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Investigational New Drugs

, Volume 24, Issue 3, pp 189–194 | Cite as

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

  • Sanjay Singh Negi
  • Anil Agarwal
  • Adarsh Chaudhary
Preclinical Studies

Summary

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.

Key Words

pancreatic neoplasms androgen antagonists flutamide survival rate treatment outcome 

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Copyright information

© Springer Science + Business Media, LLC 2005

Authors and Affiliations

  • Sanjay Singh Negi
    • 1
  • Anil Agarwal
    • 1
  • Adarsh Chaudhary
    • 1
  1. 1.Department of Gastrointestinal Surgery, Gobind Ballabh Pant HospitalUniversity of DelhiNew DelhiIndia

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