Irinotecan with 5-FU/FA in advanced biliary tract adenocarcinomas: a multicenter phase II trial.
OBJECTIVE
Biliary cancer has a poor prognosis and lacks a standard palliative chemotherapy. The purpose of this prospective single-arm phase II study was to determine the activity and tolerability of irinotecan, 5-fluorouracil, and folinic acid in advanced biliary cancer.


METHODS
Patients with inoperable intrahepatic cholangiocarcinoma (ICC) or gallbladder cancer (GBC) and no prior chemotherapy were eligible. Irinotecan 80 mg/m2, followed by folinic acid 500 mg/m2 and 5-FU 2000 mg/m2 infused over 24 hours (Fufiri) were administered weekly 6 times, every 8 weeks. The primary endpoint was response rate, and secondary endpoints were overall survival (OS), progression-free survival (PFS), and toxicity.


RESULTS
Seventeen patients with ICC and 13 patients with GBC were enrolled. All patients were evaluable for safety. WHO grade 3/4 drug-related adverse events occurred in 8 patients (27%), consisting of diarrhea and leukopenia in 5 and 3 patients, respectively. One patient with diarrhea grade 4 finally succumbed to sepsis. Objective response rate was 10% (95% confidence interval, 2.1%-26.5%), with an additional 10% of patients showing stable disease. Median overall survival was 166 days and 273 days, and median progression-free survival was 84 days and 159 days for ICC and GBC, respectively.


CONCLUSIONS
Fufiri is a well-tolerated regimen in patients with ICC and GBC but has only modest activity in advanced biliary tract cancer.
Feisthammel
Jürgen
J
Department of Internal Medicine II, University of Leipzig, Leipzig, Germany.
Schoppmeyer
Konrad
K
Mössner
Joachim
J
Schulze
Manfred
M
Caca
Karel
K
Wiedmann
Marcus
M
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005492:Folic Acid / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D014803:Vitamin B Complex / Q000627:therapeutic use
D000970:Antineoplastic Agents; D014803:Vitamin B Complex; D000077146:Irinotecan; D005492:Folic Acid; D005472:Fluorouracil; D002166:Camptothecin