The role of BTA stat Test in follow-up of patients with bladder cancer: results from FinnBladder studies.

OBJECTIVES

To summarize the results of the FinnBladder studies of the BTA stat Test in follow-up of bladder cancer and more importantly to provide guidelines for daily clinical practise.

METHODS

Voided urine samples of 501 patients were obtained prior to cystoscopy and split for culture, cytology and BTA stat testing. The overall sensitivity and specificity for the BTA stat Test were calculated, factors interfering with testing and the role of false positive test result were evaluated.

RESULTS

Out of 501 patients 133 (26.5%) had a bladder cancer recurrence at cystoscopy, of which BTA stat Test detected 71 (53.4%). In the remaining 368 patients, 96 (26.1%) had a positive BTA stat Test result. An additional 9 (16.4%) recurrences were detected at further examinations. The overall sensitivities and specificities for the BTA stat Test and cytology were 56.0, 19.2 and 85.7%, and 98.3%, respectively. Urine infection and past BCG instillations and present instillations of any type caused false positive test result. Out of 79 patients with positive BTA stat Test and negative cystoscopy, 6 (7.6%) had recurrence at next scheduled follow-up cystoscopy.

CONCLUSIONS

Although BTA stat Test cannot replace cystoscopy in the follow-up of patients with bladder cancer, it could replace routine cytology especially in patients with low-grade disease. Test should not be used in patients with urine infection, in those having received BCG, or in those with present instillation of any type. In case of positive test result but negative cystoscopy, urine cytology should be obtained as the first line examination. Positive cytology is the indication for further examinations, whereas patients with negative cytology might wait until the next scheduled cystoscopy.