Bladder Cancer Tissue-Based Biomarkers

  • Francesco Soria
  • Marta Sanchez-Carbayo
  • Natalya Benderska-Söder
  • Bernd J Schmidz-Dräger
  • Stefania Zamboni
  • Marco Moschini
  • Anirban P Mitra
  • Yair Lotan
Keywords: bladder cancer; tissue-based biomarkers; prognosis; prediction; immunotherapy


This consensus aimed to provide a practical update regarding the current role of tissue-based biomarkers in bladder cancer. Their prognostic and predictive role both in non-muscle-invasive (NMIBC) and in muscle-invasive disease (MIBC) has been reviewed with particular focus to their use in clinical practice.

In summary, literature information about the prediction of disease recurrence in NMIBC is inconclusive, and even less data is available for prediction of response to intravesical BCG. Concerning disease progression, external prospective validation studies suggest that mutational FGFR3 status and gene signatures may improve models based on clinico-pathologic information.

In MIBC, tissue-based biomarkers are increasing their importance since they may predict the response to systemic chemotherapy and immunotherapy. In particular, the advent of molecular characterization carries the promise to revolutionize the paradigm of decision-making in the treatment of MIBC. Molecular subtyping has shown to be able to improve the prediction of pathological stage at RC and to predict the response to systemic chemotherapy and immunotherapy. However, external and prospective validations are warranted to confirm these preliminary findings.

Several different tissue-based biomarkers such as PD-1/PD-L1 expression, tumor mutational burden, and the analysis of tumor microenvironment may, in the future, play a role in selecting patients for systemic immunotherapy. However, to date, no pretreatment recommendations can be definitively made based on any molecular predictors.

In conclusion, despite their promising role, the use of tissue-based biomarkers in bladder cancer should be limited to experimental settings.

How to Cite
Soria, F., Sanchez-Carbayo, M., Benderska-Söder , N., Schmidz-Dräger, B. J., Zamboni, S., Moschini, M., Mitra, A. P., & Lotan, Y. (2021). Bladder Cancer Tissue-Based Biomarkers. Société Internationale d’Urologie Journal, 2(1), 53-71. Retrieved from
Molecular Biomarkers in Urologic Oncology