Kaiser Permanente Colorado Clinical Practice Guideline

Breast Cancer Screening Guideline Table of Contents 1. Risk factor identification and high risk definition 2. Asymptomatic women without breast cancer risk factors Frequency of screening Discontinuation of Screening 3. Asymptomatic women with selected breast cancer risk factors Mammography Screening Recommendations Mammography / MRI Screening Recommendations 4. Breast self-examination recommendations 5. Clinical breast examination recommendations 6. Breast MRI Recommendations Last Reviewed/Revised

February 2013

Target Population

All female members aged 40 and older.

Author:

Sue Williams M.D. Physician Lead for Women’s Health, Dept. of Population and Prevention Services

Reviewd/Approved By: Ruby Kadota, MS, MD Medical Director of Clinical Prevention, PPS

Additional Metadata

1. Risk factor identification and high risk definition A. Women should have breast cancer risk factor assessment at least by age 40, repeated at least every five years, and assessed at every mammogram appointment (Consensus based) B. High risk is defined as (Consensus based) Personal history of breast cancer (including lobular and ductal carcinoma in situ) Breast biopsy showing atypical hyperplasia, atypical apocrine metaplasia or lobular hyperplasia (lobular carcinoma in situ) First degree blood relative of either sex (parent, sibling or child) diagnosed with breast cancer Documentation of an inherited genetic alteration associated with increased breast cancer risk Blood relative(s) with documentation of an inherited genetic alteration associated with increased breast cancer risk ^^Back to Top

2. Recommendations for asymptomatic women without breast cancer risk factors

A. Screening frequency will be every 1 to 2 years. Women will be prompted proactively to be screened at 2 year intervals but may be offered annual screening based on personal or clinician preference. (Consensus based.*) B. For women under age 40, routine mammography screening is not recommended. (Consensus based.) C. For women aged 40 to 49, offer mammography in the context of a shared decision-making approach, taking into consideration patient preference, family history, potential risks and benefits and clinician judgment. (Consensus based.) D. Routine mammography screening is strongly recommended for asymptomatic women aged 50 to 74. (Evidence based: A for ages 50 to 69, Consensus based for ages 70 to 74) E. For women aged 75 and older, offer mammography in the context of a shared decision-making approach, taking into consideration life expectancy, patient preference, existing co-morbidities, and clinician judgment. (Consensus based.) Frequency of screening There are no trials directly comparing different mammography screening intervals and, therefore, the optimal interval between screening examinations is not known. In the absence of direct evidence, the recommended screening frequency of every one to two years is based on the intervals studied in the seven large RCTs of mammography screening, which ranged from 12 to 33 months). Age

Recommendation

under There is no direct evidence that compares mammography screening in women under age 40. Based on the age absence of evidence, the low incidence of breast cancer in this age group, and the potential harms (e.g. false40 positive/false-negative test results, unnecessary biopsies, pain, discomfort, radiation exposure, etc.) routine mammography screening is not recommended in women under age 40. 40There are conflicting results from one previous RCT and six subgroup analysis and eight meta-analysis that 49 mammography screening improves health outcomes in women aged 40-49. In Dec 2006, Lancet published a RCT done in the UK, following 160,000 women aged 39 to 41 who were offered annual mammography or usual care. After a mean 10 years of followup, women in the mammography group had a 17% lower breast cancer mortality, although this result was not felt to be statistically significant (relative risk .83). Breast cancer screening with mammography should be offered to all women aged 40-49 in the context of shared decision making taking into account a woman’s personal preferences, family history and the balance of benefits to harms. 50 to There is good evidence from a well-designed meta-analysis of seven randomized controlled trials (RCTs) of 69 mammography screening vs. no mammography screening that screening significantly reduces mortality from breast cancer. Mammography screening is strongly recommended for women aged 50 to 69. 70 to There is insufficient evidence from subgroup analysis from two RCTs of low methodological quality that 74 mammography screening significantly reduces mortality from breast cancer in women aged 70 to 74. However, U.S. SEER data shows that the incidence of breast cancer in women advances with age and the false-positive rate of mammography screening in women 70 and older is lower than that of younger age groups. In addition, these tumors are often less aggressive and more responsive to treatment than in younger age groups. It is therefore recommended that mammography screening be continued in healthy women through age 74. 75 There are no controlled trials of mammography screening in women aged 75 or older. As noted above, SEER and data shows that the incidence of breast cancer advances with age and and reaches it’s peak in women aged older 75 to 79 in all reported race/ethnic groups. It is therefore recommended that mammography screening be offered to women aged 75 and older in the context of a shared decision-making approach, taking into account a women’s life expectancy, personal preference, existing co-morbidities and clinician judgement. Discontinuation of Screening There is no direct evidence from RCT’s comparing the optimal age at which to discontinue mammography screening. The only available data is from the large RCT’s of mammography screening described above, which included women up to age 74. In the absence of sufficient evidence, the Guideline Team recommends that the age at which to discontinue screening be determined by taking into consideration life expectancy (screening is discouraged if life expectancy is less than 5-10 years), patient preference, the risk of complications in older adults, existing co-morbidities, and clinician judgment.

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3. Recommendations for asymptomatic women with selected breast cancer risk factors A. For all women with risk factors for breast cancer, annual mammography screening is recommended (Consensus based.) B. Mammography screening is recommended for women with one or more of the following selected risk factors for breast cancer. Risk Factor:

Begin Screening:

Personal history of breast cancer (including ductal carcinoma in situ)

At age of diagnosis

Breast biopsy showing atypical hyperplasia, atypical apocrine

At age of diagnosis

metaplasia or lobular hyperplasia (lobular carcinoma in situ)

First degree blood relative of either sex (parent, sibling or child)

Diagnosed at age 50: Start age 40

diagnosed with breast cancer

Diagnosed before Age 40: start age 35 or discuss with Radiology

Prior mantle chest radiation therapy between the ages of 10-30

Age 25, or ten years after completion of radiation treatment

C. Mammography screening alternating with MRI screening at 6 month intervals is recommended for women at high genetic risk. Please see Genetic Screening Guideline Genetic Risk:

At age of test result.

Clinically significant alteration in a BRCA1 or BRCA2 gene in the

If test result before age 35, discuss

patient, or for non-tested patients with a first- or second- degree blood

with Radiology

relative with a significant BRCA1/2 mutation, or if genetic referral determines patient as high genetic risk.

1. Breast cancer screening with mammography should not be initiated earlier than age 30 years. 2. For women under age 30 years, screening with modalities that don’t involve ionizing radiation is an option (e.g. ultrasound, MRI).

For asymptomatic women with selected breast cancer risk factors, there is insufficient evidence to recommend for or

against providing routine mammography screening. However, there is indirect evidence from observational studies and RCTs that may have included high risk women that suggests some benefit would be observed in women with one or more selected risk factors. Consequently, the guideline team recommends women with breast cancer risk factors be screening with mammography on an annual basis. Age at which to begin screening varies depending on the risk factor. ^^Back to Top

4. Recommendations regarding use of breast selfexamination (BSE) A. There is currently no evidence to either recommend or discourage the use of breast self-exam, therefore, whether or not to practice breast self exam is a personal choice (Insufficient Evidence.) B. Counsel all women to seek immediate medical attention on detection of a breast lump. (Consensus based.) C. For genetic risk: Monthly breast self-examination starting in early adulthood. (Expert consensus) There is insufficient evidence from two RCTs of lower quality that breast self-exam does not reduce the risk of mortality from breast cancer. In the absence of sufficient evidence, the Guideline Team recommends a shared decision-making approach to BSE, taking into account a woman’s personal preferences and the balance of benefit to harm. ^^Back to Top

5. Recommendations regarding the use of clinical breast examinations (CBE) Population

Recommendation

Asymptomatic women without breast cancer risk factors High Risk Women (see 3B above for list) Genetic Risk

Offer clinical breast examination in the context of preventive care to asymptomatic women without breast cancer risk factors. (Consensus based.*) Annual clinical breast examination is recommended for high risk women (see 3B for list). (Consensus based.*) For genetic risk: semiannual clinical breast examination beginning 25-35 years of age.

*CBE is not a prerequisite to obtaining a mammogram. The sensitivity of mammography is limited, 71 to 96%, and clinical breast exam may detect additional breast cancers. There is no evidence to support a recommendation for or against routine clinical breast exam alone to screen for breast cancer in women with and without selected risk factors for breast cancer. In the absence of sufficient evidence, the Guideline Team recommends annual CBE for women with selected risk factors and to offer CBE in the context of health maintenence for women without selected risk factors. ^^Back to Top

6. Recommendations regarding the use of breast MRI

Population

Recommendation

asymptomatic Magnetic resonance imaging screening is not recommended for asymptomatic women without risk women factors. (Consensus based.*) without risk There is insufficient evidence to recommend for or against routine magnetic resonance imaging factors screening as a supplement to current breast cancer screening procedures for asymptomatic women without risk factors. There are currently no studies that determine the effectiveness of MRI in reducing important health outcomes. Consequently, the Guideline Team does not recommended magnetic resonance imaging screening for asymptomatic women without risk factors. very high Magnetic resonance imaging screening is an option for women at very high genetic risk as an adjunct genetic risk to other screening modalities of mammography and clinical breast exam. (Consensus based.*) Please see Breast MRI Recommendations for KPCO *There are currently no studies that determine the accuracy of MRI or its efficacy in reducing important health outcomes among women with average risk for developing breast cancer. *Evidence shows that the sensitivity of tumor detection for MRI is high compared to conventional mammography, but whether this directly impacts morbidity and mortality from breast cancer remains uncertain. Due to the absence of direct evidence from RCTs or prospective cohort studies that concurrent MRI surveillance with mammography, or MRI surveillance alone, reduces morbidity or mortality in women at high risk for breast cancer, there is insufficient evidence to recommend for or against MRI as a supplement to mammography screening in women with selected risk factors for breast cancer. In KPCO, recommendations for management of patients at very high genetic risk include alternating routine mammography with MRI screening at six month intervals. ^^Back to Top

Metadata Rationale Breast Cancer is the most common non-skin malignancy among women in the United States and second only to lung cancer as a cause of cancer-related death. The risk of developing breast cancer increases with age after age 40 and reaches its peak in all race and ethnic groups between ages 75 to 79. Tumors in the younger age group tend to be more aggressive, making screening issues more challenging. The following guideline covers identification of high risk groups, age-specific recommendations regarding mammography, and discussions/recommendations regarding clinical breast exam and breast self exam. Source of Evidence See National Breast Cancer Screening Guidelines for problem formulations, evidence discussion and evidence tables. Settings for Application Internal Medicine, Family Practice, Ob/Gyn, Radiology. Methods for Measuring Compliance Monitor Breast Cancer Screening HEDIS rates, monthly Health Trac reports and PC quality dashboard These guidelines are informational only and are not intended or designed to substitute the reasonable exercise of independent clinical judgment by providers in any particular set of circumstances for each patient encounter. The guidelines are flexible and are intended to be used as a resource for integration with a sound exercise of clinical judgment. They can be used to create an approach to care that is unique to the needs of each individual patient. These guidelines represent medical recommendations and implementation of these guidelines is not

intended to conflict with any agreed upon health plan benefits nor is it intended to prevent access to care that the practitioner believes is warranted based on clinical judgment.