Combined morphologic and fluorescence in situ hybridization analysis of voided urine samples for the detection and follow‐up of bladder cancer in patients with benign urine cytology

• Published in: Cancer Vol. 111; no. 6; pp. 517 - 524
• Main Authors: Daniely, Michal, Rona, Roni, Kaplan, Tal, Olsfanger, Shirley, Elboim, Lea, Freiberger, Avner, Lew, Sylvia, Leibovitch, Ilan
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 25.12.2007; Wiley-Liss
• Subjects: automatic scanning system; Biological and medical sciences; bladder cancer; combined analysis; Cytodiagnosis; cytology; Female; fluorescence in situ hybridization (FISH); Follow-Up Studies; Humans; In Situ Hybridization, Fluorescence; Male; Medical sciences; Neoplasm Recurrence, Local - diagnosis; Nephrology. Urinary tract diseases; Sensitivity and Specificity; transitional cell carcinoma (TCC); Tumors; Tumors of the urinary system; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - urine; Urinary tract. Prostate gland; Urine - cytology; Human; Urine; Relapse; Urinary system disease; Patient follow-up; fluorescence in situ hybridization (FISH); Cytology; combined analysis; Urinary tract disease; Malignant tumor; Bladder cancer; Baldder transitional cell carcinoma; Urology; automatic scanning system; transitional cell carcinoma (TCC); Cancerology; Fluorescence in situ hybridization; Automatic system; Cytopathology; Bladder disease; Diagnosis; Molecular biology; Cancer
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.23119

BACKGROUND. Bladder cancer is among the 5 most common malignancies worldwide. Patients with bladder cancer are closely followed with periodic cystoscopies and urine cytology analyses due to the significant risk of tumor recurrence. The UroVysion fluorescence in situ hybridization (FISH) test demonstrated higher sensitivity over urine cytology in detecting bladder cancer by most comparative studies. METHODS. In the current study, the diagnostic usefulness of a combined cytology and FISH analysis approach was tested using the Duet automatic scanning system in patients with benign urine cytology who were being monitored for recurrent urothelial carcinoma or being assessed for various urologic symptoms. RESULTS. By combining the benefits of conventional cytology with molecular diagnostics, a more sensitive detection of bladder cancer was attained. All patients who had positive cystoscopy concomitantly with urine sampling were detected by combined analysis. Additional patients that developed transitional cell carcinoma during a follow‐up period of 24 months had a previous positive result on combined analysis. Only 2 patients with a negative combined analysis result presented with late disease recurrence (20 months and 22 months, respectively, after the negative test). Therefore, negative combined analysis was found to be predictive of a lack of disease recurrence for at least 12 months. In this timeframe, the overall sensitivity, specificity, negative predictive value (NPV), and positive predictive values of the combined analysis test were 100%, 65%, 100%, and 44%, respectively. CONCLUSIONS. Given the absolute sensitivity and NPV of the combined analysis test, the management of patients with a negative combined analysis result might be revised and allow for more flexible assessment and management of bladder cancer patients relying more on urine bound tests. Cancer (Cancer Cytopathol) 2007. © 2007 American Cancer Society. The combination of morphologic evaluation followed by fluorescence in situ hybridization allows for the highly sensitive detection of cancerous cells in voided urine samples. The absolute negative predictive value of this test might influence the management of patients with negative combined analysis results.