Treatment patterns and outcomes of BCG-treated non-muscle invasive bladder cancer patients in Germany

Background: Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence and progression. Nearly half of patients become unresponsive to guideline-recommended intravesical Bacillus Calmette-Guérin (BCG) treatment. We aimed to describe contemporary treatment patterns and outcomes of BCG-treated patients in Germany. Methods: This observational, retrospective cohort study using German statutory health insurance data included NMIBC patients who received BCG instillation between 1st January 2012 and 31st December 2017. Patients were followed from BCG initiation for treatment patterns and from final BCG instillation for recurrence, progression to muscle-invasive bladder cancer (MIBC), death or end of follow-up (31st December 2019). Results: Most of the BCG-treated cohort (N=1,049) were male with a mean age of 70.4 years. Overall, patients received a median (interquartile range) of 12.0 (6.0 – 18.0) BCG instillations over a median duration of 9.8 (2.3 – 21.3) months. After receipt of their final BCG instillation (median follow-up from final BCG instillation: 2.5 years), 57% of patients did not receive any further treatment while 11% had at least one evidence record of NMIBC recurrence and 30% progressed to MIBC. Among the 353 patients who received treatment following their final BCG instillation, 33% received mitomycin and 37% underwent a radical cystectomy. Conclusions: A substantial proportion of patients with NMIBC who received further treatment after their final BCG instillation underwent a radical cystectomy, and one third were treated with mitomycin; treatment options after mitomycin varied. Findings from this study suggest an unmet need for optimal treatments for BCG-unresponsive patients who are at higher risk of recurrence but unable or unwilling to undergo radical cystectomy.