Adjuvant chemotherapy for transitional cell carcinoma of the bladder: paradigms for the design of clinical trials.

Optimal treatment of high-risk, muscle-invasive bladder cancer involves local and systemic therapy. Published trials of adjuvant chemotherapy in bladder cancer are limited, but the evidence suggests that the combination of chemotherapy and surgery in high-risk patients improves survival. The identification of biologic markers with prognostic significance will allow clinicians to better determine which patients are at high risk for relapse. The development of newer, less toxic drugs with activity in bladder cancer has set the stage for the next generation of trials. Several multicenter randomized controlled trials are evaluating new chemotherapy regimens in the adjuvant setting. These new trials represent an important step forward in improving the treatment of bladder cancer.