Literature DB >> 16133790

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

Sanjay Singh Negi1, Anil Agarwal, Adarsh Chaudhary.   

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.

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Year:  2006        PMID: 16133790     DOI: 10.1007/s10637-005-3536-2

Source DB:  PubMed          Journal:  Invest New Drugs        ISSN: 0167-6997            Impact factor:   3.651


  24 in total

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Authors:  Bao-gui Zhang; Tao Du; Ming-de Zang; Qing Chang; Zhi-yuan Fan; Jian-fang Li; Bei-qin Yu; Li-ping Su; Chen Li; Chao Yan; Qin-long Gu; Zheng-gang Zhu; Min Yan; Bingya Liu
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