Historic prediction models overestimate the risk of recurrence and progression for intermediate risk (IR) non-muscle-invasive bladder cancer (NMIBC). We report outcomes for patients with IR-NMIBC and the appropriateness of surveillance cystoscopy protocol using contemporaneous clinical trials.
Pooled individual IR-NMIBC patient data from four randomized controlled trials (RCT) were analyzed: HIVEC-II, PHOTO, BOXIT, and CALIBER. Patients with IR-NMIBC underwent complete tumor resection and were recommended to receive 6 weekly instillations of mitomycin C. Kaplan-Meier analyses were performed for oncological endpoints. Noncumulative distribution of recurrence was evaluated to determine the appropriateness of surveillance cystoscopy.
A total of 578 patients with IR-NMIBC, with a median follow-up of 34 mo (interquartile range: 25-55 mo) were included for analysis. There was no meaningful increase in recurrence from 36 to 60 mo: overall recurrence-free rates at 12, 24, 36, and 60 mo were 73%, 61%, 56%, and 54%, respectively. In the multivariable model, the risk of recurrence was higher in patients with prior recurrences (hazard ratio [HR]: 1.75, 95% confidence interval [CI]: 1.16-2.64, p = 0.008), multifocality (HR: 1.49, 95% CI: 1.13-1.95, p = 0.004), and cancer grade (HR: 1.57, 95% CI: 1.08-2.28, p = 0.018). Grade or stage progression was uncommon (<5%), and cancer-specific survival (CSS) was 99% at 60 mo. The noncumulative risk of recurrences at 36 and 60 mo were 17% and <5%, respectively.
Patients with IR-NMIBC have a high recurrent risk within 36 mo, but grade/stage progression remains low. Patients could consider terminating/reducing the frequency of cystoscopy after 60 mo because of a low risk of subsequent recurrence.
European urology oncology. 2026 May 13 [Epub ahead of print]
Wei Shen Tan, Ashish M Kamat, Rebecca Lewis, Nuria Porta, Charlotte Ackerman, Thenmalar Vadiveloo, Steven Penegar, Alberto Martini, Luke Vale, Hugh Mostafid, Graeme MacLennan, Emma Hall, Rakesh Heer, John D Kelly
Department of Urology, Yale School of Medicine, New Haven, CT, USA; Division of Surgery & Interventional Science, University College London, London, UK. Electronic address: ., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK., Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK., Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, UK., Department of Urology, University of Cincinnati, Cincinnati, OH, USA., Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK., Department of Urology, Royal Surrey County Hospital, Guildford, UK., Division of Surgery, Imperial College London, London, UK., Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals, London, UK.