WEEKLY 24 H INFUSION OF HIGH-DOSE 5-FLUOROURACIL AND LEUCOVORIN IN PATIENTS WITH BILIARY-TRACT CARCINOMAS

From October 1995 to June 1997, 19 chemotherapy-naive patients with pa thology-proven locally advanced or metastatic biliary tract carcinomas (BTC) were enrolled. The regimen consisted of 5-fluorouracil (5-FU) 2 600 mg/m(2) and leucovorin (LV) 150 mg by weekly 24 h infusion for 6 w eeks and followed by a 2 week break. The treatment was terminated if d isease progressed, the patient refused or unacceptable toxicity occurr ed. All patients required a Port-A catheter insertion and were treated at outpatient clinics by portable infusion pumps. There were 12 males and seven females with a median age of 62 years (range 45-77). The pr imary tumor sites were nine intrahepatic cholangiocarcinomas (CC), thr ee perihilar CC, one distal BTC and six gallbladder cancers. A total o f 179 chemotherapy sessions were given with a mean of 9.5 (range 2-18) . Eighteen patients were evaluable for response. The response rates we re: 33% (six of 18) partial response (PR), 39% (seven of 18) stable di sease (SD) and 28% (five of 18) progressive disease (PD). All of the p atients were evaluable for toxicity. The most common toxicities were m ild fatigue (nine of 19, 47%), loss of appetite (nine of 19, 47%), ski n hyperpigmentation (five of 19, 26%) and diarrhea (two of 19, 11%). O nly one patient had grade IV myelotoxicity with sepsis but without tre atment-related death. The median time to progression was 4 months. The overall median survival time was 7.0 months. The median survival time of the PR was not reached, SD was 8.0 months and PD 3.5 months. In co nclusion, weekly high-dose 5-FU with LV by 24 h infusion in an outpati ent setting for patients with BTC is effective, only mildly toxic and deserves further study. [(C) 1998 Lippincott-Raven Publishers.].