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

49 Scopus citations

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    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