A Phase II Trial of Continuous 5-Fluorouracil in Recurrent or Metastatic Transitional Cell Carcinoma of the Urinary Tract

Abstract Aims To assess the activity of a continuous infusion of 5-fluorouracil in patients with recurrent locally advanced or metastatic transitional cell carcinoma of the urinary tract. Materials and methods Eight centres within the UK entered 50 patients into the study. Twenty-four weeks of continuously infused 5-fluorouracil, 300mg/m 2 /day through a mini-pump, were planned. The primary outcome was tumour response at 8 weeks after the start of treatment. Results The median age of the patients was 68 years and 37 (80.4%) had a World Health Organization performance status of 0 or 1. The overall response rate at 8 weeks, according to the response evaluation criteria in solid tumors (RECIST) criteria in 46 evaluable patients, was 15% (95% confidence interval 5–26%) and 20% (95% confidence interval 8–31%) when assessments at all time points were included. The median progression-free survival was 1.9 months (95% confidence interval 1.8–2.7 months) and the median overall survival was 6.5 months (95% confidence interval 4.1–8.5 months). The most frequent grade 3/4 toxicities were mucositis and diarrhoea (each in 6.5% of patients) and nausea/vomiting and hand–foot syndrome (each in 4.3% of patients). Conclusions Continuous infusional 5-fluorouracil has activity in transitional cell carcinoma of the urinary tract. Prolonged fluoropyrimidine administration may be a useful component of future combination regimens for this disease, particularly in patients with poor renal function.