Prognostic value of inflammation or granuloma after intravesival BCG in non-muscle-invasive bladder cancer.

Objective To evaluate the prognostic value of inflammation or granuloma after intravesical bacille Calmette-Guerin (BCG) treatment in non-muscle-invasive bladder cancer (NMIBC). Materials and Methods Patients with NMIBC treated with intravesical BCG over a 5-year period were identified. The correlations between histopathological results and disease recurrence and progression were assessed, with survival analysis performed using the Kaplan–Meier method. Other relevant variables were also evaluated using univariate and multivariate analysis. A log-rank test was performed to compare time-to-event between groups. Results A total of 215 patients were treated with BCG for NMIBC and the median follow-up was 32 months. Granuloma was identified in 60 patients and inflammation in 125 patients. In 18 patients there was no evidence of either (normal histology group). A total of 12 patients did not have biopsies and were subsequently excluded. The mean recurrence-free survival rate was significantly higher in the granuloma and inflammation groups (65 months [95% CI: 58–72] and 56 months [95% CI: 49–63], respectively) than in the normal histology group (20 months [95% CI: 6–34]; log-rank P < 0.001). On the multivariate analysis, the absence of inflammation/granuloma was significantly associated with recurrence (log-rank P < 0.001). The progression-free survival rate was higher in the granuloma and inflammation groups (75 months [95% CI: 71–79] and 82 months [95% CI: 78–86], respectively) compared with the normal histology group (33 months [95% CI: 17–48]; log-rank P < 0.001). On multivariate analysis, the absence of inflammation/granuloma was significantly associated with recurrence (log-rank P < 0.001). Conclusion Inflammation or granuloma in histology samples after intravesical BCG treatment for NMIBC are positive markers of response and their absence increases the risk of recurrence and progression.