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Risk Stratification in Non-Muscle-Invasive Bladder Cancer in the Era of Expanding Therapeutic Options: Are Current
Igor Duquesne1, Mohamad Abou Chakra2, Alexandre de la Taille1
1Department of Urology, Centre Hospitalier Universitaire Henri Mondor, Créteil, France.
Background:
NMIBC risk classifications from AFU, EAU, AUA/SUO and NCCN were derived decades ago to estimate recurrence and progression, but the therapeutic landscape has since expanded, gene therapy, an IL-15 superagonist, systemic immunotherapy, and BCG-combination regimens, raising the question of whether these classifications remain adequate to guide treatment selection.
Objective:
To determine whether contemporary NMIBC risk classifications remain adequate for treatment selection, or function as prognostic instruments applied beyond their original purpose.
Data Sources:
PubMed/MEDLINE, AFU/EAU/AUA-SUO/NCCN guideline portals, FDA/EMA databases, and ClinicalTrials.gov, searched from January 2000 to August 2026.
Study Selection:
Narrative review prioritizing original derivation and validation studies of risk models, pivotal randomized trials, and current guideline texts over secondary or conference-only sources, flagged as such throughout.
Results:
AFU, EAU, AUA/SUO and NCCN diverge architecturally, producing discordant classifications for identical patients, most sharply for low-burden Ta high-grade disease and T1 disease with concomitant CIS. Four agents now hold FDA approval for BCG-unresponsive disease, and two of three recent phase III trials in BCG-naive high-risk disease (CREST, POTOMAC) were positive, but eligibility depends on treatment-exposure definitions outside baseline risk labels; real-world adherence to adequate BCG is below 50%. MRI/VI-RADS shows strong accuracy for muscle invasion but remains unvalidated for risk stratification. We propose a seven-axis, treatment-oriented framework, reassessed at clinical checkpoints, illustrated with two worked examples.
Limitations:
Narrative, not systematic, review; some evidence is conference-sourced pending peer-reviewed publication, and the framework is not yet validated.
Conclusion:
Current classifications remain necessary but insufficient alone; treatment selection increasingly requires a dynamic, multi-axial framework reassessed at defined checkpoints rather than fixed at diagnosis.
