2020
Trends in FDA cancer registration trial design over time, 1969-2020.
Warner J, Sethi T, Rivera D, Venepalli N, Osterman T, Khaki A, Rubinstein S. Trends in FDA cancer registration trial design over time, 1969-2020. Journal Of Clinical Oncology 2020, 38: 2060-2060. DOI: 10.1200/jco.2020.38.15_suppl.2060.Peer-Reviewed Original ResearchTrial designFDA approvalImmunotherapy trialsRegistration trialsCommon trial designOverall survival endpointOncology drug approvalsClass switchFDA package insertsCancer drug indicationsStudy drugCytotoxic therapyControl armTherapeutic approachesPackage insertsRCTsRCT designIndication approvalsOncology drugsLog-linear regressionSurvival endpointsTherapyTrialsDrug approvalNew drugs
2018
Treatment of newly diagnosed primary central nervous system lymphoma: current and emerging therapies
Sethi TK, Reddy NM. Treatment of newly diagnosed primary central nervous system lymphoma: current and emerging therapies. Leukemia & Lymphoma 2018, 60: 6-18. PMID: 29741421, DOI: 10.1080/10428194.2018.1466296.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAge FactorsAgedAntineoplastic Combined Chemotherapy ProtocolsBiopsyBone MarrowBrainCentral Nervous System NeoplasmsChemoradiotherapyCognitive DysfunctionCranial IrradiationFemaleHumansLymphoma, Large B-Cell, DiffuseMagnetic Resonance ImagingMiddle AgedNeoplasm Recurrence, LocalPrognosisProgression-Free SurvivalRemission InductionStem Cell TransplantationTransplantation, AutologousConceptsPrimary central nervous lymphomaDiffuse large B-cell lymphoma histologyPrimary central nervous system lymphomaAutologous stem cell transplantCentral nervous system lymphomaMulti-agent chemotherapyNervous system lymphomaStem cell transplantNon-Hodgkin lymphomaLong-term toxicityEligible patientsImmunotherapy optionsRelapsed diseaseAggressive presentationUpfront therapySystem lymphomaCell transplantFrontline treatmentPathogenetic pathwaysLymphoma histologyCurrent evidenceFrontline strategyLymphomaTherapyOngoing studies