Chemoprevention of superficial bladder cancer

The development, evaluation and approval of promising agents for bladder cancer prevention (chemoprevention)depends upon the rational integration of four key components: a) Agents (pharmaceuticals, biologics and nutrients); b) Biomakers (intermediate endpoints that predict for clinical response and risk reduction; c) Cohorts (well defined high risk target populations d) Designs (efficient trial designs linked to the clinical phase of development). The promise of this overall strategy is the ability to conduct faster, smaller and more cost effective trials which incorporate validated surrogate endpoints rather than conventional clinical endpoints (cancer incidence, recurrence and survival). Current National Cancer Institute (NCI) phase III bladder cancer chemopreventive trials in progress are described. Since most patients with superficial (transitional cell) bladder cancer present with early disease (Ta, T1, Tis lesions) that frequently recurs and is easily accessible by serial cystoscopy and urine cytology, bladder cancer serves as a powerful clinical for conducting prevention trials of new agents for a tobacco related malignancy.