RetroSearch Browse

Home - News ( United States | United Kingdom | Italy | Germany ) - Football scores

Showing content from https://pubmed.ncbi.nlm.nih.gov/9747868/ below:

Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

Clinical Trial

. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study J P Costantino, D L Wickerham, C K Redmond, M Kavanah, W M Cronin, V Vogel, A Robidoux, N Dimitrov, J Atkins, M Daly, S Wieand, E Tan-Chiu, L Ford, N Wolmark

Affiliations

Affiliation

¹ National Surgical Adjuvant Breast and Bowel Project, Allegheny University of the Health Sciences, Pittsburgh, PA 15212-5234, USA. BFISHER1@aherf.edu

PMID: 9747868
DOI: 10.1093/jnci/90.18.1371

Item in Clipboard

Clinical Trial

Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

B Fisher et al. J Natl Cancer Inst. 1998.

. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371. Authors B Fisher¹, J P Costantino, D L Wickerham, C K Redmond, M Kavanah, W M Cronin, V Vogel, A Robidoux, N Dimitrov, J Atkins, M Daly, S Wieand, E Tan-Chiu, L Ford, N Wolmark Affiliation

¹ National Surgical Adjuvant Breast and Bowel Project, Allegheny University of the Health Sciences, Pittsburgh, PA 15212-5234, USA. BFISHER1@aherf.edu

PMID: 9747868
DOI: 10.1093/jnci/90.18.1371

Item in Clipboard

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.

PubMed Disclaimer

Comment in

Re: Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 study.
Narod S. Narod S. J Natl Cancer Inst. 1999 Jan 20;91(2):188. doi: 10.1093/jnci/91.2.188. J Natl Cancer Inst. 1999. PMID: 9923863 No abstract available.
Re: Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study.
Powles TJ. Powles TJ. J Natl Cancer Inst. 1999 Apr 21;91(8):730. doi: 10.1093/jnci/91.8.730. J Natl Cancer Inst. 1999. PMID: 10218518 No abstract available.
Re: tamoxifen prevention of breast cancer: an instance of the fingerpost.
Fisher B. Fisher B. J Natl Cancer Inst. 2000 Apr 19;92(8):659-60. doi: 10.1093/jnci/92.8.659. J Natl Cancer Inst. 2000. PMID: 10772691 No abstract available.
Re: weighing the risks and benefits of tamoxifen treatment for preventing breast cancer.
Norsigian J, Napoli M, Brenner BA, Cody N, Batt S, Pearson CA, Potovsky-Beachell L, Cohen VS. Norsigian J, et al. J Natl Cancer Inst. 2000 May 3;92(9):757-8. doi: 10.1093/jnci/92.9.757. J Natl Cancer Inst. 2000. PMID: 10793117 No abstract available.
Re: Estimation of tamoxifen's efficacy for preventing the formation and growth of breast tumors.
Ménard S, Tagliabue E, Campiglio M, Balsari A. Ménard S, et al. J Natl Cancer Inst. 2000 Jun 7;92(11):943-4. doi: 10.1093/jnci/92.11.943a. J Natl Cancer Inst. 2000. PMID: 10841836 No abstract available.
Re: Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes.
Mirchandani D, Muggia F. Mirchandani D, et al. J Natl Cancer Inst. 2001 Sep 19;93(18):1420-1; author reply 1421-2. doi: 10.1093/jnci/93.18.1420-a. J Natl Cancer Inst. 2001. PMID: 11562395 No abstract available.
Do all patients with breast cancer require systemic adjuvant therapy?
Griggs JJ, Hayes DF. Griggs JJ, et al. J Natl Cancer Inst. 2011 Sep 21;103(18):1350-1. doi: 10.1093/jnci/djr331. Epub 2011 Aug 31. J Natl Cancer Inst. 2011. PMID: 21881041 Free PMC article. No abstract available.