title: Phase II trial of cisplatin, 5-fluorouracil, and interferon-alpha-2B as first line treatment of advanced urothelial cancer.
abstract: Cisplatin based combination chemotherapy remains the mainstay for treatment of advanced urothelial cancer. The combination of 5-fluorouracil and interferon has been found to be effective second line treatment of advanced urothelial cancer. Hence, we tested the combination of cisplatin, 5-fluorouracil and interferon as first line therapy in advanced urothelial cancer. Eligible patients had to have no prior chemotherapy or interferon. Treatment consisted of cisplatin 80 mg/m(2) on day one, followed by 5-fluorouracil 750 mg/m(2) as a daily infusion for 5 days and interferon alpha 2 B 5 MU/m(2) subcutaneously daily on day 1-5 of 5-fluorouracil infusion. Cycles repeated every 21 days. Eighteen patients, of which sixteen were males were enrolled. Median age was 60 years. All patients had transitional-cell carcinoma. The median number of cycles given was 4. Thirteen patients were evaluable for response. Two patients achieved CR and 3 PR for an overall response rate of 28% (95% confidence interval 7% to 49%). Median response duration was 8.3 months. Median survival was 5.5 months. Four patients died secondary to chemotherapy toxicities. Those were GI perforation in one, bronchopneumonia in one, acute renal failure in one and one patient died at home 3 weeks following the third cycle. The above regimen demonstrates excessive toxicity and moderate activity. It cannot be recommended in its present format. Novel anti-cancer agents need to explored.
authors.affiliation: Department of Oncology, King Faisal Specialist Hospital and Research Centre, PO Box 3354, Riyadh, Saudi Arabia. bazarbashi@kfshrc.edu.sa
authors.forename: Shouki
authors.initials: S
authors.lastname: Bazarbashi
authors.forename: Chandrashaker
authors.initials: C
authors.lastname: Pai
authors.forename: Madras A
authors.initials: MA
authors.lastname: Raja
authors.forename: Mohammad
authors.initials: M
authors.lastname: Rahal
authors.forename: Adnan
authors.initials: A
authors.lastname: Ezzat
authors.forename: Kamal
authors.initials: K
authors.lastname: Hanash
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001996:Bronchopneumonia / Q000209:etiology; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D007416:Intestinal Perforation / Q000139:chemically induced; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016879:Salvage Therapy; D016019:Survival Analysis; D017211:Treatment Failure; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002945:Cisplatin; D005472:Fluorouracil