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Bladder and Urothelial Cancer Treatments / Data Driven Disease Surveillance · Review
Molecular Oncology · September 7, 2026
A consensus or society position rather than new primary data.
This systematic review of 72 studies identifies a broad array of potential tissue and liquid biomarkers (particularly p53, Ki-67, pRB, and immunological markers) for predicting BCG failure in high-risk NMIBC, but finds insufficient validation and methodological rigour in the existing literature. No single biomarker or combination has achieved clinical translation; the field remains exploratory, with substantial gaps in reproducibility and feasibility across included studies.
Systematic review. Studies of non-muscle invasive bladder cancer patients receiving BCG therapy, examining non-invasive biomarkers for prediction or prognosis of therapy failure. Intervention: Non-invasive biomarker assessment (tissue and liquid biopsy-derived markers including p53, Ki-67, pRB, and immunological markers).
High-risk NMIBC recurrence rate despite BCG therapy: 30–40% of patients 72 studies included: 58 focused on prognostic markers, 6 on predictive markers, 8 examined both 55 studies examined tissue biomarkers; 28 studied liquid biopsy-derived biomarkers
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Clinicians should be aware that biomarkers to predict BCG failure remain investigational and lack sufficient validation for routine clinical use. Current evidence does not support adoption of any single biomarker or panel for treatment selection in NMIBC, and future research must prioritize reproducibility, standardization, and adequately powered prospective studies.
A systematic review synthesizing evidence on biomarkers for BCG therapy prediction in bladder cancer; provides a landscape assessment rather than a new empirical result, identifying gaps and promising directions for clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should be aware that biomarkers to predict BCG failure remain investigational and lack sufficient validation for routine clinical use. Current evidence does not support adoption of any single biomarker or panel for treatment selection in NMIBC, and future research must prioritize reproducibility, standardization, and adequately powered prospective studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
High-risk non-muscle invasive bladder cancer (NMIBC) is a common urological malignancy with a high propensity for recurrence (30-40% of patients) despite treatment with Bacillus Calmette-Guérin (BCG) instillations. Identifying patients who are likely to respond or not to BCG therapy before treatment initiation may significantly improve patient outcomes and minimise unnecessary treatments. This systematic review critically assessed the existing literature on the potential of non-invasive biomarkers to predict BCG failure in NMIBC patients. A comprehensive bibliographic search on PubMed, Scopus and Medline databases was conducted to identify relevant studies published up to July 7, 2025. After a thorough screening and selection process, 72 studies were included in the final analysis, 58 of which focused on prognostic markers, 6 on predictive markers, and 8 examined both. Moreover, 55 studies focused on tissue, while 28 studied liquid biopsy-derived biomarkers, showcasing their ability to reflect the dynamic characteristics of the tumour and its microenvironment. The most frequently studied biomarkers comprised p53, Ki-67 and pRB. Furthermore, several immunological markers were also explored, highlighting the current challenge of BCG therapy prediction biomarkers. Despite its valuable insights, this systematic review faced limitations within the included studies, such as issues related to reproducibility, feasibility, and small sample sizes. Nonetheless, the findings indicate that a wide array of molecules show potential as prognostic and/or predictive markers for BCG failure, which may improve the clinical management of this complex disease.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.