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The paper by reports the potential application of a urinary biomarker panel that would be able to determine clinical decision-making to safely avoid radical cystectomy in muscle-invasive urothelial cancer. This test indicates preliminary promise and represents a step in the right direction.

The clinical implications are remarkable as avoiding cystectomy without compromising cancer control is likely to have a hugely positive impact on the quality of life of at least 30-40% of patients with muscle-invasive bladder cancer who have achieved complete remission (CR) with systemic therapy.

The rate of pathologic CR is also improving with the advent of systemic therapy. The recently reported NIAGARA study demonstrated a 48% pathologic CR when neoadjuvant chemo and immunotherapy (cisplatin + gemcitabine + durvalumab) combination was used in muscle-invasive bladder cancer. This regimen will likely become the new standard of care and a biomarker that can help avoid radical cystectomy will impact a larger magnitude of patients.

The urine test demonstrated that the sensitivity, specificity, positive predictive value, and negative predictive value (NPV) were 91%, 50%, 86%, and 63%, respectively, in predicting pathologic CR at radical cystectomy.

The results are promising, but are not ready for clinical application, especially given the low NPV. Combination with imaging and detailed cystoscopy evaluation can enhance the results. Currently, the biomarker is not capable of distinguishing Tis or T1 disease from residual T2. Combining with techniques such as bi/multiparametric magnetic resonance imaging will improve the performance of the urine biopsy test.

The cancer preventive effect of radical cystectomy also should not be underestimated, and patient counseling regarding surveillance for recurrent bladder tumors based on "field cancerization" effect would be advisable.

To summarize: The urine biopsy holds promise as a test to predict the ability to safely avoid radical cystectomy. Further investigation with streamlining the test, combining with imaging and evaluation in larger sample size, is needed before clinical application.

Ulka Vaishampayan, MD, is the Beverly Mitchell MD Research Professor of Medicine, Ambulatory Clinical Chief (Hem/Onc), Director of the MET (Phase I ) team, and Co-Leader of the Translational Clinical Research Program at Rogel Cancer Center of the University of Michigan in Ann Arbor.

Read the study here and an interview about it here.