1 / 19

Wishing on a STAR: Primary Prevention of Breast Cancer

Wishing on a STAR: Primary Prevention of Breast Cancer. Kristin Steffen, MD Primary Care Conference March 14, 2007. I have no financial disclosures. Objectives. Identify the only SERM approved for primary prevention of breast cancer in premenopausal and postmenopausal women

kirk-armstrong
Download Presentation

Wishing on a STAR: Primary Prevention of Breast Cancer

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Wishing on a STAR: Primary Prevention of Breast Cancer Kristin Steffen, MD Primary Care Conference March 14, 2007

  2. I have no financial disclosures.

  3. Objectives • Identify the only SERM approved for primary prevention of breast cancer in premenopausal and postmenopausal women • Identify potential future medications for primary prevention of breast cancer • Identify the potential benefits and risks of the SERMs tamoxifen and raloxifene

  4. Case SS is a 65 yo F who is highly motivated to pursue preventive health measures of all sorts. She comes in to discuss a medication she read about recently as a breast cancer preventive measure (plus 9 other issues). PMH: s/p hysterectomy at age 33, osteoporosis, metatarsal fx age 58, atrophic vaginitis, fibromyalgia+ many others (no DVT/PE) FH: No breast cancer SH: Married, nonsmoker Meds:Estring, Actonel, Lipitor, Prilosec, + more

  5. Tamoxifen • FDA approved • Only SERM with proven efficacy in pre-menopausal women • 50% incidence of invasive and noninvasive breast cancer •  risk of endometrial cancer predominantly in women ages 50+ •  risks of stroke, PE, DVT more frequently in women 50+

  6. Raloxifene • FDA approval expected for breast cancer prevention in postmenopausal women based on STAR trial findings • MORE: 76% invasive breast cancer risk • CORE: 69% invasive breast cancer risk • RUTH: 44% invasive breast cancer risk (12/10,000) •  risks stroke (49%, 7/10,000), VTE (44%, 12,10,000) in RUTH • NO increased risk of endometrial cancer

  7. STAR trial/STAR QOL study • Objective: Compare relative effects and safety of raloxifene and tamoxifen on developing invasive breast cancer and other disease outcomes

  8. STAR: Design and Setting • Prospective double blind RCT in nearly 200 centers in North America • 19,747 postmenopausal women, mean age 58.5 years with increased 5 year breast cancer risk (per Gail Model)

  9. STAR: Intervention • Trial: Oral tamoxifen 20 mg daily or raloxifene 60 mg daily over 5 years • Study: 36 item symptom checklist, Medical Outcomes Study Short form(SF-36), Center for Epidemiologic Studies-depression (CES-D), Medical Outcomes Study Sexual Activity Questionnaire

  10. STAR: Outcome Measures • Trial: incidence of invasive breast cancer, incidence of noninvasive breast cancer, bone fractures, thromboembolic events • Study: SF-36 physical and mental component summaries

  11. STAR: Results • Tamoxifen=Raloxifene: • Rates of invasive cancer • Rates of CV events (include stroke) • Rates of osteoporotic fracture • Pt reported outcomes for physical and mental health (ie minimal difference in adverse effect burden and QOL but see below)

  12. STAR: Results • Tamoxifen differed in: • Fewer noninvasive (lobular CA in situ, ductal CA in situ), but uncertain clinical significance • vasomotor symptoms • leg cramps • bladder control problems

  13. STAR Results • Raloxifene differed in: • 30%  risk VTE • 38%  risk endometrial cancer, (BUT not statistically significant) • 84%  risk endometrial hyperplasia • 56% risk hysterectomy • 20%  risk cataract/cataract surgery •  MSK problems, dyspareunia, weight gain

  14. Issues to Ponder • NNT estimates 55-126 for invasive breast CA • Risk/benefit ratio for an individual • Patient acceptance • Physician acceptance • “Side benefit” of therapy for osteoporosis • Length of therapy unknown • Pts will look to primary care providers for guidance

  15. Case Patient SS • Discuss her preferences, adverse risks, potential benefits • Consider dual role for osteoporosis treatment, she has taken Actonel > 5 years and the debate on length of bisphosphonate therapy • Postmenopausal and s/p hysterectomy: both addition of Tamoxifen, or addition/substitution of Raloxifene (when FDA approved) could be considered

  16. The Future • Breast cancer prevention trials comparing raloxifene to aromatase inhibitor and aromatase inhibitor to placebo are ongoing

  17. References • Barrett-Connor E, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women.N Engl J Med 2006; 355:125-137. • Cummings SR et al. The effect of raloxifene on breast cancer in postmenopausal women:results from the MORE randomized trial.JAMA 1999;281:2189-2197.

  18. Reference, cont • Fisher B et al. Tamoxifen for prevention of breast cancer:report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study.J Natl Cancer Inst 1998;90:1371-1388. • Fisher B et al.Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 Study.J Natl Cancer Inst 2005;97:1652-1662.

  19. References, cont. • Land SR et al. Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.JAMA 2006;295:2742-2751. • Vogel VG et al. Effects of Tamoxifen and Raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.JAMA 2006;295:2727-2741.

More Related