© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 2, 143-144,
January 16, 2002
© 2002 Oxford University Press
CORRESPONDENCE |
RESPONSE: Re: Risk-Reduction Mastectomy: Clinical Issues and Research Needs
Affiliation of authors: M. Stefanek, W. Nelson, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD; L. Hartmann, Division of Medical Oncology, Mayo Clinic, Rochester, MN.
Correspondence to: Michael Stefanek, Ph.D., National Institutes of Health, Rm. 4066, Executive Plaza North, MSC 7363, Bethesda, MD 20892 (e-mail: ms496r{at}nih.gov).
Dr. Swanson raises several important concerns about risk-reduction mastectomy (RRM) in response to our review (1). These include how best to communicate risk and benefit, avoid unnecessary procedures, and direct future research.
With respect to quantifying risk reduction, relative risk is the accepted standard for reporting in clinical trials, which is why we presented our data in this manner. In the Mayo Clinic study (2), the cumulative risk of breast cancer among high-risk women who had RRM at 14 years of follow-up was 1.4%, compared with 18% among sisters who did not choose RRM. Another study that we reported (3) noted that the cumulative risk of breast cancer was 13% (n = 8) in the surveillance group, compared with 0% in the surgery group, at a median of 3 years of follow-up. Dr. Swanson comments that all of the remaining women in these studies underwent RRM "unnecessarily." This statement ignores the remaining lifetime risk for these women beyond the follow-up intervals noted above. It is also decidedly post hoc. That is, we could look at the number of mammograms, clinical breast examinations, or doses of tamoxifen prescribed for a woman at increased risk destined never to develop breast cancer and label these "unnecessary." Unfortunately, as we counsel a woman at high risk, we do not have the luxury of definitive information on whether she will develop breast cancer over time. Thus, we do not know how "unnecessary" any prevention or screening strategy will be for her. We do agree with Dr. Swanson that presenting absolute risk differences could help women in their decision-making process. In fact, we note the need for such research in our section on research needs.
Dr. Swanson notes that our discussion of screening and chemoprevention was presented with a "negative tenor." In examining our Table 5 (1), we find that the benefits and risks associated with currently available clinical options are presented in what we consider to be a balanced fashion. In fact, one could argue that all of the options are presented somewhat negatively given their respective limitations.
We neither endorse nor discourage RRM for women at high risk. The decision-making process is painfully difficult for women, their families, and health care professionals. Our task is to provide the most objective information in the most useful and understandable format while recognizing that all of the clinical management options are less than perfect.
Finally, we fully agree with Dr. Swanson that future research should focus on how best to avoid the option of RRM: "Clearly, if we are to consider interventions that involve costs and potential benefits, particularly irreversible ones such as RRM, we must improve our ability to identify those women with a very high likelihood of developing breast cancer. By improving our precision, we may prevent not only breast cancer but also the unnecessary interventions, worry, and distress experienced by women designated high risk who are destined never to develop the disease" (1).
REFERENCES
1
Stefanek M, Hartmann L, Nelson W. Risk-reduction mastectomy: clinical issues and research needs. J Natl Cancer Inst 2001;93:1297–306.
2
Hartmann LC, Schaid DJ, Woods JE, Crotty TP, Myers JL, Arnold PG, et al. Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med 1999;340:77–84.
3
Meijers-Heijboer HJ, van Geel B, van Putten WL, Henzen-Logmans SC, Seynaeve C, Manke-Pluymers MB, et al. Breast cancer after prophylactic bilateral mastectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 2001;345:159–64.
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