Abstract | PURPOSE: To test the hypothesis that risk factors related to lifetime estrogen exposure predict breast cancer incidence and to test if any subgroups experience enhanced benefit from raloxifene. PATIENTS AND METHODS: Postmenopausal women with osteoporosis (N = 7,705), enrolled onto the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, were randomly assigned to receive placebo, raloxifene 60 mg/d, or raloxifene 120 mg/d for 4 years. Breast cancer risk was analyzed by the following baseline characteristics indicative of estrogen exposure: previous hormone replacement therapy, prevalent vertebral fractures, family history of breast cancer, estradiol level, bone mineral density (BMD), body mass index, and age at menopause. Therapy-by-subgroup interactions were assessed using a logistic regression model. RESULTS: Overall, women with the highest one-third estradiol levels (> or = 12 pmol/L) had a 2.07-fold increased invasive breast cancer risk compared with women with lower levels. Raloxifene significantly reduced breast cancer risk in both the low- and high- estrogen subgroups for all risk factors examined (P <.05 for each comparison). The women with the highest BMD and those with a family history of breast cancer experienced a significantly greater therapy benefit with raloxifene, compared with the two thirds of patients with lower BMD or those without a family history, respectively; the subgroup-by- therapy interactions were significant (P =.005 and P =.015, respectively). CONCLUSION:
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Authors | M E Lippman, K A Krueger, S Eckert, A Sashegyi, E L Walls, S Jamal, J A Cauley, S R Cummings |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 19
Issue 12
Pg. 3111-6
(Jun 15 2001)
ISSN: 0732-183X [Print] United States |
PMID | 11408508
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Estrogens
- Selective Estrogen Receptor Modulators
- Raloxifene Hydrochloride
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Topics |
- Aged
- Aged, 80 and over
- Breast Neoplasms
(epidemiology, etiology, prevention & control)
- Double-Blind Method
- Estrogens
(adverse effects, metabolism, physiology)
- Female
- Humans
- Incidence
- Middle Aged
- Osteoporosis
(drug therapy)
- Postmenopause
- Raloxifene Hydrochloride
(pharmacology, therapeutic use)
- Risk
- Risk Factors
- Selective Estrogen Receptor Modulators
(pharmacology, therapeutic use)
- Treatment Outcome
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