Seth Lerner, MD
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2025
Chapter 49 Phase 0 & window of opportunity clinical trials
Reddy A, Bansal U, Lerner S. Chapter 49 Phase 0 & window of opportunity clinical trials. 2025, 249-253. DOI: 10.1016/b978-0-323-90186-4.00009-2.Peer-Reviewed Original ResearchExploratory investigational new drugClinical trialsPhase 1 clinical trialPreclinical animal studiesFood and Drug AdministrationInvestigational new drugOn-target effectsPhase 0 studiesDrug pharmacokineticsDrug efficacyDrug AdministrationAnimal studiesOncology drugsDrug trialsSuboptimal pharmacological propertiesNew drugsDrug approvalDrugDrug approval processCosts associated with drug developmentPharmacological propertiesDrug safetyTrialsDrug developmentTherapeutic areas
2024
Correlation of Body Mass Index with Overall Survival Among Patients with Metastatic Hormone-sensitive Prostate Cancer: Analysis of Patient-level Data from SWOG-1216
Swami U, Jo Y, Narang A, Plets M, Hage Chehade C, Gebrael G, Gupta S, Myint Z, Tangen C, Lara P, Thompson I, Hussain M, Dorff T, Lerner S, Agarwal N. Correlation of Body Mass Index with Overall Survival Among Patients with Metastatic Hormone-sensitive Prostate Cancer: Analysis of Patient-level Data from SWOG-1216. European Urology Oncology 2024 PMID: 39521639, DOI: 10.1016/j.euo.2024.10.013.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerHormone-sensitive prostate cancerAndrogen deprivation therapyBody mass indexAssociated with better OSHigher body mass indexOverall survivalPhase 3 trialProstate cancerMass indexMetastatic castration-resistant prostate cancerAssociated with better overall survivalBaseline prostate-specific antigenCastration-resistant prostate cancerNormal body mass indexIncidence of visceral metastasesBaseline body mass indexZubrod performance statusCorrelation of body mass indexAnalysis of patient-level dataProstate-specific antigenGroup of patientsPost hoc exploratory analysisRisk of deathMedian OSDNA Damage Response Alterations Predict for Neoadjuvant Chemotherapy Sensitivity in Muscle-Invasive Bladder Cancer: A Correlative Analysis of the SWOG S1314 Trial
Iyer G, Tangen C, Sarfaty M, Regazzi A, Lee I, Fong M, Choi W, Dinney C, Flaig T, Thompson I, Lerner S, McConkey D, Rosenberg J. DNA Damage Response Alterations Predict for Neoadjuvant Chemotherapy Sensitivity in Muscle-Invasive Bladder Cancer: A Correlative Analysis of the SWOG S1314 Trial. JCO Precision Oncology 2024, 8: e2400287. PMID: 39499893, DOI: 10.1200/po.24.00287.Peer-Reviewed Original ResearchConceptsNeoadjuvant cisplatin-based chemotherapyMuscle-invasive bladder cancerProgression-free survivalDDR alterationsDNA damage response alterationPathological responseBladder cancerDNA damage responseAssociated with pathological responseNeoadjuvant chemotherapy sensitivityPretreatment tumor specimensPathological response rateCisplatin-based chemotherapyDNA damage response genesEstimates of hazard ratiosOverall survivalRadical cystectomyTumor specimensPerformance statusClinical stageChemotherapy sensitivityCox regressionHazard ratioNext-generation sequencingPatientsEligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer
Singh P, Ballas L, Sonpavde G, Chen R, Bangs R, Bauman B, Nagar H, Delacroix S, Lerner S, Efstathiou J. Eligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer. Bladder Cancer 2024, 10: 199-213. PMID: 39493817, PMCID: PMC11530036, DOI: 10.3233/blc-240036.Peer-Reviewed Original ResearchBladder cancer treatmentTransurethral resection of bladder tumorEastern Cooperative Oncology GroupTrimodality therapyLong-term outcomesClinical trialsCancer treatmentRadical cystectomySystemic therapyEligibility criteriaSecondary endpointsTrial eligibility criteriaBladder cancerMaximal transurethral resection of bladder tumorEndpoint definitionsAlternative to radical cystectomyResection of bladder tumorCo-primary end pointsConcurrent systemic therapyMaximal transurethral resectionPhase II/III clinical trialsLocalized bladder cancerEvent-free survivalCooperative Oncology GroupBladder cancer researchStandard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer
Lerner S, Tangen C, Svatek R, Daneshmand S, Pohar K, Skinner E, Schuckman A, Sagalowsky A, Smith N, Kamat A, Kassouf W, Plets M, Bangs R, Koppie T, Alva A, La Rosa F, Pal S, Kibel A, Canter D, Thompson I. Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. New England Journal Of Medicine 2024, 391: 1206-1216. PMID: 39589370, PMCID: PMC11599768, DOI: 10.1056/nejmoa2401497.Peer-Reviewed Original ResearchCirculating Tumor Cell Count and Overall Survival in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Goldkorn A, Tangen C, Plets M, Bsteh D, Xu T, Pinski J, Ingles S, Triche T, MacVicar G, Vaena D, Crispino A, McConkey D, Lara P, Hussain M, Quinn D, Dorff T, Lerner S, Thompson I, Agarwal N. Circulating Tumor Cell Count and Overall Survival in Patients With Metastatic Hormone-Sensitive Prostate Cancer. JAMA Network Open 2024, 7: e2437871. PMID: 39374015, PMCID: PMC11581504, DOI: 10.1001/jamanetworkopen.2024.37871.Peer-Reviewed Original ResearchConceptsMetastatic hormone-sensitive prostate cancerMetastatic castration-resistant prostate cancerCirculating tumor cell countCirculating tumor cellsHormone-sensitive prostate cancerTumor cell countOverall survivalProstate cancerPrognostic valueCTC countsPrognostic factorsProgression to metastatic castration-resistant prostate cancerDiagnosed mHSPCPeripheral blood circulating tumor cellsClinical trialsBlood circulating tumor cellsCastration-resistant prostate cancerPrognostic studyCell countBaseline CTC countProgression-free survivalLines of therapyEnhanced overall survivalProstate-specific antigenIncreased prognostic valueMitochondrial reprogramming by activating OXPHOS via glutamine metabolism in African American patients with bladder cancer
Reddy K, Piyarathna D, Park J, Putluri V, Amara C, Kamal A, Xu J, Kraushaar D, Huang S, Jung S, Eberlin L, Johnson J, Kittles R, Ballester L, Parsawar K, Siddiqui M, Gao J, Gramer A, Bollag R, Terris M, Lotan Y, Creighton C, Lerner S, Sreekumar A, Kaipparettu B, Putluri N. Mitochondrial reprogramming by activating OXPHOS via glutamine metabolism in African American patients with bladder cancer. JCI Insight 2024, 9: e172336. PMID: 39253977, PMCID: PMC11385078, DOI: 10.1172/jci.insight.172336.Peer-Reviewed Original ResearchConceptsBladder cancerOxidative phosphorylationComponents of complex IComplex IElevated mitochondrial oxidative phosphorylationComprehensive RNA-seqReduced basal respirationActive oxidative phosphorylationMitochondrial oxidative phosphorylationDecreased tumor growthTumor growth potentialIncreased disease progressionMitochondrial respiration rateAfrican American patientsRNA-seqRace-specific differencesMitochondrial reprogrammingEuropean AmericansMetabolic rewiringOXPHOS activityBasal respirationGlutamine metabolismGLS1 expressionPreclinical studiesATP productionFinal Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma
Barata P, Tangen C, Plets M, Thompson I, Narayan V, George D, Heng D, Shuch B, Stein M, Gulati S, Tretiakova M, Tripathi A, Bjarnason G, Humphrey P, Adeniran A, Vaishampayan U, Alva A, Zhang T, Cole S, Lara P, Lerner S, Balzer-Haas N, Pal S. Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. Journal Of Clinical Oncology 2024, 42: 3911-3916. PMID: 39255440, PMCID: PMC11575905, DOI: 10.1200/jco.24.00767.Peer-Reviewed Original ResearchAdvanced papillary renal cell carcinomaPapillary renal cell carcinomaRenal cell carcinomaOverall survivalCell carcinomaProlonged progression-free survivalLack of survival benefitProgression-free survivalRandomized phase IIMedian follow-upPrimary end pointOpen-label trialOverall survival analysisCrizotinib armMedian OSSurvival benefitClinical trial updateNo significant differenceCabozantinibTreatment armsSunitinibFollow-upClinical trialsSavolitinibCrizotinib1620P Inherited variants in SRD5A genes and response to hormonal therapy in prostate cancer (SWOG S1216)
Ingles S, Pinski J, Manojlovic Z, Xiong S, Weisenberger D, Goldkorn A, Tangen C, McConkey D, Lara P, Hussain M, Quinn D, Thompson I, Lerner S, Dorff T, Agarwal N. 1620P Inherited variants in SRD5A genes and response to hormonal therapy in prostate cancer (SWOG S1216). Annals Of Oncology 2024, 35: s978. DOI: 10.1016/j.annonc.2024.08.1701.Peer-Reviewed Original ResearchLong‐term outcomes of bladder‐sparing therapy vs radical cystectomy in BCG‐unresponsive non‐muscle‐invasive bladder cancer
Taylor J, Kamat A, O'Donnell M, Annapureddy D, Howard J, Tan W, McElree I, Davaro F, Yim K, Harrington S, Dyer E, Black A, Kanabur P, Roumiguié M, Lerner S, Black P, Raman J, Preston M, Steinberg G, Huang W, Li R, Packiam V, Woldu S, Lotan Y. Long‐term outcomes of bladder‐sparing therapy vs radical cystectomy in BCG‐unresponsive non‐muscle‐invasive bladder cancer. BJU International 2024 PMID: 39183466, DOI: 10.1111/bju.16509.Peer-Reviewed Original ResearchNon-muscle-invasive bladder cancerBladder-sparing therapyUpfront RCRadical cystectomyCohort of patientsBladder cancerBCG-unresponsive NMIBCRetrospective cohort of patientsProgression to MIBCUpfront radical cystectomyCancer-specific survivalInstitutional review board approvalMetastasis-free survivalFood and Drug Administration criteriaRate of recurrenceReview board approvalLong-term outcomesStatistically significant differenceNodal diseaseRe-resectionSystemic immunotherapyIntravesical chemotherapyOncological outcomesOverall survivalOncological risk
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