1265 NUCLEAR MATRIX PROTEIN 22 (NMP22) AS URINE-BASED TUMOR MARKER FOR DETECTION OF PRIMARY AND RECURRENT BLADDER CANCER: COMPARISON OF THE POINT-OF-CARE VERSION (BLADDERCHEK®) AND THE ELISA

Abstract

included in the trial based on positive urinary cytology and/or ultrasonographic suspicion of bladder tumors. The 181 cases of the study group underwent both WLC and HAL-BLC, while patients in the control group benefited from standard cystoscopy alone. A single postoperative mytomicin-C instillation was performed in all resection cases. No additional instillations were used in low risk patients, while adjuvant chemotherapy was applied in intermediate risk cases and BCG immunotherapy for high risk patients. The follow-up protocol consisted of abdominal ultrasound, urinary cytology and WLC, performed every 3 months for a period of 2 years and every 6 months in the third year. RESULTS: In the 142 NMIBC patients of the study group, HALBLC emphasized significantly improved CIS (95.2% versus 71.4%), pTa (95.3% versus 87.1%) and overall (95.8% versus 85.9%) cases’ detection rates. Additional tumors were found by HAL-BLC in a significantly higher proportion of cases (35.2% versus 14.1%). Consequently, the recurrence (16.2% versus 4.9%) and progression (21.1% versus 7%) risk categories of patients changed significantly due to HAL-BLC by comparison to WLC. As a result, the postoperative treatment was modified due to HAL-BLC for a significantly larger proportion of patients (19% versus 6.3%). A total of 115 and respectively 106 NMIBC cases of the two study arms completed the 36 months’ evaluation period. The 3 months’ recurrence rate was significantly lower in the HAL-BLC series (6.9% versus 15.1%) due to fewer other site recurrences (0.9% versus 6.6%). During the long term follow-up, the overall 1 (20.9% versus 31.1%), 2 (30.4% versus 44.3%) and 3 (35.6% versus 51.9%) years’ recurrence rates were significantly reduced in the HAL-BLC study arm. CONCLUSIONS: HAL-BLC emphasized superior NMIBC patients’ detection rates as well as a significant impact in terms of additional tumors’ cases, risk category changes and postoperative treatment modifications. Subsequently, the 3 months’, 1, 2 and 3 years’ recurrence rates were significantly improved in the HAL-BLC group.