Chimiothérapie des adénocarcinomes du pancreas non résécables par 5-fluorouracile, acide folinique et cisplatine (LV5FU2-P)

Aim - To prospectively evaluate efficacy and tolerance of the 5-fluorouracil + folinic acid + cisplatin (LV5FU2-P) combination in the treatment of unresectable pancreatic carcinoma. Patients and methods - Between March 1998 and June 2000, 35 patients, mean age 61 years (37-75), with advanced (n = 2) or metastatic (n = 33) pancreatic cancer and initial performance status (WHO) of 0 (n = 9), 1 (n = 14) or 2 (n = 12) were enrolled in the study. Two consecutive groups of patients were treated twice monthly, the first group (n = 19) received the LV5FU2 regimen: a 2 hour-infusion of leucovorin 200 mg/m², 5-FU bolus 400 mg/m², followed by 22-hour continuous infusion of 5-FU 600 mg/m² on 2 consecutive days and cisplatin 50 mg/m² on day 2. The second group (n = 16) received a simplified schedule with bolus leucovorin 40 mg/m², 5-FU bolus 400 mg/m² on day 1, followed by 5-FU 2400 mg/m² 48-hour infusion and cisplatin 50 mg/m² on day 2. Clinical symptoms and performance status were monitored together with weight changes. Tumor assessment was performed every 2 months. Results - Three patients (9%) exhibited grade 4 neutropenia and grade 3 toxicity occurred in 31% of the patients (neutropenia: n = 3, thrombocytopenia: n = 1, vomiting: n = 3, mucositis: n = 3, diarrhea: n = 1). There were no treatment-related deaths. Objective response was observed in 10 patients (29%, 95% confidence interval: 20-40%) including one complete response. Median progression-free survival and overall survival were 4.5 and 9 months, respectively. Six-months and 1-year survival rates were 70% and 25%, respectively. Weight gain was observed in 40% of the patients and performance status improved in 50%. Conclusion - LV5FU2-P regimen is active and well tolerated. It should be compared to gemcitabine as a first line therapy in advanced and metastatic pancreatic cancer.