CORRESPONDENCE

RESPONSE: Re: Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

Bernard Fisher, Joseph P. Costantino

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, University of Pittsburgh.

Correspondence to: Joseph P. Costantino, Dr.P.H., National Surgical Adjuvant Breast and Bowel Project, Biostatistical Center, Statistical Division, 230 McKee Place, Suite 403, Pittsburgh, PA 15213 (e-mail: costan+{at}pitt.edu).

The risk/benefit assessment provided by Dr. Love is inappropriate. First, the population selected (the women in the Breast Cancer Prevention Trial) represents a mixture of women who comprise a broad range of 5-year breast cancer risk levels and ages. Because the risk/benefit ratio is a direct function of breast cancer risk and age, an appropriate risk/benefit assessment would be performed on populations of homogeneous risks and ages. Second, Dr. Love has simply summed all events without any regard for the relative severity of the different outcomes. His summation considers a cataract to be as severe as a breast cancer, an endometrial cancer, and a stroke. The concept of severity of the condition must be considered in an appropriate risk/benefit assessment.

The complexities of developing methodology for performing risk/benefit assessments for tamoxifen treatment are substantial. The Chantilly Workshop Working Group spent more than 9 months developing statistically sound algorithms to quantify risk/benefit for any subset of the population. The special article describing this work appears in this issue of the Journal (1). Sound conclusions regarding who would or would not be likely to benefit from treatment can be drawn from this type of assessment.

REFERENCES

1 Gail MH, Costantino JP, Bryant J, Croyle R, Freedman L, Helzlsouer K, et al. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999;91:1829-46.[Abstract/Free Full Text]



             
Copyright © 1999 Oxford University Press (unless otherwise stated)
Oxford University Press Privacy Policy and Legal Statement