title: Phase II trial of ifosfamide, fluorouracil, and folinic acid (FIFO regimen) in relapsed and refractory urothelial cancer.
abstract: There is no known effective salvage chemotherapy for patients with refractory or relapsed urothelial tumors after methotrexate/cisplatin-based regimen. We report the results of a phase II trial with the FIFO regimen that includes from day 1 to 5: fluorouracil 350 mg/m2, folinic acid 20 mg/m2, and ifosfamide 1000 mg/m2, Q4W. Fifteen patients with metastatic measurable urothelial cancer were enrolled in this trial. Previous therapy included M-VAC regimen in 11 patients, CMV regimen in 3 patients, and both regimens in 1 patient. Thirty-one courses were delivered. Toxicity was moderate, including encephalopathy grade 2 in 2 patients and hematological toxicity grade 3 in 2 others. However, an early death occurred on day 1 in a patient who progressed rapidly and died from hepatic insufficiency after initial encephalopathy. No objective response was seen. Twelve patients progressed during FIFO therapy and 3 patients experienced a stable disease. Despite almost encouraging results of fluorouracil and ifosfamide in the literature, their combination according to our schedule is not active in urothelial cancer.
authors.affiliation: Department of Medicine, Institut Gustave Roussy, Villejuif, France.
authors.forename: J
authors.initials: J
authors.lastname: Kattan
authors.forename: S
authors.initials: S
authors.lastname: Culine
authors.forename: C
authors.initials: C
authors.lastname: Theodore
authors.forename: J P
authors.initials: JP
authors.lastname: Droz
mesh_terms: D000310:Adrenal Gland Neoplasms / Q000188:drug therapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000556:secondary*; D005472:Fluorouracil / Q000008:administration & dosage; D006501:Hepatic Encephalopathy / Q000209:etiology; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy / Q000556:secondary; D016879:Salvage Therapy; D017211:Treatment Failure; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D007069:Ifosfamide