ISSN:
1569-8041
Keywords:
breast cancer
;
clinical efficacy
;
endocrine activity
;
vorozole
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Background: Aminoglutethimide was the first aromatase inhibitor to beused successfully in breast cancer patients. However, this drug alsoinhibits mineralcorticoid and glucocorticoid synthesis, making co-medicationwith corticosteroids necessary, and it is often poorly tolerated. Theprimary objective of this trial was to evaluate the clinical efficacy andtolerability of vorozole, a new non-steroidal oral aromatase inhibitor, inpostmenopausal breast cancer patients. The secondary objective was toevaluate the pharmacodynamic activity of the drug. Subjects and methods: Thirty-four postmenopausal patients previouslytreated with tamoxifen in the adjuvant setting and/or for advanced diseasewere treated with vorozole, 2.5 mg once daily. Patients were monitored withrespect to treatment efficacy and safety. Hormonal evaluations wereperformed at baseline and during the course of treatment in order toevaluate the pharmacodynamic efficacy and safety of vorozole. Results: According to UICC criteria, there were seven responders, onecomplete and six partial, for an overall response rate of 21%(95% confidence interval (CI) 9%–38%). The medianduration of response was 9.6 months (95% CI 4.6–0), the mediantime to progression for the entire group was 4.7 months (95% CI2.9–6.6) and the median survival time was 29.7 months (95% CI19.1–0). Tolerability was excellent to good in 97% of thepatients. Oestradiol and oestrone levels were suppressed to the limit ofdetection of the assays used. No effect was observed on the other endocrineparameters. Conclusions: Our results suggest that vorozole is an effective and safedrug for the treatment of advanced postmenopausal breast cancer followingtamoxifen failure.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008292329569
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