Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS).

Autor:	Prasad SM; Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, New Jersey., Huang WC; NYU Langone Urology Associates, New York, New York., Shore ND; Carolina Urologic Research Center, Myrtle Beach, South Carolina., Hu B; The Department of Urology, Loma Linda University, Loma Linda, California., Bjurlin M; The Department of Urology, University of North Carolina, Chapel Hill, North Carolina., Brown G; New Jersey Urology, Cherry Hill, New Jersey., Genov P; Department of Urology, University Multiprofile Hospital for Active Treatment 'Kanev,' Ruse, Bulgaria., Shishkov D; Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria., Khuskivadze A; Urology Department, LTD Gidmedi, Tbilisi, Georgia., Ganev T; Urology Clinic, Multiprofile Hospital for Active Treatment 'Sveta Anna,' Varna, Bulgaria., Marchev D; Department of Urology Multiprofile Hospital for Active Treatment-Shumen, Shumen, Bulgaria., Orlov I; Department of Urology, St Luka Clinical Hospital, Saint Petersburg, Russia., Kopyltsov E; Department of Urology and Oncology, Clinical Oncology Center, Omsk, Russia., Zubarev V; Department of Urology, Medical and Sanitary Unit 70 of Passazhiravtotrans, Saint Petersburg, Russia., Nosov A; Oncourology Department, NN Petrov National Medical Research Center of Oncology, Leningrad, Russia., Komlev D; Medical Center for Diagnostics and Prevention Plus, Yaroslavl, Russia., Burger B; UroGen Pharma, Princeton, New Jersey., Raju S; UroGen Pharma, Princeton, New Jersey., Meads A; UroGen Pharma, Princeton, New Jersey., Schoenberg M; UroGen Pharma, Princeton, New Jersey.; The Department of Urology, The Albert Einstein College of Medicine & The Montefiore Medical Center, Bronx, New York.
Jazyk:	angličtina
Zdroj:	The Journal of urology [J Urol] 2023 Oct; Vol. 210 (4), pp. 619-629. Date of Electronic Publication: 2023 Aug 07.
DOI:	10.1097/JU.0000000000003645
Abstrakt:	Purpose: Low-grade intermediate-risk nonmuscle-invasive bladder cancer is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor. We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent transurethral resection of bladder tumor, to transurethral resection of bladder tumor alone in patients with low-grade intermediate-risk nonmuscle-invasive bladder cancer. Materials and Methods: This prospective, randomized, phase 3 trial recruited patients with new or recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer to receive initial treatment with either UGN-102 once weekly for 6 weeks or transurethral resection of bladder tumor. Patients were followed quarterly by endoscopy, cytology, and for-cause biopsy. The primary end point was disease-free survival. All patients were followed for adverse events. Results: 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 transurethral resection of bladder tumor (n=142) or transurethral resection of bladder tumor 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 transurethral resection of bladder tumor. The estimated probability of disease-free survival 15 months after randomization was 72% for UGN-102 ± transurethral resection of bladder tumor and 50% for transurethral resection of bladder tumor (hazard ratio 0.45). The most common adverse events (incidence ≥10%) in the UGN-102 group were dysuria, micturition urgency, nocturia, and pollakiuria. Conclusions: Primary, nonsurgical chemoablation with UGN-102 for the management of low-grade intermediate-risk nonmuscle-invasive bladder cancer offers a potential therapeutic alternative to immediate transurethral resection of bladder tumor monotherapy and warrants further investigation.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu