2025
Determinants 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 changesTumorProceedings of the National Cancer Institute Workshop on combining immunotherapy with radiotherapy: challenges and opportunities for clinical translation
Morris Z, Demaria S, Monjazeb A, Formenti S, Weichselbaum R, Welsh J, Enderling H, Schoenfeld J, Brody J, McGee H, Mondini M, Kent M, Young K, Galluzzi L, Karam S, Theelen W, Chang J, Huynh M, Daib A, Pitroda S, Chung C, Serre R, Grassberger C, Deng J, Sodji Q, Nguyen A, Patel R, Krebs S, Kalbasi A, Kerr C, Vanpouille-Box C, Vick L, Aguilera T, Ong I, Herrera F, Menon H, Smart D, Ahmed J, Gartrell R, Roland C, Fekrmandi F, Chakraborty B, Bent E, Berg T, Hutson A, Khleif S, Sikora A, Fong L. Proceedings of the National Cancer Institute Workshop on combining immunotherapy with radiotherapy: challenges and opportunities for clinical translation. The Lancet Oncology 2025, 26: e152-e170. PMID: 40049206, DOI: 10.1016/s1470-2045(24)00656-9.Peer-Reviewed Original ResearchConceptsAnti-tumor immune responseDelivery of radiotherapyTumor immune recognitionSelection of immunotherapyBiomarker-guided approachesNational Cancer Institute workshopClinical trial dataImmunotherapy combinationsClinical responseImprove patient outcomesPreclinical modelsPatient selectionRadiotherapyImmunotherapyClinical endpointsClinical dataClinical studiesImmune recognitionImmune responseImmune effectsAnimal studiesClinical translationPatient outcomesTrial dataNegative trialsComputational Nuclear Oncology Toward Precision Radiopharmaceutical Therapies: Current Tools, Techniques, and Uncharted Territories.
Yusufaly T, Roncali E, Brosch-Lenz J, Uribe C, Jha A, Currie G, Dutta J, El-Fakhri G, McMeekin H, Pandit-Taskar N, Schwartz J, Shi K, Strigari L, Zaidi H, Saboury B, Rahmim A. Computational Nuclear Oncology Toward Precision Radiopharmaceutical Therapies: Current Tools, Techniques, and Uncharted Territories. Journal Of Nuclear Medicine 2025, jnumed.124.267927. PMID: 39947910, DOI: 10.2967/jnumed.124.267927.Peer-Reviewed Original ResearchRadiopharmaceutical therapyImage-based dosimetryPrediction of doseInternal dosimetryPersonalized treatment plansMetastatic diseaseDosimetryNuclear oncologyClinical outcomesNuclear medicineClinical endpointsTreatment planningOncology communityDose responseEtiological mechanismsTargeted deliveryRadiobiologyRadiotherapyMalignancyRadiationLong-termTherapyPharmacotherapyDoseRadiopharmacokinetics
2024
Factor XI: structure, function and therapeutic inhibition
Ali A, Becker R. Factor XI: structure, function and therapeutic inhibition. Journal Of Thrombosis And Thrombolysis 2024, 57: 1315-1328. PMID: 38622277, PMCID: PMC11645426, DOI: 10.1007/s11239-024-02972-5.Peer-Reviewed Original ResearchFactor XI inhibitorsVitamin K antagonistsEnd-stage renal diseaseFactor XITraditional anticoagulantsSafety profileInherent risk of bleedingPhase 3 clinical trialsPhase 2 studyMultiple coagulation factorsRisk of bleedingFactor XI deficiencyIntrinsic pathway of coagulationPathway of coagulationFXI inhibitorsK antagonistsOral anticoagulantsAnticoagulant therapyTherapeutic anticoagulationVenous thromboembolismPreclinical studiesAtrial fibrillationClinical endpointsRenal diseaseClinical trialsSurrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis
Gharzai L, Morris E, Suresh K, Nguyen-Tân P, Rosenthal D, Gillison M, Harari P, Garden A, Koyfman S, Caudell J, Jones C, Mitchell D, Krempl G, Ridge J, Gensheimer M, Bonner J, Filion E, Dunlap N, Stokes W, Le Q, Torres-Saavedra P, Mierzwa M, Schipper M. Surrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis. The Lancet Oncology 2024, 25: 366-375. PMID: 38423050, PMCID: PMC10962533, DOI: 10.1016/s1470-2045(24)00016-0.Peer-Reviewed Original ResearchConceptsLocoregional progression-free survivalProgression-free survivalIntermediate clinical endpointsMetastasis-free survivalOverall survivalClinical endpointsOropharyngeal cancerComposite endpointIncidence of human papillomavirus (HPV)-related cancersP16-positive squamous cell carcinomaHuman papillomavirus (HPV)-related cancersP16-positive oropharyngeal cancerCancer treated with chemotherapyIndividual patient data meta-analysisMedian follow-upPatient data meta-analysisSquamous-cell carcinomaSquamous cell carcinomaPatient levelClinical trial endpointsTreatment effectsData meta-analysisLocoregional progressionNational Cancer InstituteDistant metastasis
2023
Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment The VIVID Registry
Simonato M, Whisenant B, Unbehaun A, Kempfert J, Ribeiro H, Kornowski R, Erlebach M, Bleiziffer S, Windecker S, Pilgrim T, Tomii D, Guerrero M, Ahmad Y, Forrest J, Montorfano M, Ancona M, Adam M, Wienemann H, Finkelstein A, Villablanca P, Codner P, Hildick-Smith D, Ferrari E, Petronio A, Shamekhi J, Presbitero P, Bruschi G, Rudolph T, Cerillo A, Attias D, Nejjari M, Abizaid A, Felippi de Sá Marchi M, Horlick E, Wijeysundera H, Andreas M, Thukkani A, Agrifoglio M, Iadanza A, Baer L, Nanna M, Dvir D. Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment The VIVID Registry. JACC Cardiovascular Interventions 2023, 16: 2615-2627. PMID: 37968032, DOI: 10.1016/j.jcin.2023.08.047.Peer-Reviewed Original ResearchConceptsLeft ventricular outflow tractLeft ventricular outflow tract obstructionAssociated with residual stenosisResidual stenosisDepth of implantationValve stenosisValve Academic Research Consortium definitionsAssociated with LVOT obstructionAcademic Research Consortium definitionsMitral valve-in-valveVentricular outflow tractMitral valve stenosisValve-in-valveCore lab evaluationLVOT obstructionOutflow tractHemodynamic outcomesSuboptimal hemodynamicsClinical endpointsSAPIEN 3Atrial implantsBalloon-expandableStenosisObstructionImplantationExercise Does Not Independently Improve Histological Outcomes in Biopsy-Proven Non-Alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis
Chen G, Banini B, Do A, Gunderson C, Zaman S, Lim J. Exercise Does Not Independently Improve Histological Outcomes in Biopsy-Proven Non-Alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Genes 2023, 14: 1811. PMID: 37761951, PMCID: PMC10531443, DOI: 10.3390/genes14091811.Peer-Reviewed Original ResearchConceptsNon-alcoholic fatty liver diseaseBiopsy-proven non-alcoholic fatty liver diseaseEffects of exerciseFatty liver diseaseHistological outcomesLiver histologyLiver diseaseClinical trialsHistological endpointsSystematic reviewSignificant histopathological improvementNAFLD activity scoreImpact of exerciseIndependent effectsRandom-effects modelSystematic literature searchHistopathological improvementExercise interventionActivity scoreClinical endpointsPooled estimatesMeta-AnalysisTotal participantsLiterature searchComparison groupBiological rhythms in COVID-19 vaccine effectiveness in an observational cohort study of 1.5 million patients
Hazan G, Duek O, Alapi H, Mok H, Ganninger A, Ostendorf E, Gierasch C, Chodick G, Greenberg D, Haspel J. Biological rhythms in COVID-19 vaccine effectiveness in an observational cohort study of 1.5 million patients. Journal Of Clinical Investigation 2023, 133: e167339. PMID: 37053011, PMCID: PMC10231992, DOI: 10.1172/jci167339.Peer-Reviewed Original ResearchConceptsCOVID-19 vaccinationBreakthrough infectionsVaccine effectivenessVaccination timingCOVID-19 breakthrough infectionsCOVID-19-related hospitalizationCOVID-19 vaccine effectivenessBasic immune processesSecond booster doseObservational cohort studyEmergency department visitsMass vaccination programBooster doseVaccination timeBooster dosesCohort studyOlder patientsPatient ageDepartment visitsVaccine protectionCox regressionIsraeli cohortClinical endpointsVaccination programImmunization time
2022
Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials
Shurtz L, Schwartz C, DiStefano C, McPartland JC, Levin AR, Dawson G, Kleinhans NM, Faja S, Webb SJ, Shic F, Naples AJ, Seow H, Bernier RA, Chawarska K, Sugar CA, Dziura J, Senturk D, Santhosh M, Jeste SS. Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials. Autism 2022, 27: 952-966. PMID: 36086805, PMCID: PMC9995606, DOI: 10.1177/13623613221121425.Peer-Reviewed Original ResearchConceptsConcomitant psychotropic medicationsPsychotropic medicationsClinical trialsMedication useSchool-aged childrenClinical representativenessSelective serotonin reuptake inhibitorsConcomitant medication useVariety of medicationsAutism spectrum disorderSerotonin reuptake inhibitorsPsychotropic medication useNew treatment optionsGreater overall impairmentCentral nervous systemSpectrum disorderMedication classesReuptake inhibitorsAlpha agonistsTreatment optionsClinical endpointsInclusion criteriaStudy populationMedicationsNervous system
2020
Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement
Butala NM, Strom JB, Faridi KF, Kazi DS, Zhao Y, Brennan JM, Popma JJ, Shen C, Yeh RW. Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement. JACC Cardiovascular Interventions 2020, 13: 1777-1785. PMID: 32682677, PMCID: PMC7444647, DOI: 10.1016/j.jcin.2020.03.049.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overAortic Valve StenosisBioprosthesisClinical Trials as TopicData AccuracyData MiningDatabases, FactualFemaleHealth Services ResearchHeart Valve ProsthesisHumansInternational Classification of DiseasesMaleMedicarePostoperative ComplicationsReproducibility of ResultsTranscatheter Aortic Valve ReplacementTreatment OutcomeUnited StatesConceptsTranscatheter aortic valve replacementAortic valve replacementNegative predictive valuePositive predictive valueValve replacementPivotal trialsAdministrative claimsPredictive valueAortic valve reinterventionProcedural billing codesAcute kidney injuryPermanent pacemaker implantationKappa agreement statisticsBleeding eventsValve reinterventionKidney injuryTrial patientsPacemaker implantationProcedural complicationsOutcome ascertainmentTrial endpointsClinical endpointsMyocardial infarctionInpatient claimsClinical trialsThe state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda
Loflin MJE, Kiluk BD, Huestis MA, Aklin WM, Budney AJ, Carroll KM, D'Souza DC, Dworkin RH, Gray KM, Hasin DS, Lee DC, Le Foll B, Levin FR, Lile JA, Mason BJ, McRae-Clark AL, Montoya I, Peters EN, Ramey T, Turk DC, Vandrey R, Weiss RD, Strain EC. The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda. Drug And Alcohol Dependence 2020, 212: 107993. PMID: 32360455, PMCID: PMC7293929, DOI: 10.1016/j.drugalcdep.2020.107993.Peer-Reviewed Original ResearchConceptsClinical outcome assessmentCannabis use disorderClinical trialsOutcome assessmentForms of cannabisCannabis-related harmsCannabis reductionPrimary outcomeFunctional outcomeInterpretation of outcomesClinical endpointsNew pharmacotherapiesPsychomotor impairmentOutcome measuresSelf-report assessmentsDiagnostic criteriaUse disordersOptimal durationCannabis useStudy designBiologic assaysTrialsOptimal outcomesLack of consensusCannabisSurrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial
Martini A, Pfail J, Montorsi F, Galsky M, Oh W. Surrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial. Prostate Cancer And Prostatic Diseases 2020, 23: 638-645. PMID: 32313142, DOI: 10.1038/s41391-020-0231-5.Peer-Reviewed Original ResearchMeSH KeywordsAgedAndrogen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDisease ProgressionDocetaxelHumansKallikreinsMaleMiddle AgedMulticenter Studies as TopicNeoplasm MetastasisProstate-Specific AntigenProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantRandomized Controlled Trials as TopicSurvival RateTreatment OutcomeUnited StatesConceptsAndrogen deprivation therapyCastration-resistant PCDevelopment of castration-resistant PCOverall survivalProstate cancerCombination therapyMetastatic hormone-sensitive prostate cancerAndrogen Ablation Randomized TrialMetastatic hormone-sensitive PCHormone-sensitive prostate cancerHormone-sensitive PCNonmetastatic prostate cancerMonths of randomizationIntermediate clinical endpointsMethodsWe analyzed dataCHAARTED trialChemohormonal therapyOS ratesOS surrogatePSA responseDeprivation therapyMetastatic diseasePredicting OSClinical endpointsRandomized trialsRelevance of Microvascular Flow Assessments in Critically Ill Neonates and Children: A Systematic Review.
Maitoza LA, Neeman E, Funaro M, Pierce RW. Relevance of Microvascular Flow Assessments in Critically Ill Neonates and Children: A Systematic Review. Pediatric Critical Care Medicine 2020, 21: 373-384. PMID: 31834246, PMCID: PMC10061570, DOI: 10.1097/pcc.0000000000002201.Peer-Reviewed Original ResearchConceptsIll childrenMicrovascular flowSystematic reviewMicrocirculatory dysfunctionIll neonatesMicrocirculatory changesBlood flowImpact of patientMicrovascular blood flowMicrocirculatory blood flowFull-text reviewWeb of ScienceMacrovascular functionPatients 0Critical illnessEffect of ageSuch patientsMedical managementPoor outcomeBirth weightMicrocirculatory variablesClinical endpointsInclusion criteriaNeonatesMacrocirculatory variables
2019
The Shock Index is not accurate at predicting outcomes in patients with upper gastrointestinal bleeding
Saffouri E, Blackwell C, Laursen SB, Laine L, Dalton HR, Ngu J, Shultz M, Norton R, Stanley AJ. The Shock Index is not accurate at predicting outcomes in patients with upper gastrointestinal bleeding. Alimentary Pharmacology & Therapeutics 2019, 51: 253-260. PMID: 31642558, DOI: 10.1111/apt.15541.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overArea Under CurveBlood TransfusionCohort StudiesEndoscopy, GastrointestinalFemaleGastrointestinal HemorrhageHospitalizationHumansMaleMiddle AgedMortalityPredictive Value of TestsPrognosisProspective StudiesReproducibility of ResultsRisk AssessmentSeverity of Illness IndexShockSurvival AnalysisUpper Gastrointestinal TractYoung AdultConceptsUpper gastrointestinal bleedingGlasgow-Blatchford scoreShock indexGastrointestinal bleedingABC scoreMajor transfusionAcute upper gastrointestinal bleedingUK National Confidential EnquiryAdmission Rockall scoreSevere gastrointestinal bleedingMajor clinical endpointsPredictors of outcomeNational Confidential EnquiryRockall scoreBlatchford scoreEndoscopic therapyConsecutive patientsHospital admissionConfidential EnquiryProspective studyClinical endpointsPatient outcomesRisk scoreDeath reportsBleedingA.01 Relieving the burden of myasthenia gravis: eculizumab reduces exacerbation, hospitalization and rescue therapy rates
Siddiqi Z, Howard J, Jacob S, Guptill J, Meisel A, Wiendl H, Murai H, Utsugisawa K, Nowak R, Fujita K, O’Brien F, Patra K, Muppidi S. A.01 Relieving the burden of myasthenia gravis: eculizumab reduces exacerbation, hospitalization and rescue therapy rates. Canadian Journal Of Neurological Sciences / Journal Canadien Des Sciences Neurologiques 2019, 46: s8-s8. DOI: 10.1017/cjn.2019.83.Peer-Reviewed Original ResearchPre-study yearOpen-label extensionHealthcare resource utilizationMyasthenia gravisEculizumab treatmentDisease burdenSignificant healthcare resource utilizationAnti-acetylcholine receptorExacerbations/hospitalizationsGreater disease burdenPoisson regression modelsMG crisisTherapy ratesRescue therapyResponsive patientsTherapy useTherapy usageClinical endpointsExacerbationHospitalizationPatientsMeaningful benefitREGAIN studyPatient recordsEvent ratesAnalysis of real-world data (RWD) on treatment (tx) sequencing in patients with advanced non-small cell lung cancer (aNSCLC).
Ma M, Zhou X, Goldsweig H, Hahner N, Han D, Dietz M, Jones S, Mullaney T, Redfern A, Jappe W, Liu Z, Yadav K, Zimmerman M, Prentice T, Pan Q, Hirsch F, Oh W, Schadt E, Li D, Chen R. Analysis of real-world data (RWD) on treatment (tx) sequencing in patients with advanced non-small cell lung cancer (aNSCLC). Journal Of Clinical Oncology 2019, 37: e20642-e20642. DOI: 10.1200/jco.2019.37.15_suppl.e20642.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerTyrosine kinase inhibitorsCheckpoint inhibitorsSystemic therapyClinical trialsNon-small cell lung cancerSurrogate clinical endpointsImmune checkpoint inhibitorsKaplan-Meier analysisPlatinum-based chemotherapyCell lung cancerPivotal clinical trialsMaximal clinical benefitMount Sinai HospitalChemo groupClinical outcomesPlatinum therapyClinical benefitTreatment sequencingClinical endpointsLung cancerPatient outcomesObservational studyTherapeutic modalitiesSinai HospitalTreatment of Metastatic Castration-resistant Prostate Cancer With Abiraterone and Enzalutamide Despite PSA Progression
BECKER D, IYENGAR A, PUNEKAR S, NG J, ZAMAN A, LOEB S, BECKER K, MAKAROV D. Treatment of Metastatic Castration-resistant Prostate Cancer With Abiraterone and Enzalutamide Despite PSA Progression. Anticancer Research 2019, 39: 2467-2473. PMID: 31092441, DOI: 10.21873/anticanres.13366.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAbi/enzaCastration-resistant prostate cancerPSA progressionEnd of lifeProstate cancerVeterans AffairsOlder patientsBlack patientsClinical benefitClinical endpointsHospice servicesNational guidelinesPatientsEnza treatmentAdditional studiesProgressionENZAAbirateroneRegression analysisCancerTreatmentABIEnzalutamideEndpointUrinary Sodium Profiling in Chronic Heart Failure to Detect Development of Acute Decompensated Heart Failure
Martens P, Dupont M, Verbrugge FH, Damman K, Degryse N, Nijst P, Reynders C, Penders J, Tang WHW, Testani J, Mullens W. Urinary Sodium Profiling in Chronic Heart Failure to Detect Development of Acute Decompensated Heart Failure. JACC Heart Failure 2019, 7: 404-414. PMID: 31047021, DOI: 10.1016/j.jchf.2019.02.011.Peer-Reviewed Original ResearchConceptsChronic HF patientsHF patientsHeart failureSodium excretionAcute decompensated heart failureAcute heart failure hospitalizationLongitudinal changesChronic heart failureDecompensated heart failureHeart failure hospitalizationHigher sodium excretionUrinary sodium concentrationGlomerular filtration rate measurementInterindividual differencesLarge interindividual differencesFiltration rate measurementAHF hospitalizationDyspnea scoreFailure hospitalizationNT-proBNPChronic heartEjection fractionIndependent predictorsClinical endpointsPathophysiologic interactions
2018
Evaluation of classical clinical endpoints as surrogates for overall survival in patients treated with immune checkpoint blockers: a systematic review and meta-analysis
Kaufman HL, Schwartz LH, William WN, Sznol M, Fahrbach K, Xu Y, Masson E, Vergara-Silva A. Evaluation of classical clinical endpoints as surrogates for overall survival in patients treated with immune checkpoint blockers: a systematic review and meta-analysis. Journal Of Cancer Research And Clinical Oncology 2018, 144: 2245-2261. PMID: 30132118, DOI: 10.1007/s00432-018-2738-x.Peer-Reviewed Original ResearchConceptsImmune checkpoint blockersOS hazard ratioPFS hazard ratioHazard ratioOverall survivalPFS ratesOS ratesCheckpoint blockersPooled analysisClinical endpointsSolid tumor patientsChemotherapy armTreatment armsOdds ratioTumor patientsPredictive valueChemotherapySystematic reviewImperfect surrogatePatientsEndpointBlockersCongress proceedingsSurvivalArmChapter 22 Current Status of Medical Therapy of Thoracic Aortic Aneurysm and Dissection
Percy A, Mukherjee S, Ziganshin B, Elefteriades J. Chapter 22 Current Status of Medical Therapy of Thoracic Aortic Aneurysm and Dissection. 2018, 235-249. DOI: 10.1016/b978-0-12-809979-7.00022-5.Peer-Reviewed Original ResearchThoracic aortic aneurysmAortic aneurysmMost thoracic aortic aneurysmsAngiotensin receptor blockersClasses of medicationsAortic aneurysm developmentRelevant clinical endpointsAortic aneurysm expansionAsymptomatic patientsLifestyle modificationReceptor blockersMedical therapySurgical repairAortic catastropheClinical evidencePathophysiologic pathwaysSurgical interventionPathophysiologic basisTreatment modalitiesAneurysm expansionClinical endpointsClinical trialsCurrent guidelinesAneurysm formationClinical studies
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