Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor (TURBT). We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent TURBT, to TURBT alone in patients with LG IR NMIBC.
This prospective, randomized, Phase 3 trial recruited patients with new or recurrent LG IR NMIBC to receive initial treatment with either UGN-102 once weekly for 6 weeks or TURBT. Patients were followed quarterly by endoscopy, cytology, and for-cause biopsy. The primary endpoint was disease-free survival (DFS). All patients were followed for adverse events.
Trial enrollment was halted by the sponsor to pursue an alternative development strategy after 282 of a planned 632 patients were randomized to UGN-102 ± subsequent TURBT (n=142) or TURBT monotherapy (n=140), rendering the trial underpowered to perform hypothesis testing. Patients were predominantly male and ≥65 years of age. Tumor-free complete response 3 months after initial treatment was achieved by 92 patients (65%) who received UGN-102 and 89 patients (64%) treated by TURBT. The estimated probability of DFS 15 months after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT [hazard ratio 0.45]. The most common adverse events (incidence ≥10%) in the UGN-102 group were dysuria, micturition urgency, nocturia, and pollakiuria.
Primary, non-surgical chemoablation with UGN-102 for the management of LG IR NMIBC offers a potential therapeutic alternative to immediate TURBT monotherapy and warrants further investigation.
The Journal of urology. 2023 Aug 07 [Epub ahead of print]
Sandip M Prasad, William C Huang, Neal D Shore, Brian Hu, Marc Bjurlin, Gordon Brown, Pencho Genov, Dimitar Shishkov, Alexandre Khuskivadze, Tosho Ganev, Dobri Marchev, Igor Orlov, Evgeny Kopyltsov, Vadim Zubarev, Alexander Nosov, Dmitrii Komlev, Brent Burger, Sunil Raju, Andrew Meads, Mark Schoenberg
Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ ()., NYU Langone Urology Associates, New York, NY ()., Carolina Urologic Research Center, Myrtle Beach, SC ()., The Department of Urology, Loma Linda University, Loma Linda, CA ( )., The Department of Urology, Univeristy of North Carolina, Chapel Hill, NC( )., New Jersey Urology, Cherry Hill, NJ ()., Department of Urology, University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Bulgaria ()., Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria ()., Urology Department, LTD Gidmedi, Tbilisi, Georgia ()., Urology Clinic, Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Bulgaria ()., Department of Urology Multiprofile Hospital for Active Treatment - Shumen, Shumen, Bulgaria ()., Department of Urology, St. Luka Clinical Hospital, Saint Petersburg, Russia ()., Department of Urology and Oncology, Clinical Oncology Center, Omsk, Russia ()., Department of Urology, Medical and Sanitary Unit 70 of Passazhiravtotrans, Saint Petersburg, Russia ()., Oncourology Department, N.N. Petrov National Medical Research Center of Oncology, Leningrad, Russia ()., Medical Center for Diagnostics and Prevention Plus, Yaroslavl, Russia ()., UroGen Pharma, Princeton, NJ (, , , ).
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37548555
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