554 Demonstrated efficiency of 5fluorouracil (5FU) continuous infusion (CI) and cisplatin (P) in patients with advanced biliary tract carcinoma

Abstract

Little is known about the efficiency of chemotherapy in advanced biliary tract carcinoma. Accordingly, we conducted a phase II study of combined 5FU CI and P in this disease. 28 patients (pts) (13 M/15 F) were included. Median age: 57 years. ECOG performance status: grade (g) 0;1: 79%, g 2: 18%, g 3: 3%. More than 10% weight loss: 36% Primary tumor: gallbladder: 11, Vater ampulla: 5, cholangiocarcinoma: 5, bile ducts: 7. 25 patients had metastases, 2 had local recurrences of their tumor and 1 a nodulary intrahepatic non resectable form. Sites of the metastases: liver: 12 pts, abdominal lymph nodes: 6 pts, lung: 6 pts, peritoneum: 6 pts, mediastinal lymph nodes: 1 pt. Treatment schedule: 5FU CI: 1g/m² × 5 days, P: 100mg/m² day 2 repeated every 4 weeks. <h3>Results</h3> Median number of cycles: 4. 25 pts are evaluable for the tumor response (1 too early, 2 non evaluable), no complete response, partial response (PR): 8, objective response rate=29% (CI: 12–46%). Minor response: 2, stabilisation: 10, progressive disease: 6. Toxicity was tolerable: g 3 vomiting: 21% of the pts, g 3 mucositis: 4%. Some pts experienced haematological toxicity: g 3 granulocytopenia: 18%, g 4: 4%; no g 3–4 thrombocytopenia. Other toxicities: g 1–2 renal: 3 pts; g 1 neuropathy: 1 pt. No toxic death. Median survival was 10 months and 1-year actuarial survival 33%. We conclude that this regimen is tolerable and active in patients with advanced biliary tract cancer.