Comparative investigation of several commercial test systems for bladder cancer diagnostics in actual clinical practice

Apolihin O.I., Sivkov A.V., Roschin D.A., Perepechin D.V., Loschilov Yu.A., Nikonova L.M., Kasatonova E.V., Polozhenceva M.O.

A constant upwards trend is observed in Russian federation with regard to the bladder cancer (BCA) incidence. Early diagnostics plays a crucial role for the treatment efficacy. Biomarkers are contemporary used for diagnostics with some substances considered to be feasible for this application (tumor antigens, proliferation, adhesion and angiogenesis markers, etc.) More than 10 test systems were integrated in the clinic, which were more effective than urine cytology (UC), but nevertheless had some limitations. Thus, hematuria and inflammation are often leading to false positives.

This study concentrated at the comparison of four test systems (UBC, BTA, NMP-22, CYFRA 21-1) for BCA diagnostics with conventional bladder ultrasound and UC. Sensitivity and specificity were following: UBC (ICA) – 62.2% and 57.8%, UBC (IFA) – 64.4% and 57.8%, BTA (ICA) – 68.9% and 55.6%, BTA (IFA) – 73.3% and 57.8%, NMP-22 – 48.9% and 68.9%, CYFRA 21-1 – 21.4% and 84.4%, UC – 20.5% and 93.3%, ultrasound – 91.1% and 86.7%.

Two control groups were used: urothelial chronical inflammation patients and healthy volunteers. Chronic inflammation group presented with false positives at the rate of: UBC (ICA) – 80%; UBC (IFA) – 66.6%; BTA (ICA) – 96.7%; BTA (IFA) – 90%; NMP-22 – 30%.

It is important to state that ideal marker or set of the markers for BCA as alternative to UC are lacking. Different clinical factors could influence the sensitivity and specificity of these tests. One of the most important questions is whether if one or several markers could be used for the follow up of patients after transurethral resection due to non-muscle invasive cancer for recurrence control as alternative to cystoscopy.

Based on our data patients in the EAU good and intermediate risk groups could benefit from the combination of the markers and ultrasound as alternative to cystoscopy for recurrence control.

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