Chemoprevention of breast cancer - A joint guideline from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative's Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer

Objective: To assist women and their physicians in making decisions regardi ng the prevention of breast cancer with tamoxifen and raloxifene. Evidence: Systematic review of English-language literature published from 1 966 to August 2000 retrieved from MEDLINE, HealthSTAR, Current Contents and Cochrane Library. Values: The strength of evidence was evaluated using the methods of the Can adian Task Force on Preventive Health Care and the Steering Committee on Cl inical Practice Guidelines for the Care and Treatment of Breast Cancer. Recommendations: Women at low or normal risk of breast cancer (Gail risk assessment index < 1.66% at 5 years): There is fair evidence to recommend against the use of t amoxifen to reduce the risk of breast cancer in women at low or normal risk of the disease (grade D recommendation). Women at higher risk of breast cancer (Gail index greater than or equal to 1.66% at 5 years): Evidence supports counselling women at high risk on the potential benefits and-harms of breast cancer prevention with tamoxifen (gr ade B recommendation). The cutoff for defining high risk is arbitrary, but the National Surgical Adjuvant Breast and Bowel Project P-1 Study included women with a 5-year projected risk of at least 1.66% according to the Call index, and the average risk of patients entered in the trial was 3.2%. Exam ples of high-risk clinical situations are 2 first-degree relatives with bre ast cancer, a history of lobular carcinoma in situ or a history of atypical hyperplasia. As the risk of breast cancer increases above 5% and the benef its outweigh the harms, a woman may choose to take tamoxifen. The duration of tamoxifen use in such situations is 5 years based on the results from tr ials of tamoxifen involving women with early breast cancer. If a woman rais es concerns or has already been evaluated and is calculated to be at high r isk, then individuals experienced and skilled in counselling may discuss th e potential benefits and harms of tamoxifen use. Important additional issues: Prevention of breast cancer with raloxifene. Current evidence does not supp ort recommending chemoprevention of breast cancer with raloxifene outside o f a clinical trial setting. Screening using the Gall risk assessment index: This index was the main eli gibility criterion for enrolling women in the one study that showed potenti al benefit from chemoprevention. However, it has not been evaluated Tor use as a routine screening or case-finding instrument; validation of the index is required. Overall, current evidence does not support a shift to its rou tine use in physicians' offices for screening or case finding. However, whe n a woman or her physician is concerned about the woman's increased risk of breast cancer, the index can be a useful tool in deciding whether to pursu e an in-depth discussion of the potential benefits and harms of chemopreven tion. Hence, the approach to identifying women at higher risk who warrant c ounselling and shared decision-making will vary across practices. (The risk assessment index is available online at http://bcra.nci.nih.gov/brc/). [A patient version of these guidelines appears in Appendix 2.] Validation: The authors' original text was revised by both the Canadian Tas k Force on Preventive Health Care and the Steering Committee on Clinical Pr actice Guidelines for the Care and Treatment of Breast Cancer. The final do cument reflects a consensus of these contributors. Sponsor: Health Canada. Completion date: February 2001.