METHODS.
The authors used a polymerase chain reaction (PCR)-based telomeric repeat amplification protocol (TRAP) assay to determine the presence of te-Department of Urology, Mount Sinai School of lomerase activity in voided urine samples from patients with known but yet un-Medicine, New York, New York.
treated bladder carcinoma (n ร
104) and from patients with hematuria of benign causes (n ร
47). For 88 of the patients with bladder carcinoma, cytology was determined independently of the telomerase results or the pathology findings.
RESULTS.
Of the 104 bladder carcinoma specimens, 88 (85%) tested positive for the presence of telomerase. Seventy-nine percent (23 of 29) of the Grade 1 tumors, 84% (32 of 38) of the Grade 2 tumors, and 87.5% (28 of 32) of the Grade 3 tumors were positive for telomerase activity. Five patients with carcinoma in situ (100%) were also positive. Telomerase activity was not found in 31 of 47 patients with bladder calculi, benign urethral stricture, benign prostatic hyperplasia, or inflammation. In the 16 patients (34%) who did have a false-positive result when tested for telomerase, all had either chronic or severe inflammation, including 1 patient with an inverted papilloma, 1 patient with cystitis cystica, and 1 patient with cystitis glandularis. However, for 35 normal, healthy volunteers whose voided urine samples were also assayed for the presence of telomerase activity, none was found.
By comparison, only 51% (45 of 88) of the cytology samples from patients with bladder carcinoma yielded positive findings, whereas 49% (43 of 88) resulted in false-negative readings for tumors. Only 13% (3 of 23) of the Grade 1 tumors, 44% (14 of 32) of the Grade 2 tumors, and 82% (23 of 28) of the Grade 3 tumors were diagnosed by cytology. All five patients with carcinoma in situ were positive for cytology as well as for telomerase activity. When cytology was compared with the Preliminary data for this article was presented PCR-based telomerase assay in determining the presence of bladder carcinoma, in abstract form during the 1997 Annual Meetthe difference in the overall detection rates (85% for telomerase vs. 51% for cytoling of the American Urological Association.
ogy) was significant (P รต 0.001). Furthermore, when telomerase activity was compared with cytology for low grade lesions (Grades 1 and 2), the difference in the The authors acknowledge the technical assisdetection rates (82% for telomerase vs. 31% for cytology) was also significant tance of Wei-Ping Shu, which involved running (P รต 0.001). some of the initial telomerase assays.
CONCLUSIONS.
Urinary cytology yields poor results for low grade tumors. This