Multicenter evaluation of the role of UroVysion FISH assay in surveillance of patients with bladder cancer: does FISH positivity anticipate recurrence?

Abstract

Patients with a positive FISH and atypical cytology are more likely to recur even in the absence of visible tumor. FISH positivity may portend a higher risk for progression. These findings require prospective validation.

The value of the UroVysion® FISH assay in the risk‐stratification of patients with “atypical urothelial cells” in urinary cytology specimens

“…9,38 With the exception of a recently published small study of cases reclassified as "AUC" according to the Paris System criteria 67 that found that the sensitivity and specificity of U-FISH for predicting urothelial carcinoma were only 85.7% and respectively 33.3%, no previous study was designed to specifically address the value of U-FISH tests in patients with a diagnosis of AUC. 9,38 With the exception of a recently published small study of cases reclassified as "AUC" according to the Paris System criteria 67 that found that the sensitivity and specificity of U-FISH for predicting urothelial carcinoma were only 85.7% and respectively 33.3%, no previous study was designed to specifically address the value of U-FISH tests in patients with a diagnosis of AUC.…”

“…12 However, since the U-FISH test positivity can precede ("anticipate") the UC diagnosis by 30 months 37 or even more 38 we used extended follow-up periods of 18 and 36 months to determine if there is any improvement of the U-FISH test performance with longer follow-up intervals. This follow-up period was selected to allow accrual of follow-up data on both high risk and low risk patients, and to account for "anticipatory" positive results, i.e., positive U-FISH tests that are initially considered falsepositive as they precede a diagnosis of UC, but which frequently become true positive within 12 months of the index U-FISH test.…”

“…This follow-up period was selected to allow accrual of follow-up data on both high risk and low risk patients, and to account for "anticipatory" positive results, i.e., positive U-FISH tests that are initially considered falsepositive as they precede a diagnosis of UC, but which frequently become true positive within 12 months of the index U-FISH test. 12 However, since the U-FISH test positivity can precede ("anticipate") the UC diagnosis by 30 months 37 or even more 38 we used extended follow-up periods of 18 and 36 months to determine if there is any improvement of the U-FISH test performance with longer follow-up intervals.…”

An up-to-date catalog of available urinary biomarkers for the surveillance of non-muscle invasive bladder cancer

“…Patients with a positive cytology are usually taken to the operating room for a biopsy and selective upper tract cytology, but that is not the case for positive markers. The concept of anticipatory positives is based on the concern that a marker can detect disease before it is visualized, but it is still not clear if this is clinically useful information [15]. …”

“…Seideman et al investigated the role of FISH in patients with previous BCa who presented at follow-up with both negative cytology and cystoscopy. In such cases, FISH was able to anticipate disease Rec at a median follow-up of 26 months; mean time to Rec was 12.6 months in patients who were FISH positive compared to 17.9 months in those with negative FISH ( p  = 0.03) [15]. …”