The decision to enter a randomized trial of tamoxifen for the prevention of breast cancer in healthy women: an analysis of the tradeoffs.
OBJECTIVE
Interest in breast cancer prevention has led to the Breast Cancer Prevention Trial (BCPT), a controversial randomized trial of tamoxifen for women at risk for breast cancer. The goal of our study was to determine whether the potential benefits of enrolling in the randomized trial of prophylactic tamoxifen outweigh the potential risks.


METHODS
We used a decision analytic model based on the available data on tamoxifen treatment benefits in women with breast cancer and extrapolated to its use in healthy women.


RESULTS
For a 50-year-old woman with a breast cancer risk twice that of the average woman her age, the BCPT offers an increase in life expectancy of about 9 days, a gain that is modest compared with other health interventions. For women ages 35 to 60 who meet the minimum risk of breast cancer for trial eligibility, the trial increases life expectancy by about 8 or 9 days. Assumptions about the effect of tamoxifen on the incidence of endometrial and liver cancer and on quality of life associated with tamoxifen did not alter our findings.


CONCLUSIONS
Advocates and opponents of the BCPT should temper their concerns to reflect the modest absolute benefits and harms associated with the trial. Although women at increased risk for breast cancer should be aware of the likely overall benefit associated with entry into the trial, for most women, entry into the BCPT is unlikely to alter substantially their length of life, in either a beneficial or harmful manner.
Nease
R F
RF
Department of Medicine, Washington University Medical School, St. Louis, Missouri 63110, USA.
Ross
J M
JM
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000401:mortality* / Q000517:prevention & control*; D003657:Decision Making; D016889:Endometrial Neoplasms / Q000139:chemically induced / Q000401:mortality; D005260:Female; D006620:Hip Fractures / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D008017:Life Expectancy; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D013923:Thromboembolism / Q000139:chemically induced / Q000401:mortality
D013629:Tamoxifen