Pharmacological Treatments for BCG-Refractory Cancer of the Urinary Bladder

sitional cell carcinoma, or TCC) of the urinary bladder is the 4th most common cancer among men and the 11th most common cancer among women in the United States, according to the American Cancer Society.1 An estimated 68,810 new cases of TCC of the bladder are expected to occur in 2008, resulting in 14,100 deaths.1 Outcomes are determined by several factors, including the stage and grade of the tumor. Carcinoma in situ (CIS) of the urinary bladder, a type of TCC of the bladder, carries a high risk of recurrence and a moderate risk of stage progression and death. Persons who have CIS of the bladder in whom standard treatment—transurethral resection of the bladder tumor (TURBT) followed by intravesical therapy with bacillus Calmette-Guerin (BCG) therapy BCG vaccine (TheraCys, TICE BCG)—fails, have few viable treatment options besides radical cystectomy. Although radical cystectomy is an effective surgical treatment, it poses a high risk of morbidity and mortality for persons with CIS, especially those who are older, are in frail health, and/or have significant comorbidities. However, therapeutic options for persons with recurrent CIS are increasing with the return of FDA-approved valrubicin (Valstar) to the market as well as with continuing research on other investigational therapies, including mitomycin (Mutamycin), gemcitabine(Gemzar), docetaxel (Taxotere), and the combination of interferon alpha-2b (Intron A) and BCG.