PHASE-II STUDY OF SINGLE-AGENT GEMCITABINE IN PREVIOUSLY UNTREATED PATIENTS WITH METASTATIC UROTHELIAL CANCER

Purpose: To determine the activity of single-agent gemcitabine in prev iously untreated patients with metastatic transitional cell cancer. Me thods: Forty patients with measurable disease and a Karnofsky performa nce status greater than or equal to 60% were enrolled at five institut ions between March 1994 and October 1995, Treatment consisted of gemci tabine (1,200 mg/m(2)) administered weekly times three on a 4-week cyc le. One patient was ineligible for response evaluation because patholo gy review showed a metastatic melanoma, Responses were confirmed by al l investigators and an independent radiologist and were maintained for at least 4 weeks. Results: There were four complete and seven partial responses, for an overall response rate of 28%, Responses were seen a t all sites, including liver, Median progression-free and overall surv ival times were 20 and 54 weeks, respectively, Toxicity was mild, with only two grade 4 toxicities. Twenty-five percent of patients experien ced grade 3 neutropenia or thrombocytopenia that was rapidly reversibl e. Conclusion: Gemcitabine exhibits significant activity in metastatic transitional cell cancer with minimal toxicity, but survival remains short, Trials of gemcitabine in combination with other active agents a re thus suggested. (C) 1997 by American Society of Clinical Oncology.