Mp43-08 bcg vs Chemohyperthermia With Mitomycin C for High-Risk Non-Muscle Invasive Bladder Carcinoma: Preliminary Results of Hivec-Hr Randomized Clinical Trial

Abstract

A urine sample was collected prior to cystoscopy and mutation/methylation status of 6 genes was determined in DNA from urinary cells and combined with age. This existing diagnostic model was validated on this cohort and optimized using logistic regression. Clinical usefulness was determined by the net benefit approach.RESULTS: In 838 patients, the mutation/methylation status could be determined for all genes. Urothelial cancer was observed in 112 patients (98/457 in the gross and 14/381 in the microscopic hematuria group) Application of the existing model resulted in an AUC of 0.93. Combining the assay with the type of hematuria resulted in the final optimal model with an AUC of 0.96 (96% sensitivity, 73% specificity, 99% negative predictive value). The assay also detected all six upper tract urothelial tumors that are not visible by cystoscopy. Net benefit analysis showed that the urine test should be preferred over 'cystoscopy for all'. Application of the optimal model on patients whose biomarker status was incomplete, resulted in the identification of 5 additional tumors. Implementing the urine test as a triage tool could lead to a 63% reduction in cystoscopies.CONCLUSIONS: The urine test detects urothelial cancer in hematuria patients with high accuracy. It appears a simple selection tool, in particular for patients with microscopic hematuria.

Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

“…A total of 2,277 articles were excluded upon initial screening, and 79 studies were further excluded upon full-text screening. Finally, four RCTs (24)(25)(26)(27) were included for metaanalysis, and one observational retrospective study (28) was retrieved and included for qualitative synthesis. Two studies included both intermediate-and high-risk NMIBC patients (24,25), and the other three studies included high-risk NMIBC patients only (26)(27)(28).…”

“…Finally, four RCTs (24)(25)(26)(27) were included for metaanalysis, and one observational retrospective study (28) was retrieved and included for qualitative synthesis. Two studies included both intermediate-and high-risk NMIBC patients (24,25), and the other three studies included high-risk NMIBC patients only (26)(27)(28). All studies were non-inferiority trials and did not specifically focus on primary or recurrent cases.…”

“…Four RCTs with 327 patients were included ( 24 – 27 ). There was no significant difference between the two groups (RR FE 0.60, 95% CI 0.26–1.41, p = 0.24; low certainty of evidence) ( Figure 3 ).…”

“…Three RCTs were included in the meta-analysis ( 24 , 25 , 27 ). In terms of RFS, no significant difference was noted between the CHT group and the BCG group (HR RE 0.81, 95% CI 0.42–1.56, p = 0.53; very low certainty of evidence) ( Supplementary Material ).…”

“…Four RCTs with 368 patients were included (24)(25)(26)(27). For Grade 1-2 AEs, there was no significant difference between the CHT group and the BCG group (RR FE 1.11, 95% CI 0.93-1.32, p = 0.26; moderate certainty of evidence), and no significant heterogeneity was detected (I 2 = 0%, p = 0.96) (Figure 4).…”