P3-11-04: A Randomized Phase II Biomarker Study of Atorvastatin in Premenopausal Women at Increased Risk for Breast Cancer

Autor: SS Grubs, J. A. Ellerton, Hyman B. Muss, Marie E. Wood, F. Kingsley, James N. Atkins, Judy Garber
Rok vydání: 2011
Předmět:
Zdroj: Cancer Research. 71:P3-11
ISSN: 1538-7445
0008-5472
Popis: Statins have been shown in epidemiological and laboratory studies to have breast cancer risk reduction properties. We evaluated the effect of atorvastatin on breast mammographic density (MD) and other breast cancer biomarkers in a small randomized placebo controlled trial. Methods: Premenopausal women at increased risk for breast cancer (due to family history, BRCA positivity, prior biopsy history or history of chemoradiotherapy for Hodgkins disease) enrolled after signing informed consent and received either 40 mg of atorvastatin or placebo daily for 1 year. Biomarker assessment was performed prior to initiation and prior to completion of study medication. MD was determined using both Breast Imaging Reporting and Data System (BI-RADS) and the Visual Analogue Scale (VAS). Results: 63 women were enrolled between 7/05 - 8/10 in this multi-institutional trial. 44 have completed study medication and 3 remain on study. 25% have withdrawn; 17% of them for toxicity/side effects. Of those completing the study; mean age was 47 (range 35–50), 96% Caucasian, mean BMI 26.8. 66% had a strong family history (2% were BRCA+), 27.7% had ADH/LCIS. We present analysis of MD in the first 37 women completing study drug. The two treatment groups were well balance for age, BMI, risk factors and baseline density. Mean density by VAS was 31.6% at study entry and 32.4% at end of treatment. There was no different in change in density over time between atorvastatin and placebo using either BIRAD or VAS; controlling for BMI did not change results. Futility analysis demonstrates low probability of a significant difference between treatment groups and the study was closed. Conclusions: In this multi-institutional randomized prospective clinical trial of premenopausal women at increased risk for breast cancer we have failed to demonstrate a significant effect of atorvastatin on mammographic density. There are several possible reasons for this relating to: the study population, method of density determination and/or biomarker analyzed. While the primary aim of this study (MD) was not met we have shown that biomarker studies can be done in a multi-institutional setting. Further biomarker evaluation may prove informative. Funding: This study is sponsored by grants from Breast Cancer Research Foundation and Cancer and Leukemia Group B to M. Wood. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-11-04.
Databáze: OpenAIRE
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