A retrospective multicenter study developed a risk model to predict BCG-unresponsive disease or progression to muscle-invasive/metastatic cancer in 2,211 BCG-naïve patients with high-grade Ta/T1 NMIBC (±CIS) who received adequate BCG therapy across 13 academic centers (2003–2024).
Five independent risk factors were identified: T1 stage (aHR 1.52), persistent HG/T1 tumor at restaging TURBT (aHR 2.51), multifocality (aHR 1.46), concomitant CIS (aHR 1.46), and WHO HG/grade 3 (aHR 1.56). The model outperformed EORTC and EAU 2021 stratification (C-index 0.68 vs 0.61 vs 0.56); 5-year BCG-unresponsive-free survival ranged from 88% (lowest risk) to 49% (highest risk).
Retrospective design with inherent selection bias; internal validation only (no external cohort validation); BCG strain and dosing heterogeneity across 13 centers not fully accounted for.
Use this five-factor risk score (T1 stage, persistent tumor at restaging TURBT, multifocality, CIS, HG/grade 3) to stratify HG NMIBC patients before BCG and identify those at highest risk of BCG failure early, supporting timely discussions about intensified surveillance or early cystectomy referral.
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