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Objective: Cisplatin-based combination chemotherapy has been considered as standard therapy for advanced or metastatic urothelial carcinoma. A recent study has, however, revealed that gemcitabine may have the potential to act synergistically with cisplatin. Therefore, the side effects of gemcitabine plus cisplatin (GC) therapy were compared with those of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) therapy in patients with advanced or metastatic urothelial carcinoma., Patients and Methods: Twenty-two patients received GC therapy. Gemcitabine (1000 mg/m2) was administered on days 1, 8 and 15 of each 28-day cycle. Cisplatin (70 mg/m2) was administered on day 2 of each cycle. As a control group, 24 patients received MVAC therapy (methotrexate at 30 mg/m2 on days 1, 15, 22, vinblastine at 3 mg/m2 on days 2, 15, 22, doxorubicin at 30 mg/m2 on day 2, and cisplatin at 70 mg/m2 on day 2 of each 28-day cycle., Results: In the group of patients which received GC therapy, the overall response rates based on independent radiologic reviews of the 20 patients with measurable disease were 55%, with 20% CR and 35% PR. Fewer GC patients as compared with MVAC patients had grade 3/4 anorexia (4.5% vs. 75%, respectively), stomatitis (9.0% vs. 66.7%, respectively), and alopecia (27.3% vs. 100%, respectively). On the other hand, there were no significant differences in the incidence or pattern of hematologic toxicities between the group receiving GC therapy and that receiving MVAC therapy. Fatal neutropenic sepsis occurred in one patient receiving MVAC therapy., Conclusion: GC therapy is effective for the treatment of advanced or metastatic urothelial carcinoma, with an acceptable clinical safety profile. This study also indicates that GC therapy may be better tolerated and safer than MVAC therapy.