Efficacy of combined gemcitabine/cisplatin chemotherapy for locally advanced or metastatic urothelial cancer.

Purpose: We wanted to determine and report on the outcome of combined gemcitabine/cisplatin chemotherapy for patients suffering with locally advanced or metastatic urothelial cancer.
Materials and Methods: Between July 1999 and December 2004, 43 selected patients were enrolled in this study. Group 1 (the adjuvant chemotherapy group) had undergone radical surgery with removal of evident tumor from the following primary sites: bladder (n=8), renal pelvis (n=7) and ureter (n=3). Group 2 (the salvage chemotherapy group) had undergone palliative surgery with a remnant tumor at the following primary sites; bladder (n=23) and renal pelvis (n=2). All the patients were given gemcitabine/ciplatin and they evaluated for the therapeutic effect and toxicity. The patients were initially treated with gemcitabine 1000 mg/m(2) intravenously for 30 minutes on days 1, 8 and 15 of a 28-day cycle, and cisplatin 70 mg/m(2) was administered intravenously on day 1 using prehydration measures.
Results: Group 1: The median follow-up period was 16.5 months. The mean age was 63 years (males: 15 cases, females: 3 cases), and eleven patients (61%) remained alive. The estimated median relapse-free survival period and 2-year survival rate were 24 months and 63%, respectively. Group 2: the median follow-up period was 20 months, the mean patient age was 63.8 years (males: 22 cases, females: 3 cases), and nine patients (36%) remained alive. The overall response and 2-year survival rates were 36% and 43%, respectively. Toxicities: Grade 3 toxicities developed in 14 cycles during the total 232 cycles. Grade 4 toxicity did not occur.
Conclusions: The results of this study confirm that adjuvant and salvage chemotherapy with using gemcitabine and cisplatin is tolerable and safe.