Bladder cancer is one of the most common urological malignancies, and about three-quarters of cases are initially diagnosed at a non-muscle-invasive stage. Within this group, patients with high-risk (HR) or very high-risk (VHR) disease face a significant chance of progression to muscle-invasive or even metastatic cancer. This has long sparked debate among clinicians: should these patients be managed with intravesical Bacillus Calmette–Guérin (BCG) immunotherapy, or should they undergo an upfront radical cystectomy, the surgical removal of the bladder, to reduce the risk of progression?
To explore this question, researchers analyzed data from a large, contemporary European multicenter cohort. The study included 1,491 patients diagnosed between 2015 and 2024 with HR- or VHR-non-muscle-invasive bladder cancer (NMIBC). Patients were treated either with at least five doses of BCG or with immediate radical cystectomy. To ensure fair comparison, the investigators used a method called propensity score matching, which balances patient characteristics across treatment groups. The main outcome was cancer-specific mortality (CSM), while progression was defined as development of muscle-invasive or metastatic disease.
Only 7% of patients underwent upfront radical cystectomy, with most receiving BCG as initial therapy. After a median follow-up of 2.6 years, matched analysis showed no significant difference in 5-year cancer-specific mortality: 13% in the BCG group compared to 16% in the upfront cystectomy group. Among the 1,134 patients initially treated with BCG, about 7% eventually required delayed cystectomy. Nearly half of these had already progressed to muscle-invasive disease by the time of surgery. In this subgroup, outcomes were substantially worse, with a 3-year CSM rate of 31%, compared to 13% for patients who underwent delayed cystectomy before progression. Notably, when surgery was performed before progression, survival outcomes were comparable to those of patients who had undergone upfront cystectomy.
These findings suggest that, for patients with HR- or VHR-NMIBC, starting with BCG does not confer a survival disadvantage compared to immediate cystectomy. However, the timing of surgery is crucial: outcomes decline sharply if cystectomy is delayed until after progression. The study underscores the need for careful monitoring and timely surgical intervention in patients showing signs of advancing disease.
Scilipoti, P., Longoni, M., de Angelis, M., Zaurito, P., Ślusarczyk, A., Soria, F., Pradere, B., Krajewski, W., D'Andrea, D., Mari, A., Del Giudice, F., Pichler, R., Subiela, J.D., Marcq, G., Gallioli, A., Afferi, L., Mastroianni, R., Simone, G., Albisinni, S., Mertens, L.S., Laukhtina, E., Oberneder, K., Rodríguez Elena, J.L., Aranda, J., Puentedura, A.L., Caño Velasco, J., Contieri, R., Hurle, R., Mori, K., Radziszewski, P., Shariat, S.F., Gontero, P., Necchi, A., Rouprêt, M., Montorsi, F., Salonia, A., Briganti, A., Moschini, M. and the European Association of Urology - Young Academic Urologists (EAU-YAU), Urothelial carcinoma working group (2025), Outcomes of BCG vs upfront radical cystectomy for high-risk non-muscle-invasive bladder cancer. BJU Int, 136: 47-54. https://doi-org.sanraffaele.idm.oclc.org/10.1111/bju.16675
