Baseline titers were not associated with response. On-treatment titers >800 were seen in 89% and 59% of responders (R) and nonresponders (NR), respectively (p[0.001). Sensitivity of this test for detecting R was 89% (negative predictive value, 78%). Ontreatment Ab fold change >8 from baseline was seen in 51% and 27% of R and NR, respectively (p[0.02). Elevated on-treatment Ab titers and fold change from baseline were noted in 47% and 18% of R and NR, respectively (p[0.004). Specificity of the combined test for detecting R was 82% (positive predictive value, 73%). These findings were also corroborated in the CISAETa/T1 subcohort.CONCLUSIONS: Secondary analysis of the prospective, multicenter phase 3 nadofaragene firadenovec trial in BCGunresponsive NMIBC indicates a role for assaying baseline and ontreatment Ab titers. A combination of Ab titer and fold-change levels can potentially predict response to this novel therapeutic in a patient population with urgent unmet clinical need.
BCG sepsis is rarely seen with modern intravesical therapy and therefore its presentation may not be apparent to recently trained urologists. We describe BCG sepsis occurring in a patient treated with combined intravesical and intraurethral BCG which resulted in lung consolidation with acid-fast bacilli requiring cessation of BCG and initiation of systemic antibiotic therapy.
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