5-Fluorouracil, leucovorin and interferon alpha 2b in advanced pancreatic cancer: A pilot study

Background: On the basis of data suggesting the possibility of maximizing the efficacy of 5-FU by LV and IFN, a pilot clinical trial was initiated in advanced pancreatic cancer. Patients and methods: Twenty-four patients received weekly 5-FU 600 mg/m2 bolus 1 hour after the initiation of a 2-hour infusion of 500 mg/m2 of leucovorin. Three MU of interferon alpha 2b was administered subcutaneously three times a week. Results: Two of 22 evaluable patients obtained partial responses (8%, confidence interval 3%–33%). Toxicity was severe. Diarrhea and stomatitis were the most common side effects, occuring in 50% and 25% of patients, respectively. Conclusion: Because of the presence of severe toxicity we suggest that further clinical trials in pancreatic cancer be attempted only after a better definition in preclinical studies of interactions among 5-FU, leucovorin and interferon.