Bone Mineral Density and Lipid Changes During 5 Years of Follow-up in a Study of Prevention of Breast Cancer with Toremifene in Healthy, High-risk Pre- and Post-menopausal Women
| Autor: | T. J. Powles, Jorma Heikkinen, Leena Mattila, Mika Mustonen, B Toivola, P Korhonen, Risto Erkkola |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Selective Estrogen Receptor Modulators Cancer Research medicine.medical_specialty Bone density Urology Blood lipids Breast Neoplasms Pilot Projects Breast cancer Double-Blind Method Bone Density Internal medicine medicine Humans Toremifene Finland Triglycerides Bone mineral Analysis of Variance Dose-Response Relationship Drug business.industry Middle Aged medicine.disease United Kingdom Postmenopause Cholesterol Endocrinology Premenopause Oncology Selective estrogen receptor modulator Chemoprophylaxis Female business Tamoxifen medicine.drug |
| Zdroj: | Breast Cancer Research and Treatment. 93:277-287 |
| ISSN: | 1573-7217 0167-6806 |
| DOI: | 10.1007/s10549-005-5701-x |
| Popis: | A double-blind, randomised, placebo-controlled pilot study was initiated to evaluate the feasibility of chemoprevention with toremifene 60 mg/day in healthy women at high risk for breast cancer. Enrolment in the study was terminated earlier than planned because of slow patient accrual, although 13% of patients continued for 5 years. The revised efficacy outcomes were change in bone mineral density (BMD) from baseline at four skeletal sites, plus effects on serum lipids. In premenopausal women there was a trend for sustained increase in BMD during toremifene therapy after year 1 in lumbar spine. In postmenopausal women, toremifene had little or no effect on BMD trends. Levels of total and low-density lipoprotein (LDL) cholesterol were largely unchanged from baseline in premenopausal women treated with toremifene but were often slightly lower than in the placebo group during follow-up. Total and LDL cholesterol levels declined slightly from baseline in the postmenopausal women and were, at several points during the first 3 years, significantly lower than in the corresponding placebo group (p < 0.01). We conclude that: (a) assessment of toremifene 60 mg/day in chemoprevention will require further clinical trials; (b) toremifene 60 mg/day has no substantive negative effects on BMD in pre- or postmenopausal women and may exert a minor favourable influence (in particular, the effects of toremifene 60 mg/day on BMD in premenopausal women may make the drug an attractive alternative to tamoxifen 20 mg/day for that patient subset); (c) lipid effects of toremifene 60 mg/day are, at minimum, neutral and may be modestly favourable for reducing cardiovascular risk. |
| Databáze: | OpenAIRE |
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