A national perspective on the management of high-risk BCG-unresponsive non-muscle-invasive bladder cancer in Romania

Purpose: BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) remains a persistent challenge. This study examines Romanian urologists’ clinical practices, focusing on treatment preferences and awareness of emerging therapies for BCG-unresponsive disease.
Methods: A cross-sectional, web-based survey comprising 24 items was distributed to selected urologists who manage NMIBC via professional mailing lists. Data were collected between May 15 and June 30, 2025.
Results: Out of 400 invited urologists, 216 completed the survey. Radical cystectomy (RC) was the most preferred treatment for BCG-unresponsive NMIBC, recommended by 67% of respondents, followed by tumor resection with surveillance (15%), repeat BCG instillation (14%), and intravesical chemotherapy (4%). Neither clinical trials nor intravenous checkpoint inhibitors were used. Among those using intravesical chemotherapy, gemcitabine was the most commonly used agent (85%), followed by mitomycin C (5%), gemcitabine/docetaxel (4%), gemcitabine/ mitomycin C (3%), docetaxel (2%), and valrubicin (1%). Oncological safety concerns were the main barrier to adopting bladder-sparing therapies. Awareness of FDA-approved therapies for BCG-unresponsive disease, Nadofaragene firadenovec, Nogapendekin alfa inbakicept-pmln, and Pembrolizumab, was limited; 61% of urologists were unaware of all three, and only 1% had used any. BCG shortages were reported by 93% of respondents at some point, who adapted by reducing doses and prioritizing high-grade T1 and CIS cases. Most recognized intravesical chemotherapy as an alternative and were willing to use it if needed.
Conclusions: Though RC remains the predominant approach for BCG-unresponsive cases, over half of urologists’ report using intravesical chemotherapy, reflecting interest in bladder-sparing strategies rather than newly approved FDA agents.