Introduction
Patients and methods
Study design
Statistical analysis
Results
N | % | Negative results in both tests (n = 214) | Positive result in one of the tests (n = 91) | Positive results in both tests (n = 21) | ||||
---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | |||
Male | 281 | 86.2 | 184 | 86.0 | 80 | 87.9 | 17 | 81.0 |
Female | 45 | 13.8 | 30 | 14.0 | 11 | 12.1 | 4 | 19.0 |
Age, years | ||||||||
Median (range) | 71 (26–91) | 70 (26–90) | 72 (40–91) | 69 (40–85) | ||||
History of bladder cancer | ||||||||
Primary | 226 | 69.3 | 151 | 70.6 | 61 | 67.8 | 14 | 66.7 |
Recurrent | 100 | 30.7 | 63 | 29.4 | 30 | 32.2 | 7 | 33.3 |
No. of lesions | ||||||||
Single | 151 | 46.3 | 97 | 45.3 | 44 | 48.3 | 10 | 47.6 |
Multiple | 136 | 41.7 | 90 | 42.1 | 41 | 45.1 | 5 | 23.8 |
Cannot be evaluated | 39 | 12.0 | 27 | 12.6 | 6 | 6.6 | 6 | 28.6 |
Gradea | ||||||||
Low grade | 138 | 41.9 | 97 | 45.3 | 30 | 33.0 | 11 | 52.4 |
High grade | 141 | 44.0 | 90 | 42.1 | 44 | 48.3 | 7 | 33.3 |
Cannot be evaluated | 47 | 14.1 | 27 | 12.6 | 17 | 18.7 | 3 | 14.3 |
TNM stage | ||||||||
Ta | 192 | 58.9 | 129 | 60.3 | 48 | 52.7 | 15 | 71.4 |
T1 | 104 | 31.9 | 68 | 31.8 | 33 | 36.3 | 3 | 14.3 |
Tis | 23 | 7.1 | 14 | 6.5 | 6 | 6.6 | 3 | 14.3 |
Cannot be evaluated | 7 | 2.1 | 3 | 1.4 | 4 | 4.4 | 0 | 0 |
Presence of CIS | ||||||||
No | 255 | 78.2 | 168 | 78.5 | 70 | 76.9 | 17 | 81.0 |
Yes | 71 | 21.8 | 46 | 21.5 | 21 | 23.1 | 4 | 19.0 |
Smoking | ||||||||
Current | 60 | 18.4 | 39 | 18.2 | 17 | 18.7 | 4 | 19.1 |
Former | 112 | 34.4 | 71 | 33.2 | 31 | 34.0 | 10 | 47.6 |
Never | 91 | 27.9 | 62 | 29.0 | 24 | 26.4 | 5 | 23.8 |
Unknown | 63 | 29.3 | 42 | 19.6 | 19 | 20.9 | 2 | 9.5 |
Total | Negative results in both tests | Positive result in one of the tests | Positive results in both tests | |
---|---|---|---|---|
No. of patients | 326 | 214 | 91 | 21 |
No. of recurrences (%) | 40 (12.3) | 18 (8.4) | 15 (16.5) | 7 (33.3) |
TNM stage, Grade (%) | ||||
Ta low | 20 (50) | 9 (50) | 8 (53.3) | 3 (42.9) |
Ta high/T1/Tis | 15 (37.5) | 8 (44.4) | 4 (26.7) | 3 (42.9) |
T2 or greater | 3 (7.5) | 1 (5.6) | 1 (0.7) | 1 (14.2) |
Cannot be evaluated | 2 (5) | 0 | 2 (1.3) | 0 |
Variable (n) | Number of patients | Univariate | Multivariate | ||
---|---|---|---|---|---|
HR (95% CI) | P value* | HR (95% CI) | P value* | ||
Age, years | |||||
< 70 | 160 | 1 (reference) | 0.5422 | ||
71 < | 166 | 0.824(0.437–1.53) | |||
Sex | |||||
Female | 45 | 1 (reference) | 0.166 | ||
Male | 281 | 2.10 (0.758–8.71) | |||
History of bladder cancer | |||||
Primary | 226 | 1 (reference) | 0.00250 | 1 (reference) | 0.0069 |
Recurrent | 100 | 2.63 (1.41–4.94) | 2.39 (1.27–4.51) | ||
No. of lesions | |||||
Single | 151 | 1 (reference) | 0.0650 | ||
Multiple | 136 | 1.87 (0.926–3.94) | |||
T stage | |||||
Ta | 192 | 1 (reference) | 1 (reference) | ||
T1 | 104 | 0.502 (0.200–1.11) | 0.0899 | 0.566 (0.224–1.26) | 0.1708 |
Tis | 23 | 2.57 (1.02–5.70) | 0.0459 | 2.16 (0.848–4.82) | 0.1012 |
Grade | |||||
Low | 138 | 1 (reference) | 0.214 | ||
High | 141 | 0.809 (0.389–1.67) | |||
Presence of CIS | |||||
No | 255 | 1 (reference) | 0.346 | ||
Yes | 71 | 1.41 (0.674–2.74) | |||
Postoperative intravesical therapy | |||||
No | 97 | 1 (reference) | 0.866 | ||
BCG | 116 | 0.831 (0.376–1.85) | |||
Chemotherapy | 113 | 0.990 (0.463–2.16) | |||
Smoking | |||||
Never | 91 | 1 (reference) | 0.640 | ||
Former | 112 | 1.34 (0.608–3.08) | |||
Current | 60 | 1.39 (0.554–3.46) | |||
Combination of two consecutive analyses of UroVysion tests | |||||
Negative results in both tests | 214 | 1 (reference) | 1 (reference) | ||
Positive result in one of the tests | 91 | 2.02 (1.00–4.02) | 0.0488 | 2.06 (1.01–4.13) | 0.0467 |
Positive results in both tests | 21 | 4.71 (1.83–10.8) | 0.0024 | 4.15 (1.59–9.65) | 0.0051 |