EVALUATION OF DD23 AS A MARKER FOR DETECTION OF RECURRENT TRANSITIONAL CELL CARCINOMA OF THE BLADDER IN PATIENTS WITH A HISTORY OF BLADDER CANCER SCOTT M. GILBERT, ROBERT W. VELTRI, ALEX SAWCZUK, AHMAD SHABSIGH, DAVID R. KNOWLES, STEVEN BRIGHT, GERALD J. O’DOWD, CARL A. OLSSON, MITCHELL C. BENSON, AND IHOR S. SAWCZUK ABSTRACT Objectives. To determine whether DD23 increases the sensitivity of urinary-based detection of transitional cell carcinoma (TCC) recurrence. The murine monoclonal antibody DD23 recognizes a 185-kDa tumor- associated antigen that is expressed in human bladder cancer cells in vitro and in vivo but is not detected in normal urothelium. Methods. Using alcohol-fixed urinary cytology, matched voided urine and bladder wash specimens were evaluated for the contribution of DD23 antigen expression in the detection of recurrent TCC. The selected patient population had a history of bladder cancer, and urine cytology analysis was performed in a single commercial reference laboratory. DD23 antigen expression in a cohort of 81 patients was compared with urine cytology findings, and the sensitivity and specificity for each urine-based test was determined. The presence of recurrent disease was determined by positive pathologic biopsy. Results. The 81-patient cohort produced 151 urine specimens for which both biopsy and cytology infor- mation were obtained. Of these specimens, 64 were confirmed by a tissue diagnosis for TCC recurrence. These biopsy-proven recurrences were used as the dependent variable to assess the accuracy of cytology testing. For the detection of TCC, the DD23 antigen had a sensitivity of 70.3% and a specificity of 59.8%. Combined with cytopathologic findings, DD23 enhanced the sensitivity for the detection of TCC from 43.8% (cytology alone) to 78.1%. For low-grade TCC (n = 20) DD23 enhanced the sensitivity from 20.0% (cytology alone) to 55.0%. For high-grade TCC (n = 25), DD23 enhanced the sensitivity from 64.0% (cytology alone) to 76.0%. In patients with a prior history of intravesical treatment, DD23 had a sensitivity of 94.7% and a specificity of 33.3% compared with a sensitivity of 52.6% and a specificity of 83.3% for cytology. Conclusions. DD23 antigen expression can be used as an adjunct to cytopathologic evaluation to enhance the sensitivity of urinary cytology detection of TCC. In addition, DD23 does not appear to lose sensitivity in patients with a prior history of bladder cancer treated with intravesical agents. UROLOGY 61: 539–543, 2003. © 2003, Elsevier Science Inc. B ladder cancer is the second most common can- cer of the urinary tract, the fourth most com- mon cancer overall in men, and the eighth most common cancer in women. In 2001, approxi- mately 54,000 new cases were diagnosed in the United States, and the disease accounted for more than 12,400 deaths. 1 More than 90% of bladder cancers are transitional cell carcinoma (TCC), and most of these lesions are superficial tumors that are treated with transurethral resection. 2 Superficial I. S. Sawczuk is a member of the speaker’s bureau for UroCor. From the Department of Urology, Columbia University Col- lege of Physicians and Surgeons, New York-Presbyterian Hospital, New York, New York; Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Urology and Cancer Center, Hacken- sack University Medical Center, Hackensack, New Jersey; and UroCor Division of Dianon Systems, Inc., Oklahoma City, Oklahoma Reprint requests: Ihor Sawczuk, M.D., Department of Urology, Hackensack University Medical Center, 20 Prospect Avenue, Hackensack, NJ 07601 Submitted: April 3, 2002, accepted (with revisions): October 15, 2002 ADULT UROLOGY CME ARTICLE © 2003, ELSEVIER SCIENCE INC. 0090-4295/03/$30.00 ALL RIGHTS RESERVED doi:10.1016/S0090-4295(02)02400-7 539