ADXBLADDER test results demonstrate an anticipatory effect in the follow-up of cystoscopy negative non muscle invasive bladder cancer patients in a large multicentric European cohort
BAUS ePoster online library. Dudderidge T. 06/22/21; 319016; p10-8
Disclosure(s): Paid Consultant of Arquer Diagnostics Ltd
Tim Dudderidge
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Abstract
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INTRODUCTION:
Urinary biomarkers frequently demonstrate positive results where there is no tumour detected by cystoscopy. Previous studies have shown a significant proportion of these false positives will manifest tumours within 1 year, suggesting an anticipatory positive effect. This study reports an anticipatory effect of ADXBLADDER in the follow-up of patients negative for recurrence in a large European multicentre study.
PATIENTS & METHODS:
Patients were previously enrolled in a large multicentre prospective study (Research Ethics committee approval reference-17/NE/0174), based upon a previous diagnosis of NMIBC and provided urine for ADXBLADDER testing prior to undergoing their routine cystoscopic surveillance. Results were compared to outcomes of cystoscopy and pathological results of TURBT/biopsy. 12 months following completion of the study a follow-up of all patients negative for recurrence was conducted, collecting data on subsequent cystoscopy and pathological findings in comparison to their original ADXBLADDER results.
RESULTS:
1 year follow-up data was available for 1136 patients negative for recurrence in the previous study. Significantly more patient who previously tested positive for ADXBLADDER were found to have recurrent bladder tumours within the 12 month follow-up period (p=0.02), with high-grade recurrences more prevalent in ADXBLADDER positive patients (p=0.01). Only 0.6% of ADXBLADDER negative patients went on to recur with a non-pTa tumour, versus 4.7% of ADXBLADDER positive patients demonstrating an NPV of 99.4% for up to 12 months.
CONCLUSIONS:
Significantly more patients with a positive ADXBLADDER test will recur within 12 months, with ADXBLADDER negative patients continuing to demonstrate a high NPV for up to 12 months.
Urinary biomarkers frequently demonstrate positive results where there is no tumour detected by cystoscopy. Previous studies have shown a significant proportion of these false positives will manifest tumours within 1 year, suggesting an anticipatory positive effect. This study reports an anticipatory effect of ADXBLADDER in the follow-up of patients negative for recurrence in a large European multicentre study.
PATIENTS & METHODS:
Patients were previously enrolled in a large multicentre prospective study (Research Ethics committee approval reference-17/NE/0174), based upon a previous diagnosis of NMIBC and provided urine for ADXBLADDER testing prior to undergoing their routine cystoscopic surveillance. Results were compared to outcomes of cystoscopy and pathological results of TURBT/biopsy. 12 months following completion of the study a follow-up of all patients negative for recurrence was conducted, collecting data on subsequent cystoscopy and pathological findings in comparison to their original ADXBLADDER results.
RESULTS:
1 year follow-up data was available for 1136 patients negative for recurrence in the previous study. Significantly more patient who previously tested positive for ADXBLADDER were found to have recurrent bladder tumours within the 12 month follow-up period (p=0.02), with high-grade recurrences more prevalent in ADXBLADDER positive patients (p=0.01). Only 0.6% of ADXBLADDER negative patients went on to recur with a non-pTa tumour, versus 4.7% of ADXBLADDER positive patients demonstrating an NPV of 99.4% for up to 12 months.
CONCLUSIONS:
Significantly more patients with a positive ADXBLADDER test will recur within 12 months, with ADXBLADDER negative patients continuing to demonstrate a high NPV for up to 12 months.
INTRODUCTION:
Urinary biomarkers frequently demonstrate positive results where there is no tumour detected by cystoscopy. Previous studies have shown a significant proportion of these false positives will manifest tumours within 1 year, suggesting an anticipatory positive effect. This study reports an anticipatory effect of ADXBLADDER in the follow-up of patients negative for recurrence in a large European multicentre study.
PATIENTS & METHODS:
Patients were previously enrolled in a large multicentre prospective study (Research Ethics committee approval reference-17/NE/0174), based upon a previous diagnosis of NMIBC and provided urine for ADXBLADDER testing prior to undergoing their routine cystoscopic surveillance. Results were compared to outcomes of cystoscopy and pathological results of TURBT/biopsy. 12 months following completion of the study a follow-up of all patients negative for recurrence was conducted, collecting data on subsequent cystoscopy and pathological findings in comparison to their original ADXBLADDER results.
RESULTS:
1 year follow-up data was available for 1136 patients negative for recurrence in the previous study. Significantly more patient who previously tested positive for ADXBLADDER were found to have recurrent bladder tumours within the 12 month follow-up period (p=0.02), with high-grade recurrences more prevalent in ADXBLADDER positive patients (p=0.01). Only 0.6% of ADXBLADDER negative patients went on to recur with a non-pTa tumour, versus 4.7% of ADXBLADDER positive patients demonstrating an NPV of 99.4% for up to 12 months.
CONCLUSIONS:
Significantly more patients with a positive ADXBLADDER test will recur within 12 months, with ADXBLADDER negative patients continuing to demonstrate a high NPV for up to 12 months.
Urinary biomarkers frequently demonstrate positive results where there is no tumour detected by cystoscopy. Previous studies have shown a significant proportion of these false positives will manifest tumours within 1 year, suggesting an anticipatory positive effect. This study reports an anticipatory effect of ADXBLADDER in the follow-up of patients negative for recurrence in a large European multicentre study.
PATIENTS & METHODS:
Patients were previously enrolled in a large multicentre prospective study (Research Ethics committee approval reference-17/NE/0174), based upon a previous diagnosis of NMIBC and provided urine for ADXBLADDER testing prior to undergoing their routine cystoscopic surveillance. Results were compared to outcomes of cystoscopy and pathological results of TURBT/biopsy. 12 months following completion of the study a follow-up of all patients negative for recurrence was conducted, collecting data on subsequent cystoscopy and pathological findings in comparison to their original ADXBLADDER results.
RESULTS:
1 year follow-up data was available for 1136 patients negative for recurrence in the previous study. Significantly more patient who previously tested positive for ADXBLADDER were found to have recurrent bladder tumours within the 12 month follow-up period (p=0.02), with high-grade recurrences more prevalent in ADXBLADDER positive patients (p=0.01). Only 0.6% of ADXBLADDER negative patients went on to recur with a non-pTa tumour, versus 4.7% of ADXBLADDER positive patients demonstrating an NPV of 99.4% for up to 12 months.
CONCLUSIONS:
Significantly more patients with a positive ADXBLADDER test will recur within 12 months, with ADXBLADDER negative patients continuing to demonstrate a high NPV for up to 12 months.
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