Abstract
ObjectivesWith the advent of novel genomic and transcriptomic technologies, new urinary biomarkers have been identified and tested for bladder cancer (BCa) surveillance. To summarize the current status of urinary biomarkers for the detection of recurrence and/or progression in the follow-up of non-muscle invasive BCa patients, and to assess the value of urinary biomarkers in predicting response to intravesical Bacillus Calmette–Guerin (BCG) therapy.Methods and materialsA medline/pubmed© literature search was performed. The performance of commercially available and investigational biomarkers has been reviewed. End points were cancer detection (recurrence), cancer progression, and response to BCG therapy.ResultsThe performance requirements for biomarkers are variable according to the clinical scenario. The clinical role of urinary biomarkers in the follow-up of non-muscle invasive BCa patients remains undefined. The FDA-approved tests provide unsatisfactory sensitivity and specificity levels and their use is limited. Fluorescence in situ hybridization (FISH) has been shown to be useful in specific scenarios, mostly as a reflex test and in the setting of equivocal urinary cytology. FISH and immunocytology could conceivably be used to assess BCG response. Recently developed biomarkers have shown promising results; upcoming large trials will test their utility in specific clinical scenarios in a manner similar to a phased drug development strategy.ConclusionsCurrent commercially available urinary biomarker-based tests are not sufficiently validated to be widely used in clinical practice. Several novel biomarkers are currently under investigation. Prospective multicenter analyses will be needed to establish their clinical relevance and value.
Highlights
Bladder cancer (BCa) has the highest lifetime cost per patient of all cancers [1]
The most used urinary test, cytology, suffers from insufficient reproducibility and robustness to suffice for utility in various clinical scenarios such as surveillance of the most common type of BCa [5, 6]
A medline/pubmed© literature search was performed with different combinations of the terms “urinary biomarker”, “bladder cancer”, “superficial bladder cancer”, “non-muscle invasive bladder cancer”, “surveillance”, “follow-up”, “performance”, and “Bacillus Calmette–Guerin (BCG) response”
Summary
Bladder cancer (BCa) has the highest lifetime cost per patient of all cancers [1]. This is mainly due to the high recurrence rate and the consequent need for close, long-term follow-up based on the patient’s risk profile. The most used urinary test, cytology, suffers from insufficient reproducibility and robustness to suffice for utility in various clinical scenarios such as surveillance of the most common type of BCa (low-grade NMIBC) [5, 6]. Urinary biomarkers in the surveillance setting have three aims: to reduce the frequency of invasive testing while still detecting early disease recurrence (Rec), to exclude the presence of recurrent disease and to detect progression (Prog) in non-muscle invasive bladder cancer (NMIBC) patients and predicting response to therapies [9]
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