444 Predictive value of urine-based tumor markers in a bladder cancer screening population

444 - Predictive value of urine-based tumor markers in a bladder cancer screening populat... Page 1 of 2

e444 Predictive value of urine-based tumor markers in a bladder cancer screening population 1

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Banek S. , Schwentner C. , Tager D. , Nasterlack M. , Leng G. , 2

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Pesch B. , Sievert K.D. , Eberle F. , Wiens C. , Bierfreund K.G. , 2

Brüning T. , Stenzl A.

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University of Tübingen, Dept. of Urology, Tübingen, Germany, RuhrUniversity Bochum, Institute for Prevention and Occupational Medicine of The German Social Accident Insurance (IPA), Bochum, Germany,

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BASF SE, Dept. of Occupational Medicine and Health Protection, 4

Ludwigshafen, Germany, Currenta GmbH & Co. OHG, Dept. of Health Protection and Occupational Safety, Leverkusen, Germany INTRODUCTION & OBJECTIVES: In recent years, non-invasive tumor marker assays for detecting bladder cancer (BC) have been developed. However, there is no prospective trial which analyzed their significance in a screening scenario of high- risk patients. UroScreen is a prospective study aiming to evaluate the predictive value of TM

TM

NMP22 , UroVysion and urine cytology in such a high-risk cohort. In addition, we analyzed the Influence of patient-related factors using fluorescence in situ hybridization. MATERIAL & METHODS: From September 2003 until June 2010, 1,609 chemical workers with former exposure to aromatic amines, mean age 62 years, were examined. 7,091 preventive medical checkups were performed. Urine samples were collected for urine cytology, chromosomal aberrations by the UroVysion test, and quantitative determination of nuclear matrix protein 22 (NMP22). In case of at least one positive urine test, cystoscopy was recommended and performed in an ambulatory setting. RESULTS: Overall, 3 PUNLMPs, 5 recurrent BCs and 13 primary BCs (2 Cis, 7 pTa, 1 pTa+Cis, 4 pT1, 1 pT1+Cis, 1 pT2, 2 pT3b) were

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e444a detected. Microhaematuria was diagnosed in seven (33%) of these patients only. Eight of the tumors were identified by positive cytology. Six tumors were not detected by any of the markers (1 PUNLMP, 2 pTa, 1 pT1, 1 pT1+Cis, 1 pT2). Cancer predictive values for urinebased tumor markers were as follows: NMP22: PPV= 3.51%, NPV=98.96%, sensitivity= 28.57%, specificity= 89.60%; Cytology: PPV= 28.13%, NPV=99.24%, sensitivity= 42.86%, specificity= 98.55%; Urovysion: PPV= 16.07%, NPV= 99.22%, sensitivity= 42.86%, specificity= 97.02% Altogether, Urovysion was significantly altered by smoking status (OR 2.241, Cl 1.122-4.478), crystalluria (OR 1.671, Cl 0.798-3.277) as well as urinary creatinine <0.5g/l (OR 2.67, Cl 1.5714.535). A moderate influence was found by the presence of diabetes mellitus (OR 1.359, Cl 0.693 – 2.666). No influence could be observed due to leucocyturia (>5/µl), hematuria (>5Erys/µl) or benign prostatic hyperplasia (OR 1.121, 0.923 and 0.656, Cl 0.448–2.808, 0.521-1.635 and 0.089-4.823). CONCLUSIONS: FISH results are altered by various patient-related factors. However, UroVysion can be applied in cases of urinary tract infection, hematuria and benign prostatic hyperplasia. The low sensitivity and PPV may be explained by the relatively low incidence of BC in this study population. Invasive BC is a potentially lethal disease and early diagnosis and treatment are the only means to reduce mortality. Due to the limited diagnostic yield of urinary markers cystoscopy remains the gold standard for the diagnosis of BC. Nevertheless, urine-based tumor markers might be a valuable adjunct in the follow-up of BC.

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