Bladder-sparing Therapy for Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection
Li R, Hensley P, Gupta S, Al-Ahmadie H, Babjuk M, Black P, Brausi M, Bree K, Fernández M, Guo C, Horowitz A, Lamm D, Lerner S, Lotan Y, Mariappan P, McConkey D, Mertens L, Mir C, Ross J, O'Donnell M, Palou J, Pohar K, Steinberg G, Soloway M, Spiess P, Svatek R, Tan W, Taoka R, Buckley R, Kamat A. Bladder-sparing Therapy for Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection. European Urology 2024 PMID: 39183090, DOI: 10.1016/j.eururo.2024.08.001.Peer-Reviewed Original ResearchNon-muscle-invasive bladder cancerInternational Bladder Cancer GroupBladder-sparing treatmentCarcinoma in situNadofaragene firadenovecRadical cystectomyBladder cancerOptimal selection of patientsAbsence of randomized trialsBladder-sparing therapySingle-agent chemotherapyBladder cancer groupSelection of patientsDevelopment of agentsPatient selectionSystemic toxicityCancer groupUnapproved agentsClinical trial participationPatient characteristicsRandomized trialsMitomycin CTumor attributesConsensus recommendationsCancer expertsEfficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin–Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial
Narayan V, Boorjian S, Alemozaffar M, Konety B, Shore N, Gomella L, Kamat A, Bivalacqua T, Montgomery J, Lerner S, Busby J, Poch M, Crispen P, Steinberg G, Schuckman A, Downs T, Mashni J, Lane B, Guzzo T, Bratslavsky G, Karsh L, Woods M, Brown G, Canter D, Luchey A, Lotan Y, Inman B, Williams M, Cookson M, Chang S, Sankin A, O’Donnell M, Sawutz D, Philipson R, Parker N, Yla-Herttuala S, Rehm D, Jakobsen J, Juul K, Dinney C. Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin–Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial. Journal Of Urology 2024, 212: 74-86. PMID: 38704840, DOI: 10.1097/ju.0000000000004020.Peer-Reviewed Original ResearchConceptsNonmuscle-invasive bladder cancerPhase 3 trialBladder cancerFollow-upAdenoviral vector-based gene therapyProgression to muscle-invasive diseaseOpen-label phase 3 trialVector-based gene therapyCystectomy-free survivalMuscle-invasive diseaseMedian follow-upCarcinoma in situBladder preservationNadofaragene firadenovecOverall survivalGene therapyCytological assessmentTa/T1PatientsUS sitesCohortReceiving treatmentMonthsCancerHGRFEFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER: 36-MONTH FOLLOW-UP FROM A PHASE 3 TRIAL
Boorjian S, Narayan V, Master V, Konety B, Shore N, Kamat A, Dinney C, Bivalacqua T, Kates M, Montgomery J, Lerner S, Crispen P, Steinberg G, Agarwal P, Schuckman A, Svatek R, Lane B, Karsh L, Bjurlin M, Brown G, Lotan Y, Inman B, Williams M, Cookson M, Chang S, Kim E, Sankin A, O'Donnell M, Jakobsen J, Juul K. EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER: 36-MONTH FOLLOW-UP FROM A PHASE 3 TRIAL. Urologic Oncology Seminars And Original Investigations 2024, 42: s70. DOI: 10.1016/j.urolonc.2024.01.201.Peer-Reviewed Original ResearchBCG-unresponsive NMIBCNon-muscle invasive bladder cancerPhase 3 studyFollow-up resultsNadofaragene firadenovecCarcinoma in situPapillary diseaseTreatment optionsFollow-upProgression to muscle-invasive diseaseDiscontinuation due to adverse eventsOpen-label phase 3 studyVector-based gene therapyTreatment of adult patientsBenefit-to-risk ratioDuration of follow-upCystectomy-free survivalHigh-grade recurrenceMuscle-invasive diseaseDurability of responseDuration of CRInvasive bladder cancerMonths of treatmentNovel treatment optionsBCG-unresponsive