Flutamide in unresectable pancreatic adenocarcinoma: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
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.
Negi
Sanjay Singh
SS
Department of Gastrointestinal Surgery, Gobind Ballabh Pant Hospital, University of Delhi, New Delhi-110002, India.
Agarwal
Anil
A
Chaudhary
Adarsh
A
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005485:Flutamide / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D047368:Tumor Burden / Q000187:drug effects
D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D005485:Flutamide