Optimization of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of leucovorin, 5-FU and cisplatin (LV5FU2-P regimen) in patients with biliary tract carcinoma

• Published in: Annals of oncology Vol. 13; no. 8; pp. 1192 - 1196
• Main Authors: Taïeb, J., Mitry, E., Boige, V., Artru, P., Ezenfis, J., Lecomte, T., Clavero-Fabri, M. C., Vaillant, J. N., Rougier, P., Ducreux, M.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.08.2002
• Subjects: 5-fluorouracil; Adenocarcinoma - drug therapy; Adenocarcinoma - secondary; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biliary Tract Neoplasms - drug therapy; Biliary Tract Neoplasms - pathology; Biological and medical sciences; Chemotherapy; Cholangiocarcinoma - drug therapy; Cholangiocarcinoma - pathology; cisplatin; Cisplatin - administration & dosage; Female; Fluorouracil - administration & dosage; Gastrointestinal Diseases - chemically induced; Humans; Key words: biliary tract carcinoma; Leucovorin - administration & dosage; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Medical sciences; Middle Aged; Neutropenia - chemically induced; Pharmacology. Drug treatments; Prospective Studies; Survival Rate; Thrombocytopenia - chemically induced; Treatment Outcome; Antineoplastic agent; Biliary tract; Carcinoma; Intravenous administration; Toxicity; Hepatic disease; Calcium folinate; Biliary tract disease; Phase II trial; Advanced stage; Fluorouracil; Platinum II Complexes; Human; Drug combination; Enzyme; Transferases; Treatment efficiency; Fluoropyrimidine derivatives; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Cisplatin; Alkylating agent; Chemotherapy; Treatment; Methyltransferases; Antimetabolic; Digestive diseases; Pyrimidine derivatives; Metastatic; Treatment planning
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdf201

Background: Unresectable biliary tract carcinoma (BTC) is associated with a very poor prognosis. To improve efficacy and tolerance of the 5-fluorouracil (5-FU)/cisplatin combination in BTC, we designed a new therapeutic schedule, the LV5FU2-P regimen. Patients and methods: Twenty-nine patients with advanced or metastatic BTC were prospectively enrolled in the study. The treatment (LV5FU2-P regimen) consisted of a biweekly administration of a 2‐h infusion of leucovorin 200 mg/m2, a 400 mg/m2 bolus of 5-FU followed by a 22-h continuous infusion of 600 mg/m2 5-FU on two consecutive days and cisplatin 50 mg/m2 on day 2. Clinical symptoms, performance and weight changes were monitored. Results: Objective responses were observed in 10 patients (34%) (95% confidence interval 23% to 45%) including one complete response and nine partial responses (stabilization 38%, progression 28%). Median progression-free survival and overall survival were 6.5 and 9.5 months, respectively. Weight gain was observed in 45% of patients and performance status improved in 60%. One patient had a grade 4 thrombocytopenia, and grade 3 toxicity occurred in 41% of patients. There were no treatment-related deaths. Conclusions: This study, one of the largest phase II trials performed for this disease, shows that the LV5FU2-P regimen is an active and well-tolerated chemotherapy for advanced and metastatic BTC.