A 70-year-old man with NMIBC (Ta, high-grade) recurs 3 months after BCG induction therapy. According to EAU guidelines, BCG-unresponsive disease is defined by which criterion, and what is the preferred next treatment?

• A High-grade disease persisting at 3 months after adequate BCG induction, or recurrence within 6 months of BCG maintenance; radical cystectomy or pembrolizumab (FDA-approved) for BCG-unresponsive CIS ✓
• B Any recurrence after BCG induction; second BCG course is indicated
• C Recurrence at 12 months after BCG; intravesical gemcitabine-docetaxel is guideline-recommended
• D Any T1 high-grade recurrence after first BCG cycle; repeat TURBT only is adequate

Explanation

BCG-unresponsive disease is defined as high-grade tumour persisting or recurring within 3 months of adequate BCG induction (at least 5 of 6 induction doses), or recurrence within 6 months after the last BCG dose despite adequate maintenance. Radical cystectomy remains the gold standard. Pembrolizumab (anti-PD-1) received FDA approval in 2020 for BCG-unresponsive CIS unable or unwilling to undergo cystectomy. Intravesical gemcitabine-docetaxel (gem-doce) is an EAU-recognized alternative for BCG-unresponsive papillary disease in clinical practice though not yet a level 1 guideline recommendation.

Reference: Bailey & Love's Short Practice of Surgery, 27th ed.

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Written and medically reviewed by the StethoPrep medical team.