Oncological Outcomes of Intravesical Bacillus Calmette-Guérin Versus Early Radical Cystectomy in Very High-Risk Non-Muscle-Invasive Bladder Cancer: A Retrospective Cohort From a Latin American Referral Center.

BACKGROUND: Very high-risk (VHR) bladder tumors represent a subcategory of non-muscle-invasive bladder cancer (NMIBC) with a high potential for progression to muscle-invasive bladder cancer (MIBC). Early radical cystectomy (ERC) is the standard treatment. However, for patients unfit for or refusing surgery, intravesical Bacillus Calmette-Guérin (BCG) immunotherapy remains a commonly used bladder-preserving approach. This study aimed to assess oncological outcomes in patients with VHR NMIBC treated with intravesical BCG or ERC. METHODS: We conducted a retrospective cohort study, including patients with VHR NMIBC treated with BCG or ERC between July 2008 and May 2023. Data were collected from an institutional electronic database. Only patients who received adequate BCG treatment, according to predefined induction and early maintenance criteria, were included in the BCG group. We analyzed clinical and pathological features, overall survival (OS), and cancer‑specific survival (CSS). Secondary objectives included progression and high-grade intravesical recurrence rates among BCG-treated patients. RESULTS: Among 112 patients included, 99 received BCG and 13 underwent ERC. Patients undergoing ERC were younger and more frequently presented with adverse pathological features, including lymphovascular invasion and variant histology. No statistically significant differences in OS or CSS were observed between the groups. The estimated 60-month CSS was 91.1% in the BCG group and 100% in the ERC group. In the BCG cohort, 48 patients (48.5%) experienced recurrence and 15 progressed to muscle-invasive disease. CONCLUSIONS: In this retrospective cohort of patients with VHR NMIBC, intravesical BCG was associated with acceptable oncological outcomes in selected cases. However, due to significant baseline imbalances and the small size of the ERC group, these findings should be interpreted with caution, and cannot be considered evidence of equivalence between treatment strategies. Further prospective multicenter studies are needed to refine patient selection and optimize treatment strategies in this population.