Effect of raloxifene on the incidence of invasive breast cancer in postmenopausal women with osteoporosis categorized by breast cancer risk

Marc E Lippman, Steven R. Cummings, Damon P. Disch, John L. Mershon, Sherie A. Dowsett, Jane A. Cauley, Silvana Martino

Research output: Contribution to journalArticle

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Abstract

Purpose: To assess the effect of raloxifene, indicated for osteoporosis treatment and prevention, on invasive breast cancer in subgroups of postmenopausal women defined by risk factors for breast cancer. Experimental Design: Data from the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial (N = 7,705) and a follow-up study, the 4-year Continuing Outcomes Relevant to Evista (CORE) trial (N = 4,011), were analyzed. Prespecified subgroups were defined by age (≥65 versus <65 years), age at menopause (≥49 versus <49 years), body mass index (≥25 versus <25 kg/m2), family history of breast cancer (yes/no), serum estradiol level (5-10 versus <5, >10 versus <5 pmol/L), prior estrogen therapy (yes/no), and bone mass at MORE baseline, and 5-year predicted risk, assessed using the modified Gail model (≥1.67 versus <1.67%), at CORE baseline. Time-to-first invasive breast cancer was analyzed using Cox proportional hazards models. Results: In the placebo group, older age, higher estradiol level, and a family history of breast cancer were associated with an increased breast cancer risk (P < 0.05). Raloxifene therapy was associated with a reduced breast cancer risk in both women at lower and those at higher breast cancer risk. Hazard ratio point estimates were 0.11 to 0.67, corresponding to a 33% to 89% reduction in breast cancer risk with raloxifene versus placebo. The therapy by family history interaction was significant (P = 0.04). Conclusions: Raloxifene therapy was associated with a reduced risk of invasive breast cancer in postmenopausal women irrespective of the presence/absence of risk factors; its effect was greater in women with a family history of breast cancer.

Original languageEnglish
Pages (from-to)5242-5247
Number of pages6
JournalClinical Cancer Research
Volume12
Issue number17
DOIs
StatePublished - Sep 1 2006
Externally publishedYes

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Osteoporosis
Breast Neoplasms
Incidence
Placebos
Raloxifene Hydrochloride
Family Therapy
Therapeutics
Proportional Hazards Models
Estradiol
Estrogens
Research Design
Age Groups
Bone and Bones

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Lippman, M. E., Cummings, S. R., Disch, D. P., Mershon, J. L., Dowsett, S. A., Cauley, J. A., & Martino, S. (2006). Effect of raloxifene on the incidence of invasive breast cancer in postmenopausal women with osteoporosis categorized by breast cancer risk. Clinical Cancer Research, 12(17), 5242-5247. https://doi.org/10.1158/1078-0432.CCR-06-0688

Effect of raloxifene on the incidence of invasive breast cancer in postmenopausal women with osteoporosis categorized by breast cancer risk. / Lippman, Marc E; Cummings, Steven R.; Disch, Damon P.; Mershon, John L.; Dowsett, Sherie A.; Cauley, Jane A.; Martino, Silvana.

In: Clinical Cancer Research, Vol. 12, No. 17, 01.09.2006, p. 5242-5247.

Research output: Contribution to journalArticle

Lippman, Marc E ; Cummings, Steven R. ; Disch, Damon P. ; Mershon, John L. ; Dowsett, Sherie A. ; Cauley, Jane A. ; Martino, Silvana. / Effect of raloxifene on the incidence of invasive breast cancer in postmenopausal women with osteoporosis categorized by breast cancer risk. In: Clinical Cancer Research. 2006 ; Vol. 12, No. 17. pp. 5242-5247.
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abstract = "Purpose: To assess the effect of raloxifene, indicated for osteoporosis treatment and prevention, on invasive breast cancer in subgroups of postmenopausal women defined by risk factors for breast cancer. Experimental Design: Data from the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial (N = 7,705) and a follow-up study, the 4-year Continuing Outcomes Relevant to Evista (CORE) trial (N = 4,011), were analyzed. Prespecified subgroups were defined by age (≥65 versus <65 years), age at menopause (≥49 versus <49 years), body mass index (≥25 versus <25 kg/m2), family history of breast cancer (yes/no), serum estradiol level (5-10 versus <5, >10 versus <5 pmol/L), prior estrogen therapy (yes/no), and bone mass at MORE baseline, and 5-year predicted risk, assessed using the modified Gail model (≥1.67 versus <1.67{\%}), at CORE baseline. Time-to-first invasive breast cancer was analyzed using Cox proportional hazards models. Results: In the placebo group, older age, higher estradiol level, and a family history of breast cancer were associated with an increased breast cancer risk (P < 0.05). Raloxifene therapy was associated with a reduced breast cancer risk in both women at lower and those at higher breast cancer risk. Hazard ratio point estimates were 0.11 to 0.67, corresponding to a 33{\%} to 89{\%} reduction in breast cancer risk with raloxifene versus placebo. The therapy by family history interaction was significant (P = 0.04). Conclusions: Raloxifene therapy was associated with a reduced risk of invasive breast cancer in postmenopausal women irrespective of the presence/absence of risk factors; its effect was greater in women with a family history of breast cancer.",
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