.2020. PMID: 33941592, PMCID: PMC8598376, DOI: 10.1158/2159-8290.cd-20-1557.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-positive early-stage breast cancerTherapeutic resistancePathologic complete response rateEarly-stage breast cancerNeoadjuvant clinical trialsComplete response rateSubset of patientsHER2 therapyPretreatment biopsiesEvaluable casesCure rateT-DM1Trastuzumab emtansineClinical trialsTreatment strategiesTreatment responseTreatment selectionResponse rateRelated commentaryTherapyIssue featureAdjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE
Mamounas EP, Untch M, Mano MS, Huang C, Geyer CE, von Minckwitz G, Wolmark N, Pivot X, Kuemmel S, DiGiovanna MP, Kaufman B, Kunz G, Conlin AK, Alcedo JC, Kuehn T, Wapnir I, Fontana A, Hackmann J, Polikoff J, Saghatchian M, Brufsky A, Yang Y, Zimovjanova M, Boulet T, Liu H, Tesarowski D, Lam LH, Song C, Smitt M, Loibl S. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Annals Of Oncology 2021, 32: 1005-1014. PMID: 33932503, DOI: 10.1016/j.annonc.2021.04.011.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant T-DM1Residual invasive diseaseT-DM1 armNeoadjuvant chemotherapyEarly breast cancerHigh-risk tumorsRisk of recurrenceT-DM1Central nervous systemPeripheral neuropathyCNS recurrenceInvasive diseaseBreast cancerHER2-positive eBC patientsInvasive early breast cancerAnthracycline-based neoadjuvant chemotherapyHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Overall riskAdjuvant trastuzumab emtansineBaseline peripheral neuropathyLonger PN durationMore grade 3
2020
Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer
Kunst N, Wang SY, Hood A, Mougalian SS, DiGiovanna MP, Adelson K, Pusztai L. Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer. JAMA Network Open 2020, 3: e2027074. PMID: 33226431, PMCID: PMC7684449, DOI: 10.1001/jamanetworkopen.2020.27074.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Agents, PhytogenicBreast NeoplasmsCase-Control StudiesCost-Benefit AnalysisCross-Linking ReagentsDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMiddle AgedNeoadjuvant TherapyPaclitaxelQuality-Adjusted Life YearsReceptor, ErbB-2TrastuzumabTubulin ModulatorsUnited StatesConceptsErbB2-positive breast cancerAdjuvant treatment strategiesAdjuvant T-DM1Pathologic complete responseT-DM1Treatment strategiesBreast cancerKATHERINE trialResidual diseaseNeoadjuvant regimenHigher health benefitsHealth care payer perspectiveAdjuvant trastuzumab emtansineAnthracycline/cyclophosphamideDifferent adjuvant therapiesFlatiron Health databaseIncremental cost-effectiveness ratioNeoadjuvant treatment optionsHealth benefitsPositive breast cancerCare payer perspectiveCost-effectiveness ratioBase-case analysisDecision analytic modelH. PatientsA phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC).
Waks A, Keenan T, Li T, Tayob N, Wulf G, Richardson E, Mittendorf E, Overmoyer B, Krop I, Winer E, Van Allen E, Agudo J, Tolaney S. A phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1046-1046. DOI: 10.1200/jco.2020.38.15_suppl.1046.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdverse eventsT-DM1PD-L1 combined positive scoreTumor-infiltrating lymphocyte (TIL) statusClinical benefit rateDose-finding cohortMedian age 54Phase 2 dosePhase Ib studyCombined positive scoreAnti-PD1 antibodyPhase 1 trialDe-escalation designEligible patientsLymphocyte statusMetastatic HER2Expansion cohortOral mucositisPrimary endpointSecondary endpointsAntitumor immunityImmune signaturesPrior linesPrimary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).
Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patients
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