Ductal Lavage for Breast Cancer Risk Assessment

Lisa A. Newman, MD, MPH, FACS, Cassann Blake, MD


Cancer Control. 2002;9(6) 

In This Article

Tamoxifen Use

The need for an accurate risk assessment tool is even more compelling in light of the available data regarding the efficacy of tamoxifen for breast cancer risk reduction. The National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention Trial (BCPT) randomized more than 13,000 high-risk women to receive either tamoxifen or a placebo for 5 years.[25] Eligibility criteria to participate in this study as a high-risk patient included a 5-year Gail model risk estimate of at least 1.66%, age over 60 years, and a history of lobular carcinoma in situ. The study was unblinded early, after approximately 4 years, because of the magnitude of difference in breast cancer incidence for the two arms of the study. The participants taking tamoxifen had a 49% lower breast cancer incidence compared with the participants assigned to the placebo arm.

Unfortunately, the BCPT confirmed the previously demonstrated potential adverse effects associated with tamoxifen use: statistically significant increases in incidence of uterine cancer, thromboembolic events, and vasomotor symptoms among the tamoxifen users. These adverse effects are generally rare, and the risk of experiencing them is easier to justify in a woman with an established breast cancer diagnosis, where the primary concern is to address and eradicate micrometastatic disease. However, in otherwise healthy women, the decision to take tamoxifen for pure prophylaxis and face the risk of medication-associated morbidity is more difficult. Port et al[33] recently documented the fact that even among high-risk women, there is substantial reluctance regarding a commitment to tamoxifen chemoprevention therapy. Forty-three patients at increased risk for breast cancer (including 23% with lobular carcinoma in situ and 61% with 5-year Gail model risk estimate of at least 1.7%) were provided with risk reduction counseling and education. Although all 43 patients were offered tamoxifen on the basis of their risk profiles, 15 patients (35%) declined definitively; and 26 (61%) were undecided, and only 2 (4.7%) accepted this recommendation. A clear assessment of the underlying risk of breast cancer and the parallel understanding of benefits gained by chemoprevention would facilitate the decision-making process for the undecided patients.

Detection of atypia is a marker of risk that may clarify the risk-benefit ratio for the individual patient. Among the BCPT participants, the women with a history of atypia experienced the greatest benefit from tamoxifen use. In this subset, chemoprevention resulted in a risk reduction of 86%.[25] Nipple aspirate fluid is currently being investigated for levels of expression of HER-2/neu.[34] It may therefore be speculated that a variety of proteins and molecular markers will ultimately be identified in breast ductal lavage fluid, and some of these may become important for risk assessment as well.

Appropriate follow-up management of patients electing to undergo ductal lavage is an evolving area of study. Patients wishing to undergo serial lavage for ongoing risk assessment should understand that standards for this management strategy have not yet been developed, although annual or biennial studies might be considered. Morrow et al[35] have proposed a surveillance strategy that addresses these options. One possible algorithm for incorporating ductal lavage and its findings into clinical risk assessment practice is shown in Fig 2.

Algorithm for incorporating ductal lavage into risk assessment strategies.


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