Management of Women at High Risk

3. 45-year-old premenopausal woman with breast biopsy
demonstrating . . .

A. Lobular carcinoma in situ (LCIS). No family history of breast cancer.

B. LCIS. BRCA 1 & 2-negative. Patient's mother was diagnosed with breast cancer at age 40.

C. Atypical hyperplasia. No family history of breast cancer.

D. Atypical hyperplasia. Patient's mother was diagnosed with breast cancer at age 40.

E. Excisional biopsy revealed fibrocystic changes. Patient's mother and sister have breast cancer. Patient is BRCA 1 2-negative. Five-year Gail model risk is 4.5%; lifetime risk is 34.5%.

Your suggested management:

Patrick Borgen, MD

Case A.

These numbers reflect a bit of a skewed population of physicians, because they traveled to Miami to update their knowledge about breast cancer at the meeting. So, this might not be the U.S. national average that we're looking at. Also, what people say they would do and what they do are often two different things. We know that the FDA approval of tamoxifen as a chemopreventive agent didn't stimulate 65 percent of cases like Case A to receive tamoxifen. I think people believe in their heart that chemoprevention is the right thing to do, but I'm not sure that these numbers reflect, necessarily, what's going on in practice.

Andrew Seidman, MD

Case A.

For this case, I'm very influenced by the data from the prevention study, and tamoxifen would be entirely appropriate, and it would definitely be something I would discuss extensively with the patient.

Case B.

It's well-documented that the combination of LCIS and family history adds even further to a woman's ultimate risk of developing invasive breast cancer. Therefore, the participants have more enthusiasm for chemoprevention. It's interesting that bilateral mastectomy was considered by 11 percent of the respondents, compared to two percent without a family history. Family history has a very important psychological impact on the decision of a woman to have prophylactic surgery. Women who have seen their mother or sister, particularly, die of this disease may be driven to have prophylactic surgery and may push their physicians to accept that decision, rather than the opposite. For some women, the level of psychological distress and its impact on quality of life, living with the known risk, may be worse than the intervention. This is an incredibly individualized process. We always need to be cognizant of the fact that there's usually no great urgency to make this decision rapidly. Going slow is perhaps the best rule in considering prophylactic surgery. We also want to be sure that patients have thought this process through and are making their decisions not solely based on the life experience of having lost a loved one. It only takes one death in the family to motivate somebody to take this kind of drastic step. Fortunately, we now have greater availability of talented genetic counselors —people who can coach women through this process. So, whenever prophylactic surgery is being considered at my institution, we almost make it mandatory for a woman to participate in the process of counseling. It also involves knowledge of options of reconstruction

.

Case C.

In the P1 trial this subset of women benefited at least as much, if not more proportionately, than women with other pre-malignant histologies or being high-risk as determined by the Gail model. So, assuming that this woman is not going to be getting pregnant in the next few years, she would be an appropriate candidate for chemoprevention with tamoxifen.

4. To what extent are you concerned that by not discussing the option of tamoxifen for a high-risk woman, you may be exposing yourself to medical legal liability? (The question was asked after Dr Borgen's presentation on this subject.)

Patrick Borgen, MD

I was overwhelmed after the meeting with letters, calls, e-mails and invitations to speak on this subject. I'm impressed that 75 percent of a savvy audience was concerned about this. Our entire practice pattern is colored by medical-legal concerns. And we firmly believe in our hearts that if a plaintiff attorney could file an action for failure to prevent, he would certainly do that. Since last year's meeting, we have identified three cases in the court system where this is an issue. On one of them, I'm actually on the defense team. A lesion was missed on mammography, but the plaintiff's attorney were very savvy and also said, "Wait a minute. You saw Dr X after the FDA approval of tamoxifen. You had a family history of breast cancer. Your Gail model was 2.2 percent. Did he mention tamoxifen?"The physician had not mentioned it, and they included that as one of the actions in the lawsuit for failure to prevent breast cancer. That's going to be a hard one to get around on the part of the defense team.

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