Eligibility 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 researchA phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design.
Sadeghi S, Plets M, Lara P, Tangen C, Berg S, Brown J, Bangs R, Nakagawa D, Daneshmand S, Ian M. Jr., Flaig T, Petrylak D, Lerner S. A phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design. Journal Of Clinical Oncology 2024, 42: tps4617-tps4617. DOI: 10.1200/jco.2024.42.16_suppl.tps4617.Peer-Reviewed Original ResearchProgression free survivalMetastatic urothelial carcinomaMedian progression free survivalStandard of careOverall survivalEnfortumab vedotinSacituzumab govitecanFree survivalCisplatin-ineligible metastatic urothelial carcinomaPhase III randomized trialMedian overall survivalStudies of eribulinEndpoint of OSFGFR alterationsLiver metastasesSystemic therapyEligible ptsUrothelial carcinomaPrimary endpointGenitourinary cancersTreatment changesEribulinResponse rateActivity of EORRSWOG S1931 (PROBE): PHASE III RANDOMIZED TRIAL OF IMMUNE CHECKPOINT INHIBITOR (ICI) COMBINATION REGIMEN WITH OR WITHOUT CYTOREDUCTIVE NEPHRECTOMY (CN) IN ADVANCED RENAL CANCER [NCT04510597]
Kim H, Tangen C, Vaishampayan U, Tripathi A, Patel S, Shuch B, Barata P, Tan A, Esfeller L, Lara P, Sanchez A, Lerner S, Thompson I. SWOG S1931 (PROBE): PHASE III RANDOMIZED TRIAL OF IMMUNE CHECKPOINT INHIBITOR (ICI) COMBINATION REGIMEN WITH OR WITHOUT CYTOREDUCTIVE NEPHRECTOMY (CN) IN ADVANCED RENAL CANCER [NCT04510597]. Urologic Oncology Seminars And Original Investigations 2024, 42: s4. DOI: 10.1016/j.urolonc.2024.01.044.Peer-Reviewed Original ResearchCytoreductive nephrectomyPrimary tumorImmune checkpointsSystemic therapySurvival outcomesTrials of immune checkpoint inhibitorsHigher neoantigen loadPROBE study designImmune checkpoint inhibitorsSynchronous primary tumorsAdvanced renal cancerWeeks of therapyOverall survival outcomesShorter survival outcomeStandard of careCARMENA trialNeoantigen loadSunitinib therapyAdvanced RCCAntigen spreadingImmune therapyUrologic evaluationFrontline settingCombination therapySurgical candidates