Gemcitabine plus cisplatin, an active regimen in advanced urothelial cancer: A phase II trial of the National Cancer Institute of Canada clinical trials group

Purpose: To evaluate the efficacy and toxicity of gemcitabine (2',2'-difluo rodeoxycytidine) plus cisplatin in previously untreated patients with advan ced transitional-cell carcinoma. Patients and Methods: Thirty-one patients with measurable advanced transiti onal-cell carcinoma who had received no prior chemotherapy for metastatic d isease were scheduled to receive gemcitabine 1,000 mg/m(2) intravenously ov er 30 minutes on days 1, 8, and 15 and cisplatin 70 mg/m(2) over 1 hour on day 2 of a 28-day cycle. Prior adjuvant or neoadjuvant therapy far locally advanced disease was allowed ii this was completed more than 1 year before study entry. Results: There were six complete responses and 10 partial responses in 28 a ssessable patients, for an overall response rate of 16 of 28 (57%). The res ponse rate on an intent-to-treat basis was 16 of 31 patients (52%). The med ian survival is 13.2 months, with 18 patients still alive at this time. Tox icity war primarily hematologic, with 12 of 31 patients (39%) having greate r than or equal to grade 3 granulocytopenia and 17 of 31 (55%) having great er than or equal to grade 3 thrombocytopenia, Two patients had febrile neut ropenia. All patients required a dose modification of gemcitabine at some p oint in their therapy: the primary reason was thrombocytopenia and/or neutr openia, Conclusion: Gemcitabine plus cisplatin is an active regimen for the treatme nt of urothelial cancer. (C) 1999 by American Society of Clinical Oncology.