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Selective aromatase inhibition for patients with androgen-independent prostate carcinoma : A Phase II study of letrozole

✍ Scribed by Matthew R. Smith; Donald Kaufman; Daniel George; William K. Oh; Maryanne Kazanis; Judith Manola; Philip W. Kantoff


Publisher
John Wiley and Sons
Year
2002
Tongue
English
Weight
61 KB
Volume
95
Category
Article
ISSN
0008-543X

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✦ Synopsis


Background:

First and second-generation aromatase inhibitors have shown activity in patients with androgen-independent prostate carcinoma. these early-generation aromatase inhibitors are nonselective, however, and inhibition of other steroidogenic enzymes may contribute to their reported clinical activity. the authors conducted a phase ii clinical study of letrozole to determine the safety and efficacy of a potent and selective third-generation aromatase inhibitor in men with androgen-independent prostate carcinoma.

Methods:

Forty-three men with androgen-independent prostate carcinoma were treated with oral letrozole (2.5 mg daily). treatment was continued until progressive disease or grade 3 toxicity developed. response and progressive disease were defined according to recommendations of the prostate specific antigen working group.

Results:

In total, 380 weeks of treatment were administered to the 43 study patients. the median duration of treatment was 8 weeks. forty men discontinued treatment due to progressive disease. only one patient responded to treatment with a sustained decrease > 50% in serum prostate specific antigen (psa) levels. three other patients experienced transient minor decreases (< 50%) in serum psa levels. there were no serious treatment-related adverse events.

Conclusions:

Selective aromatase inhibition with letrozole is not active in men with androgen-independent prostate carcinoma.


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