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Comparative Study
. 2025 Jul;136(1):47-54.
doi: 10.1111/bju.16675. Epub 2025 Feb 18.

Outcomes of BCG vs upfront radical cystectomy for high-risk non-muscle-invasive bladder cancer

Pietro Scilipoti  1   2 , Mattia Longoni  1   2 , Mario de Angelis  1   2 , Paolo Zaurito  1   2 , Aleksander Ślusarczyk  3 , Francesco Soria  4 , Benjamin Pradere  5 , Wojciech Krajewski  6 , David D'Andrea  7 , Andrea Mari  8 , Francesco Del Giudice  9 , Renate Pichler  10 , José Daniel Subiela  11 , Gautier Marcq  12 , Andrea Gallioli  13 , Luca Afferi  14 , Riccardo Mastroianni  15 , Giuseppe Simone  15 , Simone Albisinni  16 , Laura S Mertens  17 , Ekaterina Laukhtina  7 , Katharina Oberneder  7 , José Luis Rodríguez Elena  18 , Javier Aranda  18 , Alfonso Lafuente Puentedura  19 , Jorge Caño Velasco  19 , Roberto Contieri  20 , Rodolfo Hurle  20 , Keiichiro Mori  21 , Piotr Radziszewski  3 , Shahrokh F Shariat  7   22   23   24   25 , Paolo Gontero  4 , Andrea Necchi  1   2 , Morgan Rouprêt  26 , Francesco Montorsi  1   2 , Andrea Salonia  1   2 , Alberto Briganti  1   2 , Marco Moschini  1   2 ; European Association of Urology – Young Academic Urologists (EAU‐YAU), Urothelial carcinoma working group
Affiliations
Comparative Study

Outcomes of BCG vs upfront radical cystectomy for high-risk non-muscle-invasive bladder cancer

Pietro Scilipoti et al. BJU Int. 2025 Jul.

Abstract

Objective: To assess the oncological outcomes of patients with high-risk (HR) and very high-risk (VHR) non-muscle-invasive bladder cancer (NMIBC) treated with upfront radical cystectomy (RC) vs Bacillus Calmette-Guérin (BCG) instillations from a contemporary European multicentre cohort.

Patients and methods: We conducted a retrospective analysis of 1491 patients diagnosed with HR- or VHR-NMIBC from a European multicentre database between 2015 and 2024. Patients were included if they received either upfront RC or at least five doses of BCG. A 1:1 propensity score matching (PSM) according to clinically relevant variables was applied. Progression was defined as muscle-invasive or metastatic disease. Cumulative incidence plots and multivariable competing risk regression models addressing cancer-specific mortality (CSM) were fitted.

Results: Among the 1221 patients with HR- (n = 1221 [90%]) or VHR-NMIBC (n = 121 [10%]), 87 (7.1%) underwent upfront RC. The median follow-up was 2.6 years. After PSM (87 vs 87 patients), the 5-year CSM rate was similar in patients treated with BCG (13%) vs their upfront RC counterparts (16%) (hazard ratio: 1.77, 95% confidence interval [CI] 0.66-4.73; P = 0.3). Of the 1134 patients who initially received BCG, 73 (6.6%) eventually required delayed RC, with 34 (47%) progressing to muscle-invasive bladder cancer before delayed RC. The 3-year CSM rate was comparable in upfront RC (13%) vs delayed RC (11%) among non-progressing patients (P = 0.3). However, patients who progressed before delayed RC had worse 3-year CSM relative to those who did not (13% vs 31%, hazard ratio: 0.32, 95% CI 0.13-0.83; P = 0.018).

Conclusion: Within a European cohort of patients with HR- and VHR-NMIBC, upfront RC was rarely performed. Patients treated with BCG did not exhibit a CSM disadvantage relative to their upfront RC counterparts. After matching, long-term CSM was similar between BCG therapy and upfront RC. Delayed RC, led to worse outcomes if performed after progression, but matched upfront RC when performed before progression, underscoring importance of timely surgery.

Keywords: Bacillus Calmette–Guérin; high risk; non‐muscle‐invasive bladder cancer; survival analysis; upfront radical cystectomy; very high risk.

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References

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