Long-term follow-up of a randomized trial comparing sequential bacillus Calmette-Guerin and electromotive mitomycin C with Bacillus Calmette-Guerin alone in high risck superfial bladder cancer.

most systemic regimens and are based on the logical concept of increasing therapeutic effi cacy while reducing the emergence of resistant malignant cells. Curiously, this approach is not often applied to the use of intravesical agents for the treatment of superfi cial bladder cancer. We conducted a prospective controlled study, comparing a unique protocol of sequential bacillus Calmette-Guerin (BCG) and electromotive mitomycin C (MMC) administration with that of BCG alone in two groups of patients with high-risk superfi cial bladder cancer. MATERIAL & METHODS: From January 1994 to June 2002, following transurethral resection and multiple biopsies, we randomised 212 T1 bladder cancer patients in 2 groups. BCG group (n=105) received BCG 81 mg for 6 weekly instillations. BCG/MMC group (n=107) received 2 sequential BCG and 1 electromotive (intravesical electric current 20 mA for 30 min) MMC at weekly intervals x 3 cycles, totaling 6 BCG and 3 MMC instillations. Non responders repeated courses at 3 months. All complete responders underwent maintenance regimens of monthly instillations: in BCG group for 10 BCG treatments and in BCG/MMC group following the scheme (MMC, MMC, BCG) x 3. All analysis were performed on an intent-to-treat basis. RESULTS: After a median follow-up of 76 months, BCG/MMC treated group showed better results than BCG alone group, with a lower recurrence rate (42.1% versus 58.1%, p=0.019), a longer time to recurrence (median 25 versus 12 months, p<0.001), a lower progression rate (9.3% versus 21.9%, p=0.011), a longer time to progression (median 40 versus 17 months, p=0.011), and a lower disease-specifi c mortality rate (5.7% versus 16.2.4%, p=0.023). Side effects were mainly localised to the bladder. CONCLUSIONS: Intravesical sequential BCG/MMC is superior to BCG alone in the treatment of high-risk superfi cial bladder cancer. The reduction in disease-specifi c mortality requires further investigation as the numbers are too small to assess the underlying reasons for this result.