© 2004 by Oxford University Press
© 2004 Oxford University Press
ARTICLE |
Continuing Outcomes Relevant to Evista: Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene
For the CORE Investigators
Affiliations of authors: Cancer Institute Medical Group, Santa Monica, CA (SM); University of Pittsburgh, Pittsburgh, PA (JAC); University of California, San Diego, La Jolla, CA (EBC); Institute of Cancer Research, Parkside Oncology Clinic, London, United Kingdom (TJP); Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN (JM, DD, RJS); San Francisco Coordinating Center, the California Pacific Medical Center Research Institute and the Department of Epidemiology and Biostatistics at the University of California, San Francisco, CA (SRC).
Correspondence to: Silvana Martino, DO, Cancer Institute Medical Group, 2001 Santa Monica Blvd., Ste. 560W, Santa Monica, CA 90404 (e-mail: smartino{at}cimg.org)
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.
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Correspondence about this Article
- Re: Continuing Outcomes Relevant to Evista: Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene
- Bulent Yalcin, Abdullah Buyukcelik, Samet Yalcin, Gungor Utkan, Hatice Doruk, Mutlu Dogan, and Mehmet Altan
J Natl Cancer Inst 2005 97: 542.[Extract] [Full Text] [PDF]
- RESPONSE: Re: Continuing Outcomes Relevant to Evista: Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene
- Silvana Martino, Jane A. Cauley, Elizabeth Barrett-Connor, Trevor J. Powles, John Mershon, Damon Disch, Roberta J. Secrest, and Steven R. Cummings
J Natl Cancer Inst 2005 97: 542-543.[Extract] [Full Text] [PDF]
Editorial about this Article
- Defining the Role of Raloxifene for the Prevention of Breast Cancer
- Mamta Kalidas, Susan Hilsenbeck, and Powel Brown
J Natl Cancer Inst 2004 96: 1731-1733.[Extract] [Full Text] [PDF]
Related Memo to the Media
- Press Release: Study Finds Continued Reduction in Breast Cancer Incidence Associated With Longer Use of Raloxifene
- Sarah L. Zielinski
J Natl Cancer Inst 2004 96: 1727.[Extract] [Full Text]
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