uCyt+ test: alternative to cystoscopy for less-invasive follow-up of patients with low risk of urothelial carcinoma.

OBJECTIVES

To assess the utility of ImmunoCyt/uCyt+ in combination with cytology to reduce the number and cost of cystoscopies in the follow-up of patients with urothelial cancer of the bladder.

METHODS

A total of 216 patients under follow-up after transurethral resection of the bladder for urothelial cancer were enrolled in the present study. The mean follow-up time was 26 months (range 3 to 96). Patients were tested for bladder cancer with ImmunoCyt/uCyt+, urinary cytology, and cystoscopy every 3 months. All patients with positive cystoscopy results for recurrence or suspect areas underwent transurethral resection of the bladder. Cystoscopy was considered the reference standard to establish the bladder tumor diagnosis. The patients were divided into low, intermediate, and high risk groups for progression according to the European Association of Urology criteria.

RESULTS

A total of 195 patients were suitable for evaluation. The urine samples from 21 patients were considered not evaluable for ImmunoCyt/uCyt+, and those patients were excluded from the study. Of all the control patients, 69.7% had negative cystoscopy findings. In the low-risk group, 84 patients underwent 131 cystoscopies, which diagnosed 30 Stage pTaG1 recurrences but no progression. Cytology and ImmunoCyt/uCyt+ together had a sensitivity of 86.6% and a negative predictive value of 95.2%.

CONCLUSIONS

Of the cystoscopies performed during the 26 months of follow-up, 69.7% were negative. In the low-risk group, 30 Stage pTaG1 tumors and no progression was detected at a total cost of 14,672 Euros (USD 17,606). ImmunoCyt/uCyt+ and cytology every 6 months combined with annual cystoscopy reduced the morbidity and cost of follow-up in this group.