The purpose of the study was to determine, in addition to well-known progno
stic factors, histological grade, stage, tumour size and multiplicity, the
correlation of BTA stat Test on disease free interval (DFI) on primary supe
rficial bladder cancer. A total of 116 patients with newly diagnosed bladde
r cancer were evaluated in a prospective multicentre study. A voided urine
sample was obtained prior to TURB and split for culture, cytology and BTA s
tat testing. Follow-up data for the patients were collected until the first
recurrence or the last visit and the DFI was analysed by Kaplan-Meier meth
od and Cox analysis. Ninety-seven of the 116 (83.6%) patients were eligible
for analysis. The BTA stat Test was positive in 73 (75.3%) patients, where
as cytology detected 20 (20.6%) cases. The DFI was found to be shorter amon
g patients with a positive BTA stat Test, and also among those with interme
diate or high-grade tumours, The BTA stat Test result divided patients with
grade 2 tumours into two prognostic groups, in that those testing positive
had 68.6% risk of recurrence during the first year compared to 42.9% risk
of those with a negative test result (P = 0.041). Although the effect of tu
mour size on DFI was notable, the difference did not reach statistical sign
ificance (P = 0.064). Number of tumours was not related to DFI, nor was the
difference between different stage of tumour of significance. BTA stat Tes
t is not only sensitive in detection of primary bladder cancer, but also mi
ght have some independent prognostic significance. (C) 2001 Cancer Research
Campaign.