TUR-BT : transurethral resection of bladder tumor. 95 transitional cell carcinoma : Cytokeratin ; CK 8 11nm kD CK 1 8

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1 Clinical evaluation of total amount of Urinary cytokeratin 8 and cytokeratin 18 measurement for detection of transitional cell carcinoma of the bladder. Kyoko ARAI Mikihiko HONDA Ken-Ichiro YOSHIDA 95transitional cell carcinoma : TCC 1, , 2 TUR-BT : transurethral resection of bladder tumor 1, Cytokeratin ; CK 8 11nm 40 68kD typeck 9 20 type CK 1 8 CK Department of Urology, Dokkyo University School of Medicine (880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi)

2 CK CK 514 CK , 5 CK CK 4 Moll CK CK 8 CK 18 5 CK 8 CK T. Stigbrand ISOBM TD-5 Workshop 7 30 clone CK ISOBM-code BIAcore technology epitop map CK 8 CK 18 code 206 clone : 6D7 CK 8 code 181 clone : 3F3 CK 18 2 CK 19 ISOBM TD-5 workshop CK 8 CK 18 CK IDL Biotech AB sweden 1999 CK 8CK 18 UBC Urinary Bladder Cancer Antigen ; UBC EIA 4 6 CK 8 6D7 CK 18 3F3 CK 8 CK 18 CK 8 CK 18 HRP 17, 18 UBC EIA CK 8 CK 18 UBC EIA 17, 18 UBC Rapid 4, 5, 8 2 6D73F3 CK 8 18 helix rich Cytokeratin 8 Cytokeratin 18 Cytokeratin 19 6D7 3F3 : positive reaction: negative reaction Code206Clone : 6D7CK 8 Code181Clone : 3F3CK 18

3 UBC EIA 17, CK 6D73F ngml 1 100rHRP CK 100r 24 2 CK , 3, 5, 5 -tetra methyl benzidine 200r r30 450nm 3 CK 8CK 18 CK 8 CK 18 CK 8 CK 18 ngml CK 8CK CK 8CK 18 Cr data not shown 6, 17, 18 CK 8 CK 18 Cr Cr CK 8CK 18 CK 8CK 18 CK 8CK 18Cr ; ngmgcr Cr CK 8 CK 18 ROC CK 8 CK 18 16ngmgCr UBC 16ngmgCr ,

4 CK 8CK Cr CK 8CK 18 group 1 CK 8CK 18 control 1 CK 8CK 18 control 17 CK 8CK 18 control control UBC CK fragment release 17 Follow-up CK 8CK 18 control Follow-up BT CK 8CK 18 NMP22 Matritech UNMP22 Group Follow-up a. b. c. d. e. f. control Total range a a a a a a a a a Values are expressed as mean SD. a ; p0.05 vs group5 62 : : 6 21 : 8 56 : : 0 11 : 7 70 : : 20 5 : 8 85 : : 111 Cr mgdl Group CK 8CK 18 NMP22 CK 8CK 18Cr ngmgcr NMP22 Uml Follow-up a b a, b a, b b a a b a, b a c a, b a d a, b a e a, b a f a, b b 4 5 control a, b a a a Values are expressed as mean SD. a ; p0.05 vs group1, b ; p0.05 vs group5.

5 Marker UBCngmgCr NMP22Uml BTAqualitatative sensitivity specificity accuracy BTA BTA 8 14, 17 CK 8CK 18 16ng mgcrnmp22 12Uml sensitivityspecificity accuracybta CK 8CK NMP BTA NMP NMP22 nuclear matrix protein 22 8, fragment BTA 40 BTA fragment 15 fragment 16.7 BTA 1 3 CK 8CK 18 gradestage Papanicolaou CK 8 CK 18 4, 5 pta pt1 Grade CK 8CK CK 8CK 18 CK 8CK 18 Group Follow-up a. b. c. d. e. f. control Total CK 8CK 18Cr ngmgcr NMP22 Uml BTA

6 CK 8CK 18 : small3cm Large3cm : single multiple Grade : Stage : pta -1 T2, 3, 4 : Total CK 8CK 18Cr ngmgcr Cytology CK 8CK 18Cr Cytorogy CK 8CK 18 follow-up control 16 1, follow-up CK 8CK 18 follow-up CK 8CK 18 CK 8CK 18 TUR-BT 1 Malmstrom P U, Busch C and Norlen B J : Recurrence, progression and survival in bladder cancer. A retrospective analysis of 232 patients with greater than or equal to 5-year follow up. Scand J Urol Nephrol, : , Herr H W : Natural history and implications for urothelial cancer prevention. J Cell Biol Chem : , Heney N M, et al.: Superficial bladder cancer : Progression and recurrence. J Urology : , Moll R, et al.: The catalog of Human Cytokeratins : Patterns of Expression in Normal Epithelia, Tumors and Cultured Cells. Cell : 11-24, Moll R, et al.: Cytokeratins in Normal and Malignant Transitional Epithelium : Maintenance of Expression of Urothelial Differentiation Features in Transitional Cell Carcinomas and Bladder Carcinoma Cell Culture Lines. Amer J Pathology : , Sumi S, et al.: Preliminary Report of the Clinical Performance of a New Urinary Bladder Cancer Antigen Test : Comparison to Voided Urine Cytology in the Detection of Transitional Cell Carcinoma of the Bladder. Clin Chim Acta : , Stigbrand T, et al.: Epitope specificity of 30 monoclonal antibodies against cytokeratin antigens ; The ISOBM

7 TD5-1 workshop. Tumor Biol : , Hakenberg O W, et al.: Qualitative and Quantitative assessment of urinary cytokeratin 8 and 18 fragments compared with voided urine cytology in diagnosis of bladder carcinoma. Urology : , Sanchez-Carbayo M, et al.: Comparative Sensitivity of Urinary Cyfra 21-1, Urinary Bladder Cancer Antigen, Tissue Polypeptide Antigen and NMP22 to Detect Bladder Cancer. J Urology : , Heicappell R, et al.: Evaluation of Urinary Bladder Cancer Antigen as a Marker for Diagnosis of Transitional Cell Carcinoma of the Urinary Bladder. Scand J Clin Lab Invest : , Mian C. et al.: Comparison of the Monoclonal UBC- ELISA Test and the NMP22 ELISA Test for the Detection of Urothelial Cell Carcinoma of the Bladder. Urology : , Dicarlo A, et al.: Role of cytokeratins, nuclear matrix proteins, Lewis antigen and epidermal growth factor receptor in human bladder tumors. Int J Oncol, , Sanchez-Carbayo M, et al.: Initial Evaluation of the Diagnostic performance of the New Urinary Bladder Cancer Antigen Test as a Tumor Marker for Transitional Cell Carcinoma of the Bladder. J Urology : , Mostifi F KSobin L H and Torloni H : Histological typing of urinary bladder tumors. In : WHO International Histological Classification of Tumors, World Health Organization. 9-35, Soloway M S, et al.: Use of a new tumor marker, urinary NMP22, in the detection of occult or rapidly recurring transitional cell carcinoma of the urinary tract following surgical treatment. J Urol : 3-8, Pode D, et al.: noninvasive detection of bladder cancer with BTA stat test. J Urol : , UBC NMP22, BTA. 4: , UBC EIA. 5: , 2009.

MEDICAL POLICY SUBJECT: URINARY TUMOR MARKERS FOR BLADDER CANCER. POLICY NUMBER: CATEGORY: Technology Assessment

MEDICAL POLICY SUBJECT: URINARY TUMOR MARKERS FOR PAGE: 1 OF: 5 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial product, including