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High-risk non-muscle-invasive bladder cancer is notoriously difficult to treat. It recurs at an extremely high rate and can progress to muscle invasion and metastases. Radical cystectomy is curative in 80–85% of patients when offered in the early stages of the disease. However, many patients seek ...

High-risk non-muscle-invasive bladder cancer is notoriously difficult to treat. It recurs at an extremely high rate and can progress to muscle invasion and metastases. Radical cystectomy is curative in 80–85% of patients when offered in the early stages of the disease. However, many patients seek alternatives in an attempt to preserve their bladder, or simply have too many comorbidities and are therefore ineligible for cystectomy, which carries substantial morbidity and mortality. Non-surgical treatments for unresponsive high- risk non-muscle-invasive bladder cancer have been suboptimal, including repeated BCG induction and maintenance therapy and intravesical alternative chemotherapy. Until recently, only intravesical valrubicin had been approved by the US Food and Drug Administration (FDA) for use in patients with carcinoma in situ in whom BCG therapy had failed.

One issue that should be addressed in high-risk non-muscle-invasive bladder cancer studies is to obtain new efficacy drugs by high quality and precision patient-oriented studies. Consequently, well-designed single-arm phase 2–3 trials to compare novel therapies to pre-specified study endpoints and stratification of patients according to their molecular profile should be the standard for evolution of treatments for this disease.

Here we will present the most recent studies and evidence for bladder sparing treatment of patients with high-risk NMIBC. We will investigate the role of molecular markers in optimizing the adequate selection of patients for studies in order to not consume resources.

Topics of interest includes:
-The current status of art of the treatment for HR NMIBC
-Understanding BCG failure classification
-The current status of art of molecular biomarkers
-Immunologic landscape of microenvironment of NMIBC
-Therapies in pipeline (phase II/III) for HG-NMIBC
-New frontiers in urinary microbiota in NMIBC

Please note: manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.

Keywords: bladder cancer, therapy, BCG, new drugs, molecular biomarkers, high-risk NMIBC


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