Endocrine therapy for breast cancer prevention in high-risk women: clinical and economic considerations

References

• GLOBOCAN 2012. Estimated cancer incidence, mortality and prevalence worldwide in 2012. World Health Organization. Lyon, France: International agency for research on cancer; 2015 [cited 2015 Jan 12]. Available from: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
   Google Scholar
• Bernstein L, Ross RK. Endogenous hormones and breast cancer risk. Epidemiol Rev. 1993;15:48–65.
   PubMed Web of Science ®Google Scholar
• Jordan VC, Robinson SP. Species-specific pharmacology of anti-estrogens: role of metabolism. Fed Proc. 1987;46:1870–1847.
   PubMedGoogle Scholar
• Osborne CK. Tamoxifen in the treatment of breast cancer. NEJM. 1998;339:1609–1618.
   PubMed Web of Science ®Google Scholar
• Love RR, Mazess RB, Barden HS, et al. Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer. NEJM. 1992;326:852–856.
   PubMed Web of Science ®Google Scholar
• Delmas PD, Bjarnason NH, Mitlak BH, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. NEJM. 1997;337:1641.
   PubMed Web of Science ®Google Scholar
• Dowsett M, Jones A, Johnston SR, et al. In vivo measurement of aromatase inhibition by letrozole (CGS 20267) in postmenopausal patients with breast cancer. Clin Cancer Res. 1995;1:1511–1515.
   PubMed Web of Science ®Google Scholar
• Geisler J, King N, Dowsett M, et al. Influence of anastrozole (Arimidex), a selective non-steroidal aromatase inhibitor, on in vivo aromatization and plasma estrogen levels in postmenopausal women with breast cancer. Br J Cancer. 1996;74:1286–1291.
   PubMed Web of Science ®Google Scholar
• Geisler J, King N, Anker G, et al. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients. Clin Cancer Res. 1998;4:2089–2093.
   PubMed Web of Science ®Google Scholar
• Kubatka P, Sadlonova V, Kajo K, et al. Preventive effects of letrozole in the model of premenopausal mammary carcinogenesis. Neoplasma. 2008;55:72–76.
   Google Scholar
• Kubatka P, Sadlonova V, Kajo K, et al. Chemopreventive effects of anastrozole in a premenopausal breast cancer model. Anticancer Res. 2008;28:2819–2824.
   PubMed Web of Science ®Google Scholar
• Early Breast Cancer Trialists Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet. 1998;351:1451–1467.
   PubMed Web of Science ®Google Scholar
• Powles T, Eeles R, Ashley S, et al. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet. 1998;352:98–101.
   PubMed Web of Science ®Google Scholar
• Powles TJ, Ashley S, Tidy A, et al. Twenty-year follow-up of the Royal Marsden randomized, double-blinded tamoxifen breast cancer prevention trial. J Natl Cancer Inst. 2007;99:283–290.
   PubMed Web of Science ®Google Scholar
• Veronesi U, Maisonneuve P, Costa A, et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women. Italian Tamoxifen Prevention Study. Lancet. 1998;352:93–97.
   PubMed Web of Science ®Google Scholar
• Veronesi U, Maisonneuve P, Rotmensz N, et al. Tamoxifen for the prevention of breast cancer: late results of the Italian Randomized Tamoxifen Prevention Trial among women with hysterectomy. J Natl Cancer Inst. 2007;99:727–737.
   PubMed Web of Science ®Google Scholar
• Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the national surgical adjuvant breast and bowel project P1 study. J Natl Cancer Inst. 1998;90:1371–1388.
   PubMed Web of Science ®Google Scholar
• Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the national surgical adjuvant breast and bowel project P1 study. J Natl Cancer Inst. 2005;97:1652–1662.
   PubMed Web of Science ®Google Scholar
• Cuzick J, Forbes J, Edwards R, et al. for the IBIS investigators. First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial. Lancet. 2002;360:817–824.
   PubMed Web of Science ®Google Scholar
• Cuzick J, Forbes JF, Sestak I, et al. Long-term results of tamoxifen prophylaxis for breast cancer—96-month follow-up of the randomized IBIS-I trial. J Natl Cancer Inst. 2007;99:272–282.
   PubMed Web of Science ®Google Scholar
• Cuzick J, Sestak I, Cawthorn S, et al. Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial. Lancet. 2015;16:67–75.
   PubMed Web of Science ®Google Scholar
• Vogel VG, Costantino JP, Wickerham DL, et al. Effects of tamoxifen vs 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.
   PubMed Web of Science ®Google Scholar
• Vogel VG, Costantino JP, Wickerham DL, et al. Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: preventing breast cancer. Cancer Prev Res. 2010;3:696–706.
   PubMed Web of Science ®Google Scholar
• Cuzick J, Sestak I, Bonanni B, et al. Selective oestrogen receptor modulators in prevention of breast cancer: an updated meta-analysis of individual participant data. Lancet. 2013;381:1827–1834.
   PubMed Web of Science ®Google Scholar
• Cauley JA, Norton L, Lippman ME, et al. Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial. Multiple outcomes of raloxifene evaluation. Breast Cancer Res Treat. 2001;65:125–134.
   PubMed Web of Science ®Google Scholar
• 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;96:1751–1761.
   PubMed Web of Science ®Google Scholar
• Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006;355:125–137.
   PubMed Web of Science ®Google Scholar
• LaCroix AZ, Powles T, Osborne CK, et al. Breast cancer incidence in the randomized PEARL trial of lasofoxifene in postmenopausal osteoporotic women. J Natl Cancer Inst. 2010;102:1706–1715.
   PubMed Web of Science ®Google Scholar
• Powles TJ, Diem SJ, Fabian CJ, et al. Breast cancer incidence in postmenopausal women with osteoporosis or low bone mass using arzoxifene. Breast Cancer Res Treat. 2012;134:299–306.
   PubMed Web of Science ®Google Scholar
• Dowsett M, Cuzick J, Ingle J, et al. Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen. J Clin Oncol. 2010;28:509–518.
   PubMed Web of Science ®Google Scholar
• Goss P, Ingle J, Ales-Martinez J, et al. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011;364:2381–2391.
   PubMed Web of Science ®Google Scholar
• Cuzick J, Sestak I, Forbes JF, et al. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomized placebo-controlled trial. Lancet. 2014;383:1041–1048.
   PubMed Web of Science ®Google Scholar
• Garcia-Bercerra R, Santos N, Diaz L, et al. Mechanisms of resistance to endocrine therapy in breast cancer: focus on signaling pathways, miRNAs and genetically based resistance. Int J Mol Sci. 2013;14:108–145.
   Web of Science ®Google Scholar
• King MC, Wieand S, Hale K, et al. Tamoxifen and breast cancer incidence among women with inherited mutations in BRCA1 and BRCA 2: national adjuvant surgical bowel and breast project (P1) breast cancer prevention trial. JAMA. 2001;286:2251–2256.
   PubMed Web of Science ®Google Scholar
• Phillips KA, Milne RL, Rookus MA, et al. Tamoxifen and risk of contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. J Clin Oncol. 2013;31:3091–3099.
   PubMed Web of Science ®Google Scholar
• Visvanathan K, Hurley P, Bantug E, et al. Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2013;31:2942–2962.
   PubMed Web of Science ®Google Scholar
• Breast Cancer Risk reduction, version 1. NCCN clinical practice guidelines in oncology. Fort Washington, PA: National Comprehensive Cancer Network; 2014 [cited 2015 Jan 7]. Available from: www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf
   Google Scholar
• Breast cancer: medications for risk reduction. Final recommendation statement, U.S. preventive services task force. Rockville, MD: USPSTF Program Office; 2013 [cited 2015 Jan 3]. Available from: www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-medications-for-risk-reduction#Pod2
   Google Scholar
• Smith SG, Sestak I, Forster A, et al. Factors affecting uptake and adherence to breast cancer chemoprevention: a systematic review and meta-analysis. Ann Oncol. 2015;00:1–16.
   Google Scholar
• Noe LL, Becker RV III, Gradishar WJ, et al. The cost effectiveness of tamoxifen in the prevention of breast cancer. Am J Manag Care. 1999;5:S389–406.
   PubMed Web of Science ®Google Scholar
• Smith T, Hillner B. Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women. J Clin Oncol. 2000;18:284–286.
   PubMed Web of Science ®Google Scholar
• Grann V, Sundararajan V, Jacobson J, et al. Decision analysis of tamoxifen for the prevention of invasive breast cancer. Cancer J. 2000;6:169–178.
   PubMed Web of Science ®Google Scholar
• Hershman D, Sundararajan V, Jacobson JS, et al. Outcomes of tamoxifen chemoprevention for breast cancer in very high-risk women: a cost effectiveness analysis. J Clin Oncol. 2002;20:9–16.
   PubMed Web of Science ®Google Scholar
• Cykert S, Phifer N, Hansen C. Tamoxifen for breast cancer prevention: a framework for clinical decisions. Obstet Gynecol. 2004;104:433–442.
   PubMed Web of Science ®Google Scholar
• Melnikow J, Kuenneth C, Helms LJ, et al. Chemoprevention: drug pricing and mortality: the case of tamoxifen. Cancer. 2006;107:950–958.
   PubMed Web of Science ®Google Scholar
• Noah-Vanhoucke J, Green L, Dinh T, et al. Cost-effectiveness of chemoprevention of breast cancer using tamoxifen in a postmenopausal US population. Cancer. 2011;117:3322–3331.
   PubMed Web of Science ®Google Scholar
• Eckermann S, Martin A, Stockler M, et al. The benefits and costs of tamoxifen for breast cancer prevention. Aust N Z J Public Health. 2003;27:34–40.
   PubMed Web of Science ®Google Scholar
• Kondo M, Hoshi SL, Toi M. Economic evaluation of chemoprevention of breast cancer with tamoxifen and raloxifene among high-risk women in Japan. Br J Cancer. 2009;100:281–290.
   PubMed Web of Science ®Google Scholar
• Guerrieri-Gonzaga A, Lazzeroni M, Botteri E, et al. Effect of low-dose tamoxifen after surgical excision of ductal intraepithelial neoplasia: results of a large retrospective monoinstitutional cohort study. Ann Oncol. 2013;24:1859–1866.
   PubMed Web of Science ®Google Scholar
• Younis T, Groom A. The value-for-money of adjuvant aromatase inhibitors: time to put the debate to rest? Curr Oncol. 2015;22:77–79.
   PubMed Web of Science ®Google Scholar
• DeCensi A, Thorat MA, Bonanni B, et al. Barriers to preventative therapy for breast and other major cancers and strategies to improve uptake. Ecancermedicalscience. 2015;9:595.
   PubMed Web of Science ®Google Scholar