Second-line treatment with a combination of 5-fluorouracil, adriamycin, and mitomycin-C (FAM) in gemcitabine-pretreated pancreatic and biliary tract cancer

15606 Background: Gemcitabine based chemotherapy is regarded as the standard treatment for patients with pancreatic and biliary tract cancer. But a standard second-line chemotherapy regimen has yet to be defined after gemcitabine treatment. We performed to evaluate the efficacy and safety of the combination of 5-fluorouracil (5-FU), adriamycin and mitomycin-C (FAM) as second line treatment in patients with pancreatic and biliary tract cancer. Patients and Methods: Patients with advanced pancreatic or biliary tract cancer previously treated with gemcitabine based chemotherapy were included in the study. Chemotherapy was given as follows: 5-FU, 800 mg/m2 on days 1–5 over 10 hour; mitomycin-C, 8 mg/m2 on day 1; and doxorubicin, 30 mg/m2 on days 1 every 4 weeks. Result: A total of 31 patients received 95 cycles of chemotherapy. 15 patients had pancreatic cancer. 11 patients had cholangiocarcinoma. Gall bladder cancer was observed 5 patients. Four (12.9%) patients evidenced partial responses. Eight patients (25.8%) showed stable disease. The median time to progression and overall survival time were 2.3 (95% CI: 1.0–3.6) months and 6.7 (95% CI: 4.4–9.0) months, respectively. Major hematologic toxicities included grade 1–2 anemia (43.2%), thrombocytopenia (20%), neutropenia (15.7%), and grade 3–4 neutropenia (13.7%). The most frequently detected non-hematological toxicities were grade 2 and 3 nausea/vomiting (31.3%). One patient of hemolytic uremic syndrome was observed after 8 cycles of treatment. Conclusion: The FAM regimen appears a safe and feasible salvage therapy in advanced pancreatic and biliary tract cancer previously treated with gemcitabine based chemotherapy. No significant financial relationships to disclose.