Gemcitabine/carboplatin in advanced urothelial cancer

Transitional cell carcinoma of the urothelium is a highly chemosensitive tumor. Combination chemotherapy can provide both palliation and a modest survival advantage in patients with advanced disease. As shown in a recent phase III trial, the new gold standard should be considered gemcitabine/cisplatin, although toxicity remains important. Bladder cancer is a common tumor in our population (Spain), usually affecting elderly patients with comorbid diseases and renal impairment. Thus, most of these patients may not benefit from cisplatin-based regimens. The development of new combinations for treating such patients is, therefore, of vital importance. The identification of new active agents against transitional cell carcinoma, such as taxanes and gemcitabine, is promising. We believe that the combination of gemcitabine plus carboplatin could also be useful in this subset of patients. On this basis, we treated bladder cancer patients in two trials using gemcitabine 1,000 mg/m(2) on days 1 and 8, and carboplatin (area under the curve 5) on day 1, every 21 days. The overall response rate for evaluable patients with and without renal impairment was 60%, with a 95% confidence interval of 40% to 72%. The potential clinical benefit of this new doublet in the treatment of transitional cell carcinoma warrants testing in future phase III studies. Semin Oncol 28 (suppl 10):19-24.