2025
Longitudinal graphics of patient-reported physical function in patients treated for hematologic malignancies
Thanarajasingam G, Bhatnagar V, Noble B, Chen T, Fiero M, Hoffman R, Jeffery M, Mazza G, Mascarenhas J, Mesa R, Murugappan M, Ross J, Sidana S, Warsame R, Kluetz P, Dueck A. Longitudinal graphics of patient-reported physical function in patients treated for hematologic malignancies. BMC Medical Research Methodology 2025, 25: 189. PMID: 40775758, PMCID: PMC12329971, DOI: 10.1186/s12874-025-02617-y.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCross-Sectional StudiesFemaleHematologic NeoplasmsHumansLongitudinal StudiesMaleMiddle AgedMulticenter Studies as TopicPatient Reported Outcome MeasuresQuality of LifeRandomized Controlled Trials as TopicSurveys and QuestionnairesUnited StatesUnited States Food and Drug AdministrationConceptsFood and Drug AdministrationHematologic malignanciesPhysical functionCAR-T cell therapyUS Food and Drug AdministrationPatient-reported physical functionCore patient-reported outcomesPROMIS-29 questionnairePatient-reported outcomesEORTC QLQ-C30CAR-TStacked bar chartsAutologous transplantationMyeloproliferative neoplasmsTolerability endpointsTreatment toleranceMultiple myelomaBackgroundThe US Food and Drug AdministrationCell therapyClinical trialsMalignancyCancer clinical trialsPatient stakeholdersPROMIS-29Fact QuestionnaireTreating Chronic Hand Eczema with Upadacitinib: Insights from Clinical Trials and Real-World Experience.
Alani O, Shqair L, Liszewski W, Yu H, Draw I, Wahood S, Galimberti F, Sweney B, Obagi S, Mastro A, Dasilva D, Bunick C. Treating Chronic Hand Eczema with Upadacitinib: Insights from Clinical Trials and Real-World Experience. Journal Of Drugs In Dermatology 2025, 24: 702-707. PMID: 40627583, DOI: 10.36849/jdd.9156.Peer-Reviewed Original ResearchConceptsChronic hand eczema patientsChronic hand eczemaPhase 3 randomized controlled trialsHand Eczema Severity IndexUPA-treated patientsAtopic dermatitisTopical therapyRefractory chronic hand eczemaModerate-to-severe ADDoses of upadacitinibChronic inflammatory skin conditionProportion of patientsHand eczemaInflammatory skin conditionClinician-reported outcome measuresStatistically significant improvementOral upadacitinibSustained reliefTherapeutic optionsWeek 8Clinical severityTherapeutic alternativeClinical trialsInterference with workSymptom reliefOlezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial
Bergmark B, Marston N, Prohaska T, Alexander V, Zimerman A, Moura F, Kang Y, Murphy S, Zhang S, Lu M, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano R, Sabatine M. Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial. American Heart Journal 2025, 286: 116-124. PMID: 40081744, PMCID: PMC12065083, DOI: 10.1016/j.ahj.2025.02.022.Peer-Reviewed Original ResearchMeSH KeywordsAgedApolipoprotein C-IIICardiovascular DiseasesClinical Trials, Phase III as TopicComputed Tomography AngiographyCoronary AngiographyDouble-Blind MethodFemaleHeart Disease Risk FactorsHumansHypertriglyceridemiaMaleMiddle AgedOligonucleotidesOligonucleotides, AntisenseRandomized Controlled Trials as TopicTriglyceridesConceptsCoronary Computed Tomography AngiographyCardiovascular riskTriglyceride levelsModerate hypertriglyceridemiaBaseline coronary computed tomography angiographyPlacebo-controlled phase 3 trialClearance of triglyceride-rich lipoproteinsApoC-IIIBaseline triglyceride levelsBaseline to 6 monthsLipid-Lowering TherapyAntisense oligonucleotidesNoncalcified coronary plaquesPhase 3 trialComputed tomography angiographyLowering triglyceride levelsIncreased cardiovascular riskElevated cardiovascular riskReduce cardiovascular riskAtherosclerotic cardiovascular diseaseTriglyceride-rich lipoproteinsPotential therapeutic strategyPooled placeboApolipoprotein C-IIIDouble-blind
2024
Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial
Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothé F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nature Communications 2024, 15: 10402. PMID: 39613746, PMCID: PMC11607438, DOI: 10.1038/s41467-024-54621-3.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, ImmunologicalBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMiddle AgedNeoplasm Recurrence, LocalPrognosisRandomized Controlled Trials as TopicReceptor, ErbB-2TrastuzumabTumor MicroenvironmentConceptsHER2-positive breast cancerMolecular subtypesBreast cancerRate of pathological complete responseSensitive to HER2-targeted therapiesClinical trialsRisk of distant recurrenceBreast cancer molecular subtypesPathological complete responseHER2-Targeted TherapyCancer molecular subtypesPotential clinical implicationsNeoALTTO trialDistant recurrenceComplete responseAdjuvant trastuzumabPrognostic/predictive valueHeterogeneous biologySurvival outcomesI-SPY2Clinical outcomesMicroenvironment featuresGene expression profilesExternal cohortTumor
2023
Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial
Rees C, Brousseau D, Cohen D, Villella A, Dampier C, Brown K, Campbell A, Chumpitazi C, Airewele G, Chang T, Denton C, Ellison A, Thompson A, Ahmad F, Bakshi N, Coleman K, Leibovich S, Leake D, Hatabah D, Wilkinson H, Robinson M, Casper T, Vichinsky E, Morris C. Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial. Trials 2023, 24: 538. PMID: 37587492, PMCID: PMC10433602, DOI: 10.1186/s13063-023-07538-z.Peer-Reviewed Original ResearchMeSH KeywordsAcademies and InstitutesAdolescentAnalgesics, OpioidAnemia, Sickle CellArginineChildClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSaline SolutionYoung AdultConceptsPediatric Emergency Care Applied Research NetworkSickle cell disease treatmentVaso-occlusive episodesSickle cell diseaseSTART trialArginine therapyIntravenous arginineLoading doseNormal saline three timesYoung adultsBlood Institute guidelinesParental opioid usePlacebo loading doseSubstantial illness burdenDisease-modifying therapiesPatient-reported outcomesDisease treatmentPhase 3Emergency medicine providersSaline three timesMulticenter research networkResearch NetworkIntravenous opioidsLast doseStudy drugJanus kinase inhibitors for alopecia areata
King B, Craiglow B. Janus kinase inhibitors for alopecia areata. Journal Of The American Academy Of Dermatology 2023, 89: s29-s32. PMID: 37591562, DOI: 10.1016/j.jaad.2023.05.049.Peer-Reviewed Original ResearchMeSH KeywordsAlopecia AreataClinical Trials, Phase III as TopicHumansJanus Kinase InhibitorsPatient SelectionAbrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study
Reich K, Silverberg J, Papp K, Deleuran M, Katoh N, Strober B, Beck L, de Bruin‐Weller M, Werfel T, Zhang F, Biswas P, DiBonaventura M, Chan G, Johnson S, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 2056-2066. PMID: 37335885, DOI: 10.1111/jdv.19280.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase III as TopicDermatitis, AtopicDouble-Blind MethodHumansImmunoglobulin APruritusSeverity of Illness IndexTreatment OutcomeConceptsTreatment-emergent adverse eventsSevere atopic dermatitisSerious treatment-emergent adverse eventsPhase 3 studyAtopic dermatitisSafety profileAbrocitinib 200Frequent treatment-emergent adverse eventsLong-term extension studyUpper respiratory tract infectionLong-term safety profileChronic atopic dermatitisManageable safety profileProportion of patientsRespiratory tract infectionsFull treatment periodLong-term efficacyLong-term safetyPruritus improvementSkin clearanceEfficacy endpointSafety endpointAdverse eventsTract infectionsAD trialsZiritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis
Maher T, Ford P, Brown K, Costabel U, Cottin V, Danoff S, Groenveld I, Helmer E, Jenkins R, Milner J, Molenberghs G, Penninckx B, Randall M, Van Den Blink B, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins T, Wuyts W, Kreuter M, Verbruggen N, Prasad N, Wijsenbeek M, Chambers D, Chia M, Corte T, Glaspole I, Goh N, Holmes M, Malouf M, Thien F, Veitch E, Bondue B, Dahlqvist C, Froidure A, Slabbynck H, Wuyts W, Cartagena Salinas C, Feijoó Seoane R, Martínez V, Maturana R, Pavie Gallegos J, Rosenblut A, Silva R, Undurraga Pereira A, Doubkova M, Pauk N, Plackova M, Sterclova M, Bendstrup E, Shaker S, Titlestad I, Budweiser S, Grohé C, Koschel D, Kreuter M, Prasse A, Weber M, Wirtz H, Antoniou K, Daniil Z, Gaga M, Papakosta D, Izumi S, Okamoto M, Guerreros Benavides A, Iberico Barrera C, Peña Villalobos A, Campo Ezquibela A, Cifrian Martinez J, Fernandez Fabrellas E, Leiro V, Molina-Molina M, Nieto Barbero A, Sellares Torres J, Valenzuela C, Cheng S, Kuo P, Lee K, Sheu C, Gunen H, Mogulkoc Bishop N, Nayci S, Adamali H, Bianchi S, Chaudhuri N, Gibbons M, Hart S, Molyneaux P, Parfrey H, Saini G, Spencer L, Wiscombe S, Antin-Ozerkis D, Bascom R, Belperio J, Britt E, Fitzgerald J, Gomez Manjarres D, Gotfried M, Gupta N, Hotchkin D, Kaye M, Kreider M, Kureishy S, Lacamera P, Lancaster L, Lasky J, Lorch D, Mannem H, Morrow L, Moua T, Nambiar A, Raghu G, Raj R, Ramaswamy M, Reddy R, Russell T, Scholand M, Shea B, Suliman S, Swigris J, Thavarajah K, Tolle L, Tomic R, Warshoff N, Wesselius L, Yung G, Bergna M, De Salvo M, Fernandez Acquier M, Rodriguez A, Saez Scherbovsky P, Assayag D, Dhar A, Khalil N, Morisset J, Provencher S, Ryerson C, Shapera S, Bourdin A, Crestani B, Lebargy F, Reynaud-Gaubert M, Bonella F, Claussen M, Hammerl P, Karagiannidis C, Keller C, Randerath W, Stubbe B, Csánky E, Medgyasszay B, Muller V, Adir Y, Bar-Shai A, Berkman N, Fink G, Kramer M, Shitrit D, Bargagli E, Gasparini S, Harari S, Ravaglia C, Richeldi L, Vancheri C, Ebina M, Fujita M, Ichikado K, Inoue Y, Ishikawa N, Kato M, Kawamura T, Kondoh Y, Nishioka Y, Ogura T, Owan I, Saito T, Sakamoto N, Sakamoto K, Shirai M, Suda T, Tomii K, Chung M, Jeong S, Park C, Park J, Song J, Uh S, Chavarria Martinez U, Montano Gonzalez E, Ramirez A, Selman Lama M, Bresser P, Kramer H, Mostard R, Nossent E, Veltkamp M, Wijsenbeek M, Beckert L, Chang C, Veale A, Wilsher M, Bednarek M, Gasior G, Jasieniak-Pinis G, Jassem E, Mroz R, Piotrowski W, Abdullah I, Ambaram A, Irusen E, Van der Linden M, van Zyl-Smit R, Williams P, Allen J, Averill F, Belloli E, Brown A, Case A, Chaudhary S, Criner G, DeBoer K, Dilling D, Dorf J, Enelow R, Ettinger N, Feldman J, Gibson K, Golden J, Hamblin M, Hunninghake G, Karunakara R, Kim H, Luckhardt T, Menon P, Morrison L, Oldham J, Patel N, Schmidt S, Strek M, Summer R, Sussman R, Tita J, Veeraraghavan S, Whelan T, Zibrak J. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis. JAMA 2023, 329: 1567-1578. PMID: 37159034, PMCID: PMC10170340, DOI: 10.1001/jama.2023.5355.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedClinical Trials, Phase III as TopicFemaleHumansIdiopathic Pulmonary FibrosisLungMaleMiddle AgedMulticenter Studies as TopicPhosphodiesterase InhibitorsQuality of LifeRandomized Controlled Trials as TopicRespiratory Physiological PhenomenaRespiratory System AgentsTreatment OutcomeConceptsIdiopathic pulmonary fibrosisKey secondary outcomesFVC declineSecondary outcomesPulmonary fibrosisCare treatmentSt George's Respiratory Questionnaire (SGRQ) total scoreRespiratory-related hospitalizationsSafety Monitoring CommitteeQuestionnaire total scoreNovel autotaxin inhibitorAnnual rateCause mortalityWeek 52Lung functionPrimary outcomeClinical outcomesVital capacityStudy terminationClinical trialsDisease progressionPlaceboMAIN OUTCOMEPatientsAutotaxin inhibitorsTreatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary
Strober B, Thaçi D, Sofen H, Kircik L, Gordon K, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp K. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy 2023, 15: 787-797. PMID: 37150956, DOI: 10.2217/imt-2023-0062.Peer-Reviewed Original ResearchMeSH KeywordsAdultClinical Trials, Phase III as TopicHumansPsoriasisSkinThalidomideTreatment OutcomeConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksCommon side effectsMonths of treatmentUndesirable side effectsPatch of skinDaily pillPsoriasis treatmentClinical trialsPlaceboPsoriasisDeucravacitinibLarger studyTreatmentApremilastGreater improvementMore participantsSimilar ratesPillsMedical journalsParticipantsSimilar numberSTIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2
Zeidan A, Giagounidis A, Sekeres M, Xiao Z, Sanz G, Van Hoef M, Ma F, Hertle S, Santini V. STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2. Future Oncology 2023, 19: 631-642. PMID: 37083373, DOI: 10.2217/fon-2022-1237.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAntimetabolites, AntineoplasticAzacitidineClinical Trials, Phase III as TopicHumansLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicMyelodysplastic SyndromesConceptsHigh-risk myelodysplastic syndromeChronic myelomonocytic leukemiaMyelodysplastic syndromeCMML-2Tim-3Hematopoietic stem cell transplantationT-cell immunoglobulin domainMucin domain 3Risk myelodysplastic syndromesPhase III trialsStem cell transplantationLeukemic stem cellsFavorable tolerabilityIII trialsNovel immunotherapiesPoor outcomeCell transplantationLeukemic blastsClinical trialsNovel therapiesMyelomonocytic leukemiaDurable benefitImmune systemMyeloid malignanciesMeaningful improvements
2022
Full automation of total metabolic tumor volume from FDG-PET/CT in DLBCL for baseline risk assessments
Jemaa S, Paulson J, Hutchings M, Kostakoglu L, Trotman J, Tracy S, de Crespigny A, Carano R, El-Galaly T, Nielsen T, Bengtsson T. Full automation of total metabolic tumor volume from FDG-PET/CT in DLBCL for baseline risk assessments. Cancer Imaging 2022, 22: 39. PMID: 35962459, PMCID: PMC9373298, DOI: 10.1186/s40644-022-00476-0.Peer-Reviewed Original ResearchConceptsDiffuse large B-cell lymphomaProgression-free survivalOverall survivalFDG-PETUntreated diffuse large B-cell lymphomaHazard ratioHigh-risk DLBCL patientsCentral nervous system relapseLarge B-cell lymphomaMetabolic tumor volumeImaging-based risk factorsB-cell lymphomaEnhanced risk stratificationHigh-risk populationImaging metricsRisk increaseDLBCL patientsFDG-PET/CTSystemic relapseTumor volumeOrgan involvementPrognostic improvementRisk stratificationInvasive proceduresClinical dataImmune-checkpoint inhibitors for glioblastoma: what have we learned?
Omuro A. Immune-checkpoint inhibitors for glioblastoma: what have we learned? Arquivos De Neuro-Psiquiatria 2022, 80: 266-269. PMID: 35976319, PMCID: PMC9491432, DOI: 10.1590/0004-282x-anp-2022-s129.Peer-Reviewed Original ResearchMeSH KeywordsBrain NeoplasmsClinical Trials, Phase III as TopicGlioblastomaHumansImmune Checkpoint InhibitorsImmunotherapyIpilimumabNeoplasm Recurrence, LocalNivolumabRandomized Controlled Trials as TopicTemozolomideTumor MicroenvironmentConceptsImmune checkpoint inhibitorsRecurrent glioblastomaBrain tumorsRandomized phase 3 trialCommon malignant primary brain tumorPost-treatment tumor samplesMalignant primary brain tumorSuccessful immunotherapeutic approachesPhase 3 trialPhase 1 studySelection of patientsT cell dysfunctionNew safety concernsHigh mutational burdenPrimary brain tumorsCheckpoint inhibitorsRadiographic responseImmunotherapeutic approachesPD-L1Survival improvementImmunologic responseTherapeutic optionsClinical trialsCNS microenvironmentCell dysfunctionA Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design
Albers G, Campbell B, Lansberg M, Broderick J, Butcher K, Froehler M, Schwamm L, Nouh A, Liebeskind D, Toy F, Yang M, Massaro L, Schoeffler M, Purdon B. A Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design. International Journal Of Stroke 2022, 18: 237-241. PMID: 35262424, DOI: 10.1177/17474930221088400.Peer-Reviewed Original ResearchConceptsAcute ischemic strokeInternal carotid arteryPlacebo-controlled trialRankin Scale scoreSymptom onsetDay 90Scale scoreMiddle cerebral artery occlusionEfficacy of tenecteplaseLate-window patientsSafety of tenecteplaseSymptomatic intracranial hemorrhageCerebral artery occlusionLarge vessel occlusionPhase IIIPrimary efficacy objectiveBetter clinical outcomesAdverse eventsArtery occlusionEndovascular thrombectomyIschemic strokeMCA occlusionClinical outcomesIntracranial hemorrhageSalvageable tissuePrognostic mutational subtyping in de novo diffuse large B-cell lymphoma
Kim E, Jiang Y, Xu T, Bazeos A, Knapp A, Bolen C, Humphrey K, Nielsen T, Penuel E, Paulson J. Prognostic mutational subtyping in de novo diffuse large B-cell lymphoma. BMC Cancer 2022, 22: 231. PMID: 35236331, PMCID: PMC8892802, DOI: 10.1186/s12885-022-09237-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEnhancer of Zeste Homolog 2 ProteinExome SequencingFemaleHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedMutationPrognosisProto-Oncogene Proteins c-bcl-2RNA-SeqSulfonamidesTreatment OutcomeConceptsSequence dataWhole-exome sequencing dataExome-sequencing dataTargeted sequencing platformsExome sequencing dataTargeted sequencing dataBackgroundDiffuse large B-cell lymphomaLarge B-cell lymphomaSequencing platformsRNA-seqDe novo DLBCLImproved overall survivalTarget sequenceB-cell lymphomaVenetoclax therapyMutation subtypesPrognostic subsetsMutationsOverall survivalMolecular subsetsSubset distributionMutation groupSurvival outcomesMutation profilesClinical associationsTRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma
Harris W, Bataillard E, Choi Y, El-Galaly T, Cuchelkar V, Henneges C, Kwan A, Schneider D, Paulson J, Nielsen T. TRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma. JCO Clinical Cancer Informatics 2022, 6: e2100121. PMID: 35044836, DOI: 10.1200/cci.21.00121.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase III as TopicCyclophosphamideDoxorubicinHumansLymphoma, Large B-Cell, DiffusePrednisoneRituximabVincristineConceptsDiffuse large B-cell lymphomaLarge B-cell lymphomaB-cell lymphomaR-CHOPFirst-line treatment of diffuse large B-cell lymphomaDiagnosed DLBCLTreatment of diffuse large B-cell lymphomaCourses of R-CHOPPresence of cardiovascular diseaseFirst-line treatmentProportion of patientsArea under the curveRoutine clinical settingCharlson Comorbidity IndexStandard of careHigh-risk categoryStandard chemoimmunotherapyChemotherapy toxicityCreatinine clearanceInferior outcomesBaseline characteristicsLogistic regression modelsComorbidity indexPatient frailtyEnd points
2021
Low Programmed Death-Ligand 1–Expressing Subgroup Outcomes of First-Line Immune Checkpoint Inhibitors in Gastric or Esophageal Adenocarcinoma
Zhao J, Yap D, Chan Y, Tan B, Teo C, Syn N, Smyth E, Soon Y, Sundar R. Low Programmed Death-Ligand 1–Expressing Subgroup Outcomes of First-Line Immune Checkpoint Inhibitors in Gastric or Esophageal Adenocarcinoma. Journal Of Clinical Oncology 2021, 40: 392-402. PMID: 34860570, DOI: 10.1200/jco.21.01862.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaB7-H1 AntigenClinical Trials, Phase III as TopicDisease ProgressionEsophageal NeoplasmsHumansImmune Checkpoint InhibitorsProgression-Free SurvivalRandomized Controlled Trials as TopicStomach NeoplasmsTime FactorsConceptsProgrammed death-ligand 1Combined positive scoreImmune checkpoint inhibitorsKEYNOTE-062First-line treatmentCheckMate-649Checkpoint inhibitorsEsophageal adenocarcinomaKaplan-MeierEstimate time-to-event outcomesFirst-line immune checkpoint inhibitorsPD-L1 combined positive scoreProgrammed death ligand 1 subgroupsPatients treated with pembrolizumabPD-L1-expressing tumorsRandomized phase III trialEfficacy of ICIsPD-L1 subgroupsProgression-free survivalDeath-ligand 1Phase III trialsUS Food and Drug AdministrationPrimary manuscriptsFood and Drug AdministrationCPS-1Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer
O'Sullivan CC, Ballman KV, McCall L, Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM, Irvin WJ, Lee M, Goetz MP, Symmans WF, Borges VF, Krop I, Carey LA, Partridge AH. Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Future Oncology 2021, 17: 4665-4676. PMID: 34636255, PMCID: PMC8600597, DOI: 10.2217/fon-2021-0753.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreastBreast NeoplasmsChemoradiotherapy, AdjuvantChemotherapy, AdjuvantClinical Trials, Phase III as TopicDisease-Free SurvivalDouble-Blind MethodFemaleFollow-Up StudiesHumansMastectomyMiddle AgedMulticenter Studies as TopicNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm, ResidualOxazolesPlacebosProspective StudiesPyridinesQuinazolinesRandomized Controlled Trials as TopicReceptor, ErbB-2ConceptsInvasive disease-free survivalDisease-free survivalBrain metastasis-free survivalBreast cancer-free survivalDistant recurrence-free survivalT-DM1Overall survivalResidual diseaseHER2-positive invasive breast cancerAdjuvant T-DM1Cancer-free survivalRecurrence-free survivalInvasive breast cancerMetastasis-free survivalPharmacokinetic end pointsOutcomes of interestQuality of lifeEligible patientsAdjuvant radiotherapyEndocrine therapyNeoadjuvant chemotherapyCorrelative biomarkersCare guidelinesBreast cancerPlaceboEvaluating the Role of Ketamine/Esketamine in the Management of Major Depressive Disorder with Suicide Risk
Nikayin S, Sanacora G. Evaluating the Role of Ketamine/Esketamine in the Management of Major Depressive Disorder with Suicide Risk. CNS Drugs 2021, 35: 1069-1079. PMID: 34491545, DOI: 10.1007/s40263-021-00851-8.Peer-Reviewed Original ResearchMeSH KeywordsAntidepressive AgentsClinical Trials, Phase III as TopicDepressive Disorder, MajorDisease ManagementHumansKetamineRisk AssessmentSuicidal IdeationConceptsMajor depressive disorderDepressive disorderSuicidal ideationFirst large-scale trialKetamine/esketamineTreatment of patientsRole of ketamineSerious suicidal thoughtsActive suicidal ideationLarge-scale trialsAcute settingImminent riskClinical trialsPivotal studiesEsketamineClinical meaningfulnessRecent approvalPatientsSuicidal thoughtsSuicide riskNovel therapeuticsDisordersTrialsDepressed individualsIdeationEffect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis
Reich K, Mrowietz U, Menter A, Griffiths C, Bagel J, Strober B, Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: 2409-2414. PMID: 34255891, DOI: 10.1111/jdv.17520.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase III as TopicHumansNail DiseasesPsoriasisQuality of LifeSeverity of Illness IndexThalidomideTreatment OutcomeConceptsDermatology Life Quality IndexWeek 32Treatment targetsPooled analysisNail Psoriasis Severity IndexGlobal assessmentPhysician global assessmentSevere plaque psoriasisBaseline disease severitySeverity IndexPsoriasis Severity IndexLong-term outcomesLife Quality IndexSevere skin diseaseImportant clinical conceptsESTEEM 1Plaque psoriasisDisease durationMost patientsPsoriasis AreaModerate diseasePsoriasis severityDisease characteristicsPsoriasis guidelinesSubgroup analysisGene Expression Signature Correlates with Outcomes in Metastatic Renal Cell Carcinoma Patients Treated with Everolimus Alone or with a Vascular Disrupting Agent
Yang ES, Nassar AH, Adib E, Jegede OA, Alaiwi SA, Manna DLD, Braun DA, Zarei M, Du H, Pal SK, Naik G, Sonpavde GP. Gene Expression Signature Correlates with Outcomes in Metastatic Renal Cell Carcinoma Patients Treated with Everolimus Alone or with a Vascular Disrupting Agent. Molecular Cancer Therapeutics 2021, 20: 1454-1461. PMID: 34108261, DOI: 10.1158/1535-7163.mct-20-1091.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzofuransBiomarkers, TumorCarcinoma, Renal CellClinical Trials, Phase III as TopicEverolimusFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansKidney NeoplasmsMaleMiddle AgedOrganophosphatesPrognosisSurvival RateTranscriptomeValidation Studies as TopicConceptsMetastatic renal cell carcinomaMedian PFSClinical benefitDiscovery cohortMetastatic renal cell carcinoma patientsPhase I/II trialRenal cell carcinoma patientsPhase III trialsCell carcinoma patientsLonger median PFSRenal cell carcinomaFour-gene signaturePropensity score covariate adjustmentVascular Disrupting AgentsCheckMate 025Monotherapy useStable diseaseII trialGene expression signaturesIII trialsAppropriate patientsCarcinoma patientsImmune checkpointsCell carcinomaVEGF inhibitors
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