2025
Cost-effectiveness of ribociclib plus endocrine therapy in HR-positive, HER2-negative early breast cancer in the United States.
Potnis K, Ito S, Kunst N, Richman I, Winer E, Goshua G. Cost-effectiveness of ribociclib plus endocrine therapy in HR-positive, HER2-negative early breast cancer in the United States. Journal Of Clinical Oncology 2025, 43: 11049-11049. DOI: 10.1200/jco.2025.43.16_suppl.11049.Peer-Reviewed Original ResearchHER2- early breast cancerEarly breast cancerIncremental cost-effectiveness ratioEndocrine therapyBreast cancerQuality-adjusted life yearsDeterministic sensitivity analysisHR-positiveHER2-negative early breast cancerWTP thresholdCost-effectiveness of ribociclibInvasive disease-free survivalDisease-free survival curvesAcceptable WTP thresholdDisease-free survivalBase-caseHigher WTP thresholdNonsteroidal aromatase inhibitorBase-case analysisCyclin-dependent kinase 4Cost-effectiveness ratioHER2-negativeCDK4/6 inhibitorsAromatase inhibitorsHealth system perspectiveUse of baseline plasma circulating tumor DNA (ctDNA) to predict duration of endocrine therapy (ET) and CDK4/6 inhibitor (CDK4/6i) therapy (tx) and to analyze intrinsic vs acquired endocrine resistance.
De Placido P, Hughes M, Weipert C, Sammons S, Morganti S, Parsons H, Abravanel D, Giordano A, Smith K, Patel A, Kirkner G, Stever C, Suggs G, Sendrick K, Snow C, Winer E, Tolaney S, Lin N, Jeselsohn R. Use of baseline plasma circulating tumor DNA (ctDNA) to predict duration of endocrine therapy (ET) and CDK4/6 inhibitor (CDK4/6i) therapy (tx) and to analyze intrinsic vs acquired endocrine resistance. Journal Of Clinical Oncology 2025, 43: 1075-1075. DOI: 10.1200/jco.2025.43.16_suppl.1075.Peer-Reviewed Original ResearchMetastatic breast cancerCirculating tumor DNACopy number lossHR+/HER2- metastatic breast cancerAcquired ResistanceEndocrine therapyLiver metastasesGenomic profilingCDKN2A copy number lossHormone receptor-positive/HER2-negativePlasma circulating tumor DNADuration of endocrine therapyPresence of liver metastasesIntrinsic resistanceCompare genomic profilesBaseline TFPlasma samplesAcquired endocrine resistanceMetastatic breast cancer diagnosisStandard-of-careCox regression modelsESR1 fusionsTumor sheddingSecond-lineMedian durationProspective decision impact study of the Breast Cancer Index: Results from the BCI Registry study.
Sanft T, Siuliukina N, O'Neal B, Anderson A, Jankowitz R, Pegram M, Diab S, Zhang Y, Treuner K, O'Shaughnessy J. Prospective decision impact study of the Breast Cancer Index: Results from the BCI Registry study. Journal Of Clinical Oncology 2025, 43: 531-531. DOI: 10.1200/jco.2025.43.16_suppl.531.Peer-Reviewed Original ResearchPercentage of physiciansBreast Cancer IndexPhysician confidenceRegistry studyPatient preferencesTest questionnaireEndocrine therapyReduce patient concernsPhysician decision-makingEarly-stage breast cancerQuality of lifeClinical decision-makingCancer indexPhysician recommendationWilcoxon Signed Rank TestLikelihood of benefitPatient concernsClinical careBenefit of endocrine therapyBreast cancer patientsLong-term clinical outcomesDrug safetyDecision impact studyEndocrine therapy benefitLate distant recurrenceUtilization of tumor-informed ctDNA to de-escalate treatment or monitoring in metastatic breast cancer exceptional responders.
Janda G, Goetz M, Haddad T, Peethambaram P, Leon-Ferre R, Calkins H, Scott N, Rodriguez A, Liu M, Giridhar K. Utilization of tumor-informed ctDNA to de-escalate treatment or monitoring in metastatic breast cancer exceptional responders. Journal Of Clinical Oncology 2025, 43: e13042-e13042. DOI: 10.1200/jco.2025.43.16_suppl.e13042.Peer-Reviewed Original ResearchMetastatic breast cancerSystemic therapyCtDNA testingContinuous endocrine therapyRadiographic remissionRestaging scansEndocrine therapyExceptional respondersER+/HER2- metastatic breast cancerCohort of ptsDiscontinued systemic therapySystemic therapy optionsTreatment de-escalationBreast cancer characteristicsMedian Follow-UpDe-escalate treatmentTreating medical oncologistMetastatic breast cancer diagnosisIRB-approved protocolIncreased imaging frequencyConventional treatment paradigmsProgression of diseaseCtDNA-positiveHER2+Median durationDeterminants of response and molecular dynamics in HER2+ER+ breast cancers from the NA-PHER2 trial receiving HER2-targeted and endocrine therapies
Callari M, Dugo M, Barreca M, Győrffy B, Galbardi B, Vigano L, Locatelli A, Dall’Ara C, Ferrarini M, Bisagni G, Colleoni M, Mansutti M, Zamagni C, Del Mastro L, Zambelli S, Frassoldati A, Biasi O, Pusztai L, Valagussa P, Viale G, Gianni L, Bianchini G. Determinants of response and molecular dynamics in HER2+ER+ breast cancers from the NA-PHER2 trial receiving HER2-targeted and endocrine therapies. Nature Communications 2025, 16: 2195. PMID: 40038334, PMCID: PMC11880565, DOI: 10.1038/s41467-025-57293-9.Peer-Reviewed Original ResearchConceptsTumor-infiltrating lymphocytesBreast cancerEndocrine therapyImmune infiltrationPrediction of pCRAnti-HER2 therapyLuminal A phenotypeHigher immune infiltrationFemale breast cancerHER2 blockadeDeterminants of responseTumor responseInfiltrating lymphocytesCDK4/6 inhibitionAnti-HER2HER2 targetingClinical endpointsER signalingKi67Response groupCancerTherapyTherapeutic targetMolecular changesTumorClinical Implications of Breast Cancer Intrinsic Subtypes
Rios-Hoyo A, Shan N, Karn P, Pusztai L. Clinical Implications of Breast Cancer Intrinsic Subtypes. Advances In Experimental Medicine And Biology 2025, 1464: 435-448. PMID: 39821037, DOI: 10.1007/978-3-031-70875-6_21.Peer-Reviewed Original ResearchConceptsBasal-like cancersBreast cancerDistant recurrenceLuminal cancersEndocrine therapyAdjuvant chemotherapyClinical behaviorOncotype DX recurrence scorePathologic complete response rateTreated with preoperative chemotherapyExcellent long-term survivalRisk of early recurrenceBasal-like breast cancerBreast cancer intrinsic subtypesHER2-enriched cancersImmunotherapy to chemotherapyLuminal A cancersComplete response rateImmune checkpoint inhibitorsEstrogen receptor-negativeHER2-Targeted TherapyEstrogen receptor-positiveLevel of immune infiltrationHER2 gene amplificationAdjuvant endocrine therapyAdjuvant Dose-Dense Chemotherapy in Hormone Receptor–Positive Breast Cancer
Filho O, Ballman K, Campbell J, Liu M, Ligibel J, Watson M, Chen E, Du L, Stover D, Carey L, Partridge A, Kirshner J, Muss H, Hudis C, Winer E, Norton L, Symmans W. Adjuvant Dose-Dense Chemotherapy in Hormone Receptor–Positive Breast Cancer. Journal Of Clinical Oncology 2025, 43: 1229-1239. PMID: 39746162, PMCID: PMC11954676, DOI: 10.1200/jco-24-01875.Peer-Reviewed Original ResearchConceptsDose-dense chemotherapyDisease-free survivalOverall survivalBreast cancerTumor burdenMenopausal statusLong-term disease-free survivalHormone receptor-positive breast cancerHazard ratioNode-positive breast cancerSensitivity to endocrine therapyReceptor-positive breast cancerDose-dense therapyER-negative subsetEstrogen receptor-positiveER+ breast cancerMolecular subtype classificationSustained long-term benefitsER+ cancersDose-denseER statusReceptor-positiveEndocrine therapyConventional chemotherapyChemotherapy scheduleOutcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13])
DeMichele A, Dueck A, Hlauschek D, Martin M, Burstein H, Pfeiler G, Zdenkowski N, Wolff A, Bellet-Ezquerra M, Winer E, Balic M, Miller K, Colleoni M, Lake D, Rubovsky G, Cameron D, Balko J, Singer C, Nowecki Z, Iwata H, Wolmark N, Parraga K, Rugo H, Steger G, Traina T, Werutsky G, Czajkowska D, Metzger O, El-Abed S, Theall K, Lu R, O’Brien P, Fesl C, Mayer E, Gnant M. Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]). Breast Cancer Research 2025, 27: 12. PMID: 39849600, PMCID: PMC11761723, DOI: 10.1186/s13058-024-01941-3.Peer-Reviewed Original ResearchConceptsLocoregional relapse-free survivalStandard adjuvant endocrine therapyYears of palbociclibAdjuvant endocrine therapyEndocrine therapyOverall survivalStage IIAPALLAS trialBreast cancerFollow-upBreast cancer-free survivalReducing breast cancer recurrenceStage IIA patientsHigher stage diseaseHormone-receptor-positiveRelapse-free survivalStage IIA diseaseYears of follow-upCancer-free survivalMedian Follow-UpPhase III trialsEarly breast cancerBreast cancer recurrenceBreast Cancer Study GroupNegative breast cancerPatterns of adjuvant bone modifying agent use in patients with early-stage breast cancer in the United States
Odzer N, Chehayeb R, Schellhorn S, Lustberg M, Gross C, Lee D, Foldi J. Patterns of adjuvant bone modifying agent use in patients with early-stage breast cancer in the United States. Breast Cancer Research 2025, 27: 102. PMID: 40500761, PMCID: PMC12160112, DOI: 10.1186/s13058-025-02062-1.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBone-modifying agentsBreast cancerAssociated with increased receiptHealth care practicesFactors associated with receiptPost-menopausal statusInconsistent prescribingCare practicesRetrospective cohort studyElectronic health record-derived databaseReceipt of adjuvant chemotherapyEstrogen receptor (ER)-positiveSurvey-based studyYears of ageClinical guidelinesCohort studyUnited StatesProportion of patientsChi-squareAdjuvant bisphosphonatesResultsOur cohortNode-negativeEndocrine therapyPrescribing
2024
Efficacy of Subsequent Treatments After Disease Progression on CDK4/6 Inhibitors in Patients With Hormone Receptor–Positive Advanced Breast Cancer
Ravani L, Calomeni P, Vilbert M, Madeira T, Wang M, Deng D, Testa L, Bonadio R, Clifton K, Wander S, Lustberg M. Efficacy of Subsequent Treatments After Disease Progression on CDK4/6 Inhibitors in Patients With Hormone Receptor–Positive Advanced Breast Cancer. JCO Oncology Practice 2024, 21: 832-842. PMID: 39689274, DOI: 10.1200/op-24-00649.Peer-Reviewed Original ResearchProgression-free survivalAdvanced breast cancerEndocrine therapyOverall survivalDisease progressionET monotherapyHormone receptor-positive/human epidermal growth factor receptor 2-negativeBreast cancerHormone receptor-positive advanced breast cancerAssociated with longer progression-free survivalPooled analysisHR+ HER2- advanced breast cancerCyclin-dependent kinase 4/6 inhibitorsHER2- advanced breast cancerMeta-analysis searching PubMedLonger progression-free survivalProgression-free survival benefitStandard of careIndividual patient dataPatient dataCDK4/6i therapyProlonged OSCDK4/6 inhibitorsCDK4/6iTreatment optionsDevelopment and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Rae J, Baehner R, Sharma P, Kalinsky K. Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer. Journal Of Clinical Oncology 2024, 43: 919-928. PMID: 39621968, PMCID: PMC11885031, DOI: 10.1200/jco-24-01507.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scorePostmenopausal womenClinicopathological factorsClinicopathological modelOncotype DX Breast Recurrence ScoreLymph node-positive breast cancerInvasive disease-free survivalNode-positive breast cancerHormone receptor-positiveNode-positive diseaseDisease-free survivalCox proportional hazards regression modelsIndividual recurrence riskProportional hazards regression modelsRisk estimatesHealth Service RegistryEstimation of prognosisHazards regression modelsPremenopausal patientsEndocrine therapyReceptor-positiveChemotherapy benefitMenopausal statusPatient-level dataPhase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3947-3956. PMID: 39236276, PMCID: PMC11575912, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/IB StudyHormone receptor-positiveProgression-free survivalAdvanced/Metastatic Breast CancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positiveReal‐world treatment patterns of adjuvant endocrine therapy and ovarian suppression in premenopausal HR+/HER2+ breast cancer
Sukumar J, Sardesai S, Ni A, Williams N, Johnson K, Quiroga D, Ramaswamy B, Wesolowski R, Cherian M, Stover D, Gatti‐Mays M, Pariser A, Sudheendra P, George M, Lustberg M. Real‐world treatment patterns of adjuvant endocrine therapy and ovarian suppression in premenopausal HR+/HER2+ breast cancer. Cancer Medicine 2024, 13: e7317. PMID: 38895891, PMCID: PMC11185945, DOI: 10.1002/cam4.7317.Peer-Reviewed Original ResearchConceptsOvarian suppressionEndocrine therapyAdjuvant endocrine therapyBreast cancerClinicopathological featuresAromatase inhibitorsOS useHR+/HER2+ breast cancerOptimal adjuvant endocrine therapyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Real-world treatment patternsCohort of premenopausal womenAnti-HER2 therapyPremenopausal breast cancerClinicopathological risk factorsMultivariable logistic regression assessed associationsLogistic regression assessed associationsPremenopausal BCPrescribed tamoxifenPremenopausal patientsPremenopausal womenBC subtypesContemporary cohortAnti-HER2Correlating Predicted Adjuvant Therapy Benefit and Risk of Recurrence Between Breast Cancer Index (BCI) and the 21-Gene Oncotype DX Recurrence Score (RS)
Casasanta N, Patel R, Raymond S, Kier M, Blanter J, Sohval S, Hovstadius M, Wu C, Zimmerman B, Cascetta K, Bagiella E, Tiersten A. Correlating Predicted Adjuvant Therapy Benefit and Risk of Recurrence Between Breast Cancer Index (BCI) and the 21-Gene Oncotype DX Recurrence Score (RS). Clinical Breast Cancer 2024, 24: 585-596. PMID: 38971641, DOI: 10.1016/j.clbc.2024.06.005.Peer-Reviewed Original ResearchBreast Cancer IndexEarly-stage breast cancerOncotype DX RSAssociated with discordanceOncotype DX recurrence scoreAdjuvant therapy benefitReview of womenOncotype DXRecurrence scoreRecurrence riskEndocrine therapyCancer indexRetrospective chart review of womenChart review of womenRetrospective review of womenRisk of distant recurrenceTherapy benefitRisk of recurrenceRetrospective chart reviewRegression modelsUnivariate logistic regression modelLogistic regression modelsPrediction scoreDistant recurrenceAdjuvant therapyPhase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus armEfficacy of subsequent treatments after disease progression on CDK4/6 inhibitors therapy in patients with hormone receptor-positive metastatic breast cancer: A Kaplan-Meier derived individual-patient data meta-analysis.
Ravani L, Calomeni P, Vilbert M, Madeira T, Wang M, Deng D, Testa L, Clifton K, Wander S, Lustberg M. Efficacy of subsequent treatments after disease progression on CDK4/6 inhibitors therapy in patients with hormone receptor-positive metastatic breast cancer: A Kaplan-Meier derived individual-patient data meta-analysis. Journal Of Clinical Oncology 2024, 42: 1065-1065. DOI: 10.1200/jco.2024.42.16_suppl.1065.Peer-Reviewed Original ResearchProgression-free survivalRandomized Controlled TrialsEndocrine therapyOverall survivalET monotherapyDisease progressionHormone receptor-positive/human epidermal growth factor receptor 2-negativeAssociated with longer progression-free survivalHormone receptor-positive metastatic breast cancerPooled analysisPooling of randomized controlled trialsCohort studyCyclin-dependent kinase 4/6 inhibitorsLonger progression-free survivalProgression-free survival benefitCDK4/6 inhibitor therapyIndividual-patient data meta-analysisMetastatic breast cancerPhase III trialsMeta-analysisStandard-of-careObservational cohort studyPotential clinical benefitIndividual patient dataPatient dataDevelopment and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer.
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Hayes D, Rae J, Baehner F, Sharma P, Kalinsky K. Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer. Journal Of Clinical Oncology 2024, 42: 508-508. DOI: 10.1200/jco.2024.42.16_suppl.508.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scoreClinicopathological factorsBreast cancerPostmenopausal patientsNode-negative breast cancerNode-positive breast cancerHormone receptor-positiveNode-positive diseaseHR+/HER2- breast cancerRisk estimatesHigh-risk patientsEstimating 5-year riskEstimation of recurrence riskLikelihood ratioPremenopausal patientsHER2-negativeReceptor-positiveChemotherapy benefitEndocrine therapyMenopausal statusRisk patientsInvasive diseasePrognostic informationPostmenopausal modelETHAN: A phase II study comparing different endocrine therapies for male breast cancer.
Leone J, Ruddy K, Rashid N, Giordano S, Gupta G, Hilsenbeck S, Gucalp A, Walsh E, Sukumar J, Makhlin I, Ortiz-Perez T, Spanheimer P, Calhoun B, Wolff A, Krop I, Thompson A. ETHAN: A phase II study comparing different endocrine therapies for male breast cancer. Journal Of Clinical Oncology 2024, 42: tps632-tps632. DOI: 10.1200/jco.2024.42.16_suppl.tps632.Peer-Reviewed Original ResearchResidual cancer burdenMale breast cancerPreoperative endocrine prognostic indexTranslational Breast Cancer Research ConsortiumBreast cancerEndocrine therapyKi-67Patient-reported outcomesNeoadjuvant phaseArm BAromatase inhibitorsHuman epidermal growth factor receptor 2 (HER2)-negative breast cancerOutcome of endocrine therapyResidual cancer burden indexWindow phaseCyclin-dependent kinase 4/6Ki-67 reductionHormone receptor-positivePhase II studyInflammatory breast cancerLack of clinical trialsPhase II trialHR+/HER2- breast cancerAnti-cancer therapyStandard of careA phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer.
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Homji Mishra N, Maity A, Bogg O, Liu L, Li M, LoRusso P. A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer. Journal Of Clinical Oncology 2024, 42: 3006-3006. DOI: 10.1200/jco.2024.42.16_suppl.3006.Peer-Reviewed Original ResearchHER2- metastatic breast cancerTreatment-related adverse eventsMetastatic breast cancerCirculating tumor DNABreast cancerGene mutationsFrequent treatment-related adverse eventsMedian duration of follow-upAntitumor activityDuration of follow-upClinical benefit rateProgression-free survivalHER2 breast cancerMutant allele frequencyExpansion doseFulvestrant combinationMedian DORESR1 mutationsMetastatic settingDose modificationEndocrine therapySystemic therapyMedian durationTumor DNACDK4/6 inhibitors184MO First-in-human phase I/IIa study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 in combination with endocrine therapy (ET) in patients (pts) with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors (CDK4/6i): Safety and efficacy update
Yap T, Sharma M, Hamilton E, Lorusso P, Basu C, Delioukina M, Liu F, Neumann H, Park J, Giordano A. 184MO First-in-human phase I/IIa study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 in combination with endocrine therapy (ET) in patients (pts) with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors (CDK4/6i): Safety and efficacy update. ESMO Open 2024, 9: 103206. DOI: 10.1016/j.esmoop.2024.103206.Peer-Reviewed Original Research
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