Benefit/Risk Assessment for Breast Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 Years or Older

• Published in: Journal of clinical oncology Vol. 29; no. 17; pp. 2327 - 2333
• Main Authors: Freedman, Andrew N, Yu, Binbing, Gail, Mitchell H, Costantino, Joseph P, Graubard, Barry I, Vogel, Victor G, Anderson, Garnet L, McCaskill-Stevens, Worta
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Society of Clinical Oncology 10.06.2011
• Subjects: Age; Aged; Biological and medical sciences; Breast cancer; Breast Neoplasms - prevention & control; Cancer; Chemoprevention; Chemotherapy; Clinical Trials as Topic; Estrogen Antagonists - therapeutic use; Female; Females; Gynecology. Andrology. Obstetrics; Hispanic Americans; Humans; Mammary gland diseases; Medical sciences; Middle Aged; Original Reports; Post-menopause; Prevention; Raloxifene Hydrochloride - adverse effects; Raloxifene Hydrochloride - therapeutic use; Risk assessment; Risk reduction; Tamoxifen - adverse effects; Tamoxifen - therapeutic use; Tumors; Antineoplastic agent; Estrogen receptor; Chemoprophylaxis; Breast disease; Antiestrogen; Antihormone; Benzothiophene derivatives; Prevention; Selective estrogen receptor modulator; Cancerology; Adult; Female; Woman; Non steroid compound; Age; Human; Breast cancer; Malignant tumor; Tamoxifene; Mammary gland diseases; Chemotherapy; Treatment; Risk factor; Raloxifene; Agonist antagonist; Elderly; Cancer
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2010.33.0258

The Study of Tamoxifen and Raloxifene (STAR) demonstrated that raloxifene was as effective as tamoxifen in reducing the risk of invasive breast cancer (IBC) in postmenopausal women and had lower risks of thromboembolic events, endometrial cancer, and cataracts but had a nonstatistically significant higher risk of noninvasive breast cancer. There is a need to summarize the risks and benefits of these agents. Baseline incidence rates of IBC and other health outcomes, absent raloxifene and tamoxifen, were estimated from breast cancer chemoprevention trials; the Surveillance, Epidemiology and End Results Program; and the Women's Health Initiative. Effects of raloxifene and tamoxifen were estimated from STAR and the Breast Cancer Prevention Trial. We assigned weights to health outcomes to calculate the net benefit from raloxifene compared with placebo and tamoxifen compared with placebo. Risks and benefits of treatment with raloxifene or tamoxifen depend on age, race, breast cancer risk, and history of hysterectomy. Over a 5-year period, postmenopausal women with an intact uterus had a better benefit/risk index for raloxifene than for tamoxifen. For postmenopausal women without a uterus, the benefit/risk ratio was similar. The benefits and risks of raloxifene and tamoxifen are described in tables that can help identify groups of women for whom the benefits outweigh the risks. We developed a benefit/risk index to quantify benefits from chemoprevention with tamoxifen or raloxifene. This index can complement clinical evaluation in deciding whether to initiate chemoprevention and in comparing the benefits and risks of raloxifene versus tamoxifen.