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Back to the future in bladder cancer research

The ultimate objective of clinical proteomics is clinical implementation and patient benefit through efficient (early) disease detection, diagnosis, stratification, selection of therapeutic intervention and monitoring of treatment effectiveness. The clinical needs differ widely between diseases, depending, for example, on the prevalence and existence of gold standards for diagnosis, prognosis and therapy. In the case of bladder cancer (BC), which will be employed as a paradigm in this discussion, the low prevalence of the disease diminishes the need for, and expected clinical impact of, markers for screening the entire population. In addition, the low prevalence mandates a very high specificity, not likely to be easily reached. By contrast, the very high recurrence rate and associated death with metastatic disease render the identification of markers for surveillance and stratification of tumors key clinical needs in this area [1,2]. There has been a vast effort in the discovery of biomarkers for BC over the past decades. Reflective of the resources and effort devoted in this research area, a medline search using the key words ‘breast cancer and protein marker’ lists 1880 publications for the last decade alone (3154 for the last two decades); this number increases to 2560 when using the key words ‘breast cancer and marker’ (4280 in the last 20 years). It becomes evident that all levels of molecular control in the cell have been rigorously investigated for alterations associated with BC, including chromosomal and gene alterations, including epigenetic changes, and transcriptome, proteome/peptidome and metabolome alterations [3,4]. As a result, significant information has been collected, which has increased our understanding of the biology of the disease and pinpointed to a plethora of putative biomarkers. A limited number of noninvasive diagnostic biomarkers have received approval from regulatory agencies (e.g., the US FDA) to be employed as adjuncts to the current gold standard diagnostic modalities (i.e., cystoscopy and urine cytology) [5].