Flutamide in unresectable pancreatic adenocarcinoma: A randomized, double-blind, placebo-controlled trial

Abstract

Purpose: To evaluate the impact of flutamide on survival of patients with unresectable pancreatic cancer. Methods: This single institution, randomized, double-blind, placebo controlled study compared flutamide in the dose of 250 mg three times daily (n = 23) versus placebo (n = 23) in patients with histologically proven, previously untreated unresectable pancreatic adenocarcinoma. The primary end point was overall survival; secondary endpoints included 6-month and 1-year survival rates, performance status and response rate. Results: Both the groups were well matched with regards to demographic, disease related and treatment variables. This small sample sized study, failed to demonstrate a dramatic effect on survival with the use of flutamide. Median overall survival was 151 days with the use of flutamide as compared to 136 with placebo (p = 0.51). The 6-month survival rate was 39.13% in both arms of study and 1-year survival was 4.35% versus 13.04% for the flutamide group. There was no statistically significant difference in time to deterioration of performance status (flutamide 90 days versus placebo 68 days, p = 0.59) and all patients died as a result of tumor progression. Conclusions: Anti-androgen drug flutamide in the dose of 250 mg three times daily does not appear to prolong overall survival in unresectable pancreatic cancer. © 2005 Springer Science + Business Media, LLC.