2025
Off-Label Use of First-Line Immunotherapy for Metastatic Renal Cell Carcinoma
McManus H, Long J, Westvold S, Leapman M, Hurwitz M, Mitchell A, Pollack C, Gross C, Dinan M. Off-Label Use of First-Line Immunotherapy for Metastatic Renal Cell Carcinoma. Clinical Genitourinary Cancer 2025, 23: 102330. PMID: 40186898, PMCID: PMC12084128, DOI: 10.1016/j.clgc.2025.102330.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaImmune checkpoint inhibitorsFood and Drug AdministrationRenal cell carcinomaOff-labelCell carcinomaOlder patientsImmune checkpoint inhibitor useFood and Drug Administration approvalFirst-line immunotherapyMultivariate logistic regressionOff-label useCo-morbid conditionsCheckpoint inhibitorsFirst-lineCo-morbiditiesDrug AdministrationPatientsCo-morbidityPostapproval settingLogistic regressionCarcinomaDemographic characteristicsPostapprovalPostapproval period
2021
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients
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