2025
Predictive and monitoring value of blood‐based biomarkers for apathy treatment in Alzheimer’s disease
Lanctôt K, Tumati S, Vieira D, Bawa K, Andreazza A, Scherer R, Rosenberg P, van Dyck C, Padala P, Brawman‐Mintzer O, Porsteinsson A, Lerner A, Craft S, Levey A, Burke W, Perin J, Shade D, Mintzer J, Herrmann N. Predictive and monitoring value of blood‐based biomarkers for apathy treatment in Alzheimer’s disease. Alzheimer's & Dementia 2025, 20: e095596. PMCID: PMC11712725, DOI: 10.1002/alz.095596.Peer-Reviewed Original ResearchTreatment responseBlood-based biomarkersBlood-based biomarkers of neurodegenerationNPI-aClinical predictorsAlzheimer's diseaseClinical predictors of responsePredictive value of biomarkersTumor necrosis factor-alphaOxidative stressNeurofilament lightAffecting treatment responsePredictors of responseNecrosis factor-alphaBiomarkers of neurodegenerationInterleukin (IL)-6Treatment response predictionMonths end pointAssociated with apathyValue of biomarkersNeuropsychiatric Inventory apathy subscalePresence of anxietyPeripheral inflammation
2024
Psilocybin: From Psychiatric Pariah to Perceived Panacea
Fonzo G, Wolfgang A, Barksdale B, Krystal J, Carpenter L, Kraguljac N, Grzenda A, McDonald W, Widge A, Rodriguez C, Nemeroff C. Psilocybin: From Psychiatric Pariah to Perceived Panacea. American Journal Of Psychiatry 2024, 182: 54-78. PMID: 39741437, PMCID: PMC11694823, DOI: 10.1176/appi.ajp.20230682.Peer-Reviewed Original ResearchConceptsPsychiatric disordersTreatment of obsessive-compulsiveTreatment of psychiatric disordersTreatment of MDDSubstance use disordersEvidence-based treatmentsObsessive-compulsiveDepressive disorderEvidence basePsychiatric treatmentExpectancy effectsRandomized controlled trialsPsilocybinPredictors of responseDiverse sampleMechanism of actionDisordersHead-to-head comparisonsEnglish-language articlesKnowledge of mechanisms of actionOpen-labelClinical responseDosing considerationsImproved blindingCancer diagnosisPredictors of response to venetoclax and therapeutic potential of CDK7 inhibition in multiple myeloma
Dutta R, Thibaud S, Leshchenko V, Ram M, Melnekoff D, Bhalla S, Restrepo P, Gupta V, Barwick B, Newman S, McCafferty J, Hantash F, Nooka A, Cho H, Richard S, Rodriguez C, Rossi A, Sanchez L, Chari A, Boise L, Jagannath S, Richter J, Parekh S, Laganà A. Predictors of response to venetoclax and therapeutic potential of CDK7 inhibition in multiple myeloma. Blood Neoplasia 2024, 1: 100049. DOI: 10.1016/j.bneo.2024.100049.Peer-Reviewed Original ResearchCyclin-dependent kinase 7Progression-free survivalMultiple myelomaAnalysis of RNA-seq dataMM cellsTherapeutic strategiesPatients treated with venetoclaxCDK7 inhibitor THZ1Overcome venetoclax resistanceRNA-seq dataSix-gene signaturePredictors of responseChromosome 1q gainPersonalized therapeutic strategiesDevelopment of personalized therapeutic strategiesInduce cell deathMarkers of sensitivityBCL2 inhibitorsCDK7 inhibitionMCL1 genePrognostic importanceStratify patientsCyclin-dependentMCL1 levelsPatient populationTBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2.
Tung N, Robson M, Nanda R, Li T, Vinayak S, Shah P, Khoury K, Kimmick G, Santa-Maria C, Brufsky A, DeMeo M, Vieira J, Carey L, Wulf G, Domchek S, Krop I, Wolff A, Winer E, Garber J. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. Journal Of Clinical Oncology 2024, 42: 1021-1021. DOI: 10.1200/jco.2024.42.16_suppl.1021.Peer-Reviewed Original ResearchProgression-free survivalDuration of responseMetastatic breast cancerClinical benefit rateTriple-negative breast cancerMedian duration of responseMedian progression-free survivalMutant allele frequencyExpansion cohortHER2-negativeHER2-positiveCohort 2aNon-respondersBreast cancerEarly due to slow enrollmentMetastatic chemotherapy regimensResponse to olaparibPhase 2 studyPhase II trialKaplan-Meier methodPredictors of responseCohort of womenWilcoxon rank sum testRank sum testBRCA1mAdvanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587).
Serzan M, Jegede O, Alter R, Bilen M, Braun D, Einstein D, Haas N, Herchenhorn D, King J, Runcie K, Sosman J, Sternberg C, Yang Y, Signoretti S, CHOUEIRI T, Atkins M. Advanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587). Journal Of Clinical Oncology 2024, 42: tps4614-tps4614. DOI: 10.1200/jco.2024.42.16_suppl.tps4614.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsArm BArm APrimary endpointRate of immune-related adverse eventsMetastatic clear cell renal cell carcinomaImmune-related adverse eventsMolecular predictors of responseVEGF receptor tyrosine kinase inhibitorReceptor tyrosine kinase inhibitorsEnhance T cell primingOne-sided significance levelClear cell renal cell carcinomaAnti-PD1 inhibitorsIMDC risk groupsTreatment free intervalProgression-free survivalT cell primingTreatment-free survivalCell renal cell carcinomaSubpopulations of TregsFirst-line treatmentRenal cell carcinomaPredictors of responseAssociated with increased presenceUnderstanding and overcoming resistance to immunotherapy in genitourinary cancers
Evans S, Jani Y, Jansen C, Yildirim A, Kalemoglu E, Bilen M. Understanding and overcoming resistance to immunotherapy in genitourinary cancers. Cancer Biology & Therapy 2024, 25: 2342599. PMID: 38629578, PMCID: PMC11028033, DOI: 10.1080/15384047.2024.2342599.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsResistance to immunotherapyImmunotherapy resistanceTargeted therapyGenitourinary (GU) cancersCombined immune checkpoint inhibitorsIntroduction of novel immunotherapiesMechanisms of immunotherapy resistanceOvercome resistance to immunotherapyCancer cellsHost immune profileResponse to immunotherapyNovel targeted therapiesImmune system's rolePredictors of responseAttack cancer cellsImmune system's abilityStandard of careCheckpoint inhibitorsSequential therapyNovel immunotherapiesCombination therapyTreatment failureGU cancersTreatment landscapeAdvanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587).
Serzan M, Jegede O, Bilen M, Braun D, Einstein D, Haas N, Hammers H, King J, Runcie K, Sosman J, Sternberg C, Yang Y, Choueiri T, Signoretti S, Atkins M. Advanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587). Journal Of Clinical Oncology 2024, 42: tps492-tps492. DOI: 10.1200/jco.2024.42.4_suppl.tps492.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsArm BArm APrimary endpointRate of immune-related adverse eventsMetastatic clear cell renal cell carcinomaImmune-related adverse eventsMolecular predictors of responseVEGF receptor tyrosine kinase inhibitorReceptor tyrosine kinase inhibitorsEnhance T cell primingOne-sided significance levelClear cell renal cell carcinomaAnti-PD1 inhibitorsIMDC risk groupsTreatment free intervalProgression-free survivalT cell primingTreatment-free survivalCell renal cell carcinomaSubpopulations of TregsFirst-line treatmentRenal cell carcinomaPredictors of responseAnti-tumor activity
2023
Impact of Type of Hypomethylating Agent (HMA) Used on Outcomes of Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) - a Large, Multicenter, Retrospective Analysis
Bewersdorf J, Kewan T, Blaha O, Stahl M, Al Ali N, DeZern A, Sekeres M, Uy G, Carraway H, Desai P, Griffiths E, Stein E, Brunner A, McMahon C, Zeidner J, Savona M, Stempel J, Chandhok N, Ramaswamy R, Roboz G, Rolles B, Wang E, Harris A, Amaya M, Hawkins H, Grenet J, Gurnari C, Shallis R, Xie Z, Maciejewski J, Sallman D, Della Porta M, Komrokji R, Zeidan A. Impact of Type of Hypomethylating Agent (HMA) Used on Outcomes of Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) - a Large, Multicenter, Retrospective Analysis. Blood 2023, 142: 4613. DOI: 10.1182/blood-2023-178728.Peer-Reviewed Original ResearchCox multivariable regression modelOverall survivalHMA initiationHypomethylating agentMultivariable regression modelsTP53 mutationsAllo-HCTComplete remissionComplex karyotypePartner drugsBone marrowSurvival analysisAllogeneic hematopoietic cell transplantMultivariable Cox regression modelsTreatment typeOverall responseAdverse genetic featuresMedian overall survivalOutcomes of patientsHematopoietic cell transplantAdverse overall survivalKaplan-Meier methodCox regression modelLog-rank testPredictors of responsePredictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray
Turkoz I, Nelson J, Wilkinson S, Borentain S, Macaluso M, Trivedi M, Williamson D, Sheehan J, Salvadore G, Singh J, Daly E. Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray. Psychiatry Research 2023, 323: 115165. PMID: 37019044, DOI: 10.1016/j.psychres.2023.115165.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionEsketamine nasal sprayNasal sprayDay 28Day 8Clinical Global Impression-Severity scoreCGI-S scoresCurrent depressive episodePredictors of responsePlacebo nasal sprayIdentification of predictorsOral antidepressantsBaseline patientAcute trialPooled analysisDepressive episodeRemissionPsychiatric characteristicsPatientsSignificant anxietyYounger ageTreatment assignmentPotential predictorsPhase 3PredictorsOutcomes of intraventricular 131-I-omburtamab and external beam radiotherapy in patients with recurrent medulloblastoma and ependymoma
Tringale K, Wolden S, Karajannis M, Haque S, Pasquini L, Yildirim O, Rosenblum M, Benhamida J, Cheung N, Souweidane M, Basu E, Pandit-Taskar N, Zanzonico P, Humm J, Kramer K. Outcomes of intraventricular 131-I-omburtamab and external beam radiotherapy in patients with recurrent medulloblastoma and ependymoma. Journal Of Neuro-Oncology 2023, 162: 69-78. PMID: 36853490, PMCID: PMC10050019, DOI: 10.1007/s11060-022-04235-w.Peer-Reviewed Original ResearchConceptsExternal beam radiotherapyCompartmental radioimmunotherapyOverall survivalCraniospinal axisBeam radiotherapyRecurrent medulloblastomaCases of radiation necrosisAssociated with progression-freeRecurrent primary brain tumorsCases of radionecrosisImprove survival outcomesMedium follow-upProspective clinical trialKaplan-Meier analysisPredictors of responseExtent of diseasePatterns of failurePrimary brain tumorNED statusUpfront therapyProgression-freeRadiation necrosisConclusionFor patientsEpendymoma patientsMultimodal therapy
2022
Noninvasive biomarkers for the diagnosis and management of autoimmune hepatitis
Harrington C, Krishnan S, Mack CL, Cravedi P, Assis DN, Levitsky J. Noninvasive biomarkers for the diagnosis and management of autoimmune hepatitis. Hepatology 2022, 76: 1862-1879. PMID: 35611859, PMCID: PMC9796683, DOI: 10.1002/hep.32591.Peer-Reviewed Original ResearchConceptsAutoimmune hepatitisNormal serum transaminasesPediatric autoimmune hepatitisFirst-line treatmentAcute liver failureImmune cell phenotypesPredictors of responseHigh clinical valueNovel candidate biomarkersPersonalized therapeutic managementSystemic corticosteroidsCurrent regimensMedication titrationHistological activityMost patientsClinical courseLiver failureLiver injurySerum transaminasesMedication dosingTherapeutic managementUnclear etiologyHepatic fibrosisClinical valueElevated riskHistological changes associated with laser interstitial thermal therapy for radiation necrosis: illustrative cases
Fomchenko EI, Leelatian N, Darbinyan A, Huttner AJ, Chiang VL. Histological changes associated with laser interstitial thermal therapy for radiation necrosis: illustrative cases. Journal Of Neurosurgery Case Lessons 2022, 4: case21373. PMID: 35855352, PMCID: PMC9257400, DOI: 10.3171/case21373.Peer-Reviewed Original ResearchLaser interstitial thermal therapyRadiation necrosisInterstitial thermal therapyBrain metastasesAssociated cerebral edemaStage IV diseaseUse of immunotherapyPredictors of responseOngoing immunotherapySurgical decompressionCerebral edemaPerilesional edemaSurgical approachClinical historyLung cancerNeurological compromiseGood patientHistological changesStereotactic radiosurgeryPatientsEarly reductionSized lesionsImmunotherapyTherapyThermal therapyFirst in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response
Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.Peer-Reviewed Original ResearchConceptsSubset of patientsPredictive biomarkersPharmacodynamic biomarkersModest objective response rateNon-small cell lung cancer trialsCD4 T cell populationCell lung cancer trialsPhase IObjective response ratePhase II doseAdvanced solid tumorsCD4 T cellsFavorable safety profilePotential predictive biomarkersLung cancer trialsPredictors of responseT cell populationsGreater clinical benefitClinical outcomesClinical benefitSafety profileCancer trialsNivolumabT cellsPatientsPredictors of objective response to first-line immuno-oncology combination therapies in metastatic renal cell carcinoma: Results from the international metastatic renal cell database consortium (IMDC).
Navani V, Ernst M, Wells C, Yuasa T, Takemura K, Donskov F, Basappa N, Schmidt A, Pal S, Meza L, Wood L, Ernst D, Szabados B, McKay R, Weickhardt A, Suárez C, Kapoor A, Lee J, Choueiri T, Heng D. Predictors of objective response to first-line immuno-oncology combination therapies in metastatic renal cell carcinoma: Results from the international metastatic renal cell database consortium (IMDC). Journal Of Clinical Oncology 2022, 40: 310-310. DOI: 10.1200/jco.2022.40.6_suppl.310.Peer-Reviewed Original ResearchAssociated with responseCytoreductive nephrectomyIpi-nivoLung metastasesMetastatic renal cell carcinomaPresence of lung metastasesResponse to first-lineImmunotherapy combination regimensMedian overall survivalRenal cell carcinomaPredictors of responseEndothelial growth factorIpilimumab-nivolumabSarcomatoid histologyRECIST v1.1Combination regimensOverall survivalCombination therapyCell carcinomaFirst-lineResponse of CRNon-respondersPrognostic riskClinical variablesPatient counseling
2021
Poster: TCL-194: Change in Lymphocyte Count as a Predictor of Response to Mogamulizumab in Patients with Mycosis Fungoides or Sézary Syndrome
Foss F, Ito T, Dwyer K, Herr F. Poster: TCL-194: Change in Lymphocyte Count as a Predictor of Response to Mogamulizumab in Patients with Mycosis Fungoides or Sézary Syndrome. Clinical Lymphoma Myeloma & Leukemia 2021, 21: s248. DOI: 10.1016/s2152-2650(21)01564-0.Peer-Reviewed Original ResearchPredictors of responseLymphocyte countSézary syndromeMycosis fungoidesMogamulizumabFungoidesPatientsSyndromeTCL-194: Change in Lymphocyte Count as a Predictor of Response to Mogamulizumab in Patients with Mycosis Fungoides or Sézary Syndrome
Foss F, Ito T, Dwyer K, Herr F. TCL-194: Change in Lymphocyte Count as a Predictor of Response to Mogamulizumab in Patients with Mycosis Fungoides or Sézary Syndrome. Clinical Lymphoma Myeloma & Leukemia 2021, 21: s412. DOI: 10.1016/s2152-2650(21)01926-1.Peer-Reviewed Original ResearchGrade 0Blood involvementSézary syndromeMycosis fungoidesB2 patientsLymphocyte countClinical responseSézary cellsGrade 1Refractory mycosis fungoidesSeverity of lymphopeniaAbsolute lymphocyte countSkin responseT lymphocyte populationsPredictors of responseIncidence of infectionAnti-CCR4 antibodyMechanism of actionAbsolute lymphocyteAdvanced diseaseClinical outcomesLymphocyte populationsInfections/infestationsMogamulizumabT cellsCopy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial.
Venet D, Rediti M, Maetens M, Fumagalli D, Brown DN, Majjaj S, Salgado R, Pusztai L, Harbeck N, El-Abed S, Wang Y, Saura C, Gomez H, Semiglazov VF, de Azambuja E, Huober J, Nuciforo P, Di Cosimo S, Piccart M, Loi S, Rothé F, Sotiriou C. Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial. Clinical Cancer Research 2021, 27: clincanres.1317.2021. PMID: 34321278, DOI: 10.1158/1078-0432.ccr-21-1317.Peer-Reviewed Original ResearchConceptsPathologic complete responseNeoALTTO trialCopy number aberrationsBreast cancerHER2-positive early-stage breast cancerEstrogen receptor-positive subgroupNeoadjuvant anti-HER2 therapyEarly-stage breast cancerHER2-positive breast cancerPhase III clinical trialsAnti-HER2 therapyAnti-HER2 agentsPredictors of responseReceptor-positive subgroupNumber aberration analysisCopy number levelsWarrants further investigationHeterogeneity of responseComplete responseSurvival outcomesWhole cohortClinical trialsImmune processesPatientsSignificant associationClinical and molecular predictors of response and survival following venetoclax therapy in relapsed/refractory AML
Stahl M, Menghrajani K, Derkach A, Chan A, Xiao W, Glass J, King A, Daniyan A, Famulare C, Cuello B, Horvat T, Abdel-Wahab O, Levine R, Viny A, Stein E, Cai S, Roshal M, Tallman M, Goldberg A. Clinical and molecular predictors of response and survival following venetoclax therapy in relapsed/refractory AML. Blood Advances 2021, 5: 1552-1564. PMID: 33687434, PMCID: PMC7948282, DOI: 10.1182/bloodadvances.2020003734.Peer-Reviewed Original ResearchConceptsLow-dose cytarabineAcute myeloid leukemiaMolecular predictors of responseRR-AMLPredictors of responseHigh response rateVenetoclax therapyOverall survivalResponse rateMolecular predictorsAssociated with higher response ratesMorphologic leukemia-free stateAllogeneic stem cell transplantationAssociated with worse OSRefractory acute myeloid leukemiaRelapsed/refractory acute myeloid leukemiaEvaluate novel agentsIncomplete hematologic recoveryMedian overall survivalVenetoclax combination therapyStem cell transplantationOverall response rateAcquisition of novel mutationsVenetoclax combinationsAdverse cytogenetics
2019
Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial.
Wulfkuhle J, Yau C, Wolf D, Gallagher R, Brown Swigart L, Hirst G, Campbell M, Nanda R, Liu M, Pusztai L, Esserman L, Berry D, van 't Veer L, Petricoin E. Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial. Journal Of Clinical Oncology 2019, 37: 2631-2631. DOI: 10.1200/jco.2019.37.15_suppl.2631.Peer-Reviewed Original ResearchI-SPY 2 TRIALImmune checkpoint inhibitorsCheckpoint inhibitorsTumor epitheliumPD1 inhibitor pembrolizumabTumor antigen presentationHER2-negative subtypeMHC-II expressionTumor cell expressionPredictors of responseWilcoxon rank sum testPositive associationRank sum testProtein expression levelsImmune activationControl armAntigen presentationResponse predictorsHR subgroupsB cellsCell expressionPatientsSum testProtein expressionTumorsHER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.
Metzger Filho O, Viale G, Trippa L, Li T, Yardley D, Mayer I, Abramson V, Arteaga C, Spring L, Waks A, Janiszewska M, Wrabel E, Demeo M, Bardia A, King T, Polyak K, Winer E, Krop I. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial. Journal Of Clinical Oncology 2019, 37: 502-502. DOI: 10.1200/jco.2019.37.15_suppl.502.Peer-Reviewed Original ResearchPathologic complete responseER statusRCB 0T-DM1HER2 heterogeneitySignificant associationUltrasound-guided core biopsyRoutine pathology evaluationMedian tumor sizeProspective clinical trialsPredictors of responseAreas of tumorHigh rateCurative settingRCB-IIRCB-IIIPrimary endpointComplete responseHER2 positivityPathologic responseTherapy regimenEvaluable casesTumor sizeCore biopsyClinical trials
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