A phase II study of mitomycin, fluorouracil, folinic acid, and irinotecan (MFI) for the treatment of transitional cell carcinoma of the bladder.

Background and objectives: Cisplatin-based chemotherapy is standard care for metastatic transitional cell carcinoma (TCC) of the urinary tract. However it is not appropriate for all patients, particularly those with poor renal function. There is no clear consensus on the optimal regimen for these individuals or for those after cisplatin failure. Here we present data using mitomycin, 5-fluorouracil, and irinotecan (MFI) in these patients. Materials and methods: Patients with TCC, who had either received cisplatin-based chemotherapy previously or who were not deemed fit for cisplatin therapy (creatinine clearance was less than 60 ml/min) were eligible for treatment with the experimental combination chemotherapy regimen MFI. Results: Thirty-six patients were treated with MFI between 2001 and 2004. Overall response rate was 19% and median overall survival (OS) was 5.4 months (95% CI 3.3-8.4 months). The response rate and overall survival in both groups was 19% and 5.4 months, respectively, (95% CI 2.9-7.1 months) in the pretreated and 2.5-9.3 months in the untreated. The most common toxicity was malaise (grade 3 or 4 = 28%). Conclusions: MFI appear to be a combination which requires further investigation in patients where cisplatin and gemcitabine are not applicable. (C) 2013 Elsevier Inc. All rights reserved.