Authors: Erkkola, R.¹; Mattila, L.²; Powles, T.³; Heikkinen, J.⁴; Toivola, B.²; Korhonen, P.²; Mustonen, M.⁵

Source: Breast Cancer Research and Treatment, Volume 93, Number 3, October 2005 , pp. 277-287(11)

Publisher: Springer

Abstract:

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.

Keywords: anti-oestrogen; bone mineral density; chemoprevention; cholesterol; early termination; toremifene

Document Type: Research article

DOI: http://dx.doi.org/10.1007/s10549-005-5701-x

Affiliations: 1: Department of Obstetrics and Gynaecology, Turku University Central Hospital, Turku, Finland, 2: Orion Corporation Orion Pharma, Espoo, Finland, 3: The Royal Marsden Hospital, Breast Unit Downs Road, Sutton, UK, 4: Osteoporosis Clinic, Oulu Deaconess Institute, Oulu, Finland, 5: Orion Corporation Orion Pharma, Espoo, Finland, Email: mika.mustonen@orionpharma.com

Publication date: 2005-10-01

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• In this Subject: Obstetrics & Gynecology ,  Oncology
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