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Background/aims: To clarify the efficacy and toxicity of cisplatin, epirubicin, and continuous infusion of 5-FU (CEF therapy) in patients with advanced intrahepatic cholangiocellular carcinoma (ICC)., Methodology: Chemo-naïve patients with advanced ICC were treated with cisplatin at 80 mg/m2 and epirubicin at 50 mg/m2 on day 1, and continuous infusion of 5-FU at 500 mg/m2/day on days 1 through 5. If there was no evidence of tumor progression or unacceptable toxicity, the treatment was repeated every 4 weeks, up to a maximum of 6 courses., Results: Thirty-nine patients were enrolled in this study. The median number of courses was 2 (range, 1-6). A partial response was obtained in 4 patients (10%) with a median duration of 2.3 months. Twenty-seven patients (69%) showed no change, and 7 patients (18%) had progressive disease. The median survival time was 9.1 months and the 1-year survival rate was 23%. The progression-free survival time was 5.1 months. Grade 3 to 4 adverse effects were leukocytopenia (51%), neutropenia (74%), thrombocytopenia (23%), and nausea/vomiting (10%). Most of the toxicities were reversible, but 2 patients died of neutropenic sepsis., Conclusions: CEF therapy has marginal antitumor activity against advanced ICC, although hematological toxicity is the major and most frequent toxicity.

There are a variety of tumor markers used for diagnosis of pancreatic and biliary tract cancer including carbohydrate antigens such as CA19-9, DUPAN-2, CA50 and Span-1, the carcinoembryonic antigen and pancreatic enzymes such as elastase 1. The tumor marker kinetics in serum help to predict survival in patients receiving surgical and/or non-surgical treatment. Since each of those tumor markers remains at a low sensitivity and specificity in the early stage, none are useful for detecting early cancer. In spite of the development of various diagnostic techniques, pancreas and biliary tract cancer is usually diagnosed at an incurable stage, and the 5-year survival rate is extremely low. Therefore, improvements in survival may well result from screening for early-stage pancreatic and biliary cancer. The development of tumor markers with higher sensitivity and specificity should have the highest priority.