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During the past 2 decades, little meaningful progress has been made in the systemic management of advanced urothelial cancer. Cisplatin-based combinations — initially M-VAC (methotrexate, vinblastine, doxorubicin, cisplatin) and, more recently, cisplatin plus gemcitabine — have been the standard of care. These regimens have been associated with objective response rates of 40% to 50% and have resulted in median survival of approximately 14 months and long-term survival rates of 4% to 15%. Several phase II trials of antineoplastics (involving patients with disease progression after front-line chemotherapy) have demonstrated objective activity but have failed to provide compelling evidence of survival benefit.
In a recent phase II trial involvi…