Gemcitabine in transitional cell carcinoma of the urothelium.

Gemcitabine has become one of the key drugs in the treatment of patients with locally advanced and metastatic transitional cell carcinoma of the urothelium. The overall response rate for single-agent gemcitabine is 25% with a complete response rate of 9% and toxicity is mild-to-modest. The overall response rate for gemcitabine combined with cisplatin (GC) in Phase II studies is 47% with a complete response rate of 18% and a median survival ranging from 12.5 to 14.3 months. A randomized Phase III study comparing GC and methotrexate, vinblastine, adriamycin and cisplatin (MVAC) has demonstrated similar efficacy with respect to response, time-to-progression and overall survival, whereas GC is associated with less toxicity than MVAC. Thus, GC is now considered a standard of care for patients with locally advanced and metastatic urothelial cancer. Other promising combinations include gemcitabine together with one of the taxanes with or without cisplatin.