Intravesical sequential BCG and electromotive mitomycin versus BCG alone in high risk non-muscle invasive bladder cancer.

Abstract

4572 Background: In 2006, we reported that intravesical sequential bacillus Calmette-Guérin (BCG) and electromotive mitomycin in high risk non-muscle invasive bladder cancer leads to higher disease-free interval, lower recurrence and progression, and to improved overall survival and disease-specific survival compared with BCG alone. After an additional 6 years of follow-up, we now report estimated 16-year results. Methods: From 1994 through 2002, we randomly assigned 212 patients with high risk non.muscle invasive bladder cancer to 81 mg BCG infused over 120 min once a week for 6 weeks (n=105) or to 81 mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a month as one cycle for three cycles. The primary endpoint was disease-free interval. Analyses were done by intention to treat. Results: Median follow-up was 121 months (IQR 70.5–163.5). Patients assigned sequential BCG and electromotive mitomycin had higher disease-free interval than did those assigned BCG alone (79 months [95% CI 27–139] vs 26 months [11–113]; difference between groups 53 months [39–67], log-rank p=0.0002). Patients assigned sequential BCG and electromotive mitomycin also had lower recurrence (45% [35–55] vs 62% [50–72], difference between groups 17% [6–28], log-rank p=0.0002); progression (12% [3–21] vs 28% [17.5–38.5], difference between groups 16% [5–27], log-rank p=0.003); overall mortality (44% [33–55] vs 59% [43–75], difference between groups 15% [2–28], log-rank p=0.01); and disease-specific mortality (9% [2.5– 15.5] vs 23% [11–34], difference between groups 14% [4–24], log-rank p=0.0055). Conclusions: In patients with high risk non-muscle invasive bladder cancer intravesical BCG combined with electromotive mitomycin provided better results than BCG alone in terms of higher remission rates and longer remission times.