• Hormone therapy and breast cancer. In: Menopause and osteoporosis update 2009. J Obstet Gynaecol Can 2009 Jan;31(1 Suppl 1):S19-26. [83 references]

This is the current release of the guideline.

This guideline updates a previous version: Belisle S, Reid R, Mills C. Cancer. In: Canadian consensus conference on menopause, 2006 update. J Obstet Gynaecol Can 2006 Feb;28(2 Suppl 1):S87-94. [79 references]

• Menopause
• Breast cancer

Counseling
Management
Prevention
Risk Assessment
Treatment

Family Practice
Internal Medicine
Obstetrics and Gynecology
Oncology

Advanced Practice Nurses
Health Care Providers
Nurses
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians

To provide updated guidelines for health care providers on the management of menopause in asymptomatic healthy women as well as in women presenting with vasomotor symptoms or with urogenital, mood, or memory concerns, and on considerations related to cardiovascular disease, breast cancer, and bone health, including the diagnosis and clinical management of postmenopausal osteoporosis

• Menopause in asymptomatic healthy women
• Menopause in women presenting with vasomotor symptoms, urogenital, sexual, and mood and memory concerns and specific medical considerations, and cardiovascular and cancer issues

1. Hormone therapy (HT)
   • Combined estrogen and progestogen therapy (EPT)
   • Estrogen therapy
2. Counseling on risks of HT
3. Appropriate surveillance
4. Raloxifene

• Side effects of therapy
• Incidence of breast cancer
• Menopausal symptom relief

Searches of Electronic Databases

MEDLINE was searched up to October 1, 2008, and the Cochrane databases up to issue 1 of 2008 with the use of a controlled vocabulary and appropriate key words. Research-design filters for systematic reviews, randomized and controlled clinical trials, and observational studies were applied to all PubMed searches. Results were limited to publication years 2002 to 2008; there were no language restrictions. Additional information was sought in BMJ Clinical Evidence, in guidelines collections, and from the Web sites of major obstetric and gynaecologic associations worldwide.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly randomized controlled trial.

II-1: Evidence from well-designed controlled trials without randomization.

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group.

II-3: Evidence from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

* Adapted from the Evaluation of Evidence criteria described in: Woolf SH, Battista RN, Angerson GM, Logan AG, Eel W. Canadian Task Force on Preventive Health Care. New grades for recommendations from the Canadian Task Force on Preventive Health Care. Can Med Assoc J 2003;169(3):207-8.

Systematic Review

The authors critically reviewed the evidence and developed the recommendations according to the methodology and consensus development process of the Journal of Obstetrics and Gynaecology Canada.

Expert Consensus

Not stated

Classification of Recommendations*

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

*Adapted from the Classification of Recommendations criteria described in: Woolf SH, Battista RN, Angerson GM, Logan AG, Eel W. Canadian Task Force on Preventive Health Care. New grades for recommendations from the Canadian Task Force on Preventive Health Care. Can Med Assoc J 2003;169(3):207-8.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Not stated

Not applicable

The grades of recommendations (A-E and L) and levels of evidence (I, II-1, II-2, II-3, and III) are defined at the end of the "Major Recommendations" field.

1. Health care providers should periodically review the risks and benefits of prescribing Hormone Therapy (HT) to a menopausal woman in light of the association between duration of use and breast cancer risk. (IA)
2. Health care providers may prescribe HT for menopausal symptoms in women at increased risk of breast cancer with appropriate counselling and surveillance. (IA)
3. Health care providers should clearly discuss the uncertainty of risks associated with HT after a diagnosis of breast cancer in women seeking treatment for distressing symptoms. (IB)

Definitions:

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly randomized controlled trial.

II-1: Evidence from well-designed controlled trials without randomization.

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group.

II-3: Evidence from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Classification of Recommendations**

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

*The quality of evidence reported in these guidelines has been adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.***

**Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.***

***Woolf SH, Battista RN, Angerson GM, Logan AG, Eel W. Canadian Task Force on Preventive Health Care. New grades for recommendations from the Canadian Task Force on Preventive Health Care. Can Med Assoc J 2003;169(3):207-8.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Appropriate management and prevention of breast cancer in post menopausal women

• The risk of breast cancer appears to be greater with estrogen and progestogen therapy (EPT) than with estrogen alone. Women using EPT had an 11% greater risk of an abnormal mammogram after 5 years.
• One study showed that there is an elevated risk of breast cancers with a lobular component (these account for about 16% of invasive carcinomas in the United States) after 3 years of combined hormone therapy (HT). The authors hypothesized that EPT use may stimulate the growth of foci of lobular carcinoma that would have remained small or perhaps clinically undetectable in the absence of EPT exposure.
• Women receiving postmenopausal HT in one study were found to have increased breast density and a greater frequency of abnormal mammograms compared with those receiving placebo. Even though breast density can be increased by the use of estrogen with a progestin, it has never been shown that an acquired increase in density, as in hormone treatment, increases breast cancer risk.
• Another study found that women who used HT after a diagnosis of breast cancer had a higher recurrence risk than did women assigned to placebo.
• Raloxifene is associated with a higher, though not statistically significant, risk of noninvasive breast cancer.

This guideline reflects emerging clinical and scientific advances as of the date issued and are subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the Society of Obstetricians and Gynaecologists of Canada (SOGC).

An implementation strategy was not provided.

Staying Healthy

Effectiveness
Patient-centeredness

• Hormone therapy and breast cancer. In: Menopause and osteoporosis update 2009. J Obstet Gynaecol Can 2009 Jan;31(1 Suppl 1):S19-26. [83 references]

Not applicable: The guideline was not adapted from another source.

2006 Feb (revised 2009 Jan)

Society of Obstetricians and Gynaecologists of Canada - Medical Specialty Society

Society of Obstetricians and Gynaecologists of Canada

Not stated

Principal Authors: Robert L. Reid, MD, FRCSC, Kingston ON; Jennifer Blake, MD, FRCSC, Toronto ON; Beth Abramson, MD, FRCPC, Toronto ON; Aliya Khan, MD, FRCPC, Hamilton ON; Vyta Senikas, MD, FRCSC, Ottawa ON; Michel Fortier, MD, FRCSC, Quebec QC

The following conflicts of interest have been disclosed by the authors.

Dr Reid: Speaker or consultant to Wyeth, Bayer, Organon, Proctor and Gamble, Novo Nordisk; advisory boards: Paladin, Wyeth; research support: Organon, Bayer.

Dr Blake: Speaker or consultant to Wyeth, Merck, Glaxo Smith Kline, Bayer; advisory boards: Bayer, Wyeth and Lilly, Novo Nordisk.

Dr Abramson: Speaker or consultant to Abbott, Astra Zeneca, Boehringer Ingelheim, Bristol Myer Squibb, Dupont, Eli Lilly, Lifespeak, Norvartis, Fournier, Merck Frosst, Pfizer, Servier, Schering, Sanofi-Aventis; advisory boards: Astra Zeneca, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi-Aventis; research support: Astra Zeneca, Boehringer Ingelheim, Merck.

Dr Khan: Speaker or consultant to Amgen, Merck, Lilly, Novartis, Servier, Proctor and Gamble; research support: Merck, Lilly, Novartis, Alliance for Better Bone Health.

Dr Senikas: None declared.

Dr Fortier: Speaker or consultant to Proctor and Gamble, Merck; advisory boards: Amgen, Bayer, Novo Nordisk, Novartis, GlaxoSmith Kline, Lilly, Paladin; research support: Wyeth, Sanofi.

This is the current release of the guideline.

This guideline updates a previous version: Belisle S, Reid R, Mills C. Cancer. In: Canadian consensus conference on menopause, 2006 update. J Obstet Gynaecol Can 2006 Feb;28(2 Suppl 1):S87-94. [79 references]

None available

None available

This NGC summary was completed by ECRI Institute on May 4, 2009. The information was verified by the guideline developer on May 21, 2009.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.