Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene
- PMID: 15572757
- DOI: 10.1093/jnci/djh319
Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene
Abstract
Background: The randomized, double-blind Multiple Outcomes of Raloxifene Evaluation (MORE) trial found that 4 years of raloxifene therapy decreased the incidence of invasive breast cancer among postmenopausal women with osteoporosis by 72% compared with placebo. We conducted the Continuing Outcomes Relevant to Evista (CORE) trial to examine the effect of 4 additional years of raloxifene therapy on the incidence of invasive breast cancer in women in MORE who agreed to continue in CORE.
Methods: Women who had been randomly assigned to receive raloxifene (either 60 or 120 mg/day) in MORE were assigned to receive raloxifene (60 mg/day) in CORE (n = 3510), and women who had been assigned to receive placebo in MORE continued on placebo in CORE (n = 1703). Breast cancer incidence was analyzed by a log-rank test, and a Cox proportional hazards model was used to compute hazard ratios (HRs) and 95% confidence intervals (CIs). All statistical tests were two-sided.
Results: During the CORE trial, the 4-year incidences of invasive breast cancer and estrogen receptor (ER)-positive invasive breast cancer were reduced by 59% (HR = 0.41; 95% CI = 0.24 to 0.71) and 66% (HR = 0.34; 95% CI = 0.18 to 0.66), respectively, in the raloxifene group compared with the placebo group. There was no difference between the two groups in incidence of ER-negative invasive breast cancer during CORE (P = .86). Over the 8 years of both trials, the incidences of invasive breast cancer and ER-positive invasive breast cancer were reduced by 66% (HR = 0.34; 95% CI = 0.22 to 0.50) and 76% (HR = 0.24; 95% CI = 0.15 to 0.40), respectively, in the raloxifene group compared with the placebo group. During the CORE trial, the relative risk of thromboembolism in the raloxifene group compared with that in the placebo group was 2.17 (95% CI = 0.83 to 5.70). This increased risk, also observed in the MORE trial, persisted over the 8 years of both trials.
Conclusions: The reduction in invasive breast cancer incidence continues beyond 4 years of raloxifene treatment in postmenopausal women with osteoporosis. No new safety concerns related to raloxifene therapy were identified during CORE.
Comment in
-
Defining the role of raloxifene for the prevention of breast cancer.J Natl Cancer Inst. 2004 Dec 1;96(23):1731-3. doi: 10.1093/jnci/djh345. J Natl Cancer Inst. 2004. PMID: 15572750 No abstract available.
-
Re: Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene.J Natl Cancer Inst. 2005 Apr 6;97(7):542; author reply 542-3. doi: 10.1093/jnci/dji090. J Natl Cancer Inst. 2005. PMID: 15812082 No abstract available.
Similar articles
-
Relationship between bone mass, invasive breast cancer incidence and raloxifene therapy in postmenopausal women with low bone mass or osteoporosis.Curr Med Res Opin. 2008 Mar;24(3):807-13. doi: 10.1185/030079908X273282. Epub 2008 Feb 5. Curr Med Res Opin. 2008. PMID: 18254988 Clinical Trial.
-
Effect of raloxifene on the incidence of invasive breast cancer in postmenopausal women with osteoporosis categorized by breast cancer risk.Clin Cancer Res. 2006 Sep 1;12(17):5242-7. doi: 10.1158/1078-0432.CCR-06-0688. Clin Cancer Res. 2006. PMID: 16951244
-
Safety assessment of raloxifene over eight years in a clinical trial setting.Curr Med Res Opin. 2005 Sep;21(9):1441-52. doi: 10.1185/030079905X61839. Curr Med Res Opin. 2005. PMID: 16197663 Clinical Trial.
-
Rationale for using raloxifene to prevent both osteoporosis and breast cancer in postmenopausal women.Maturitas. 2008 Jun 20;60(2):92-107. doi: 10.1016/j.maturitas.2008.04.009. Epub 2008 Jun 4. Maturitas. 2008. PMID: 18534794 Review.
-
National surgical adjuvant breast and bowel project update: prevention trials and endocrine therapy of ductal carcinoma in situ.Clin Cancer Res. 2003 Jan;9(1 Pt 2):495S-501S. Clin Cancer Res. 2003. PMID: 12538506 Review.
Cited by 122 articles
-
Pan Arab Osteoporosis Society Guidelines for Osteoporosis Management.Mediterr J Rheumatol. 2017 Mar 28;28(1):27-32. doi: 10.31138/mjr.28.1.27. eCollection 2017 Mar. Mediterr J Rheumatol. 2017. PMID: 32185251 Free PMC article. Review.
-
Effects of Benzophenone-3 and Propylparaben on Estrogen Receptor-Dependent R-Loops and DNA Damage in Breast Epithelial Cells and Mice.Environ Health Perspect. 2020 Jan;128(1):17002. doi: 10.1289/EHP5221. Epub 2020 Jan 15. Environ Health Perspect. 2020. PMID: 31939680 Free PMC article.
-
Drug repurposing for breast cancer therapy: Old weapon for new battle.Semin Cancer Biol. 2019 Sep 21. doi: 10.1016/j.semcancer.2019.09.012. Online ahead of print. Semin Cancer Biol. 2019. PMID: 31550502 Free PMC article. Review.
-
Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention.Contemp Clin Trials Commun. 2019 Aug 22;16:100433. doi: 10.1016/j.conctc.2019.100433. eCollection 2019 Dec. Contemp Clin Trials Commun. 2019. PMID: 31497674 Free PMC article.
-
Obesity May Accelerate the Aging Process.Front Endocrinol (Lausanne). 2019 May 3;10:266. doi: 10.3389/fendo.2019.00266. eCollection 2019. Front Endocrinol (Lausanne). 2019. PMID: 31130916 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
-
Full Text Sources
-
Other Literature Sources
-
Medical
-
Miscellaneous