The effect of raloxifene on risk of breast cancer in postmenopausal women: Results from the MORE randomized trial

Journal of the American Medical Association

Volumn 281, Issue 23, 1999, Pages 2189-2197

  Cummings, Steven R ^a,b   Eckert, Stephen ^c   Krueger, Kathryn A ^c   Grady, Deborah ^b   Powles, Trevor J ^d   Cauley, Jane A ^e   Norton, Larry ^f   Nickelsen, Thomas ^c   Bjarnason, Nina H ^g   Morrow, Monica ^h   Lippman, Marc E ⁱ   Black, Dennis ^b   Glusman, Joan E ^c   Costa, Alberto ^j   Jordan, V Craig ^h  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^e UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^g CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ GEORGETOWN UNIVERSITY   (United States)

^j EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM; COLECALCIFEROL; ESTROGEN RECEPTOR; PLACEBO; RALOXIFENE; TAMOXIFEN;

ADULT; AGED; ARTICLE; BRADYCARDIA; BREAST CANCER; BREAST EXAMINATION; CANCER RISK; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; EDEMA; ENDOMETRIUM CANCER; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HEMATURIA; HISTOPATHOLOGY; HOT FLUSH; HUMAN; HYPERTENSION; LEG CRAMP; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MAMMOGRAPHY; MASTALGIA; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VAGINA BLEEDING;

AGED; BREAST NEOPLASMS; DOUBLE-BLIND METHOD; ENDOMETRIAL NEOPLASMS; ESTROGEN ANTAGONISTS; ESTROGENS; FEMALE; FOLLOW-UP STUDIES; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL; PIPERIDINES; POSTMENOPAUSE; RALOXIFENE; RECEPTORS, ESTROGEN; RISK; THROMBOEMBOLISM;

EID: 0033575083     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.281.23.2189     Document Type: Article

References (44)

1. Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics. CA Cancer J Clin. 1998;48:6-29.
2. Toniolo PG, Levitz M, Zeleniuch-Jacquotte A, et al. A prospective study of endogenous estrogens and breast cancer in postmenopausal women. J Natl Cancer Inst. 1995;87:190-197.
3. Dorgan JF, Longcope C, Stephenson HE Jr, et al. Relation of prediagnostic serum estrogen and androgen levels to breast cancer risk. Cancer Epidemiol Biomarkers Prev. 1996;5:533-539.
4. Cauley JA, Lucas FL, Kuller LH, Stone K, Browner W, Cummings SR. Elevated serum estradiol and testosterone concentrations are associated with a high risk of breast cancer. Ann Intern Med. 1999;130:270-277.
5. Hankinson SE, Willett WC, Manson JE, et al. Plasma sex steroid hormone levels and risk of breast cancer in postmenopausal women. J Natl Cancer Inst. 1998; 90:1292-1299.
6. Kelsey JL, Bernstein L. Epidemiology and prevention of breast cancer. Annu Rev Public Health. 1996; 17:47-67.
7. Fisher B, Costantino J, Redmond C, et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989;320:479-484.
8. Fisher B, Dignam J, Bryant J, et al. Five vs more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996;88: 1529-1542.
9. Early Breast Cancer Trialists Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomized trials. Lancet. 1998;351:1451-1467.
10. Veronesi U, Mainsonneuve P, Costa A, et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomized trial among hysterectomized women. Lancet. 1998;352:93-97.
11. Powles T, Eeles R, Ashley S, et al. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomized chemoprevention trial. Lancet. 1998;352:98-101.
12. Fisher B, Costantino JP, Wickerham L, et al. Tamoxifen for the 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.
13. Madigan MP, Ziegler RG, Benichou J, Byrne C, Hoover RN. Proportion of breast cancer cases in the United States explained by well-established risk factors. J Natl Cancer Inst. 1995;87:1681-1685.
14. Fisher B, Costantino JP, Redmond CK, Fisher ER, Wickerham DL, Cronin WM. Endometrial cancer in tamoxifen-treated breast cancer patients: findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14. J Natl Cancer Inst. 1994;86:527-537.
15. Grese TA, Sluka JP, Bryant HU, et al. Molecular determinants of tissue selectivity in estrogen receptor modulators. Proc Natl Acad Sci U S A. 1997;94: 14105-14110.
16. Brzozowski AM, Pike AC, Dauter Z, et al. Molecular basis of agonism and antagonism in the oestrogen receptor. Nature. 1997;389:753-758.
17. Gottardis MM, Jordan VC. Antitumor actions of keoxifene and tamoxifen in the N-nitrosomethylurea-induced rat mammary carcinoma model. Cancer Res. 1987;47:4020-4024.
18. Anzano MA, Peer CW, Smith JM, et al. Chemoprevention of mammary carcinogenesis in the rat: combined use of raloxifene and 9-cis-retinoic acid. J Natl Cancer Inst. 1996;88:123-125.
19. Sato M, Rippy MK, Bryant HU. Raloxifene, tamoxifen, nafoxidine, or estrogen effects on reproductive and nonreproductive tissues in ovariectomized rats. FASEB J. 1996;10:905-912.
20. Kleinman D, Karas M, Danilenko M. et al. Stimulation of endometrial cancer cell growth by tamoxifen is associated with increased insulin-like growth factor (IGF)-I induced tyrosine phosphorylation and reduction in IGF binding proteins. Endocrinology. 1996; 137:1089-1095.
21. Kanis JA, Melton LJ III, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res. 1994;9:1137-1141.
22. Pritchard K. Is tamoxifen effective in prevention of breast cancer? Lancet. 1998;352:80-81.
23. Cauley JA, Lucas FL, Kuller LH, Vogt MT, Browner WS, Cummings SR. Bone mineral density and risk of breast cancer in older women: the Study of Osteoporotic Fractures. JAMA. 1996;276:1404-1408.
24. Zhang Y, Kiel DP, Kreger BE, et al. Bone mass and the risk of breast cancer among postmenopausal women. N Engl J Med. 1997;336:611-617.
25. Ries LAG, Kosary CL, Hankey BF, Miller BA, Edwards BK, eds. SEER Cancer Statistics Review, 1973-1995. Bethesda, Md: National Cancer Institute: 1998.
26. Spratt JS, Meyer JS, Spratt JA. Rates of growth of human neoplasms: part II. J Surg Oncol. 1996;61: 68-83.
27. Osborne CK, Coronado E, Allred DC, Wiebe V, DeGregorio M. Acquired tamoxifen resistance: correlation with reduced breast tumor levels of tamoxifen and isomerization of trans-4-hydroxytamoxifen. J Natl Cancer Inst. 1991;83:1477-1482.
28. Howell A, Dodwell DJ, Anderson H, Redford J. Response after withdrawal of tamoxifen and progestogens in advanced breast cancer. Ann Oncol. 1992; 3:611-617.
29. Gottardis MM, Jordan VC. Development of tamoxifen-stimulated growth of MCF-7 tumors in athymic mice after long-term antiestrogen administration. Cancer Res. 1988;48:5183-5187.
30. Grady D, Gebretsadik T, Kerlikowske K, Ernster V, Petitti D. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Obstet Gynecol. 1995;85:304-313.
31. Black LJ, Sato M, Rowley ER, et al. Raloxifene (LY139481 HCl) prevents bone less and reduces serum cholesterol without causing uterine hypertrophy in ovariectomized rats. J Clin Invest. 1994;93:63-69.
32. Dijkhuizen FR, Brolmann HA, Oddens BJ, et al. Transvaginal ultrasonography and endometrial changes in postmenopausal breast cancer patients receiving tamoxifen. Maturitas. 1996;25:45-50.
33. Vuento MH, Pirhonen JP, Makinen JI, et al. Endometrial fluid accumulation in asymptomatic postmenopausal women. Ultrasound Obstet Gynecol. 1996;8:37-41.
34. Goldstein SR. Postmenopausal fluid collections revisited: look at the doughnut rather than the hole. Obstet Gynecol. 1994;83:738-740.
35. Hulley SB, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA. 1998;280:605-613.
36. Walsh BW, Kuller LH, Wild RA, et al. Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women. JAMA. 1998;279: 1445-1451.
37. Delmas PD, Bjarnason NH, Mitlak BH, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997;337: 1641-1647.
38. Rutqvist LE, Mattsson A, for the Stockholm Breast Cancer Study Group. Cardiac and thromboembolic morbidity among postmenopausal women with early-stage breast cancer in a randomized trial of adjuvant tamoxifen. J Natl Cancer Inst. 1993;85:1398-1406.
39. McDonald CC, Alexander FE, Whyte BW, Forrest AP, Stewart HJ, for the Scottish Cancer Trials Breast Group. Cardiac and vascular morbidity in women receiving adjuvant tamoxifen for breast cancer in a randomised trial. BMJ. 1995;311:977-980.
40. Costantino JP, Kuller LH, Ives DG, Fisher B, Dignam J. Coronary heart disease mortality and adjuvant tamoxifen therapy. J Natl Cancer Inst. 1997;89: 776-782.
41. Love RR, Mazess RB, Barden HS, et al. Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer. N Engl J Med. 1992; 326:852-856.
42. Espeland MA, Hogan PE, Fineberg SE, et al. Effect of postmenopausal hormone therapy on glucose and insulin concentrations. Diabetes Care. 1998;21: 1589-1595.
43. Godsland IF. The influence of female sex steroids on glucose metabolism and insulin action. J Intern Med Suppl. 1996;738:1-60.
44. Love RR, Weibe DA, Newcomb PA, et al. Effects of tamoxifen on cardiovascular risk factors in postmenopausal women. Ann Intern Med. 1991;115: 860-864.