PHASE-II TRIAL OF INTRAVENOUS FLUOROURACIL AND SUBCUTANEOUS INTERFERON ALFA-2B FOR BILIARY-TRACT-CANCER

Purpose: To assess the efficacy of systemic intravenous-fluorouracil ( 5-FU) and subcutaneous recombinant human interferon alfa-2b (rlFN alph a-Sb) in patients with measurable cancer of the biliary tree. Patients and Methods: Thirty-five patients (25 with cholangiocarcinoma and 10 with gallbladder carcinoma) were registered onto this phase II protoco l between 1992 and 1995. patients received a continuous infusion of 75 0 mg/m(2)/d of 5-FU on days 1 through 5 through a centrally placed ven ous catheter and a subcutaneous injection of 5 MU/m(2) of rIFN alpha-2 b on days 1, 3, and 5. Treatment cycles were repeated every 14 days; o ne course of therapy included four treatment cycles. Disease status wa s assessed every 8 weeks. Dosages were lowered for grade III mucositis . Fourteen patients had prior treatment and, before initiating this th erapy, 17 patients required decompression of the biliary tree. Results : Eleven of 32 (34%) assessable patients had a partial response. The m edian time to disease progression was 9.5 months, and the median survi val time 12 months. Grade III to IV toxic effects were granulocytopeni a (14%), mucositis (20%), diarrhea (9%), and dermatitis (11%). Grade I II to IV asthenia and fatigue were observed in 6% of patients. Conclus ion: Drug tolerance was better among previously patients. To achieve a complete response, additional chemotherapy or radiotherapy should be considered when liver resection or transplantation is not feasible. Ho wever, if these results can be reproduced by other investigators, the regimen should be studied for adjuvant treatment of gallbladder carcin oma incidentally identified in patients undergoing cholecystectomy. (C ) 1996 by American Society of Clinical Oncology.