Gemcitabine: A promising new agent in the treatment of advanced urothelial cancer

Purpose: To evaluate the efficacy and toxicity of gemcitabine (2',2'-difluorodeoxycytidine) in previously untreated patients with advanced transitional cell carcinoma, Patients and Methods: Forty-one patients with measurable advanced transitional cell carcinoma who had received no prior chemotherapy for metastatic disease were scheduled to receive gemcitabine 1,200 mg/m(2) intravenously over 30 minutes on days 1, 8, and 15 of a 28-day cycle, Prior adjuvant or neoaduvant therapy for locally advanced disease was allowed if this was completed greater than 1 year prior to study entry. All patients were treated on an outpatient basis. Results: There were three complete responses and six partial responses seen in 37 assessable patients, for an overall response rate of nine of 37 (24.3%; 95% confidence interval, 12 to 41), Four patients remain in remission at 14, 23, 24, and 31 months, The median survival was 8 months with 17% of patients alive at 2 years, Treatment generally was well-tolerated with three patients having greater than or equal to grade 3 nonhematologic toxicity, five having grade 3 neutropenia, two having grade 3 thrombocytopenia, and two episodes of febrile neutropenia. Most patients were able to receive the drug as scheduled with the primary reason for dose reduction or dose delay being neutropenia. Conclusion: Gemcitabine has promising single-agent activity against urothelial cancer with a favorable toxicity profile, Further studies in combination with other active agents are warranted. (C) 1997 by American Society of Clinical Oncology.