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

Background: Gemcitabine-based chemotherapy is a commonly used first-line treatment for patients with pancreatic and biliary tract cancer. However, a standard second-line chemotherapy regimen has yet to be developed after gemcitabine treatment. We attempted to evaluate the efficacy and safety of a combination of continuous 5-fluorouracil, doxorubicin, and mitomycin-C (conti-FAM) as a second-line treatment in pancreatic and biliary tract cancer.

Methods: Patients with advanced pancreatic or biliary tract cancer who were previously treated with gemcitabine-based chemotherapy were enrolled in the study. Chemotherapy was administered as follows: 5-fluorouracil, 800 mg/m2 on days 1 to 5 over 10 hours; mitomycin-C, 8 mg/m2 on day 1; and doxorubicin, 30 mg/m2 on day 1 every 4 weeks.

Results: A total of 31 patients received 95 cycles of chemotherapy. Fifteen of the patients had pancreatic cancer. Eleven of the patients had cholangiocarcinoma. Gallbladder cancer was observed in 5 patients. Four (12.9%) patients evidenced partial responses. Eight patients (25.8%) had 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 to 2 anemia (64.2%), neutropenia (32.6%), thrombocytopenia (20%), and grade 3 to 4 neutropenia (10.5%). The most frequently detected nonhematological toxicities were grade 2 and 3 nausea/vomiting (35.5%). One patient was diagnosed with hemolytic uremic syndrome after 8 cycles of treatment.

Conclusion: The conti-FAM regimen seems to constitute a safe and feasible salvage therapy in patients with advanced bilio-pancreatic cancer who had been treated previously via gemcitabine-based chemotherapy.