Browsing by Subject "Bacillus Calmette-Guérin"

Objectives: The objective was to evaluate tolerability of BCG treatment and to determine if interruption impacts on treatment outcome. Furthermore, the incidence and characteristics of severe complications were recorded. Methods: We included 418 patients who received BCG instillations in our institution during 2009-2015. Reason for interruption, treatment outcome, number of instillations and diagnosis of BCG infection were recorded retrospectively. Results: Of the 418 patients who started BCG, 176 (42.1%) interrupted and discontinued BCG treatment, 23 (5.5%) interrupted due to suspicion of BCG infection. Systemic BCG infection was found in 7 (1.7%) patients and local in 5 (1.2%) patients. Other reasons for interruption were other adverse effects in 71 patients (17.0%), BCG failure in 46 patients (11.0%) and other reasons in 36 patients (8.6%). 86% of interruptions due to adverse effects occurred within the first 18 instillations. The probability of tumor recurrence (20.0% vs 10.7%) and disease progression (5.4% vs 1.2%) was higher with patients whose BCG treatment was interrupted. Conclusions: Severe complications are encountered in only <5% of patients. The propability of adverse effects and severe complications depend mostly on the host’s characteristics rather than on the BCG dose or the number of BCG instillations.