Non-muscle invasive bladder cancer burden: The impact of BCG shortage and its interaction with epidemiological patient profile—A population cohort study in Brazil.

Abstract

e16602 Background: To evaluate the impact of the Bacillus Calmette-Guérin (BCG) shortage on treatment patterns and recurrence rates in non-muscle invasive bladder cancer (NMIBC) over two decades, with a focus on patient and treatment characteristics in a Brazilian population-based cohort. Methods: This retrospective cohort study utilized data from the Fundação Oncocentro de São Paulo (FOSP) database, including 9,319 patients with confirmed NMIBC (stages 0 and I) treated between 2000 and 2022. Inclusion criteria were age ≥18 years and complete demographic, clinical, and treatment data. Factors analyzed included age, educational level, oncological center type, treatment modality, and tumor stage (Ta, T1, or carcinoma in situ). Kaplan-Meier analysis assessed recurrence rates before and during the BCG shortage. Decision tree analysis identified variables associated with reduced BCG use, with statistical tests (Chi-square, Fisher’s exact, and log-rank) performed at a 5% significance level. Results: BCG use decreased significantly after 2012 (p < 0.0001), corresponding with increased use of intravesical chemotherapy and observation. Factors associated with reduced BCG use included age > 70 years (p = 0.005), T1 stage (p = 0.0001), low educational level (p = 0.0001), treatment in public facilities (p = 0.0001), and care at UNACON centers (p = 0.007). Kaplan-Meier analysis revealed no significant difference in recurrence-free survival before and during the shortage (p = 0.430). Decision tree analysis (79% accuracy) highlighted educational level, tumor stage, and oncological center type as primary determinants of BCG access. Patients with high education, T1 stage, and care at CACON centers were highly likely to receive BCG (99%), while those with low education, Ta/Tis stage, and treatment at UNACON centers had reduced access (90%). Conclusions: This study demonstrates that educational level, tumor stage, and oncological center complexity were key determinants of BCG utilization during the shortage. Addressing disparities in treatment access requires targeted interventions and equitable healthcare policies to minimize the ethical and clinical impact of resource constraints.