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 perspective
2024
Multi-center retrospective review of vitiligo-like lesions in breast cancer patients treated with cyclin-dependent kinase 4 and 6 inhibitors
Bang A, Fay C, LeBoeuf N, Etaee F, Leventhal J, Sibaud V, Arbesman J, Wang J, Kwong B. Multi-center retrospective review of vitiligo-like lesions in breast cancer patients treated with cyclin-dependent kinase 4 and 6 inhibitors. Breast Cancer Research And Treatment 2024, 204: 643-647. PMID: 38224427, DOI: 10.1007/s10549-023-07217-2.Peer-Reviewed Original ResearchVitiligo-like lesionsProgression-free survivalSurvival benefitMedian progression-free survivalAssociated with survival benefitSkin-directed therapiesMetastatic breast cancerSun-exposed areasPotential treatment optionCyclin-dependent kinase 4ConclusionClinical characteristicsMild repigmentationRuxolitinib creamTopical ruxolitinibMethodsRetrospective reviewResultsMedian ageClinical characteristicsCase reportTreatment optionsBreast cancerKinase inhibitorsCDK4/6iInternational cohortPatientsQuality of life
2023
Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in patients with breast cancer.
Minta A, Rose L, Park C, Trovato S, Lustberg M, Sudheendra P, Cherian M, Gatti-Mays M, Stover D, Wesolowski R, Sardesai S, Ramaswamy B, Williams N, Dulmage B. Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in patients with breast cancer. Journal Of Clinical Oncology 2023, 41: e13083-e13083. DOI: 10.1200/jco.2023.41.16_suppl.e13083.Peer-Reviewed Original ResearchBreast cancerEIA patientsDermatology referralsOnset of alopeciaRetrospective cohort studyMetastatic breast cancerRisk of alopeciaCyclin-dependent kinase 4Endocrine monotherapyOral minoxidilEndocrine therapyClinical improvementCohort studyRetrospective cohortFemale patientsTherapeutic optionsCombination therapyGrade severityTherapeutic responseFavorable outcomeAndrogenetic alopeciaDean scaleCDK4/6iPatientsSignificant improvement
2021
Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)
Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, de Aránguiz B, Haddad TC, Perelló A, Bellet M, Fohler H, Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL, groups and investigators O. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). Journal Of Clinical Oncology 2021, 40: 282-293. PMID: 34874182, PMCID: PMC10476784, DOI: 10.1200/jco.21.02554.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease ProgressionDisease-Free SurvivalFemaleHumansMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPiperazinesProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsPyridinesTime FactorsConceptsHormone receptor-positive breast cancerInvasive disease-free survivalReceptor-positive breast cancerAdjuvant endocrine therapyCancer-free survivalEndocrine therapyEarly breast cancerBreast cancerAdjuvant palbociclibPALLAS trialEnd pointEarly hormone receptor-positive breast cancerBreast cancer-free survivalDistant recurrence-free survivalHuman epidermal growth factor receptorProtocol-defined analysisStandard endocrine therapyPrimary end pointSecondary end pointsAdvanced breast cancerDisease-free survivalNew safety signalsRecurrence-free survivalEvent end pointsCyclin-dependent kinase 4A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease.
Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.Peer-Reviewed Original ResearchDisease control rateNon-visceral diseaseEndocrine therapyBreast cancerVisceral metastasesProgression-free survival benefitHER2-negative breast cancerDisease controlDose-finding cohortMost common AEsMedian treatment durationOpen-label studyPhase Ib studyPhase II doseNon-measurable diseaseHypo/hyperglycemiaCyclin-dependent kinase 4Advanced hormoneCommon AEsPFS ratesExpansion cohortPostmenopausal womenPrimary endpointSecondary endpointsMedian duration
2020
CDK4/6 inhibition reprograms the breast cancer enhancer landscape by stimulating AP-1 transcriptional activity
Watt AC, Cejas P, DeCristo MJ, Metzger-Filho O, Lam EYN, Qiu X, BrinJones H, Kesten N, Coulson R, Font-Tello A, Lim K, Vadhi R, Daniels VW, Montero J, Taing L, Meyer CA, Gilan O, Bell CC, Korthauer KD, Giambartolomei C, Pasaniuc B, Seo JH, Freedman ML, Ma C, Ellis MJ, Krop I, Winer E, Letai A, Brown M, Dawson MA, Long HW, Zhao JJ, Goel S. CDK4/6 inhibition reprograms the breast cancer enhancer landscape by stimulating AP-1 transcriptional activity. Nature Cancer 2020, 2: 34-48. PMID: 33997789, PMCID: PMC8115221, DOI: 10.1038/s43018-020-00135-y.Peer-Reviewed Original ResearchConceptsSet of enhancersTranscription factor proteinsAP-1 transcriptional activityEndogenous retroviral elementsCell cycle arrestEnhancer landscapeCyclin-dependent kinase 4Cancer cell cycle arrestEnhancer activationCell chromatinApoptotic evasionTranscriptional activityPathway biologyRetroviral elementsApoptotic responsePharmacologic inhibitorsCancer cell immunogenicityFactor proteinNew enhancersKinase 4Cycle arrestLuminal differentiationCDK4/6 inhibitionCDK4/6 inhibitorsEnhancerOverall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis
Schettini F, Giudici F, Giuliano M, Cristofanilli M, Arpino G, Del Mastro L, Puglisi F, De Placido S, Paris I, De Placido P, Venturini S, De Laurentis M, Conte P, Juric D, Llombart-Cussac A, Pusztai L, Prat A, Jerusalem G, Di Leo A, Generali D. Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis. Journal Of The National Cancer Institute 2020, 112: 1089-1097. PMID: 32407488, PMCID: PMC7669227, DOI: 10.1093/jnci/djaa071.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleHumansLetrozoleNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesRandomized Controlled Trials as TopicConceptsSecond-line therapyMetastatic breast cancerEndocrine therapyCDK4/6 inhibitorsVisceral involvementBreast cancerPostmenopausal metastatic breast cancerAvailable phase IIChemotherapy-naïve patientsClear OS benefitSpecific clinical subgroupsProgression-free survivalOverall survival dataBreast cancer prognosisStudy-level factorsCyclin-dependent kinase 4Random-effects modelSystematic literature searchEndocrine monotherapyOS benefitOS independentOverall survivalUpfront therapyMenopausal statusMetastatic sites
2019
SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Edelman MJ, Redman MW, Albain KS, McGary EC, Rafique NM, Petro D, Waqar SN, Minichiello K, Miao J, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1853-1859. PMID: 31302234, PMCID: PMC6764876, DOI: 10.1016/j.jtho.2019.06.027.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCell Cycle ProteinsFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPiperazinesPyridinesSalvage TherapySurvival RateConceptsSquamous NSCLCEligible patientsStage IV squamous cell lung cancerPhase II/III trialsCell cycle gene alterationsCyclin D3 gene amplificationMedian progression-free survivalPrior platinum-based chemotherapySquamous cell lung cancerSingle-arm phase II trialMedian overall survivalPhase II studyPrimary end pointPhase II trialProgression-free survivalPlatinum-based chemotherapyCell lung cancerNormal organ functionCyclin-dependent kinase 4Cyclin-dependent kinase 4 geneKinase 4 geneStable diseaseII trialII studyIII trialsRibociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongationImmunotherapy and targeted therapy combinations in metastatic breast cancer
Esteva FJ, Hubbard-Lucey VM, Tang J, Pusztai L. Immunotherapy and targeted therapy combinations in metastatic breast cancer. The Lancet Oncology 2019, 20: e175-e186. PMID: 30842061, DOI: 10.1016/s1470-2045(19)30026-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerImmune checkpoint inhibitorsTumor-infiltrating lymphocytesDeath ligand 1Most breast cancersNew treatment modalitiesSingle-drug therapyCyclin-dependent kinase 4Development of combinationsCheckpoint inhibitorsEndocrine therapyDeath-1Immunotherapeutic approachesBiological therapyTherapy combinationsTreatment modalitiesLittle efficacyImmune evasionAngiogenesis inhibitorsTherapyImmunotherapyCancerPolymerase inhibitorsMonoclonal antibodiesPalbociclib and Fulvestrant Act in Synergy to Modulate Central Carbon Metabolism in Breast Cancer Cells
Warth B, Palermo A, Rattray NJW, Lee NV, Zhu Z, Hoang LT, Cai Y, Mazurek A, Dann S, VanArsdale T, Fantin VR, Shields D, Siuzdak G, Johnson CH. Palbociclib and Fulvestrant Act in Synergy to Modulate Central Carbon Metabolism in Breast Cancer Cells. Metabolites 2019, 9: 7. PMID: 30609717, PMCID: PMC6359333, DOI: 10.3390/metabo9010007.Peer-Reviewed Original ResearchProgression-free survivalBreast cancer cell metabolismEstrogen receptor antagonistCyclin-dependent kinase 4Breast cancer cellsCancer cell metabolismCombination chemotherapyMCF-7 cellsReceptor antagonistCombination chemotherapeuticsSurvival advantageSelective metabolic pathwaysMetabolic disruptionCancer cellsMetabolic pathwaysKinase 4Cancer metabolismSelective inhibitorPalbociclibSame metabolic pathwayDrugsMetabolismTranscriptomic changesCell modelCell metabolism
2018
CDK4/6 inhibition in breast cancer: current practice and future directions
Pernas S, Tolaney SM, Winer EP, Goel S. CDK4/6 inhibition in breast cancer: current practice and future directions. Therapeutic Advances In Medical Oncology 2018, 10: 1758835918786451. PMID: 30038670, PMCID: PMC6050811, DOI: 10.1177/1758835918786451.Peer-Reviewed Original ResearchCDK4/6 inhibitorsBreast cancerNovel immune-based therapiesPositive breast cancer patientsER-positive breast cancerProgression-free survivalImmune-based therapiesBreast cancer patientsCancer cell cycle arrestClinical trial resultsSelective CDK4/6 inhibitorsNormal breast epitheliumCyclin-dependent kinase 4Breast cancer cellsCyclin D/cyclin-dependent kinase 4Cancer cell cycleEndocrine therapyCDK4/6 pathwayCDK4/6 inhibitionCancer patientsCell cycle arrestClinical dataEstrogen receptorPreclinical studiesBreast epithelium
2017
CDK4/6 inhibition triggers anti-tumour immunity
Goel S, DeCristo MJ, Watt AC, BrinJones H, Sceneay J, Li BB, Khan N, Ubellacker JM, Xie S, Metzger-Filho O, Hoog J, Ellis MJ, Ma CX, Ramm S, Krop IE, Winer EP, Roberts TM, Kim HJ, McAllister SS, Zhao JJ. CDK4/6 inhibition triggers anti-tumour immunity. Nature 2017, 548: 471-475. PMID: 28813415, PMCID: PMC5570667, DOI: 10.1038/nature23465.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntigen PresentationBiological MimicryBreast NeoplasmsCell Cycle CheckpointsCell Line, TumorCell ProliferationCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Disease Models, AnimalFemaleHumansInterferonsMicePhosphorylationProtein Kinase InhibitorsRepressor ProteinsRNA, Double-StrandedSignal TransductionT-Lymphocytes, RegulatoryTranscriptomeVirusesTrastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial.
Spring L, Goel S, Juric D, Isakoff S, Haddad S, Habin K, Krop I, Moy B, Tolaney S, Bardia A. Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial. Journal Of Clinical Oncology 2017, 35: tps1106-tps1106. DOI: 10.1200/jco.2017.35.15_suppl.tps1106.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerHER2-positive breast cancerObjective response rateProgression-free survivalMetastatic breast cancerT-DM1Breast cancerTrastuzumab emtansinePhase 1b clinical trialDose-expansion cohortsMTD/RP2DPhase 2 doseDose-escalation designPre-clinical modelsInhibition of CDK4/6Cyclin-dependent kinase 4Multiple effective therapiesHER receptor familyEligible patientsRECIST 1.1Most patientsPatient ageDependent kinase 4Escalation design
2015
Palbociclib
Mangini N, Wesolowski R, Ramaswamy B, Lustberg M, Berger M. Palbociclib. Annals Of Pharmacotherapy 2015, 49: 1252-1260. PMID: 26324355, PMCID: PMC7331461, DOI: 10.1177/1060028015602273.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclin-Dependent KinasesDisease-Free SurvivalEstradiolFemaleFulvestrantHumansLetrozoleNeoplasms, Hormone-DependentNitrilesPiperazinesPyridinesRandomized Controlled Trials as TopicReceptor, ErbB-2TriazolesUnited StatesConceptsProgression-free survivalAdvanced breast cancerInvestigator-assessed median progression-free survivalMedian progression-free survivalPhase III trialsBreast cancerEndocrine therapyIII trialsOncology abstractsHER2-negative advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerConfirmatory phase III trialClinical Oncology abstractsMedical Oncology abstractsPALOMA-3 trialFirst-line settingPhase II trialGrowth factor receptor 2Drug Administration approvalFactor receptor 2Life-threatening diseaseCyclin-dependent kinase 4Novel small molecule inhibitor
2011
The Transcription Factor E74-Like Factor Controls Quiescence of Endothelial Cells and Their Resistance to Myeloablative Treatments in Bone Marrow
Sivina M, Yamada T, Park CS, Puppi M, Coskun S, Hirschi K, Lacorazza HD. The Transcription Factor E74-Like Factor Controls Quiescence of Endothelial Cells and Their Resistance to Myeloablative Treatments in Bone Marrow. Arteriosclerosis Thrombosis And Vascular Biology 2011, 31: 1185-1191. PMID: 21350194, PMCID: PMC3100289, DOI: 10.1161/atvbaha.111.224436.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsBone Marrow CellsCell CycleCell ProliferationCellular SenescenceChlorocebus aethiopsCOS CellsCyclin-Dependent Kinase 4DNA-Binding ProteinsDrug ResistanceEndothelial CellsFluorouracilHumansMiceMice, Inbred C57BLMice, KnockoutMyeloablative AgonistsNeovascularization, PhysiologicNIH 3T3 CellsPromoter Regions, GeneticRNA InterferenceTime FactorsTranscription FactorsTransfectionConceptsBone marrowEndothelial cellsSinusoidal blood vesselsCyclin-dependent kinase 4 expressionBlood vesselsCyclin-dependent kinase 4Human umbilical vein endothelial cellsBone marrow endothelial cellsUmbilical vein endothelial cellsMurine endothelial cellsMarrow endothelial cellsVein endothelial cellsMyeloablative treatmentCD45- CD31Cell cycle entryProgenitor cellsMarrowKinase 4Hematopoietic systemCycle entryVascular networkCellsProliferationLineage-specific progenitor cellsVessels
2000
Deregulated E2f Transcriptional Activity in Autonomously Growing Melanoma Cells
Halaban R, Cheng E, Smicun Y, Germino J. Deregulated E2f Transcriptional Activity in Autonomously Growing Melanoma Cells. Journal Of Experimental Medicine 2000, 191: 1005-1016. PMID: 10727462, PMCID: PMC2193116, DOI: 10.1084/jem.191.6.1005.Peer-Reviewed Original ResearchMeSH KeywordsCarrier ProteinsCell Cycle ProteinsCell DivisionCells, CulturedCellular SenescenceCulture Media, ConditionedCyclin-Dependent KinasesCyclinsDNA-Binding ProteinsDown-RegulationDrosophila ProteinsE2F Transcription FactorsE2F1 Transcription FactorE2F2 Transcription FactorE2F3 Transcription FactorE2F4 Transcription FactorE2F5 Transcription FactorE2F6 Transcription FactorEnzyme InhibitorsFlavonoidsHumansMelanocytesMelanomaPhosphorylationPiperidinesProtein BindingRetinoblastoma-Binding Protein 1Trans-ActivatorsTranscription Factor DP1Transcription FactorsTumor Cells, CulturedConceptsExternal growth factorsE2F DNAPocket proteinsCyclin-dependent kinase 4Normal melanocytesTranscriptional activityRetinoblastoma tumor suppressor proteinMelanoma cellsMalignant human melanocytesE2F transcription factorsE2F family membersE2F transcriptional activityTumor suppressor proteinGel shift analysisCell cycle progressionForm of pRBGrowth factorContinuous high expressionE2F activityOnly family memberTranscription factorsProtein DNASuppressor proteinFamily membersMolecular basis
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