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Dr. Levine is Chair of Health Canada's Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer, Dr. Moutquin is a member of the Canadian Task Force on Preventive Health Care, Ms. Walton is a research associate for the task force, and Dr. Feightner is Chair of the task force.Members of the Canadian Task Force on Preventive Health Care Chairman:
Dr. John W. Feightner, Professor, Department of Family Medicine, University of Western Ontario, London, Ont. Past chairman: Dr. Richard Goldbloom, Professor, Department of Pediatrics, Dalhousie University, Halifax, NS. Members: Drs. R. Wayne Elford, Professor and Chair of Research, Department of Family Medicine, University of Calgary, Calgary, Alta.; Denice Feig, Assistant Professor, Department of Endocrinology, University of Toronto, Toronto, Ont.; Michel Labrecque, Professor, Unité de médecine familiale, Université Laval, Rimouski, Que.; Robin McLeod, Professor, Department of Surgery, Mount Sinai Hospital and University of Toronto, Toronto, Ont.; Harriet MacMillan, Departments of Psychiatry and Behavioural Neurosciences and of Pediatrics, Canadian Centre for Studies of Children at Risk, McMaster University, Hamilton, Ont.; Jean-Marie Moutquin, Professor and Director, Département d'obstétrique-gynécologie, Université de Sherbrooke, Sherbrooke, Que.; Valerie Palda, Assistant Professor, Department of General Internal Medicine, University of Toronto, Toronto, Ont.; Christopher Patterson, Professor and Head, Division of Geriatric Medicine, Department of Medicine, McMaster University, Hamilton, Ont.; and Elaine E.L. Wang, Associate Professor, Departments of Pediatrics and Public Health Sciences, Faculty of Medicine, University of Toronto, Toronto, Ont. Resource people: Nadine Wathen, Coordinator, and Ruth Walton, Research Associate, Canadian Task Force on Preventive Health Care, Department of Family Medicine, University of Western Ontario, London, Ont.
Members (and nominating organizations) of the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer Chair: Dr. Mark Levine (Cancer Care Ontario), Hamilton Regional Cancer Centre and McMaster University, Hamilton, Ont. Members: Dr. David M. Bowman (Manitoba Cancer Treatment and Research Foundation), Manitoba Cancer Treatment and Research Foundation, Winnipeg, Man.; Dr. Judy Caines (Federal/Provincial/Territorial Advisory Committee on Health Services), Nova Scotia Cancer Centre, Halifax, NS; Dr. Jacques Cantin (Royal College of Physicians and Surgeons of Canada), Centre hospitalier de l'Université de Montréal, Montreal, Que.; Ms. Chris Emery (Canadian Nurses Association), BC Cancer Agency, Delta, BC; Dr. Eva Grunfeld (College of Family Physicians of Canada), Ottawa Regional Cancer Centre, Ottawa, Ont.; Dr. Maria R. Hugi (Canadian Breast Cancer Network), Providence Health Care, Vancouver, BC; Dr. Alan W. Lees (Alberta Cancer Board), Cross Cancer Institute, Edmongon, Alta.; Ms. Sabina Mallard (Canadian Breast Cancer Network), consumer representative, Stratford, PEI; Dr. Mohamed Mohamed (Saskatchewan Cancer Foundation), Saskatoon Cancer Centre, Saskatoon, Sask.; Dr. Ivo A. Olivotto (BC Cancer Agency), Vancouver Island Cancer Centre and University of British Columbia, Victoria, BC; Dr. Leonard Reyno (Cancer Care Nova Scotia), Nova Scotia Cancer Centre, Halifax, NS; Dr. Carol Sawka (Cancer Care Ontario), Toronto Sunnybrook Regional Cancer Centre, Toronto, Ont.; Dr. Hugh Scarth (Atlantic Health Sciences Corporation), Saint John Regional Hospital, Saint John, NB; Ms. Donna Seymour (Health Canada), Adult Health Division, Centre for Chronic Disease and Control, Health Canada, Ottawa, Ont.; Dr. S. Kishore Thain (Newfoundland Cancer Treatment and Research Foundation), Dr. H.B. Murphy Cancer Centre, St. John's, Nfld.; and Dr. Timothy Whelan (Cancer Care Ontario), Hamilton Regional Cancer Centre and McMaster University, Hamilton, Ont.
Objective: To assist women and their physicians in making decisions regarding the prevention of breast cancer with tamoxifen and raloxifene.
Evidence: Systematic review of English-language literature published from 1966 to August 2000 retrieved from MEDLINE, HealthSTAR, Current Contents and Cochrane Library.
Values: The strength of evidence was evaluated using the methods of the Canadian Task Force on Preventive Health Care and the Steering Committee on Clinical 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 tamoxifen 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 
1.66% at 5 years): Evidence supports counselling women at high risk on the potential benefits and harms of breast cancer prevention with tamoxifen (grade 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 Gail index, and the average risk of patients entered in the trial was 3.2%. Examples of high-risk clinical situations are 2 first-degree relatives with breast 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 benefits 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 trials of tamoxifen involving women with early breast cancer. If a woman raises concerns or has already been evaluated and is calculated to be at high risk, then individuals experienced and skilled in counselling may discuss the potential benefits and harms of tamoxifen use.
Important additional issues: · Prevention of breast cancer with raloxifene: Current evidence does not support recommending chemoprevention of breast cancer with raloxifene outside of a clinical trial setting. · Screening using the Gail risk assessment index: This index was the main eligibility criterion for enrolling women in the one study that showed potential benefit from chemoprevention. However, it has not been evaluated for 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 routine use in physicians' offices for screening or case finding. However, when 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 pursue an in-depth discussion of the potential benefits and harms of chemoprevention. Hence, the approach to identifying women at higher risk who warrant counselling 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 Task Force on Preventive Health Care and the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. The final document reflects a consensus of these contributors.
Sponsor: Health Canada.
Completion date: February 2001.
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M. Levine, J.-M. Moutquin, R. Walton, and J. Feightner Give us clear, not convoluted, clinical practice guidelines Can. Med. Assoc. J., November 1, 2001; 165(11): 1469 - 1469. [Full Text] [PDF]
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J. Sehmer Give us clear, not convoluted, clinical practice guidelines Can. Med. Assoc. J., November 1, 2001; 165(11): 1468 - 1469. [Full Text]
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I. Olivotto and M. Levine Clinical practice guidelines for the care and treatment of breast cancer: the management of ductal carcinoma in situ (summary of the 2001 update) Can. Med. Assoc. J., October 1, 2001; 165(7): 912 - 913. [Full Text] [PDF]
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