Clinical outcomes of BCG-treated high-risk NMIBC patients according to pre- and post-2021 EAU risk classifications

We evaluated clinical outcomes in high-risk non-muscle invasive bladder cancer (HR-NMIBC) patients treated with BCG, reclassified according to the updated 2021 EAU risk stratification which introduced a Very High Risk (VHR) category. Using data from the Bladder Cancer Prognosis Programme (BCPP), 212 BCG-treated pre-2021 HR-NMIBC patients were analyzed, with 141 receiving adequate BCG. For patients receiving induction-only BCG, the 2021 risk groups showed significant discrimination for progression-free survival (PFS) (p=0.037, C-index 0.66), with VHR-NMIBC associated with worse outcomes. In contrast, among patients receiving adequate BCG, no significant differences in PFS were observed between the 2021 intermediate-, high-, and very-high-risk groups (p=0.881, C-index 0.53). Recurrence-free survival (RFS) showed borderline discrimination in the induction-only group (p=0.068, C-index 0.61) and non-significant trends in the adequate BCG group (p=0.148, C-index 0.56). The 5-year progression probability for VHR-NMIBC patients with adequate BCG was considerably lower than previously reported for intravesical chemotherapy or induction-only BCG regimens. These findings suggest that adequate BCG therapy may mitigate the risk of progression in VHR-NMIBC, potentially reducing the need for immediate radical cystectomy. Further studies are warranted, potentially incorporating molecular profiling and circulating tumour DNA status.