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. 2001 Sep 1;85(9):1280–1288. doi: 10.1054/bjoc.2001.2125

First do no harm: extending the debate on the provision of preventive tamoxifen

B P Will 1, K M Nobrega 1, J-M Berthelot 1, W Flanagan 1, M C Wolfson 1, D M Logan 2, W K Evans 2
PMCID: PMC2375241  PMID: 11720461

Abstract

The Breast Cancer Prevention Trial (BCPT-P-1) demonstrated that tamoxifen could reduce the risk of invasive breast cancer in high-risk women by 49%, but that it could also increase the risk of endometrial cancer, vascular events and cataracts. This paper provides an estimate of the net health impacts of tamoxifen administration on high-risk Canadian women with no prior history of breast cancer. The results of the BCPT-P-1 were incorporated into the breast cancer and other modules of Statistics Canada’s microsimulation POpulation HEalth Model (POHEM). While the main intervention scenario conformed as closely as possible to the eligibility criteria for tamoxifen in the BCPT-P-1 protocol, 3 additional scenarios were simulated. Predicted absolute risks of breast cancer at 5 years of 1.66%, 3.32% and 4.15% were calculated for women 35 to 70 years of age. When the BCPT-P-1 results were incorporated into the simulation model, the analysis suggests no increase in life expectancy in this risk group. Tamoxifen appeared to be beneficial for women with a 5-year predicted risk of 3.32% or greater. The results of these simulations are particularly sensitive to the reduction in mortality observed in the BCPT-P-1, as well as being sensitive to other characteristics of the simulation model. Overall, the analysis raises questions about the use of tamoxifen in otherwise healthy women at high risk of breast cancer. © 2001 Cancer Research Campaign

Keywords: breast cancer, microsimulation model, prevention, tamoxifen, population health impacts

Full Text

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Footnotes

The term preventive tamoxifen is used throughout the manuscript in the same context as was used in the Breast Cancer Prevention Trial. The authors acknowledge that the FDA approval of tamoxifen was as a drug to reduce the incidence of breast cancer in high risk women and not as a breast cancer preventive agent.

Disclaimer: The views expressed in this paper are those of the authors and may not represent those of their respective organizations

Even though the trial did not specify a maximum eligibility age, we assumed that, in the Canadian context, it would be questionable to offer preventive tamoxifen to women over age 70. This is the only criterion that differs from those in the BCPT-P-1.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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