Di Stasi SM et al. (2006) Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Lancet Oncol 7: 43–51

Most systemic anticancer regimens combine drugs for increased efficacy, but this approach has rarely been applied to intravesicular treatment of bladder cancer. The current standard treatment for early-stage or superficial bladder cancer is resection followed by immunotherapeutic Bacillus Calmette–Guérin (BCG) therapy. Combination therapy with ELECTROMOTIVE ADMINISTRATION of the chemotherapeutic agent mitomycin plus BCG has shown potential: electromotive administration is thought to make the bladder mucosa more permeable, thereby helping mitomycin reach its target. Italian researchers have conducted a randomized study comparing the efficacy of BCG plus electromotive mitomycin with that of BCG alone in patients with stage pT1 transitional-cell carcinoma of the bladder.

Patients received one course of treatment per week, of either BCG alone for 6 weeks (n = 105), or three cycles of BCG (2 weeks) and mitomycin (1 week) (n = 107). Patients in the sequential group had a longer disease-free interval than those in the BCG group (69 months vs 21 months; P = 0.0012), lower overall (P = 0.045) and disease-specific (P = 0.01) mortality rates, and a longer time to progression (P = 0.0047). Adverse event profiles were similar in both groups.

The authors conclude that BCG plus electromotive mitomycin was more effective than BCG alone. They recommend that further studies be undertaken to establish an optimum regimen of BCG and the precise mechanism by which BCG and mitomycin operate together. They also suggest that all patients with stage T1 bladder cancer undergo restaging transurethral resection, and that perioperative mitomycin should be used to reduce intraoperative seeding of malignant cells.