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Annals of Oncology 13:1192-1196, 2002
© 2002 European Society for Medical Oncology

Original Paper

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

J. Taïeb1,+, E. Mitry2, V. Boige1, P. Artru2, J. Ezenfis1, T. Lecomte2, M. C. Clavero-Fabri2, J. N. Vaillant2, P. Rougier2 and M. Ducreux1

1 Département de Médecine, Institut Gustave Roussy, Villejuif; 2 Service d’Hépato-Gastro-Entérologie, Hôpital A. Paré, Boulogne, France

Received 9 October 2001; revised 1 February 2002; accepted 26 February 2002

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.

Key words: biliary tract carcinoma, chemotherapy, cisplatin, 5-fluorouracil


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