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Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene.
J Natl Cancer Inst. 2004 Dec 01; 96(23):1751-61.JNCI

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.

Authors+Show Affiliations

Martino S
Cancer Institute Medical Group, 2001 Santa Monica Blvd., Ste. 560W, Santa Monica, CA 90404, USA. smartino@cimg.org
Cauley JA
No affiliation info available
Barrett-Connor E
No affiliation info available
Powles TJ
No affiliation info available
Mershon J
No affiliation info available
Disch D
No affiliation info available
Secrest RJ
No affiliation info available
Cummings SR
No affiliation info available
CORE Investigators
No affiliation info available

MeSH

AgedAntineoplastic Agents, HormonalBreast NeoplasmsDouble-Blind MethodDrug Administration ScheduleEstrogen Receptor ModulatorsFemaleHumansIncidenceMiddle AgedOsteoporosis, PostmenopausalPatient SelectionRaloxifene HydrochlorideSelective Estrogen Receptor ModulatorsTreatment OutcomeUnited States

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15572757

Citation

Martino, Silvana, et al. "Continuing Outcomes Relevant to Evista: Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene." Journal of the National Cancer Institute, vol. 96, no. 23, 2004, pp. 1751-61.
Martino S, Cauley JA, Barrett-Connor E, et al. Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst. 2004;96(23):1751-61.
Martino, S., Cauley, J. A., Barrett-Connor, E., Powles, T. J., Mershon, J., Disch, D., Secrest, R. J., & Cummings, S. R. (2004). Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. Journal of the National Cancer Institute, 96(23), 1751-61.
Martino S, et al. Continuing Outcomes Relevant to Evista: Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene. J Natl Cancer Inst. 2004 Dec 1;96(23):1751-61. PubMed PMID: 15572757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. AU - Martino,Silvana, AU - Cauley,Jane A, AU - Barrett-Connor,Elizabeth, AU - Powles,Trevor J, AU - Mershon,John, AU - Disch,Damon, AU - Secrest,Roberta J, AU - Cummings,Steven R, AU - ,, PY - 2004/12/2/pubmed PY - 2004/12/18/medline PY - 2004/12/2/entrez SP - 1751 EP - 61 JF - Journal of the National Cancer Institute JO - J Natl Cancer Inst VL - 96 IS - 23 N2 - 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. SN - 1460-2105 UR - https://www.unboundmedicine.com/medline/citation/15572757/Continuing_outcomes_relevant_to_Evista:_breast_cancer_incidence_in_postmenopausal_osteoporotic_women_in_a_randomized_trial_of_raloxifene_ DB - PRIME DP - Unbound Medicine ER -