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Effects of raloxifene on sex steroid hormones and C-telopeptide in postmenopausal women with primary breast cancer

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Summary

Within a multicentric, double-blind, placebo-controlled phase II trial, postmenopausal women with primary breast cancer were randomized to either 60 or 600 mg daily of raloxifene or placebo administered for 2 weeks prior to surgery. Circulating levels of sex-hormone binding globulin (SHBG), dehydroepiandrosterone-sulfate (DHEA-S), estrone (E1), estrone-sulfate (E1-S), estradiol (E2), and C-terminal telopeptide (CTX), were determined at baseline and the day before surgery in 37 women enrolled at the European Institute of Oncology in Milan. Raloxifene had a statistically significant different effect compared with placebo on SHBG (p<0.001) and E2 (p=0.03), without any dose–response relationship. Women on raloxifene (n=26) showed an increase from baseline of 10.7% (inter-quartile range: 5.9; 24.2) in SHBG and of 1.3% (inter-quartile range: −8.0; 24.5) in E2, whereas women on placebo (n=11) showed a decrease by 15.5% (inter-quartile range: 7.9; 18.1) and 17.3% (inter-quartile range: 6.5; 40.0), respectively. No significant differences were found on the other variables. A positive correlation was observed between DHEA-S and E1-S (p=0.001) or E2 (p<0.001), while SHBG correlated negatively with E1-S (p=0.024) and E2 (p=0.01), and positively with DHEA-S (p=0.016) and CTX (p=0.040). Our results provide evidence for an early endocrine effect of raloxifene which further suggests a favorable impact on breast cancer prevention.

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Acknowledgements

The multicentric study was supported by Eli Lilly (Indianapolis, IN, USA), but the company was not involved in this substudy. The Division of Chemoprevention is partially supported by the Italian Foundation for Cancer Research (FIRC).

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Authors and Affiliations

  1. Division of Chemoprevention, European Institute of Oncology, Milan, Italy

    Harriet Johansson, Bernardo Bonanni, Frederique Mariette, Massimiliano Cazzaniga, Aliana Guerrieri-Gonzaga & Andrea Decensi

  2. Laboratory Medicine, European Institute of Oncology, Milan, Italy

    Maria Teresa Sandri

  3. Division of Breast Surgery, European Institute of Oncology, Milan, Italy

    Alberto Luini

  4. Division of Pathology, European Institute of Oncology, Milan, Italy

    Giuseppe Pelosi

  5. University of Milan School of Medicine, Milan, Italy

    Giuseppe Pelosi

  6. Cancer Epidemiology Centre, The Cancer Council Victoria, Melbourne, Australia

    Laura Baglietto

  7. Division of Medical and Preventive Oncology, Galliera Hospital, Genoa, Italy

    Andrea Decensi

  8. Division of Chemoprevention, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy

    Andrea Decensi

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  1. Harriet Johansson
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Correspondence to Andrea Decensi.

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Johansson, H., Bonanni, B., Mariette, F. et al. Effects of raloxifene on sex steroid hormones and C-telopeptide in postmenopausal women with primary breast cancer. Breast Cancer Res Treat 98, 167–172 (2006). https://doi.org/10.1007/s10549-005-9145-0

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