title: Benefit/risk assessment for breast cancer chemoprevention with raloxifene or tamoxifen for women age 50 years or older.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd., Bethesda, MD 20892, USA. wm57h@nih.gov
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Freedman
authors.forename: Binbing
authors.initials: B
authors.lastname: Yu
authors.forename: Mitchell H
authors.initials: MH
authors.lastname: Gail
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Costantino
authors.forename: Barry I
authors.initials: BI
authors.lastname: Graubard
authors.forename: Victor G
authors.initials: VG
authors.lastname: Vogel
authors.forename: Garnet L
authors.initials: GL
authors.lastname: Anderson
authors.forename: Worta
authors.initials: W
authors.lastname: McCaskill-Stevens
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000517:prevention & control*; D018890:Chemoprevention; D002986:Clinical Trials as Topic; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D008875:Middle Aged; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D004965:Estrogen Antagonists; D013629:Tamoxifen; D020849:Raloxifene Hydrochloride