Breast Cancer Screening Guideline July 1, 2010

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1 Breast Cancer Screening Guideline July 1, 2010 Introduction 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. 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 updated discussions/recommendations regarding clinical breast exam and breast self exam. Target Population All female members aged 40 and older. 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 Recommendations 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

2 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 2. Recommendations for asymptomatic women without breast cancer risk factors 2A 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.*) *This recommendation takes into consideration the screening frequencies used in the large trials of mammography screening, which ranged from 12 to 33 months. 2B For women under age 40, routine mammography screening is not recommended. (Consensus based.) 2C 2D 2E For women aged 40 to 49, offer mammography in the context of a shared decision-making approach, taking into consideration patient preference, potential risks and benefits and clinician judgment. (Consensus based.) 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) 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 (3 studies screened annually, 1 every 18 months, 1 every months, and 3 studies every 24 months or more). Women under age 40 There is no direct evidence that compares mammography screening in women under age 40. Based on the absence of evidence, the low incidence of breast cancer in this age group, and the potential harms (e.g. false-positive/false-negative test results, unnecessary biopsies, pain, discomfort, radiation exposure, etc.) routine mammography screening is not recommended in women under age 40. Women Aged There are conflicting results from one previous RCT and six subgroup analysis and eight metaanalysis that mammography screening improves health outcomes in women aged In Dec 2006, Lancet published a RCT done in the UK, following 160,000 women aged 39 to 41

3 who were offered annual mammography or usual care. After a mean 10 years of follow-up, 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). Therefore the true estimate of effect of mammography screening on breast cancer mortality continues to be controversial, although increasingly, patients and clinicians are promoting screening in this age group. Because data suggest that breast cancer grows more rapidly in women younger than 50, and the sensitivity of mammography is lower in this age group, shorter screening intervals (annual) for women aged have been recommended by some specialty groups. Breast cancer screening with mammography should be offered to all women aged in the context of shared decision making taking into account a woman s personal preferences and the balance of benefits to harms. Women aged 50 to 69: There is good evidence from a well-designed meta-analysis of seven randomized controlled trials (RCTs) of 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. Women aged 70 to 74 There is insufficient evidence from subgroup analysis from two RCTs of low methodological quality that 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. Women aged 75 and older There are no controlled trials of mammography screening in women aged 75 or older. As noted above, SEER data shows that the incidence of breast cancer advances with age and and reaches it s peak in women aged 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 judgment. 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. 3. Recommendations for asymptomatic women with selected breast cancer risk factors 3A 3B For all women with risk factors for breast cancer, annual mammography screening is recommended (Consensus based.) Mammography screening is recommended for women with one or more of the following selected risk factors for breast cancer.

4 Risk Factor: Personal history of breast cancer (including 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 Prior mantle chest radiation therapy between the ages of Begin Screening: At age of diagnosis At age of diagnosis Diagnosed at age 50: Start age 40 Diagnosed before Age 40: start age 35 or discuss with Radiology Age 25, or ten years after completion of radiation treatment 3C: Mammography screening alternating with MRI screening at 6 month intervals is recommended for women at high genetic risk. Genetic Risk: At age of test result. Clinically significant alteration in a BRCA1 or BRCA2 If test result before age 35, gene discuss with Radiology in the patient, or for non-tested patients with a firstor second- degree blood relative with a significant BRCA1/2 mutation, or if genetic referral determines patient as high genetic risk. Please see Genetic Screening Guideline 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. 4. Recommendations regarding use of breast self-examination (BSE) 4A: 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.) 4B: Counsel all women to seek immediate medical attention on detection of a breast lump. (Consensus based.) 4C: 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

5 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 Recommendations regarding the use of clinical breast examinations (CBE) 5A: Offer clinical breast examination in the context of preventive care to asymptomatic women without breast cancer risk factors. (Consensus based.*) *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. 6A: Annual clinical breast examination is recommended for high risk women (see 3B for list). (Consensus based.*) *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. 6B: For genetic risk: semiannual clinical breast examination beginning years of age. 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 maintenance for women without selected risk factors. 7-8 Recommendations regarding the use of breast MRI 7: Magnetic resonance imaging screening is not recommended for asymptomatic women without risk factors. (Consensus based.*) *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. There is insufficient evidence to recommend for or against routine magnetic resonance imaging 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. 8: Magnetic resonance imaging screening is an option for women at very high genetic risk as an adjunct to other screening modalities of mammography and clinical breast exam. (Consensus based.*) Please see Breast MRI Recommendations for KPCO *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.

6 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. For women considered to be at very high risk of breast cancer due to a BRCA mutation for whom standard modalities of mammography and clinical breast examination are not deemed sufficient, magnetic resonance imaging (in addition to mammography) is an option. In KPCO, recommendations for management of patients at very high genetic risk include alternating routine mammography with MRI screening at six month intervals. Responsible Party Karin Kempe, MD, Director of Clinical Prevention, Dept. of Population and Prevention Services

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