Cytokeratin-20 immunocytology in voided urine exhibits greater sensitivity and reliability than standard cytology in the diagnosis of transitional cell carcinoma of the bladder

• Published in: Urology (Ridgewood, N.J.) Vol. 66; no. 3; pp. 536 - 541
• Main Authors: Melissourgos, Nikolaos D., Kastrinakis, Nikolaos G., Skolarikos, Andreas, Pappa, Maria, Vassilakis, Georgios, Gorgoulis, Vassilis G., Salla, Charitini
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2005; Elsevier Science
• Subjects: Biological and medical sciences; Biomarkers, Tumor; Carcinoma, Transitional Cell - pathology; Female; Humans; Intermediate Filament Proteins; Keratin-20; Male; Medical sciences; Nephrology. Urinary tract diseases; Reproducibility of Results; Sensitivity and Specificity; Tumors of the urinary system; Urinary Bladder Neoplasms - pathology; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urine; Nephrology; Urinary system disease; Cytology; Standard; Tumoral marker; Malignant tumor; Urinary tract disease; Baldder transitional cell carcinoma; Standards; Urology; Sensitivity; Bladder disease; Diagnosis; Cytokeratin 20; Reliability
• ISSN: 0090-4295; 1527-9995; 1527-9995
• DOI: 10.1016/j.urology.2005.04.022

To investigate whether immunocytochemical detection of cytokeratin (CK)-20 could serve as a reliable diagnostic marker for transitional cell carcinoma (TCC) of the bladder. A total of 232 patients were enrolled in the study. Group 1 consisted of 144 patients with histologically confirmed TCC (62 at diagnosis and 82 in follow-up), and group 2 consisted of 88 subjects, including healthy volunteers and individuals with “non-TCC” conditions. Spontaneously voided urine specimens were obtained from each patient and submitted to immunocytologic and standard cytologic examination. CK-20 immunocytology yielded an overall sensitivity of 65.3%, significantly greater than the sensitivity of urine cytology (54.2%, P = 0.013). A more detailed analysis revealed a sensitivity advantage for the former technique in the detection of primary (61.3% versus 51.6%, P = 0.046), recurrent (68.3% versus 56.1%, P = 0.027), Stage pT1 (81.8% versus 59.1%, P = 0.006), grade 2 (76.2% versus 61.9%, P = 0.031), and grade 3 (82.1% versus 67.9%, P = 0.039) tumors. Moreover, CK-20 immunocytochemistry demonstrated greater overall specificity than cytology (90.9% versus 86.4%, respectively), a difference stemming from the subgroup of lithiasis patients (100% versus 66.7%, P = 0.024). In terms of reliability, the positive and negative predictive values of the immunoassay were greater than those calculated for cytology (92.2% versus 86.7% and 61.5% versus 53.5%, respectively). CK-20 immunocytology is more sensitive than standard cytology in the detection of TCC, particularly of Stage pT1, grade 2, and grade 3 tumors. In view of its high overall specificity and predictive accuracy, it is conceivable that the proposed immunoassay may progressively replace conventional cytologic screening in the diagnosis of bladder cancer.