© 1998 by Oxford University Press
Journal of the National Cancer Institute, Vol. 90, No. 18, 1371-1388,
September 16, 1998
©Copyright 1998 Oxford University Press
ARTICLES |
Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study
Affiliations of authors: B. Fisher, National Surgical Adjuvant Breast and Bowel Project (NSABP) and Allegheny University of the Health Sciences, Pittsburgh, PA; J. P. Costantino, C. K. Redmond, W. M. Cronin, V. Vogel, University of Pittsburgh; D. L. Wickerham, N. Wolmark, NSABP and Allegheny General Hospital; M. Kavanah, Boston Medical Center, MA; A. Robidoux, Hotel-Dieu de Montreal, Quebec, Canada; N. Dimitrov, Michigan State University, East Lansing; J. Atkins, Southeast Cancer Control Consortium, Winston-Salem, NC; M. Daly, Fox Chase Cancer Center, Cheltenham, PA; S. Wieand, NSABP Biostatistical Center, University of Pittsburgh; E. Tan-Chiu, Allegheny University of the Health Sciences; L. Ford, National Cancer Institute, Bethesda, MD.
Correspondence to: Bernard Fisher, M.D., Scientific Director, Allegheny University of the Health Sciences, Four Allegheny Center, Suite 602, Pittsburgh, PA 15212-5234 (BFISHER1{at}aherf.edu).
Abstract
Background: The finding of a decrease in contralateral breast cancer incidence following tamoxifen administration for adjuvant therapy led to the concept that the drug might play a role in breast cancer prevention. To test this hypothesis, the National Surgical Adjuvant Breast and Bowel Project initiated the Breast Cancer Prevention Trial (P-1) in 1992. Methods: Women (N = 13388) at increased risk for breast cancer because they 1) were 60 years of age or older, 2) were 35–59 years of age with a 5-year predicted risk for breast cancer of at least 1.66%, or 3) had a history of lobular carcinoma in situ were randomly assigned to receive placebo (n = 6707) or 20 mg/day tamoxifen (n = 6681) for 5 years. Gail's algorithm, based on a multivariate logistic regression model using combinations of risk factors, was used to estimate the probability (risk) of occurrence of breast cancer over time. Results: Tamoxifen reduced the risk of invasive breast cancer by 49% (two-sided P<.00001), with cumulative incidence through 69 months of follow-up of 43.4 versus 22.0 per 1000 women in the placebo and tamoxifen groups, respectively. The decreased risk occurred in women aged 49 years or younger (44%), 50–59 years (51%), and 60 years or older (55%); risk was also reduced in women with a history of lobular carcinoma in situ (56%) or atypical hyperplasia (86%) and in those with any category of predicted 5-year risk. Tamoxifen reduced the risk of noninvasive breast cancer by 50% (two-sided P<.002). Tamoxifen reduced the occurrence of estrogen receptor-positive tumors by 69%, but no difference in the occurrence of estrogen receptor-negative tumors was seen. Tamoxifen administration did not alter the average annual rate of ischemic heart disease; however, a reduction in hip, radius (Colles'), and spine fractures was observed. The rate of endometrial cancer was increased in the tamoxifen group (risk ratio = 2.53; 95% confidence interval = 1.35–4.97); this increased risk occurred predominantly in women aged 50 years or older. All endometrial cancers in the tamoxifen group were stage I (localized disease); no endometrial cancer deaths have occurred in this group. No liver cancers or increase in colon, rectal, ovarian, or other tumors was observed in the tamoxifen group. The rates of stroke, pulmonary embolism, and deep-vein thrombosis were elevated in the tamoxifen group; these events occurred more frequently in women aged 50 years or older. Conclusions: Tamoxifen decreases the incidence of invasive and noninvasive breast cancer. Despite side effects resulting from administration of tamoxifen, its use as a breast cancer preventive agent is appropriate in many women at increased risk for the disease. [J Natl Cancer Inst 1998;90:1371–88]
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J. C. Baker Jr., J. H. Ostrander, S. Lem, G. Broadwater, G. R. Bean, N. C. D'Amato, V. K. Goldenberg, C. Rowell, C. Ibarra-Drendall, T. Grant, et al. ESR1 Promoter Hypermethylation Does Not Predict Atypia in RPFNA nor Persistent Atypia after 12 Months Tamoxifen Chemoprevention Cancer Epidemiol. Biomarkers Prev., August 1, 2008; 17(8): 1884 - 1890. [Abstract] [Full Text] [PDF]
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H. G. Grabowski and J. L. Moe Impact of Economic, Regulatory, and Patent Policies on Innovation in Cancer Chemoprevention Cancer Prevention Research, July 1, 2008; 1(2): 84 - 90. [Abstract] [Full Text] [PDF]
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V. C. Jordan The 38th David A. Karnofsky Lecture: The Paradoxical Actions of Estrogen in Breast Cancer--Survival or Death? J. Clin. Oncol., June 20, 2008; 26(18): 3073 - 3082. [Abstract] [Full Text] [PDF]
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D. Grady, J. A. Cauley, M. J. Geiger, M. Kornitzer, L. Mosca, P. Collins, N. K. Wenger, J. Song, J. Mershon, E. Barrett-Connor, et al. Reduced Incidence of Invasive Breast Cancer With Raloxifene Among Women at Increased Coronary Risk J Natl Cancer Inst, June 18, 2008; 100(12): 854 - 861. [Abstract] [Full Text] [PDF]
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V. C. Jordan The Rise of Raloxifene and the Fall of Invasive Breast Cancer J Natl Cancer Inst, June 18, 2008; 100(12): 831 - 833. [Full Text] [PDF]
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D. H. Barnett, S. Sheng, T. Howe Charn, A. Waheed, W. S. Sly, C.-Y. Lin, E. T. Liu, and B. S. Katzenellenbogen Estrogen Receptor Regulation of Carbonic Anhydrase XII through a Distal Enhancer in Breast Cancer Cancer Res., May 1, 2008; 68(9): 3505 - 3515. [Abstract] [Full Text] [PDF]
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N. U. Lin and E. P. Winer Optimizing Endocrine Therapy for Estrogen Receptor-Positive Breast Cancer: Treating the Right Patients for the Right Length of Time J. Clin. Oncol., April 20, 2008; 26(12): 1919 - 1921. [Full Text] [PDF]
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T. E. Rohan, A. Negassa, R. T. Chlebowski, L. Habel, A. McTiernan, M. Ginsberg, S. Wassertheil-Smoller, and D. L. Page Conjugated Equine Estrogen and Risk of Benign Proliferative Breast Disease: A Randomized Controlled Trial J Natl Cancer Inst, April 16, 2008; 100(8): 563 - 571. [Abstract] [Full Text] [PDF]
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S.-C. Weng, Y. Kashida, S. K. Kulp, D. Wang, R. W. Brueggemeier, C. L. Shapiro, and C.-S. Chen Sensitizing estrogen receptor-negative breast cancer cells to tamoxifen with OSU-03012, a novel celecoxib-derived phosphoinositide-dependent protein kinase-1/Akt signaling inhibitor Mol. Cancer Ther., April 1, 2008; 7(4): 800 - 808. [Abstract] [Full Text] [PDF]
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M. Schaapveld, O. Visser, M. J. Louwman, E. G.E. de Vries, P. H.B. Willemse, R. Otter, W. T.A. van der Graaf, J.-W. W. Coebergh, and F. E. van Leeuwen Risk of New Primary Nonbreast Cancers After Breast Cancer Treatment: A Dutch Population-Based Study J. Clin. Oncol., March 10, 2008; 26(8): 1239 - 1246. [Abstract] [Full Text] [PDF]
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N. U. Lin and E. P. Winer Advances in Adjuvant Endocrine Therapy for Postmenopausal Women J. Clin. Oncol., February 10, 2008; 26(5): 798 - 805. [Abstract] [Full Text] [PDF]
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C. MacLean, S. Newberry, M. Maglione, M. McMahon, V. Ranganath, M. Suttorp, W. Mojica, M. Timmer, A. Alexander, M. McNamara, et al. Systematic Review: Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis Ann Intern Med, February 5, 2008; 148(3): 197 - 213. [Abstract] [Full Text] [PDF]
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C. Owusu, D. S.M. Buist, T. S. Field, T. L. Lash, S. S. Thwin, A. M. Geiger, V. P. Quinn, F. Frost, M. Prout, M. U. Yood, et al. Predictors of Tamoxifen Discontinuation Among Older Women With Estrogen Receptor-Positive Breast Cancer J. Clin. Oncol., February 1, 2008; 26(4): 549 - 555. [Abstract] [Full Text] [PDF]
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H. S. Rugo The breast cancer continuum in hormone-receptor positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors Ann. Onc., January 1, 2008; 19(1): 16 - 27. [Abstract] [Full Text] [PDF]
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