of 1 /1
1974 CYTOKERATIN 20 IN URINE CELLS AND BLADDER CARCINOMA 12. Wheeless, L. L., Badalament, R. A., de Vere white, R. w., Fradet, Y. and Tribukait, B.: Consensus review of the clinical utility of DNA cytometry in bladder cancer. Report of the DNA Cytometry Consensus Conference. Cytometry, 14: 478, 1993. 13. Mao, L., Schoenberg, M. P., Scicchitano,M., Erozan, Y. S., Merlo, A., Schwab, D. and Sidransky, D.: Molecular detection of pri- mary bladder cancer by microsatellite analysis. Science, 271: 659, 1996. 14. Kaempfer, R., Gerez, L., Farbstein, H., Madar, L., Hirschman, 0.. Nussinovich, R. and Shapiro, A.: Prediction of response to treatment in superficial bladder carcinoma through pattern of interleukin-2 gene expression. J. Clin. Oncol., 14: 1778, 1996. 15. Yoshida, K., Sugino, T., Tahara, H., Woodman, A., Bolodeoku, J., Naigund, V., Fellows, G., Goodison, S., Tahara, E. and Tarin, D.: Telomerase activity in bladder carcinoma and its implica- tion for noninvasive diagnosis by detection of exfoliated cancer cells in urine. Cancer, 79 362, 1997. 16. Kamata, S., Kageyama, Y., Yonese, J. and Oshima, H.: Signifi- cant telomere reduction in human superficial transitional cell carcinoma. Brit. J. Urol., 78 704, 1996. 17. Bonner, R. B., Hemstreet, G. P., 111, Fradet, Y., Rao, J. Y., Min, K. W. and Hurst, R. E.: Bladder cancer risk assessment with quantitative fluorescence image analysis of tumor markers in exfoliated bladder cells. Cancer, 72 2461, 1993. 18. Amberson, J. B. and Laino, L. P.: Image cytometric deoxyribo- nucleic acid analysis of urine specimens as an adjunct to visual cytology in the detection of urothelial cell carcinoma. J. Urol., 149 42, 1993. EDITORIAL COMMENT The standard protocol for the detection of bladder cancer involves the use of cystoscopy. Although flexible cystoscopy has made evalu- ation somewhat more acceptable to patients, the technique remains invasive. Until recently urologists were limited to using cytology and flow cytometry as noninvasive methods in the detection of transi- tional cell carcinoma of the urinary tract. However, these assays were not adequately sensitive, particularly with tumors that were well or moderately differentiated. Novel tumor markers have been developed and some are now commercially available. These markers include the Matritech NMP-22* which measures a nuclear matrix protein, the BTA TRAKT assay which measures an antigen known as factor H, and the AuraTek FDP$ which is a qualitative measurement of fibrinogen and fibrinogen degradation products in urine assays. In addition, mark- * Matritech, Newton, Massachusetts. t Bard Diagnostics, Redmond, Washington. $ Intracel Corporation, Rockville, Maryland. ers are currently being investigated for potential clinical use.' me fundamental application of tumor markers is to identify the presence and absence of disease, predict disease progresslon and monitor therapeutic response. In this report it appears that CK-20 may be useful in the detection of bladder cancer in voided urine samples. Cytokeratins are major components of the intermediate fila- ments of epithelial cells and at least 20 different cytokeratins can be distinguished in human epithelia. They are differentially ex- pressed in specific epithelial cell types or specific pathways of epithelial differentiation. For example in the normal adult human prostate the basal layer can be labeled by antibodies that recog- nize cytokeratins 5 and 14. However, the secretory luminal cells are stained by antibodies specific for cytokeratins 8 and 18. Nu- merous studies have used differential cytokeratin expressions in studying the prostate in various disease states. Similarly, this study also identified a cytokeratin that may be expressed in malignant but not normal urothelial cells. For any tumor marker to be useful it must have a high sensitivity and specificity to detect the presence and absence of disease, predict disease recurrence and/or progression, and replace and/or add value to the existing management protocol. The CK-20 marker may have the capability of fulfilling some of these criteria. The data demon- strate that CK-20 had a sensitivity of 91% among 144 patients with bladder cancer. In 27 patients with symptoms that warranted blad- der biopsy but who subsequently demonstrated no evidence of cancer the specificitywas 74%.The false-positive finding (26%) in this group of patients is not of great concern since the symptoms appeared to be significant enough to warrant a bladder biopsy. Since the expression and/or detection of CK-20 did not appear to correlate with tumor grade, CK-20 may be useful in determining disease recurrence after transurethral resection of bladder cancer. However, additional infor- mation as to the expression of CK-20 in patients with intravesical therapy is required. The most likely immediate benefits to be gained from the use of molecular markers are to detect clinically occult disease and identify patients in whom the cystocopic interval can be prolonged. However, until multicenter trials are done with the same samples examined by different laboratories using an established set of standards to see if results are reproducible, it will be difficult to determine which mark- eds) is likely to provide useful data in a particular clinical situation. Brian C.-S. Liu Department of Urology Mount Sinai School of Medicine New York, New York 1. Grossman, H. B.: New methods for detection of bladder cancer. Sem. Urol. Oncol., 1 6 17, 1998.

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Page 1: EDITORIAL COMMENT

1974 CYTOKERATIN 20 IN URINE CELLS AND BLADDER CARCINOMA

12. Wheeless, L. L., Badalament, R. A., de Vere white, R. w., Fradet, Y. and Tribukait, B.: Consensus review of the clinical utility of DNA cytometry in bladder cancer. Report of the DNA Cytometry Consensus Conference. Cytometry, 14: 478, 1993.

13. Mao, L., Schoenberg, M. P., Scicchitano, M., Erozan, Y. S., Merlo, A., Schwab, D. and Sidransky, D.: Molecular detection of pri- mary bladder cancer by microsatellite analysis. Science, 271: 659, 1996.

14. Kaempfer, R., Gerez, L., Farbstein, H., Madar, L., Hirschman, 0.. Nussinovich, R. and Shapiro, A.: Prediction of response to treatment in superficial bladder carcinoma through pattern of interleukin-2 gene expression. J. Clin. Oncol., 14: 1778, 1996.

15. Yoshida, K., Sugino, T., Tahara, H., Woodman, A., Bolodeoku, J., Naigund, V., Fellows, G., Goodison, S., Tahara, E. and Tarin, D.: Telomerase activity in bladder carcinoma and its implica- tion for noninvasive diagnosis by detection of exfoliated cancer cells in urine. Cancer, 7 9 362, 1997.

16. Kamata, S., Kageyama, Y., Yonese, J. and Oshima, H.: Signifi- cant telomere reduction in human superficial transitional cell carcinoma. Brit. J. Urol., 7 8 704, 1996.

17. Bonner, R. B., Hemstreet, G. P., 111, Fradet, Y., Rao, J. Y., Min, K. W. and Hurst, R. E.: Bladder cancer risk assessment with quantitative fluorescence image analysis of tumor markers in exfoliated bladder cells. Cancer, 7 2 2461, 1993.

18. Amberson, J. B. and Laino, L. P.: Image cytometric deoxyribo- nucleic acid analysis of urine specimens as an adjunct to visual cytology in the detection of urothelial cell carcinoma. J. Urol., 149 42, 1993.

EDITORIAL COMMENT

The standard protocol for the detection of bladder cancer involves the use of cystoscopy. Although flexible cystoscopy has made evalu- ation somewhat more acceptable to patients, the technique remains invasive. Until recently urologists were limited to using cytology and flow cytometry as noninvasive methods in the detection of transi- tional cell carcinoma of the urinary tract. However, these assays were not adequately sensitive, particularly with tumors that were well or moderately differentiated.

Novel tumor markers have been developed and some are now commercially available. These markers include the Matritech NMP-22* which measures a nuclear matrix protein, the BTA TRAKT assay which measures an antigen known as factor H, and the AuraTek FDP$ which is a qualitative measurement of fibrinogen and fibrinogen degradation products in urine assays. In addition, mark-

* Matritech, Newton, Massachusetts. t Bard Diagnostics, Redmond, Washington. $ Intracel Corporation, Rockville, Maryland.

ers are currently being investigated for potential clinical use.' me fundamental application of tumor markers is to identify the presence and absence of disease, predict disease progresslon and monitor therapeutic response. In this report it appears that CK-20 may be useful in the detection of bladder cancer in voided urine samples.

Cytokeratins are major components of the intermediate fila- ments of epithelial cells and at least 20 different cytokeratins can be distinguished in human epithelia. They are differentially ex- pressed in specific epithelial cell types or specific pathways of epithelial differentiation. For example in the normal adult human prostate the basal layer can be labeled by antibodies that recog- nize cytokeratins 5 and 14. However, the secretory luminal cells are stained by antibodies specific for cytokeratins 8 and 18. Nu- merous studies have used differential cytokeratin expressions in studying the prostate in various disease states. Similarly, this study also identified a cytokeratin that may be expressed in malignant but not normal urothelial cells.

For any tumor marker to be useful it must have a high sensitivity and specificity to detect the presence and absence of disease, predict disease recurrence and/or progression, and replace and/or add value to the existing management protocol. The CK-20 marker may have the capability of fulfilling some of these criteria. The data demon- strate that CK-20 had a sensitivity of 91% among 144 patients with bladder cancer. In 27 patients with symptoms that warranted blad- der biopsy but who subsequently demonstrated no evidence of cancer the specificity was 74%. The false-positive finding (26%) in this group of patients is not of great concern since the symptoms appeared to be significant enough to warrant a bladder biopsy. Since the expression and/or detection of CK-20 did not appear to correlate with tumor grade, CK-20 may be useful in determining disease recurrence after transurethral resection of bladder cancer. However, additional infor- mation as to the expression of CK-20 in patients with intravesical therapy is required.

The most likely immediate benefits to be gained from the use of molecular markers are to detect clinically occult disease and identify patients in whom the cystocopic interval can be prolonged. However, until multicenter trials are done with the same samples examined by different laboratories using an established set of standards to see if results are reproducible, it will be difficult to determine which mark- eds) is likely to provide useful data in a particular clinical situation.

Brian C.-S. Liu Department of Urology Mount Sinai School of Medicine New York, New York

1. Grossman, H. B.: New methods for detection of bladder cancer. Sem. Urol. Oncol., 1 6 17, 1998.