To report real-world outcomes for high-risk non-muscle-invasive bladder cancer (HRNMIBC), including bacillus Calmette-Guérin (BCG) and radical cystectomy (RC), as randomised comparisons of these have not been possible.
We detail consecutive participants screened for the BRAVO randomised controlled trial comparing RC with BCG (International Standard Randomised Controlled Trial Number [ISRCTN]12509361). Patients were prospectively registered and case-note review used for outcomes. The primary outcome was overall survival. Secondary outcomes included recurrence, progression, metastasis, and bladder cancer-specific survival.
A total of 193 patients were screened, including 106 (54.9%) who received BCG, 43 (22.3%) primary RC, 37 (19.2%) 'other' treatment and seven (3.6%) hyperthermic intravesical mitomycin C. All-cause death occurred in 55 (28.5%) patients at median (interquartile range [IQR]) of 29.0 (19.5-42.0) months. In multivariable analysis, overall mortality was more common in older patients (hazard ratio [HR] 2.63, 95% confidence interval [CI] 1.35-5.13; Cox P = 0.004 for age >70 years), those recruited from district hospitals (HR 0.53, 95% CI 0.3-0.95; P = 0.032) and those who did not undergo RC as their first treatment (HR 2.16, 95% CI 1.17-3.99; P = 0.014). In all, 17 (8.8%) patients died from bladder cancer (BC) at median (IQR) of 22.5 (19-36.25) months. In multivariable analysis, BC-specific mortality was more common in older patients (HR 4.87, 95% CI 1.1-21.6; P = 0.037) and those with Tis/T1 disease (HR 2.26, 95% CI 1.23-4.16; P = 0.008) but did not vary with initial treatment.
Patients with HRNMIBC are at high-risk of mortality. Those choosing RC as their initial treatment have lower risks of mortality than others, although this may reflect fitness and selection.
BJU international. 2024 Sep 26 [Epub ahead of print]
Samantha Conroy, Ibrahim Jubber, Aidan P Noon, Derek J Rosario, Jon Griffin, Susan Morgan, Rachel Hubbard, Steve Kennish, Stephen Mitchell, Suresh Venugopal, Kate Linton, Ramanan Rajasundaram, Syed A Hussain, James W F Catto
Division of Clinical Medicine, University of Sheffield, Sheffield, UK., Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Department of Histopathology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Department of Radiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Department of Urology, Wycombe Hospital, Buckinghamshire Healthcare NHS Trust, High Wycombe, UK., Department of Urology, The Royal Liverpool and Broadgreen University Hospitals, Liverpool, UK., Department of Urology, Chesterfield Royal Hospital NHS Foundation Trust, Chesterfield, UK., Department of Urology, Doncaster Royal Infirmary, Doncaster, UK.