2025
Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases.
Weiss S, Djureinovic D, Wei W, Tran T, Austin M, Markowitz J, Eroglu Z, Khushalani N, Hegde U, Cohen J, Sznol M, Anderson G, Johnson B, Piteo C, Mahajan A, Adeniran A, Jilaveanu L, Goldberg S, Chiang V, Forsyth P, Kluger H. Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases. Journal Of Clinical Oncology 2025, jco2402219. PMID: 40048689, DOI: 10.1200/jco-24-02219.Peer-Reviewed Original ResearchMelanoma brain metastasesOverall survivalBrain metastasesAnti-vascular endothelial growth factor therapyMedian intracranial progression-free survivalFour-year OS ratesIntracranial progression-free survivalResponse rateCirculating angiopoietin-2Median overall survivalTrial of pembrolizumabYears of pembrolizumabDose of bevacizumabProgression-free survivalPhase II trialGrowth factor therapyAdverse event ratesAssociated with responseOS ratesPD-1Radiation necrosisLocal therapyOn-therapyMetastatic tumorsFactor therapyEfficacy and safety of anesthetic agents in awake craniotomy using monitored anesthesia care protocol: a systematic review and meta-analysis
Aghajanian S, Naeimi A, Mohammadifard F, Mohammadi I, Rajai Firouzabadi S, Baradaran Bagheri A, Khorasanizadeh M, Elsamadicy A. Efficacy and safety of anesthetic agents in awake craniotomy using monitored anesthesia care protocol: a systematic review and meta-analysis. Neurosurgical Review 2025, 48: 57. PMID: 39815114, DOI: 10.1007/s10143-025-03176-y.Peer-Reviewed Original ResearchConceptsMonitored anesthesia carePostoperative neurological deficitsNeurological deficitsAwake craniotomyClinical outcomesMeta-analysisMonitored anesthesia care protocolPooled proportion of patientsRate of postoperative neurologic deficitsRisk of neurological deficitsProportion of patientsAdverse event ratesAnesthetic agentsSystematic reviewIntraoperative seizure rateSecondary adverse outcomesImpact of anesthetic agentsTumor resectionRemifentanil usePooled proportionTense brainIntraoperative seizuresAnesthetic protocolRandomized trialsAdverse outcomes
2024
Low Dose Tamoxifen for Breast Cancer Prevention: A Real-World Experience
Patel R, Jin C, Jaber D, Casasanta N, Jain M, Fu W, Wu C, Moshier E, Tiersten A. Low Dose Tamoxifen for Breast Cancer Prevention: A Real-World Experience. Clinical Breast Cancer 2024, 25: 283-290. PMID: 39837695, DOI: 10.1016/j.clbc.2024.12.020.Peer-Reviewed Original ResearchConceptsLobular carcinoma in situDuctal carcinoma in situLow dose tamoxifenCarcinoma in situAtypical hyperplasiaBreast cancer preventionLog-binomial modelsRetrospective chart review of womenPoison regression modelsChart review of womenIncidence rate of AEFrequency of adverse eventsReview of womenCompare adverse event ratesRetrospective chart reviewHigh-risk lesionsAdverse event ratesCancer preventionIncidence rateAromatase inhibitorsAtypical lesionsAdverse eventsRegression modelsDisease characteristicsHyperplasiaA Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19
Seethamraju H, Yang O, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha J, Ojha S, Hansen S, Arman A, Lalezari J. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clinical Therapeutics 2024, 46: 891-899. PMID: 39353749, DOI: 10.1016/j.clinthera.2024.08.019.Peer-Reviewed Original ResearchMild to moderate COVID-19National Early Warning Score 2SARS-CoV-2 infectionPost hoc analysisSARS-CoV-2Randomized placebo-controlled trialHoc analysisHuman IgG4 monoclonal antibodyModerate-to-severe diseaseViral replicationHIV-1 infectionPlacebo-controlled studyProduction of pro-inflammatory cytokinesExcessive production of pro-inflammatory cytokinesMild-to-moderateAdverse event ratesExploratory post hoc analysisTotal symptom scorePathophysiology of SARS-CoV-2 infectionPro-inflammatory cytokinesHeightened immune responsePathophysiology of COVID-19IgG4 monoclonal antibodyPlacebo groupDouble-blindEffect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy
Bitar R, Bozal S, Sisti A, Mojibian H, Marino A, Cornman-Homonoff J. Effect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy. Journal Of Vascular And Interventional Radiology 2024, 35: 1447-1456. PMID: 38950819, DOI: 10.1016/j.jvir.2024.06.026.Peer-Reviewed Original ResearchPulmonary artery pressureAspiration thrombectomyPulmonary embolismArterial pressureDuration of intensive care unitSeverity of adverse eventsLength of hospital stayHigh-risk PEProcedure-related complicationsAdverse event ratesIntensive care unitMarker of procedural successFluoroscopy timeTransfusion requirementsBlood lossNo significant differenceTransfusion needsHospital stayPost-procedureProcedural successAdverse eventsSurrogate markerLaboratory valuesProcedural outcomesProcedural detailsA Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions The SELUTION SFA Japan Trial
Iida O, Soga Y, Saito S, Mano T, Hayakawa N, Ichihashi S, Kawasaki D, Suzuki K, Yamaoka T, Fujihara M, Nakama T, Nakamura M, Horie K, Shah T, Lansky A, Kozuki A. A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions The SELUTION SFA Japan Trial. JACC Cardiovascular Interventions 2024, 17: 1547-1556. PMID: 38842992, DOI: 10.1016/j.jcin.2024.03.029.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleEquipment DesignFemaleFemoral ArteryHumansJapanMaleMiddle AgedPeripheral Arterial DiseasePopliteal ArteryProspective StudiesRecurrenceRisk FactorsSirolimusTime FactorsTreatment OutcomeVascular Access DevicesVascular PatencyConceptsSirolimus-coated balloonFP diseaseTreatment optionsJapan trialPrespecified performance goalTreatment of femoropopliteal lesionsClinical events committeePrimary patency rateImaging core laboratoryPeak systolic velocity ratioEffective treatment optionSingle-arm studyAdverse event ratesTarget lesion revascularizationSystolic velocity ratioAnkle-brachial index dataChronic total occlusionPrimary endpointPrimary patencySymptomatic patientsEvents committeeDays postprocedureCD-TLRDuplex ultrasoundFemoropopliteal lesionsImmunotherapy for Resectable Locally Advanced Esophageal Carcinoma
Fick C, Dunne E, Sihag S, Molena D, Cytryn S, Janjigian Y, Wu A, Worrell S, Hofstetter W, Jones D, Gray K. Immunotherapy for Resectable Locally Advanced Esophageal Carcinoma. The Annals Of Thoracic Surgery 2024, 118: 130-140. PMID: 38408631, PMCID: PMC11194153, DOI: 10.1016/j.athoracsur.2024.02.021.Peer-Reviewed Original ResearchLocally advanced esophagealImmune checkpoint inhibitorsDisease-free survivalGastroesophageal junctionPerioperative immunotherapyAdvanced esophagealNeoadjuvant chemoradiotherapyEsophageal carcinomaLocally advanced esophageal carcinomaPooled adverse event rateLocally advanced esophageal cancerPathologic complete response rateResponse rateDual checkpoint inhibitionGastroesophageal junction carcinomaAdvanced esophageal carcinomaComplete response rateAdvanced esophageal cancerEsophageal squamous cell carcinomaGastroesophageal junction cancerR0 resection rateResectable esophageal carcinomaPhase III trialsSquamous cell carcinomaAdverse event ratesPredicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion
Faridi K, Ong E, Zimmerman S, Varosy P, Friedman D, Hsu J, Kusumoto F, Mortazavi B, Minges K, Pereira L, Lakkireddy D, Koutras C, Denton B, Mobayed J, Curtis J, Freeman J. Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion. Circulation Arrhythmia And Electrophysiology 2024, 17: e012424. PMID: 38390713, DOI: 10.1161/circep.123.012424.Peer-Reviewed Original ResearchNational Cardiovascular Data RegistryLeft atrial appendage occlusionIn-hospital major adverse eventsMajor adverse eventsBedside risk scoreRisk scoreData RegistryIncreased fall riskAdverse eventsQuality improvement effortsWatchman FLXAppendage occlusionFall riskLeft atrial appendage occlusion procedureRegistry dataImprovement effortsRisk of in-hospital major adverse eventsPredicting major adverse eventsLogistic regressionAdverse event ratesModerate discriminationClinically relevant variablesFemale sexAtrial fibrillation terminationLAAO proceduresReal‐world analysis of adverse event rates after initiation of ibrutinib among Medicare beneficiaries with chronic lymphocytic leukemia
Huntington S, de Nigris E, Puckett J, Kamal‐Bahl S, Farooqui M, Ryland K, Sarpong E, Leng S, Yang X, Doshi J. Real‐world analysis of adverse event rates after initiation of ibrutinib among Medicare beneficiaries with chronic lymphocytic leukemia. Cancer Medicine 2024, 13: e6953. PMID: 38348963, PMCID: PMC10832339, DOI: 10.1002/cam4.6953.Peer-Reviewed Original ResearchConceptsChronic lymphocytic leukemiaRate of adverse eventsIncidence rate of adverse eventsAdverse eventsPatient-monthsLymphocytic leukemiaIncidence ratePatients treated with ibrutinibTreatment of chronic lymphocytic leukemiaStandard-of-care therapyNon-discontinuationInitiation of ibrutinibBTK inhibitor ibrutinibAdverse event ratesPotential side effectsInhibitor ibrutinibMedicare beneficiariesReal-world analysisAtrial fibrillationFollow-upIbrutinibSide effectsReal-world outcomesEvent ratesLeukemia
2023
Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma
Wong S, Torres-Saavedra P, Saba N, Shenouda G, Bumpous J, Wallace R, Chung C, El-Naggar A, Gwede C, Burtness B, Tennant P, Dunlap N, Redman R, Stokes W, Rudra S, Mell L, Sacco A, Spencer S, Nabell L, Yao M, Cury F, Mitchell D, Jones C, Firat S, Contessa J, Galloway T, Currey A, Harris J, Curran W, Le Q. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma. JAMA Oncology 2023, 9: 1565-1573. PMID: 37768670, PMCID: PMC10540060, DOI: 10.1001/jamaoncol.2023.3809.Peer-Reviewed Original ResearchConceptsProgression-free survivalAdverse event ratesOverall survivalStage IIIClinical trialsAcute adverse event ratesProgression-free survival ratesEnd pointEvent ratesAnti-epidermal growth factor receptor (EGFR) antibodiesBenefit of chemoradiotherapyZubrod performance statusPrimary end pointSecondary end pointsCycles of cisplatinAddition of lapatinibEGFR antibody therapyGrowth factor receptor antibodyLog-rank testDual EGFRPlus CisplatinFrontline therapyPerformance statusAntibody therapyNeck carcinomaIntracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S.
Ferro E, Alkhouli M, Nair D, Kapadia S, Hsu J, Gibson D, Freeman J, Price M, Roy K, Allocco D, Yeh R, Piccini J. Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S. JACC Clinical Electrophysiology 2023, 9: 2587-2599. PMID: 37831030, DOI: 10.1016/j.jacep.2023.08.004.Peer-Reviewed Original ResearchConceptsAtrial appendage occlusionTransesophageal echocardiographyIntracardiac echocardiographyBaseline characteristicsAppendage occlusionLeft atrial appendage occlusionPericardial effusion rateSuccessful device implantationAdverse event ratesSimilar baseline characteristicsUnadjusted mortality ratesHigh rateICE patientsTEE patientsPericardial effusionPivotal trialsDevice implantationGeneral anesthesiaAdjusted comparisonsProcedural timeLAAO devicesDevice deliveryMortality rateEvent ratesEchocardiographyMinimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.
Whang P, Patel V, Duhon B, Sturesson B, Cher D, Carlton Reckling W, Capobianco R, Polly D. Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy. The International Journal Of Spine Surgery 2023, 17: 794-808. PMID: 37798076, PMCID: PMC10753354, DOI: 10.14444/8543.Peer-Reviewed Original ResearchPatient-reported outcomesChronic SI joint painSI joint painJoint painJoint fusionAdverse event ratesSI joint fusionSacroiliac joint fusionMultiple surgical approachesImplant placement accuracyODI scoresEfficacy outcomesPain scoresRadiographic evidenceRandomized trialsSurgical interventionWound infectionPatient cohortSurgical approachSurgical techniqueImplant malpositionImplant placementSafety outcomesPainMeta-AnalysisEV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefitBeyond Survival: Adverse Events and Care Delivery Outcomes after Early Liver Cancer Treatment in a Nationally Representative Cohort
Charalel R, Mushlin A, Zheng X, Mao J, Carlos R, Brown R, Fortune B, Talenfeld A, Madoff D, Ibrahim S, Johnson M, Sedrakyan A. Beyond Survival: Adverse Events and Care Delivery Outcomes after Early Liver Cancer Treatment in a Nationally Representative Cohort. Journal Of Vascular And Interventional Radiology 2023, 34: 1997-2005.e3. PMID: 37468093, DOI: 10.1016/j.jvir.2023.07.010.Peer-Reviewed Original ResearchConceptsLiver transplantSurgical resectionHepatocellular carcinomaLT cohortBiliary injuryReadmission ratesAbscess formationIntensive care unit-level careLess healthcare utilizationNationally Representative CohortInitial hospital stayICU-level careAdverse event ratesEnd Results ProgramSmall hepatocellular carcinomaCare delivery outcomesFisher's exact testHealthcare Common Procedure Coding SystemChi-square testLow-intensity careLiver cancer treatmentPostprocedural hemorrhageHospital stayAdverse eventsSecondary outcomesEFFICACY AND SAFETY OF HYPERBARIC OXYGEN THERAPY IN FISTULIZING CROHN'S DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS
Dokmak A, Sweigart B, Orekondy N, Jangi S, Hamdeh S, Weinstock J, Kochar G, Shen B, Levy A. EFFICACY AND SAFETY OF HYPERBARIC OXYGEN THERAPY IN FISTULIZING CROHN'S DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS. Inflammatory Bowel Diseases 2023, 29: s63-s63. DOI: 10.1093/ibd/izac247.121.Peer-Reviewed Original ResearchHyperbaric oxygen therapy sessionsHyperbaric oxygen therapyInflammatory bowel diseaseClinical responseClinical remissionRandomized controlled trialsPartial responseRectovaginal fistulaFistulizing CDResponse to HBOTCrohn's diseaseControlled trialsLow adverse event ratesSystematic reviewClinical response rateOutcome dataFistulizing Crohn's diseaseAdjunctive hyperbaric oxygen therapyClosure of fistulaMeta-analysisCochrane Library databasesAdverse event ratesCessation of drainagePotential clinical benefitCase-control studyAnterior Cervical Discectomy and Fusion Outcomes in Patients With and Without Bariatric Surgery—Weight Loss Does Make a Difference
Joo P, Zhu J, Wilhelm C, Tang K, Day W, Moran J, Grauer J. Anterior Cervical Discectomy and Fusion Outcomes in Patients With and Without Bariatric Surgery—Weight Loss Does Make a Difference. Spine 2023, 48: 400-406. PMID: 36735637, DOI: 10.1097/brs.0000000000004580.Peer-Reviewed Original ResearchConceptsAnterior cervical discectomyBariatric surgeryMorbid obesityAdverse eventsCervical discectomyReoperation rateBS proceduresFive-Year Reoperation RatesRetrospective comparative cohort studyHistory of BSMinor adverse eventsNon-obese patientsAdverse event ratesComparative cohort studyElixhauser Comorbidity IndexKaplan-Meier analysisRisk of complicationsNon-obese controlsLength of stayACDF patientsElective ACDFComorbidity indexFusion patientsPulmonary embolismCohort study
2022
Open Debridement Alone Versus Open Debridement With Tendon Repair for Lateral Epicondylitis: A Comparison of Complications and 5-Year Reoperation Rates From a Large Insurance Database
Moran J, Gillinov SM, Schneble CA, Jimenez AE, Vaswani R, Mathew JI, Manzi JE, Nicholson AD, Blaine TA, Altchek DW, Gulotta LV, Dines JS. Open Debridement Alone Versus Open Debridement With Tendon Repair for Lateral Epicondylitis: A Comparison of Complications and 5-Year Reoperation Rates From a Large Insurance Database. Orthopaedic Journal Of Sports Medicine 2022, 10: 23259671221120812. PMID: 36081412, PMCID: PMC9445466, DOI: 10.1177/23259671221120812.Peer-Reviewed Original ResearchReoperation rateOpen debridementLateral epicondylitisTendon repairExtensor carpi radialis brevis tendonCarpi radialis brevis tendonStudy periodLarge insurance databaseLateral epicondylitis patientsComparison of complicationsAdverse event ratesRecalcitrant lateral epicondylitisReimbursement amountsAbsolute risk reductionLow complication rateLevel of evidenceOD cohortBrevis tendonPostoperative complicationsCohort studyComplication rateOD patientsInsurance databaseSignificant changesRisk factorsTrends in Adverse Event Rates in Hospitalized Patients, 2010-2019
Eldridge N, Wang Y, Metersky M, Eckenrode S, Mathew J, Sonnenfeld N, Perdue-Puli J, Hunt D, Brady PJ, McGann P, Grace E, Rodrick D, Drye E, Krumholz HM. Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019. JAMA 2022, 328: 173-183. PMID: 35819424, PMCID: PMC9277501, DOI: 10.1001/jama.2022.9600.Peer-Reviewed Original ResearchMeSH KeywordsAccidental FallsAdultAgedAged, 80 and overCross InfectionCross-Sectional StudiesDrug-Related Side Effects and Adverse ReactionsFemaleHeart FailureHospitalizationHumansMaleMedicareMiddle AgedMyocardial InfarctionPatient SafetyPneumoniaPostoperative ComplicationsPressure UlcerRisk AssessmentSurgical Procedures, OperativeUnited StatesConceptsMajor surgical proceduresAcute myocardial infarctionAdverse event ratesGeneral adverse eventsAdverse eventsHeart failureAdverse drug eventsAcute care hospitalsMyocardial infarctionHospital-acquired infectionsSurgical proceduresEvent ratesHospital dischargeCare hospitalDrug eventsMedicare Patient Safety Monitoring SystemSerial cross-sectional studyPatient safetyUS acute care hospitalsHospital adverse eventsSignificant decreaseSurgical procedure groupsCross-sectional studyRisk-adjusted ratesAdult patientsDeucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Morita A, Szepietowski J, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal Of The American Academy Of Dermatology 2022, 88: 29-39. PMID: 35820547, DOI: 10.1016/j.jaad.2022.07.002.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisGlobal assessment scorePlaque psoriasisWeek 16Static Physician's Global Assessment scoreResponse ratePhysician Global Assessment scoreCoprimary end pointsAdverse event ratesOne-year durationPASI 75Psoriasis AreaWeek 52Psoriasis treatmentPlaceboSafety resultsDeucravacitinibApremilastEnd pointEvent ratesAssessment scoresPsoriasisSeverity IndexKinase 2 inhibitorTyrosine kinase 2 inhibitorNatural history of bicuspid aortic valves and ascending aortic aneurysms: Aortic center experience
Bellaire CP, Tharakan SM, Roy J, Puskas JD, Di Luozzo G. Natural history of bicuspid aortic valves and ascending aortic aneurysms: Aortic center experience. Journal Of Cardiac Surgery 2022, 37: 2326-2335. PMID: 35535018, DOI: 10.1111/jocs.16597.Peer-Reviewed Original ResearchConceptsBicuspid aortic valveAdverse event ratesTAV patientsEntire cohortAortic aneurysmAortic valveComputerized tomographyLow adverse event ratesOverall adverse event rateNatural historyEvent ratesTricuspid aortic valve patientsValve typeRoutine computerized tomographyMore CT scansAortic valve patientsCoronary artery diseaseMean aneurysm sizeAneurysm growth rateAortic valve typeSimilar natural historyAortic eventsConservative managementSmoking historyUnmatched cohort
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