Objective: Response rates to systemic chemotherapy for unresectable pancreatic cancer are low. The purposes of this phases 1 and 2 study of intraarterial therapy were to ascertain the recommended dose of intraarterial chemoinfusion and to evaluate the efficacy and safety of this therapy.
Subjects and methods: Pancreatic arteries originating from the superior mesenteric artery (the anterior and posterior inferior pancreaticoduodenal and the dorsal pancreatic) were embolized to achieve a single blood supply from the celiac artery to manage pancreatic cancer, and a catheter-port system was placed. Intraarterial 5-fluorouracil (5-FU) and IV gemcitabine (fixed dose of 1000 mg/m(2)) were administered. In phase 1, doses of 5-FU were increased from 750 to 1000 mg/m(2). In phase 2, tumor response, toxicity, and survival time were assessed.
Results: A total of 20 patients were enrolled. In 19 patients (95%), the technique to unify the pancreatic blood supply was successful. No severe toxicity was observed with escalation of the 5-FU dose. The tumor response rate was 68.8%. The median overall survival time was 9.8 months and the progression-free survival time, 6.0 months. The grade 3 toxicities neutropenia (15.8%) and thrombocytopenia (5.3%) occurred.
Conclusion: In intraarterial administration of 5-FU at a dose of 1000 mg/m(2) combined with full-dose systemic gemcitabine for unresectable pancreatic cancer, the toxicity rate was acceptable, and response rate and survival time improved over those for treatment with gemcitabine alone.