Irinotecan with 5-FU/FA in advanced biliary tract adenocarcinomas: a multicenter phase II trial.

Abstract

OBJECTIVES:

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.

PATIENTS AND 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.

• Authors: Jürgen Feisthammel, Konrad Schoppmeyer, Joachim Mössner, Manfred Schulze, Karel Caca, Marcus Wiedmann
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 30 Issue 3 Pg. 319-24 (Jun 2007) ISSN: 1537-453X [Electronic] United States
• PMID: 17551313 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents
• Vitamin B Complex
• Irinotecan
• Folic Acid
• Fluorouracil
• Camptothecin

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Biliary Tract Neoplasms (drug therapy)
• Camptothecin (analogs & derivatives, therapeutic use)
• Female
• Fluorouracil (therapeutic use)
• Folic Acid (therapeutic use)
• Humans
• Irinotecan
• Male
• Middle Aged
• Survival Analysis
• Vitamin B Complex (therapeutic use)