Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer

Journal of the National Cancer Institute

Volumn 91, Issue 21, 1999, Pages 1829-1846

  Gail, Mitchell H ^a   Costantino, Joseph P ^d   Bryant, John ^d   Croyle, Robert ^a   Freedman, Laurence ^b   Helzlsouer, Kathy ^c   Vogel, Victor ^d  

^a NATIONAL CANCER INSTITUTE   (United States)

^b BAR ILAN UNIVERSITY   (Israel)

^c JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^d EPS 8032 ^*

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN RECEPTOR; PLACEBO; TAMOXIFEN;

ARTICLE; BREAST CANCER; CANCER INCIDENCE; CANCER PREVENTION; CANCER RISK; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DRUG EFFECT; ENDOMETRIUM CANCER; FEMALE; FRACTURE; HUMAN; LUNG EMBOLISM; PATIENT COUNSELING; PRIORITY JOURNAL; RACE DIFFERENCE; RISK BENEFIT ANALYSIS; RISK FACTOR; STROKE;

EID: 0033520748     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/91.21.1829     Document Type: Article

References (85)

1. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, 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;90:1371-88.
2. Powles T, Eeles R, Ashley S, Easton D, Chang J, Dowsett M, et al. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet 1998;352:98-101.
3. Veronesi U, Maisonneuve P, Costa A, Sacchini V, Maltoni C, Robertson C, et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women. Italian Tamoxifen Prevention Study. Lancet 1998;352:93-7.
4. Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, et al. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 1989; 81:1879-86.
5. Benichou J. A computer program for estimating individualized probabilities of breast cancer [published erratum appears in Comput Biomed Res 1994;27:81]. Comput Biomed Res 1993;26:373-82.
6. Gail MH, Benichou J. Assessing the risk of breast cancer in individuals. In: DeVita VT Jr, Hellman S, Rosenberg SA, editors. Cancer prevention. Philadelphia (PA): Lippincott; 1992. p. 1-15.
7. Bondy ML, Lustbader ED, Halabi S, Ross E, Vogel VG. Validation of a breast cancer risk assessment model in women with a positive family history. J Natl Cancer Inst 1994;86:620-5.
8. Spiegelman D, Colditz GA, Hunter D, Hertzmark E. Validation of the Gail et al. model for predicting individualized breast cancer risk. J Natl Cancer Inst 1994;86:600-7.
9. Costantino JP, Gail MH, Pee D, Anderson S, Redmond CK, Benichou J, et al. Validation studies for models projecting the risk of invasive and total breast cancer incidence. J Natl Cancer Inst 1999;91:1541-8.
10. Anderson SJ, Ahnn S, Duff K. NSABP breast cancer prevention trial risk assessment program. Version 2. Pittsburgh (PA): Department of Biostatistics, University of Pittsburgh; August 14, 1992.
11. Miller BA, Kolonel LN, Bernstein L, Young JL Jr, Swanson GM, West D, et al, editors. Racial/ethnic patterns of cancer in the United States. 1988-1992. Bethesda (MD): National Institutes of Health, National Cancer Institute; 1996 Report No.: DHHS Publ No. (NIH)96-4104.
12. Harris JR, Lippman ME, Veronesi U, Willett W. Breast cancer (1). N Engl J Med 1992;327:319-28.
13. Struewing JP, Hartge P, Wacholder S, Baker SM, Berlin M, McAdams M. et al. The risk of cancer associated with specific mutations of BRCA1 and BRCA2 among Ashkenazi Jews. N Engl J Med 1997;337:1401-8.
14. Easton DF, Ford D, Bishop DT. Breast and ovarian cancer incidence in BRCA1-mutation carriers. The Breast Cancer Linkage Consortium. Am J Hum Genet 1995;56:265-71.
15. Thorlacius S, Struewing JP, Hartge P, Olafsdottir GH, Sigvaldason H, Tryggvadottir L, et al. Population-based study of risk of breast cancer in carriers of BRCA2 mutation. Lancet 1998;352:1337-9.
16. Claus EB, Risch NJ, Thompson WD. Genetic analysis of breast cancer in the cancer and steroid hormone study. Am J Hum Genet 1991;48: 232-42.
17. Whittemore AS, Gong G, Itnyre J. Prevalence and contribution of BRCA1 mutations in breast cancer and ovarian cancer: results from three U.S. population-based case-control studies of ovarian cancer. Am J Hum Genet 1997;60:496-504.
18. Hanssen AM, Fryns JP. Cowden syndrome. J Med Genet 1995;32:117-9.
19. nd ed. New York (NY): Oxford University Press; 1996. p. 546-58.
20. Kelsey JL. A review of the epidemiology of human breast cancer. Epidemiol Rev 1979;1:74-109.
21. Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of early-onset breast cancer. Implications for risk prediction. Cancer 1994;73: 643-51.
22. Claus EB, Schildkraut J, Iverson ES Jr, Berry D, Parmigiani G. Effect of BRCA1 and BRCA2 on the association between breast cancer risk and family history. J Natl Cancer Inst 1998;90:1824-9.
23. Boyd NF, Byng JW, Jong RA, Fishell EK, Little LE, Miller AB, et al. Quantitative classification of mammographie densities and breast cancer risk: results from the Canadian National Breast Screening Study. J Natl Cancer Inst 1995;87:670-5.
24. Byrne C, Schairer C, Wolfe J, Pasekh N, Salane M, Brinton LA, et al. Mammographic features and breast cancer risk: effects with time, age, and menopause status. J Natl Cancer Inst 1995;87:1622-9.
25. Berry DA, Parmigiani G, Sanchez J, Schildkraut J, Winer E. Probability of carrying a mutation of breast-ovarian cancer gene BRCA1 based on family history. J Natl Cancer Inst 1997;89:227-38.
26. Newman B, Mu H, Butler LM, Millikan RC, Moorman PG, King MC. Frequency of breast cancer attributable to BRCA1 in a population-based series of American women. JAMA 1998;279:915-21.
27. Merrill RM, Feuer EJ. Risk-adjusted cancer-incidence rates (United States). Cancer Causes Control 1996;7:544-52.
28. Voight LF, Weiss NS. Epidemiology of endometrial cancer. In: Surwit E, Alberts D, editors. Endometrial cancer. Boston (MA): Kluwer Academic Publishers; 1989. p. 1-21.
29. Parazzini F, La Vecchia C, Bocciolone L, Franceschi J. The epidemiology of endometrial cancer. Gynecol Oncol 1991;41:1-16.
30. Rose PG. Endometrial carcinoma [published erratum appears in N Engl J Med 1997;336:1335]. N Engl J Med 1996;335:640-9.
31. nd ed. Philadelphia (PA): Lippincott; 1997. p. 3-29.
32. Broderick JP, Phillips SJ, Whisnant JP, O'Fallon WM, Bergstralh EJ. Incidence rates of stroke in the eighties: the end of the decline in stroke? Stroke 1989;20:577-82.
33. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton JM 3rd. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998;158: 585-93.
34. World Health Organization. Manual of the International Statistical Classification of Diseases, Injuries, and Causes of Death. Volume I. Ninth revision. Geneva (Switzerland): World Health Organization; 1977.
35. National Center for Health Statistics. Vital statistics of the United States, 1992, volume II, mortality, part A. Washington (DC): Public Health Service: DHHS Publ No. (PHS)96-1101, Table 1-27; 1996.
36. Rosamond WD, Folsom AR, Chambless LE, Wang CH, McGovern PG, Howard G, et al. Stroke incidence and survival among middle-aged adults: 9-year follow-up of the Atherosclerosis Risk in Communities (ARIC) cohort. Stroke 1999;30:736-43.
37. Fried LP, Borhani NO, Enright P, Furberg CD, Gardin JM, Kronmal KA, et al. The Cardiovascular Health Study: design and rationale. Ann Epidemiol 1991;1:263-76.
38. Kuller L, Fisher L, McClelland R, Fried L, Cushman M, Jackson S, et al. Differences in prevalence of and risk factors for subclinical vascular disease among black and white participants in the Cardiovascular Health Study. Arterioscler Thromb Vase Biol 1998;18:283-93.
39. Sacco RL, Hauser WA, Mohr JP. Hospitalized stroke in blacks and Hispanics in northern Manhattan. Stroke 1991;22:1491-6.
40. The Women's Health Initiative Study Group. Design of the Women's Health Initiative clinical trial and observational study. Control Clin Trials 1998;19:61-109.
41. Manolio TA, Kronmal RA, Burke GL, O'Leary DH, Price TR. Short-term predictors of incident stroke in older adults. The Cardiovascular Health Study. Stroke 1996;27:1479-86.
42. Whisnant JP, Wiebers DO, O'Fallon WM, Sicks JD, Frye RL. A population-based model of risk factors for ischemic stroke: Rochester, Minnesota. Neurology 1996;47:1420-8.
43. Mosca L, Manson JE, Sutherland SE, Langer RD, Manolio T, Barrett-Connor E. Cardiovascular disease in women: a statement for healthcare professionals from the American Heart Association. Writing Group. Circulation 1997;96:2468-82.
44. Goldhaber SZ. Pulmonary embolism. N Engl J Med 1998;339:93-104.
45. Melton LJ, Chrischilles EA, Cooper C, Lane AW, Riggs L. How many women have osteoporosis? J Bone Mineral Res 1992;7:1005-10.
46. Silverman SL, Madison RE. Decreased incidence of hip fracture in Hispanics, Asians, and blacks: California Hospital Discharge Data. Am J Public Health 1988;78:1482-3.
47. Jacobsen SJ, Goldberg J, Miles TP, Brody JA, Stiers W, Rimm AA. Hip fracture incidence among the old and very old: a population-based study of 745,435 cases. Am J Public Health 1990;80:871-3.
48. Baron JA, Karagas M, Barrett J, Kniffin W, Malenka D, Mayor M, et al. Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age. Epidemiology 1996;7:612-8.
49. Cummings SR, Nevitt MC, Browner WS, Stone K, Fox KM, Ensrud KE, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med 1995;332:767-73.
50. Leske MC, Chylack LT Jr, He Q, Wu SY, Schoenfeld E, Friend J, et al. Risk factors for nuclear opalescence in a longitudinal study. LSC Group. Longitudinal Study of Cataract. Am J Epidemiol 1998;147:36-41.
51. Leske MC, Chylack LT Jr, Wu SY, The Lens Opacities Case-Control Study. Risk factors for cataract. Arch Ophthalmol 1991;109:244-51.
52. The Italian-American Cataract Study Group. Incidence and progression of cortical, nuclear, and posterior subcapsular cataracts. Am J Ophthalmol 1994;118:623-31.
53. Klein BE, Klein R, Lee KE. Incidence of age-related cataract: the Beaver Dam Eye Study. Arch Ophthalmol 1998;116:219-25.
54. Podgor MJ, Leske MC, Ederer F. Incidence estimates for lens changes, macular changes, open-angle glaucoma and diabetic retinopathy. Am J Epidemiol 1998;118:206-12.
55. Seddon JM, Christen WG, Manson JE, Buring JE, Sperduto RD, Hennekens CH. Low-dose aspirin and risks of cataract in a randomized trial of US physicians. Arch Ophthalmol 1991;109:252-5.
56. Leske MC, Chylack LT Jr, Wu SY. The Lens Opacities Case-Control Study. Risk factors for cataract. Arch Ophthalmol 1991;109:244-51.
57. Hodge WG, Whitcher JP, Satariano W. Risk factors for age-related cataracts. Epidemiol Rev 1995;17:336-46.
58. Fisher B, Redmond C. New perspective on cancer of the contralateral breast: a marker for assessing tamoxifen as a preventive agent [editorial]. J Natl Cancer Inst 1991;83:1278-80.
59. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998;351: 1451-67.
60. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clin Trials 1986;7:177-88.
61. National Center for Health Statistics. Vital statistics of the United States, 1990. volume II, mortality, part A. Washington (DC): Public Health Service. DHHS Publ No. (PHS)95-1101, Table 1-27; 1994.
62. Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, et al. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol 1998;16:441-52.
63. Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, et al. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet 1999;353:1993-2000.
64. Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, et al. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med 1989;320:473-8.
65. Fisher B, Brown AM, Dimitrov NV, Poisson R, Redmond C, Margolese RG, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and flourouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol 1990;8:1483-96.
66. Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, et al. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol 1997;15:2483-93.
67. Fisher B, Dignam J, Mamounas EP, Costantino J, Wickerham DL, Redmond C, et al. Sequential methotrexate and flourouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol 1996;14:1982-92.
68. Johannsson OT, Idvall I, Anderson C, Borg A, Barkardottir RB, Egilsson V, et al. Tumour biological features of BRCA1-induced breast and ovarian cancer. Eur J Cancer 1997;33:362-71.
69. Karp SE, Tonin PN, Begin LR, Martinez JJ, Zhang JC, Pollak MN, et al. Influence of BRCA1 mutations on nuclear grade and estrogen receptor status of breast carcinoma in Ashkenazi Jewish women. Cancer 1997;80: 435-41.
70. Loman N, Johannsson O, Bendahl PO, Borg A, Ferno M, Olsson H. Steroid receptors in hereditary breast carcinomas associated with BRCA1 or BRCA2 mutations or unknown susceptibility genes. Cancer 1998;83: 310-9.
71. Verhoog LC, Brekelmans CT, Seynaeve C, van den Bosch LM, Dahmen G, van Geel AN, et al. Survival and tumour characteristics of breast-cancer patients with germline mutations of BRCA1. Lancet 1998;351:316-21.
72. Wagner TM, Moslinger RA, Muhr D. Langbauer G, Hirtenlehner K, Concin H, et al. BRCA1-related breast cancer in Austrian breast and ovarian cancer families: specific BRCA1 mutations and pathological characteristics. Int J Cancer 1998;77:354-60.
73. nd ed. Alexandria (VA): International Medical Publishing; 1996.
74. ACOG Committee opinion. Tamoxifen and endometrial cancer. Int J Gynecol Obstet 1996;53:197-9.
75. O'Connor AM, Tugwell P, Wells GA, Elmslie T, Jolly E, Hollingsworth G, et al. Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy. Med Decis Making 1998;18:295-303.
76. McCaul KD, Branstetter AD, Schroeder DM, Glasgow RE. What is the relationship between breast cancer risk and mammography? A meta-analytic review. Health Psychol 1996;15:423-9.
77. Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute. Recommendations for the development of informed consent documents for cancer clinical trials. Rockville (MD): Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks; 1998.
78. Douketis JD, Ginsberg JS, Holbrook A, Crowther M, Duku EK, Burrows RF. A reevaluation of the risk for venous thromboembolism with the use of oral contraceptives and hormone replacement therapy. Arch Intern Med 1997;157:1522-30.
79. Grodstein F, Stampfer MJ, Goldhaber SZ, Manson JE, Colditz GA, Speizer FE, et al. Prospective study of exogenous hormones and risk of pulmonary embolism in women. Lancet 1996;348:983-7.
80. Weiss NS, Szekely DR, Austin DF. Increasing incidence of endometrial cancer in the United States. N Engl J Med 1976;294:1259-62.
81. Pike MC, Peters RK, Cozen W, Probst-Hensch NM, Felix JC, Wan PC, et al. Estrogen-progestin replacement therapy and endometrial cancer. J Natl Cancer Inst 1997;89:1110-6.
82. Fritsch M, Wolf DM. Symptomatic side effects of tamoxifen therapy. In: Jordan VC, editor. Long-term tamoxifen treatment for breast cancer. Madison (WI): University of Wisconsin Press; 1994. p. 235-55.
83. Yeomans Kinney A, Vernon SW, Shui W, Weber DV, Schell M, Vogel VG. Validation of a model predicting enrollment status in a chemoprevention trial for breast cancer. Cancer Epidemiol Biomarkers Prev 1998;7: 591-5.
84. Black WC, Nease RF Jr, Tosteson AN. Perceptions of breast cancer risk and screening effectiveness in women younger than 50 years of age. J Natl Cancer Inst 1995;87:720-31.
85. st Annual San Antonio Breast Cancer Symposium. Breast Cancer Res Treat 1998;50:230.