2025
A Vaccine to Block Plasmodium falciparum Transmission.
Healy S, Sagara I, Assadou M, Katile A, Kone M, Imeru A, Kwan J, Swihart B, Fintzi J, Potter G, Zeguimé A, Dolo A, Diarra B, Narum D, Rausch K, MacDonald N, Zhu D, Mohan R, Thera I, Morrison R, Zaidi I, Doritchamou J, Sylla D, Hume J, Coulibaly M, Morelle D, Lievens M, Doumbo O, Duffy P. A Vaccine to Block Plasmodium falciparum Transmission. NEJM Evidence 2025, 4: evidoa2400188. PMID: 40552966, DOI: 10.1056/evidoa2400188.Peer-Reviewed Original ResearchConceptsStandard membrane feeding assayPfs230D1-EPASafety trialsAntibody responseEnd pointsSkin feeding assaysTransmission-reducing activityWeeks of follow-upMembrane feeding assaysAs-treated populationPrimary efficacy analysisSecondary end pointsPrimary end pointInfected mosquitoesEnzyme-linked immunosorbent assayMalian adultsMalaria vaccineComparator-controlledDouble-blindProportion of infected mosquitoesDosing regimensEfficacy analysisThird doseYears postvaccinationBlock disease transmissionInpatient Outcomes for Patients With Peripheral Artery Disease Hospitalized for Acute Myocardial Infarction.
Gusdorf J, Faridi K, Wang T, Mena-Hurtado C, Smolderen K, Rymer J, Curtis J, Li S, Secemsky E. Inpatient Outcomes for Patients With Peripheral Artery Disease Hospitalized for Acute Myocardial Infarction. Journal Of The American Heart Association 2025, 14: e040526. PMID: 40497502, DOI: 10.1161/jaha.124.040526.Peer-Reviewed Original ResearchConceptsAcute myocardial infarction typesPeripheral arterial diseaseAcute myocardial infarctionIn-Hospital MortalityPeripheral artery disease hospitalizationsIn-Hospital OutcomesAcute myocardial infarction hospitalizationsCardiac arrestHigh-risk populationAssociated with increased ratesLong-term riskRevascularized PatientsInpatient outcomesMultivariable adjustmentHeart failureArtery diseasePrimary outcomeAdverse cardiovascular outcomesUS sitesHeightened riskAge groupsSecondary end pointsSubgroup analysisDialysis initiationCoronary artery diseasePhase 1/2 study of zilovertamab vedotin in pediatric and young adult hematologic malignancies or solid tumors (LIGHTBEAM-U01A).
Kang H, Berlanga P, Campbell-Hewson Q, DuBois S, Koh K, Mauz-Körholz C, Sullivan M, Mangum D, Windsor R, Dickens D, Duarte A, Pashankar F, Ash S, Bellantoni A, Diede S, Singh R, Sidi Y, Yalon M. Phase 1/2 study of zilovertamab vedotin in pediatric and young adult hematologic malignancies or solid tumors (LIGHTBEAM-U01A). Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps10075.Peer-Reviewed Original ResearchB-cell acute lymphoblastic leukemiaEwing sarcomaPerformance statusAdverse eventsPediatric B-cell acute lymphoblastic leukemiaRefractory to frontline therapyDose of study treatmentDiagnosis of B-cell acute lymphoblastic leukemiaEnd pointsObjective response ratePhase 1/2 studyRadiographically measurable diseaseBone marrow blastsDuration of responseECOG performance statusSecondary end pointsPrimary end pointAdult hematological malignanciesAcute lymphoblastic leukemiaKarnofsky performance statusAntibody-drug conjugatesDose escalationMarrow blastsFrontline therapyOpen-labelEndovascular Stenting for Acute Ischemic Stroke Due to Cervical Artery Dissection: Nationwide Study of Stroke Recurrence
Chen H, Khunte M, Colasurdo M, Malhotra A, Gandhi D. Endovascular Stenting for Acute Ischemic Stroke Due to Cervical Artery Dissection: Nationwide Study of Stroke Recurrence. Stroke Vascular And Interventional Neurology 2025, 5 DOI: 10.1161/svin.124.001726.Peer-Reviewed Original ResearchCervical artery dissectionRate of intracranial hemorrhageNo-stent groupStent groupIntracranial hemorrhageEndovascular stentingAcute ischemic strokeArtery dissectionRate of short-term morbidityStroke recurrenceDays of follow-upSecondary end pointsShort-term morbidityRetrospective cohort studyRate of recurrent strokeRate of stroke recurrenceMaintain vessel patencyPropensity score matchingRoutine dischargeRate of routine dischargeAdult patientsRecurrence riskLogistic regression modelsOcclusive lesionsFollow-upStandalone Middle Meningeal Artery Embolization Versus Conservative Management for Nontraumatic Subdural Hematoma
Chen H, Khunte M, Colasurdo M, Malhotra A, Gandhi D. Standalone Middle Meningeal Artery Embolization Versus Conservative Management for Nontraumatic Subdural Hematoma. Stroke 2025, 56: 1404-1412. PMID: 40177795, DOI: 10.1161/strokeaha.124.050190.Peer-Reviewed Original ResearchConceptsMiddle meningeal artery embolizationNontraumatic subdural hematomaRisk of all-cause mortalitySurgical rescueAll-Cause MortalitySubdural hematomaCM patientsConservative managementLow risk of deathSecondary end pointsRetrospective cohort studyFollow-up periodLong-term risk of all-cause mortalityTime-to-event analysisStandard of careNationwide Readmissions DatabaseRisk of deathNonacute subdural hematomasLong-term riskRandomized Controlled TrialsPropensity score matchingArtery embolizationSurgical evacuationCohort studyReadmissions DatabasePhase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Bhatia A, Mehra R, Bauman J, Khan S, Wei W, Neumeister V, Sandoval‐Schaefer T, Alpaugh R, Lango M, Rimm D, Ridge J, Burtness B. Phase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck. Head & Neck 2025 PMID: 40166973, DOI: 10.1002/hed.28152.Peer-Reviewed Original ResearchHead and neck squamous cell cancerProgression-free survivalEpidermal growth factor receptorTyrosine kinase inhibitorsOverall survivalPhase II trial of chemotherapyMedian progression-free survivalRecurrent squamous cell carcinomaTreatment-related adverse eventsDual epidermal growth factor receptorTreated with carboplatinPhase 2 trialPhase II trialSecondary end pointsSquamous cell cancerNuclear translocation of epidermal growth factor receptorSquamous cell carcinomaTrials of chemotherapyHead and neckSmall patient sampleTranslocation of epidermal growth factor receptorGrowth factor receptorInhibited nuclear translocationEGFR blockadeChemotherapy backboneAnatomic Lung Resection is Associated with Improved Survival Compared with Wedge Resection for Stage IA (≤2 cm) Non-Small Cell Lung Cancer
Seder C, Chang S, Towe C, Puri V, Blasberg J, Bonnell L, Fernandez F, Habib R, Kozower B. Anatomic Lung Resection is Associated with Improved Survival Compared with Wedge Resection for Stage IA (≤2 cm) Non-Small Cell Lung Cancer. Journal Of Thoracic Oncology 2025 PMID: 40132758, DOI: 10.1016/j.jtho.2025.03.042.Peer-Reviewed Original ResearchLung cancer-specific survivalStage IA NSCLCAssociated with improved OSAssociated with improved survivalWedge resectionOverall survivalSublobar resectionLung resectionImproved survivalSociety of Thoracic Surgeons General Thoracic Surgery DatabaseClinical stage IA NSCLCHazard ratioNon-small cell lung cancerGeneral Thoracic Surgery DatabaseCancer-specific survivalEarly stage NSCLCAnatomical lung resectionSecondary end pointsThoracic Surgery DatabaseCell lung cancerLong-term survivalStabilized inverse probabilityClinical trial dataLong-term vital statusResection cohortPembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Retz M, Levesque E, McDermott R, Bracarda S, Manneh R, Levartovsky M, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial. Journal Of Clinical Oncology 2025, 43: 1638-1649. PMID: 40043230, PMCID: PMC12058370, DOI: 10.1200/jco-24-01283.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreat metastatic castration-resistant prostate cancerRadiographic progression-free survivalAndrogen receptor pathway inhibitorsCastration-resistant prostate cancerTreatment-related adverse eventsStandard of careAdverse eventsOverall survivalDouble-blindProstate cancerMedian radiographic progression-free survivalDual primary end pointsImmune-mediated adverse eventsEnd pointsBlinded independent central reviewData cutoff dateSafety of pembrolizumabAndrogen deprivation therapyProgression-free survivalIndependent central reviewSecondary end pointsPrimary end pointConcomitant prednisoneMedian OSNeoadjuvant cabozantinib for locally advanced nonmetastatic clear cell renal cell carcinoma: a phase 2 trial
Bilen M, Vo B, Liu Y, Greenwald R, Davarpanah A, McGuire D, Shiradkar R, Li L, Midya A, Nazha B, Brown J, Williams S, Session W, Russler G, Caulfield S, Joshi S, Narayan V, Filson C, Ogan K, Kucuk O, Carthon B, Del Balzo L, Cohen A, Boyanton A, Prokhnevska N, Cardenas M, Sobierajska E, Jansen C, Patil D, Nicaise E, Osunkoya A, Kissick H, Master V. Neoadjuvant cabozantinib for locally advanced nonmetastatic clear cell renal cell carcinoma: a phase 2 trial. Nature Cancer 2025, 6: 432-444. PMID: 40016487, DOI: 10.1038/s43018-025-00922-5.Peer-Reviewed Original ResearchConceptsNonmetastatic clear cell renal cell carcinomaRenal cell carcinomaClear cell renal cell carcinomaCell renal cell carcinomaCD8+ T cellsT cellsCell carcinomaAdverse eventsStem-like CD8+ T cellsMetastatic renal cell carcinomaPalmar-plantar erythrodysesthesia syndromeSingle-arm clinical trialOral multikinase inhibitorDisease-free survivalPhase 2 trialSecondary end pointsCabozantinib treatmentNeoadjuvant settingStable diseaseBiopsy-provenPartial responseSurgical resectionOverall survivalMultikinase inhibitorMyeloid populationsEconomic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial
Chew D, Mark D, Li Y, Nanna M, Kelsey M, Daniels M, Davidson-Ray L, Baloch K, Rogers C, Patel M, Anstrom K, Curzen N, Vemulapalli S, Douglas P, Investigators O. Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial. Circulation Cardiovascular Quality And Outcomes 2025, 18: e011008. PMID: 39895495, PMCID: PMC11837965, DOI: 10.1161/circoutcomes.123.011008.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngina, StableComputed Tomography AngiographyCoronary AngiographyCoronary Artery DiseaseCost SavingsCost-Benefit AnalysisFemaleFractional Flow Reserve, MyocardialHospital CostsHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsChest painObstructive coronary artery diseaseCoronary computed tomographic angiographyStable chest painCoronary artery bypass surgeryLow-risk patientsSecondary end pointsPrimary composite of deathPrecision strategyComputed Tomographic AngiographyHealth care system perspectiveComposite of deathUS health care system perspectiveArtery bypass surgeryMedical costsMean cost differenceNonfatal myocardial infarctionCoronary artery diseaseIntention-to-treatPercutaneous coronary interventionUsual testsEstimated total medical costTotal medical costsClinical practice guidelinesRisk patientsPostoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer
Machtay M, Torres-Saavedra P, Thorstad W, Nguyen-Tân P, Siu L, Holsinger F, El-Naggar A, Chung C, Cmelak A, Burtness B, Bednarz G, Quon H, Breen S, Gwede C, Dicker A, Yao M, Jordan R, Dorth J, Lee N, Chan J, Dunlap N, Bar-Ad V, Stokes W, Chakravarti A, Sher D, Rao S, Harris J, Yom S, Le Q, Bar-Ad V, Bednarz G, Bowles D, Breen S, Burtness B, Chakravarti A, Chan J, Chung C, Cmelak A, Dicker A, Dorth J, Dunlap N, El-Naggar A, Gwede C, Harris J, Holsinger F, Jones C, Jordan R, Krempl G, Le Q, Lee N, Lominska C, Ma D, Machtay M, Mell L, Nguyen-Tan P, Quon H, Raben A, Rao S, Samuels S, Sher D, Siu L, Spencer S, Stokes W, Takiar V, Thorstad W, Torres-Saavedra P, Wilke C, Yao M, Yom S, Young M. Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer. Journal Of Clinical Oncology 2025, 43: 1474-1487. PMID: 39841939, PMCID: PMC12003072, DOI: 10.1200/jco-24-01829.Peer-Reviewed Original ResearchDisease-free survivalOverall survivalToxicity ratesEpidermal growth factor receptor expressionGrowth factor receptor expressionHead and neck cancerHPV-negative diseaseIntermediate-risk cancerIntensity-modulated RTStratified log-rank testAcute toxicity ratesSecondary end pointsOral cavity cancerSquamous cell carcinomaLog-rank testHead and neckLong-term toxicityBenefit of RTFisher's exact testPostoperative RTCell carcinomaReceptor expressionNeck cancerOral cavityRadiotherapyPhase 1 trial of hypofractionated stereotactic re-irradiation in combination with nivolumab, ipilimumab, and bevacizumab for recurrent high-grade gliomas
Sahebjam S, Raval R, Forsyth P, Enderling H, Tran N, Arrington J, Macaulay R, Perlow H, Palmer J, Ghose J, Rajappa P, Giglio P, Li Z, Etame A, Mokhtari S, Cruz-Chamorro R, Bhandari M, Thapa R, Robinson T, Chen D, Yu H. Phase 1 trial of hypofractionated stereotactic re-irradiation in combination with nivolumab, ipilimumab, and bevacizumab for recurrent high-grade gliomas. Neuro-Oncology Advances 2025, 7: vdaf033. PMID: 40134851, PMCID: PMC11934552, DOI: 10.1093/noajnl/vdaf033.Peer-Reviewed Original ResearchTreatment-related adverse eventsStereotactic re-irradiationRecurrent high-grade gliomaHigh-grade gliomasRe-IrradiationPD-1PD-1 blockadeProgression-free survivalPhase I studySecondary end pointsPhase 1 trialRecurrent HGGCheckpoint immunotherapyOverall survivalRecurrent glioblastomaAnaplastic astrocytomaBevacizumabNivolumabIpilimumabGrade 3Adverse eventsClinical investigationImmune responseEnd pointsPatients
2024
Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Foss F, Kim Y, Prince H, Akilov O, Querfeld C, Seminario-Vidal L, Fisher D, Kuzel T, Yannakou C, Geskin L, Feldman T, Sokol L, Allen P, Dang N, Cabanillas F, Wong H, Ooi C, Xing D, Sauter N, Singh P, Czuczman M, Duvic M. Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2024, 43: 1198-1209. PMID: 39700456, PMCID: PMC11949209, DOI: 10.1200/jco-24-01549.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaTreatment-emergent adverse eventsTime to responseT-cell lymphomaTumor burdenRefractory cutaneous T-cell lymphomaEnd pointsEfficacy end pointCapillary leak syndromePrimary efficacy analysisSecondary end pointsHuman interleukin-2Unmet medical needMedian DORSystemic therapyInfusion reactionsOpen-labelDenileukin diftitoxEfficacy analysisAdverse eventsInterleukin-2Safety resultsQ1-Q3PatientsResponse rateSorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors
Costa P, Arora A, Fernandez Y, Yi I, Bakkila B, Tan H, Coelho P, Campoverde L, Hardy N, Bialick S, Freire A, D’Amato G, Chang Y, Mesenger J, Subhawong T, Haims A, Hurwitz M, Olino K, Turaga K, Deshpande H, Trent J. Sorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors. Cancer 2024, 131: e35647. PMID: 39543805, DOI: 10.1002/cncr.35647.Peer-Reviewed Original ResearchProgression-free survivalAnthracycline-containing regimensAnthracycline-based therapyDesmoid tumorsAdverse eventsOne-year progression-free survivalMulti-institutional retrospective analysisAnthracycline-containing regimenCommon grade 1Desmoid tumor patientsGrade 3 eventsAnthracycline-based chemotherapyHand-foot syndromeSecondary end pointsActivity of sorafenibProgressive desmoid tumorsYear of treatmentMedian TTRBaseline characteristicsTumor patientsLocal invasionTreatment responseSorafenibAnthracyclinesEnd pointsFever Prevention in Patients With Acute Vascular Brain Injury
Greer D, Helbok R, Badjatia N, Ko S, Guanci M, Sheth K, Diringer M, Mehta Y, Cava L, Hinduja A, Lele A, Sarwal A, Kulik T, Keller E, Smith G, Dennesen P, Dimitriadis K, Schonenberger S, Gunther A, Meisel A, Wolf S, Kollmar R, Barlinn K, Jeon S, Han M, Hong J, Lee R, Falcone G, Dashti S, Busl K, Ermak D, Berkeley J, Amory C, Swor R, DeGeorgia M, Green-LaRoche D, Thompson B, Hatton K, Sung G, Mehta C, Zurasky J, Da Silva I, James M, Aysenne A, Cervantes A, Devlin T, Chang I, Morris N, Venkatasubramanian C, Mushlschlegel S, Zachariah J, Chaudry F, Claassen J, Dangayach N, Choi H, Sadaka F, Miller C. Fever Prevention in Patients With Acute Vascular Brain Injury. JAMA 2024, 332: 1525-1534. PMID: 39320879, PMCID: PMC11425189, DOI: 10.1001/jama.2024.14745.Peer-Reviewed Original ResearchVascular brain injuryStandard care groupCare groupMajor adverse eventsPrimary outcomeStandard care patientsBlinded outcome assessmentIntensive care unit dischargeFunctional outcomesAdverse eventsBrain injuryFever preventionFever burdenPrincipal secondary end pointBetween-group differencesOpen-label randomized clinical trialPrevention groupFunctional recoveryPrincipal secondary outcomeCare patientsAssociated with worse outcomesMain OutcomesImpact functional outcomesSecondary end pointsTemperature management deviceInvasive Versus Conservative Strategy in Older Adults ≥75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Rout A, Moumneh M, Kalra K, Singh S, Garg A, Kunadian V, Biscaglia S, Alkhouli M, Rymer J, Batchelor W, Nanna M, Damluji A. Invasive Versus Conservative Strategy in Older Adults ≥75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal Of The American Heart Association 2024, 13: e036151. PMID: 39494560, PMCID: PMC11935716, DOI: 10.1161/jaha.124.036151.Peer-Reviewed Original ResearchConceptsNon-ST segment elevation acute coronary syndromeAcute coronary syndromeComposite of deathBurden of geriatric conditionsRandomized Controlled TrialsCoronary syndromeMyocardial infarctionYears of ageInvasive strategyOlder adultsControlled TrialsGeriatric conditionsOlder patientsCardiovascular deathOdds ratioMeta-analysis of randomized controlled trialsNon-ST segment elevationSecondary end pointsMeta-analysisFixed effects meta-analysisAll-cause deathEffects meta-analysisYounger patientsFollow-upDecreased riskAlternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy
Perkovic V, Barratt J, Rovin B, Kashihara N, Maes B, Zhang H, Trimarchi H, Kollins D, Papachristofi O, Jacinto-Sanders S, Merkel T, Guerard N, Renfurm R, Hach T, Rizk D. Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. New England Journal Of Medicine 2024, 392: 531-543. PMID: 39453772, DOI: 10.1056/nejmoa2410316.Peer-Reviewed Original ResearchProtein-to-creatinine ratioUrinary protein-to-creatinine ratioIgA nephropathyMonth 9Biopsy-confirmed IgA nephropathySupportive therapyTreatment periodDouble-blind treatment periodSecondary end point analysisTrial populationIncidence of adverse eventsIncreased risk of infectionPlacebo-controlled trialSecondary end pointsComplement pathway inhibitionProportion of patientsPathogenesis of IgA nephropathyKidney replacement therapyClinically meaningful reductionsInterim efficacy analysisRisk of infectionDouble-blindPlacebo groupSafety findingsEfficacy analysisRandomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Silverman M, Van Besien K, Schuster M, Law A, Larkin K, Pandit-Taskar N, Rowley S, Munshi P, Cook R, Levy M, Lazarus H, Sandmaier B, Pagel J, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. Journal Of Clinical Oncology 2024, 43: 201-213. PMID: 39298738, PMCID: PMC11709001, DOI: 10.1200/jco.23.02018.Peer-Reviewed Original ResearchEvent-free survivalIntention-to-treat populationIntention-to-treatHazard ratioRR-AMLOverall survivalOlder patientsPhase III open-label trialEvent-free survival HRTreatment-related adverse eventsAllogeneic hematopoietic cell transplantationConventional careIncomplete platelet recoveryOS hazard ratioSecondary end pointsHematopoietic cell transplantationOpen-label trialConventional care groupPretransplant regimenRefractory AMLRelapsed/refractory AMLChemotherapy initiationDismal prognosisPlatelet recoveryCell transplantationConsiderations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings
Kelly A, Bahlke M, Baker J, de Beaufort C, Belin R, Fonseca H, Hale P, Holm J, Hsia D, Jastreboff A, Juliusson P, Murphy M, Pak J, Paul E, Rudolph B, Srivastava G, Tornøe C, Weghuber D, Fox C. Considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings. Pediatric Obesity 2024, 19: e13161. PMID: 39289849, DOI: 10.1111/ijpo.13161.Peer-Reviewed Original ResearchAnti-obesity medicationsExcessive weight reductionClinical trialsEnd pointsDown-titrationEligibility criteriaLong-term health outcomesBMI z-scoreActive comparatorEfficacy end pointPlacebo-controlled trialSecondary end pointsRun-in phaseFollow-up periodFollow-up phaseHealth outcomesObesity expertsTrial eligibility criteriaClinical careWeight reductionMultidisciplinary groupClinical trial protocolsPrimary outcomeWeight regainTrial protocolOverall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer
Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kümmel S, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Im S, Untch M, Fasching P, Mouret-Reynier M, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. New England Journal Of Medicine 2024, 391: 1981-1991. PMID: 39282906, DOI: 10.1056/nejmoa2409932.Peer-Reviewed Original ResearchEarly-stage triple-negative breast cancerTriple-negative breast cancerPembrolizumab-chemotherapy groupPlacebo-chemotherapy groupCycles of pembrolizumabPathological complete responseEvent-free survivalOverall survivalBreast cancerAdjuvant pembrolizumabComplete responseSafety profile of pembrolizumabData cutoff dateUntreated stage IIPlatinum-containing chemotherapyMedian Follow-UpEstimate overall survivalSecondary end pointsEpirubicin-cyclophosphamideNeoadjuvant pembrolizumabNeoadjuvant therapyDoxorubicin-cyclophosphamideNeoadjuvant chemotherapyDefinitive surgeryPembrolizumab
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