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.