2022
Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial
Tan W, Prendergast A, Ackerman C, Yogeswaran Y, Cresswell J, Mariappan P, Phull J, Hunter-Campbell P, Lazarowicz H, Mishra V, Rane A, Davies M, Warburton H, Cooke P, Mostafid H, Wilby D, Mills R, Issa R, Kelly J. Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial. European Urology 2022, 83: 497-504. PMID: 35999119, DOI: 10.1016/j.eururo.2022.08.003.Peer-Reviewed Original ResearchMeSH KeywordsAdjuvants, ImmunologicAdministration, IntravesicalAntibiotics, AntineoplasticChemotherapy, AdjuvantHumansMitomycinNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsConceptsIntermediate-risk non-muscle-invasive bladder cancerNon-muscle-invasive bladder cancerDisease-free survivalAdverse eventsBladder cancerMitomycin CChemotherapy instillationOpen-labelControl armAdjuvant intravesical chemotherapyProgression-free survivalPhase 2 randomised controlled trialIntention-to-treat analysisLow gradePer-protocol analysisChemohyperthermia groupIntravesical chemotherapyUrinary cytologyHeated chemotherapyOverall survivalWeekly instillationsTumor resectionPrimary endpointRandomised controlled trialsChemohyperthermia
2018
BOXIT—A Randomised Phase III Placebo-controlled Trial Evaluating the Addition of Celecoxib to Standard Treatment of Transitional Cell Carcinoma of the Bladder (CRUK/07/004)
Kelly J, Tan W, Porta N, Mostafid H, Huddart R, Protheroe A, Bogle R, Blazeby J, Palmer A, Cresswell J, Johnson M, Brough R, Madaan S, Andrews S, Cruickshank C, Burnett S, Maynard L, Hall E, Investigators O. BOXIT—A Randomised Phase III Placebo-controlled Trial Evaluating the Addition of Celecoxib to Standard Treatment of Transitional Cell Carcinoma of the Bladder (CRUK/07/004). European Urology 2018, 75: 593-601. PMID: 30279015, DOI: 10.1016/j.eururo.2018.09.020.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntravesicalAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBCG VaccineCarcinoma, Transitional CellCardiovascular DiseasesCelecoxibCyclooxygenase 2 InhibitorsDisease ProgressionDouble-Blind MethodFemaleHumansMaleMiddle AgedMitomycinNeoplasm Recurrence, LocalNeoplasm StagingQuality of LifeRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited KingdomUrinary Bladder NeoplasmsConceptsNon-muscle-invasive bladder cancerHigh-risk non-muscle-invasive bladder cancerRisk of recurrenceIncreased risk of cardiovascular eventsRisk of cardiovascular eventsTime to recurrenceCardiovascular eventsNMIBC patientsBladder cancerStandard treatmentPhase III placebo-controlled trialIntermediate-risk non-muscle-invasive bladder cancerNon-muscle-invasive bladder cancer patientsIncreased riskPatients treated with celecoxibWeekly mitomycin C instillationsMitomycin C instillationAdjuvant intravesical therapyRecurrence-free rateMedian follow-upPlacebo-controlled trialTransitional cell carcinomaHigh-risk patientsCyclo-oxygenase 2 inhibitorsIntravesical therapy