2025
Pembrolizumab 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, jco2401283. PMID: 40043230, 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, jco2401829. PMID: 39841939, 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 surgeryPembrolizumabTROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Loriot Y. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. Journal Of Clinical Oncology 2024, 42: 3410-3420. PMID: 39186707, PMCID: PMC11458109, DOI: 10.1200/jco.23.01720.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerClinical benefit rateProgression-free survivalDuration of responseCisplatin-ineligible patientsCheckpoint inhibitor therapyPhase II studyCheckpoint inhibitorsSacituzumab govitecanCohort 2Central reviewOpen-label phase II studyPlatinum (Pt)-based chemotherapyMedian duration of responseMedian progression-free survivalTreatment-emergent adverse eventsMedian overall survivalSN-38 payloadUrothelial cancer progressionSecondary end pointsAntibody-drug conjugatesCisplatin-ineligibleInhibitor therapyOverall survivalII studyEfficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer
Santin A, Corr B, Spira A, Willmott L, Butrynski J, Tse K, Patel J, Mekan S, Wu T, Lin K, Kuo P, Dumbrava E. Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer. Journal Of Clinical Oncology 2024, 42: 3421-3429. PMID: 39083724, PMCID: PMC11458108, DOI: 10.1200/jco.23.02767.Peer-Reviewed Original ResearchProgression-free survivalDuration of responseTreatment-related adverse eventsAdvanced endometrial cancerEndometrial cancerSacituzumab govitecanTrop-2Investigator assessmentSolid tumorsTrophoblast cell surface antigen 2Median duration of responsePhase II basket studyMedian progression-free survivalEnd pointsBaseline tumor specimensClinical benefit ratePlatinum-based therapyStudy drug discontinuationAdvanced solid tumorsMedian follow-upMetastatic solid tumorsTrop-2 expressionSecondary end pointsPrimary end pointEfficacy of SGPhase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm ABone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer
Gebrael G, Jo Y, Swami U, Plets M, Chehade C, Narang A, Gupta S, Myint Z, Sayegh N, Tangen C, Hussain M, Dorff T, Lara P, Lerner S, Thompson I, Agarwal N. Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer. JAMA Network Open 2024, 7: e2419966. PMID: 38980676, PMCID: PMC11234233, DOI: 10.1001/jamanetworkopen.2024.19966.Peer-Reviewed Original ResearchConceptsProgression-free survivalAndrogen deprivation therapyProstate-specific antigenHormone-sensitive prostate cancerBone painOverall survivalPost hoc secondary analysisProstate cancerSurvival outcomesPain statusAssociated with shorter progression-free survivalClinical trialsPresence of bone painProstate-specific antigen levelAssociated with worse overall survivalCastration-resistant prostate cancerShorter progression-free survivalIntention-to-treat populationSecondary analysisZubrod performance statusHigh-volume diseaseCompare survival outcomesCox proportional hazards regression modelsSecondary end pointsProportional hazards regression modelsPhase 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 armLong-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement: Meta-analysis of Randomized Trials
Talanas G, Laconi A, Kereiakes D, Merella P, Reardon M, Spano A, Petretto G, Lauriola F, Casula M, Micheluzzi V, Isgender M, Chatzizisis Y, Farkouh M, Lansky A, Piazza N, Portoghese M, Casu G, Navarese E. Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement: Meta-analysis of Randomized Trials. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102143. PMID: 39131994, PMCID: PMC11307397, DOI: 10.1016/j.jscai.2024.102143.Peer-Reviewed Original ResearchSurgical aortic valve replacementTranscatheter aortic valve replacementAortic valve replacementLong-term outcomesMeta-analysis of randomized trialsSevere aortic stenosisValve replacementValve thrombosisPacemaker implantationValve gradientAortic stenosisParavalvular leakFollow-upStroke riskRandomized trialsLong-term outcomes of patientsBalloon-expandable transcatheter aortic valve replacementSelf-expanding transcatheter aortic valve replacementSafety of transcatheter aortic valve replacementRisk of transcatheter aortic valve replacementRisk of pacemaker implantationSecondary end pointsSurgical risk profileOutcomes of patientsMeta-analysisHealth-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Machiels J, TAO Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Black C, Norquist J, Gumuscu B, Bidadi B, Siu L. Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e39-e40. DOI: 10.1016/j.ijrobp.2024.01.091.Peer-Reviewed Original ResearchBL to weekLA-HNSCCEQ-5D VASLSM changeLocally advanced head and neck squamous cell carcinomaAdvanced head and neck squamous cell carcinomaQLQ-H&N35Head and neck squamous cell carcinomaNeck squamous cell carcinomaEnd pointsPrespecified secondary end pointsSecondary end pointsSquamous cell carcinomaExploratory end pointsCompliance rateQLQ-C30Disease symptom scoreDose of treatmentPatient-reported outcomesPhysical function scoresCell carcinomaPembroHealth-related quality of lifeChemoradiotherapyAnalysis population
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