Breast Cancer Risk Assessment Guidelines Outlined

MIAMI BEACH, Florida—The Breast Cancer Risk Assessment Working Group is completing work on its consensus guidelines for stratifying patients into risk categories for breast cancer and managing their care accordingly. The model was outlined at the 19th Annual Miami Breast Cancer Conference.

The Risk Assessment Working Group

The Risk Assessment Working Group was created in September 2001 to encourage routine, comprehensive breast cancer risk assessment, develop a consensus risk management strategy, and create educational materials about risk.

Founding members of the steering committee are Dr. Victor Vogel, Magee-Women’s Hospital/University of Pittsburgh Cancer Institute; Dr. Joyce O’Shaughnessy, Baylor-Sammons Cancer Center/US Oncology; Dr. Eva Singletary, M.D. Anderson Cancer Center; and Linda Frame, Susan G. Komen Breast Cancer Foundation. They are currently joined by 11 other breast cancer specialists and practitioners.

"This ongoing effort aims to marry evidence-based medicine with a pragmatic approach, to spur further clinical research and to help practitioners manage these high-risk women," said founding member Joyce O’Shaughnessy, MD, Baylor-Sammons Cancer Center/US Oncology, Dallas. The new guidelines, for example, suggest the use of ductal lavage to look for atypical cells as a pragmatic tool to help high-risk women make decisions regarding chemoprevention.

Although accurate tools to assess breast cancer risk have been available for some time, the Working Group effort is perhaps the first to suggest specific risk reduction strategies based on a woman’s risk assessment. "Because we now have interventions, such as tamoxifen [Nolvadex], with many others coming down the pike, it’s really time to identify women who might benefit from these interventions," Dr. O’Shaughnessy said.

The Working Group’s chair, Victor Vogel, MD, director of the Magee-Women’s Hospital/University of Pittsburgh Cancer Institute Breast Program, recommended obtaining software for the Gail or Claus assessment models or accessing the National Cancer Institute’s assessment tool at http://bcra.nci.nih.gov/brc/.

For women who are at average risk, the group recommends an annual clinical breast examination, annual mammography starting at age 40, and a reassessment of risk every 2 to 3 years.

Elevated/High-Risk Group

The elevated/high-risk group is comprised of women who have atypical ductal or lobular hyperplasia or cellular atypia, a 5-year risk of 1.7% or more on the Gail index, and/or two or more second-degree relatives who developed breast cancer before menopause. Women who have used estrogen-progesterone replacement therapy for 10 years or more are also in this group because of evidence that this therapy increases risk by 5% for each year it is taken.

The panel suggests that clinical breast examination be done at least annually and mammography annually beginning at age 40 for women in this middle group. It also urges physicians to counsel these patients about the pros and cons of continuing estrogen therapy and to recommend tamoxifen or participation in a prevention trial for those over age 35 unless contraindicated.

If the benefit/risk analysis is unclear or the patient declines tamoxifen, the panel recommends doing ductal lavage to search for atypical cells, if this would change the woman’s decision.

Should the test show atypia, the group calls on physicians to go back and counsel the patient more strongly on why she ought to consider taking tamoxifen or participating in a prevention trial.

"Most of us feel that the indication for tamoxifen would be strengthened in the woman found to have atypia on ductal lavage, and so this is the group where we feel ductal lavage will likely have the highest usefulness," Dr. O’Shaughnessy said. If atypia is not shown, the group suggests repeating lavage in 1 to 3 years.

The very high risk group is more complex, with recommendations varying according to the criteria that put the woman at risk. All women in this group are urged to have clinical breast exams every 6 months and annual mammograms.

Women who have had invasive breast cancer or ductal carcinoma in situ are considered at very high risk, "although older women in their 60s would probably be considered only at elevated/high risk," Dr. O’Shaughnessy noted.

Even if she has not had breast cancer, a woman would be considered very high risk if she has had atypical ductal or lobular hyperplasia or cellular atypia and has an affected first-degree relative. The panel suggests consideration of tamoxifen or a prevention trial, if over age 35, and offering to do a ductal lavage if atypia would affect her decision.

If a woman has had lobular carcinoma in situ, the panel strongly urges tamoxifen or a prevention trial. Again, ductal lavage would be utilized only if a finding of atypical cells would alter a woman’s clinical management.

When a patient is known to have a BRCA1 or BRCA2 mutation and/or two or more first-degree relatives with breast or ovarian cancer, the panel adds recommendations for genetic counseling and consideration of prophylactic mastectomy. Ductal lavage is advised if a finding of atypical cells would aid a woman’s decision about prophylactic mastectomy.

If a younger woman has had estrogen receptor (ER)-negative breast cancer, she may undergo ductal lavage for help in deciding about tamoxifen or entering a prevention trial. If she has ER-positive breast cancer and has never taken tamoxifen, however, the physician already has enough information to suggest tamoxifen as a risk reduction agent. For these women, the panel recommends ductal lavage only if the benefit/risk analysis of tamoxifen is unclear.