Breast Cancer Screening Recommendations PowerPoint Presentation

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Breast Cancer Screening Recommendations: What’s All The Fuss? Mary S. Davey, M.D.

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Breast cancer- the scope of the problem and who is at risk Breast cancer screening options- what is available and what is on the horizon Breast cancer screening recommendations- how to make sense of them

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The Headlines “Shocking and unconscionable” “Incredibly flawed” “Will have deadly effects for women” “Countless American women will die needlessly” “Deliberate decisions to trade women’s lives for money” November 17th, 2009 United States Preventative Services Task Force (USPSTF) new breast screening guidelines were released

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U.S. Breast Cancer Facts American Cancer Society 2010 207,090 new cases of invasive breast cancer 28% of all cancer diagnoses in women 54,010 cases of in situ breast cancer 39,840 estimated breast cancer deaths 15% of cancer deaths in women

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Nebraska Breast Cancer Facts American Cancer Society 2010 1160 women will be diagnosed with invasive breast cancer this year 210 women will die from breast cancer this year

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Breast Cancer Incidence Trends http://seer.cancer.gov/statfacts/html/breast.html 1980-1987: increased 4%/year 1987-1994 : constant 1995-1998 : increased 1.6%/year increased screening, use of hormone replacement therapy (HRT), increased obesity rates, delayed childbearing 1999-2006: decreased 2%/year Reduced use of HRT Drop in mammography utilization

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Breast Cancer Deaths http://seer.cancer.gov/statfacts/html/breast.html 1975-1990: increased 0.4%/year 1990-1995: decreased 1.8%/year 1995-1998: decreased 3.3%/year 1999-2006: decreased 1.9%/year Decline larger in women under age 50 years Decrease likely due to earlier detection, improved treatment and decreased incidence

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Lifetime probability of developing invasive breast cancer is 12% (1 in 8) Every woman’s risk is different

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Breast Cancer Risk Factors Relative risk >4.0 Female Increasing age Known genetic risk factors Two or more first degree relatives with premenopausal breast cancer Radiation therapy to chest between 10 and 30 years of age Personal history invasive breast cancer or ductal carcinoma in-situ (DCIS) History of biopsy showing atypical ductal hyperplasia or lobular neoplasia High breast density 3/6/2014 9

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Age Risk of developing cancer in next 10 years 30 year old: 1 in 250 (0.40%) 40 year old: 1 in 68 (1.47%) 50 year old: 1 in 35 (2.84%) 60 year old: 1 in 27 (3.67%) 3/6/2014 10

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Genetic risk factors 5 to 10% of breast cancer patients have a hereditary form of the disease Genetic mutations BRCA-1 and BRCA-2 Lifetime breast cancer risk 36 to 85% Other disorders with increased risk Ataxia-telangectasia (ATM), Li-Fraumeni (p53 and CHEK2), Cowden syndrome (PTEN), Hereditary diffuse gastric cancer syndrome (CDH1) 3/6/2014 11

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Breast Density The amount of fibroglandular parenchyma on a mammogram Mammogram reports describe density The breast is almost entirely fat There are scattered fibroglandular densities The breast tissue is heterogeneously dense. This may lower the sensitivity of mammography The breast tissue is extremely dense, which could obscure a lesion on mammography 3/6/2014 12

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Almost Entirely Fat 3/6/2014 13 RCC LCC RMLO LMLO

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Scattered Fibroglandular Densities 3/6/2014 14 RCC LCC RMLO LMLO

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Heterogeneously Dense 3/6/2014 15 RCC LCC RMLO LMLO

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Extremely Dense 3/6/2014 16 RCC LCC RMLO LMLO

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Breast Density Breast cancer and breast parenchyma are both white Fat is nearly black The greater amount of fat, the easier it is to recognize a cancer Heterogeneously dense and extremely dense breasts can obscure a cancer, even a large cancer 3/6/2014 17

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Cancer in Fatty Breasts 3/6/2014 19

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Cancer in Dense Breasts 3/6/2014 20

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Breast Density Cannot be predicted based on physical exam Unrelated to breast size or consistency More common in younger women, during breast feeding, women using hormone replacement therapy 60% of women under 50, 40% of women in their 50s and 25% of women in their 60s have radiographically dense breasts 3/6/2014 21

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Breast Density Sensitivity and specificity reduced Sensitivity 33 to 81% False positives increased Breast density is a significant independent risk factor for breast cancer 4-5x relative risk Connecticut law mandates patient notification and ultrasound evaluation 3/6/2014 22

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Breast Cancer Risk Factors Relative risk 2.1 to 4 One first degree relative with breast cancer High bone density

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Breast Cancer Risk Factors Relative risk 1.1-2.0 Early menarche Late menopause Late first pregnancy Nulliparity Never breastfed Hormone replacement therapy Obesity (postmenopausal) Personal history endometrial, ovarian or colon cancer Alcohol consumption Race Physical inactivity History of biopsy showing hyperplasia without atypia 3/6/2014 24

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Breast Cancer Prognosis Breast cancer is a progressive disease Early arrest of the disease improves survival Prognosis related to extent of disease Localized-98% five year survival Regional-84% Distant-23% http://seer.cancer.gov/publications/survival/surv_breast.pdf

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Breast Cancer Prognosis Larger cancers more likely to metastasize <1 cm- 10% spread to lymph node 2cm- 35% 3 cm- 50% Median size of cancer found mammographically is 1-1.5cm Median size of cancer found at clinical breast exam 2-2.5 cm

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Breast Cancer Screening Goal of screening is to reduce mortality detect cancer early when treatment is more effective and has fewer morbidities

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Early Detection Breast imaging Mammography Ultrasound MRI 3/6/2014 28

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Mammography Mammography is the best screening tool available Good sensitivity (90+%) in fatty breasts 80-90% sensitivity on average Inexpensive Widely available 3/6/2014 29

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Mammography Mammography is the only screening test which has been shown to reduce deaths due to breast cancer 20-40% mortality reduction for women in the screened groups vs. control groups

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Digital Mammography Improved breast cancer detection over analog (film-screen) mammography for: Women with dense breasts Women under 50 Premenopausal women Lower radiation dose No increase in false positive rate Expensive

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Breast Ultrasound 3/6/2014 33 Diagnostic test for evaluation of mammographic and palpable abnormalities Can differentiate cystic from solid Characterize solid masses Evaluate the axilla for metastatic disease First exam for patients less than age 30

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Breast Ultrasound Screening ultrasound No radiation, no compression 28% increase cancer detection over mammography alone Not ready for widespread use Low specificity, higher cost, lack of availability Low sensitivity for calcifications of DCIS

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Breast Ultrasound 3/6/2014 35

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Breast Ultrasound 3/6/2014 36

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Breast MRI Excellent tissue differentiation High sensitivity for breast cancer Not limited by breast density No ionizing radiation 3/6/2014 37

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Breast MRI Applications Implant evaluation Inconclusive mammography/ultrasound Cancer staging Response to chemotherapy Search for occult primary neoplasm Cancer screening 3/6/2014 38

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MRI Breast Screening Sensitivity for screening young high-risk women better than mammography 71-100% with MRI vs. 20-50% for mammography Detects 56% more cancers than mammography and ultrasound combined

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Cancer in Dense Breasts 3/6/2014 40

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MRI Breast Cancer Screening Why not everyone? Expense Invasive procedure Contraindicated in some patients Lack of expertise and MRI availability Low specificity results in excess biopsies and additional follow-up 3/6/2014 43

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Further Breast Imaging Breast scintigraphy Digital tomosynthesis Positron emission mammography (PEM) Computed Tomography (CT) Thermography, infrared imaging

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Breast Scintigraphy Molecular breast imaging, breast specific gamma imaging, nuclear medicine breast imaging Injection of radionuclide Tc99 Sestamibi Radionuclide is taken up by cancers Improved cancer detection in dense breasts

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Breast Scintigraphy AP Photo/The Mayo Clinic

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Breast Scintigraphy High whole body radiation dose precludes use in screening Dose may be reduced in future Problem solving tool For uncertain clinical findings, mammogram, or ultrasound For patients who cannot undergo MRI

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Digital Tomosynthesis 11 mammographic images Reduced callbacks, increased cancer detection Increased radiation dose, expense make widespread adoption unlikely Mitka M, New Screening Methods Offer Hope for More Accurate Breast Cancer Detection,JAMA.2008; 299: 397-398. (Photo credit: Breast Imaging Division/Massachusetts General Hospital)

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Positron Emission Mammography Injection of fluorodeoxyglucose (FDG) Cancers take up FDG High specificity but lower sensitivity than MRI High radiation dose and expense preclude use in routine screening Assess extent of disease, response to treatment, evaluation for recurrence

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Breast Computed Tomography Lindfors KK, et al, Dedicated breast CT: initial clinical experience. Radiology 2008;246(3):725–733. Good resolution Improved patient comfort over mammography Higher radiation dose, expense and lack of availability makes widespread use unlikely

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Breast Cancer Screening Recommendations American Cancer Society (ACS) United States Preventative Services Task Force (USPSTF)

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Screening Guidelines ACS Women at average risk: Ages 20 to 39 clinical breast examination at least every three years Age 40 and over annual screening mammography and clinical breast exam Breast self-exam (BSE) is an option for women starting in their 20s Elderly women continue screening as long as woman is in reasonably good health and would be a candidate for cancer treatment 3/6/2014 52

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Screening Guidelines ACS Women at high (>20% lifetime) risk Annual mammogram and MRI beginning at 30 Women at moderate (15-20% lifetime) risk Discuss with clinician the benefits and limitations of adding MRI to yearly screening Yearly MRI is not recommended for women with lifetime risk less than 15% 3/6/2014 53

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Screening Guidelines ACS High Risk Patients Known BRCA1 or BRCA2 mutation First degree relative with BRCA1 or 2 and no testing themselves Radiation therapy to the chest between the ages of 10 and 30 yrs Have Li-Fraumeni, Cowden, or hereditary diffuse gastric syndromes, or a first degree relative with one of these syndromes Risk assessment tools> 20% lifetime 3/6/2014 54

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Screening Guidelines ACS Moderately Increased Risk Personal history of breast cancer, DCIS, lobular neoplasia, atypical ductal hyperplasia Have dense breasts at mammography Risk assessment tools 15-20% lifetime

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Risk assessment tools Gail model http://www.cancer.gov/bcrisktool/ Cancer risk assessment software http://www4.utsouthwestern.edu/breasthealth/cagene/default.asp http://www.hughesriskapps.net/ Creighton Hereditary Cancer Prevention Clinic http://medschool.creighton.edu/medicine/centers/hcc/index.php csnyder@creighton.edu, (402)280-2634

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USPSTF Breast Cancer Screening Recommendations Against screening mammography before age 50 Decision to screen earlier is individual one Biennial screening mammography for women between the ages of 50 and 74 Insufficient evidence for screening women 75 years and older Against teaching breast self-examination Insufficient evidence for clinical breast exam Insufficient evidence for digital mammography or MRI instead of film mammography for screening

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USPSTF Recommendations No screening for women 40-49 years Benefit of mortality reduction considered too small compared to harms of screening Biennial screening Benefit of mortality reduction consider too small compared to harms of screening Recommendations based on metaanalyses of randomized controlled trials (RCT) and on computer generated models

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USPSTF Analysis Based on review of RCTs Screening mammography mortality reductions were 15% for women in their 40s 14% for women in their 50s 32% for women in their 60s

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In Rebuttal… The mortality benefit is likely underestimated by the USPSTF studies The harms of screening are decreasing and are not as detrimental as estimated by the USPSTF There is no other effective screening tool for detection of early curable breast cancer

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Mammography RCTs Benefits of screening underestimated Only 61-89% of women invited to be screened actually participated (noncompliance) Women in the control group often sought screening on their own (contamination) Often used poor quality or single view exams Subgroup analysis on 40-49 year old women performed when studies not designed for this

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Harms of Screening Mammography Additional interventions Anxiety False sense of security Radiation Exposure Overdiagnosis of cancer

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Harms of Screening: Additional Intervention For every 1000 mammograms 80-100 women (8-10%) asked to return for addition evaluation 45-65 told that there is nothing of concern 20 are asked to return in 6 months Probably benign (<2% prob of malignancy) 15 (1-2%) recommended to have a biopsy 2 to 5 will have cancer 10-13 have benign biopsy

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Harms of Screening: Additional Intervention Need for additional evaluation inherent Vast majority of false-positive studies resolved with mammogram or ultrasound Harm of biopsies greatly reduced by image guided needle biopsy Ultrasound guided , stereotactic or MRI guided Surgical biopsy for diagnosis rarely needed Needle biopsy is an outpatient procedure that in most cases is nearly painless

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Harm of Screening: Anxiety Psychological distress Lessen degree of distress Patient education Same day screening results for patients with history of breast cancer and those with elevated anxiety Rapid recall of abnormal mammograms, additional imaging and biopsy

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Harms of Screening: False Sense of Security Mammograms miss some cancers One in five cancers not seen at mammography Normal mammogram does not exclude cancer Negative mammogram should not deter further work-up of a clinically worrisome finding Patient education is key

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Harms of Screening: Radiation Exposure Ionizing radiation can cause cancer The risk of radiation induced breast cancer is much less than benefit of mammography Annual screening from 40-50 years results in 36.5 lives saved per life lost

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Harms of Screening -Overdiagnosis Diagnosis of cancers that would not become clinically apparent in a patient’s lifetime Undiagnosed cancer at autopsy Invasive breast cancer: 1.3% Ductal carcinoma in situ: 8.9% Biopsy, surgery, radiation, and chemotherapy have psychological and physical effects

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Harms of Screening Mammography-Overdiagnosis Treatment is in the realm of surgical, radiation and medical oncology communities Understanding of tumor biology is improving Breast cancer assays Research evaluating treatment protocols for DCIS

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What age to begin screening? http://breastscreening.cancer.gov/data/performance/screening/2009/rate_age.html

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USPSTF Findings Number needed to invite to screen to prevent one death Ages 40-49: 1904 Ages 50-59: 1339 Ages 60-69: 377 The mortality reduction is equivalent in the 40-49 and 50-59 age groups

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USPSTF Findings USPSTF computer models showed Mortality reduction starting screening at 40 Starting screening at 40 is more cost-effective in terms of life-years saved than extending screening past age 69 years.

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Women 40-49 1 in 69 diagnosed with invasive cancer 14,000 women 40-49 diagnosed with breast cancer each year 18% of breast cancer deaths in patients diagnosed in their 40s 1/3 of years of life lost to breast cancer occur among women diagnosed in their 40s Most women diagnosed with breast cancer in their 40s have no known significant risk factors

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Annual vs. Biennial screening USPSTF models suggest biennial screening has 81% of the mortality reduction of annual screening Annual screening especially important in women aged 40-49 years Cancers more aggressive in younger women Annual screening saves the most lives

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Breast Cancer Mortality Since 1990 US breast cancer mortality has declined 2%/year 30% reduction in mortality Likely due to early detection and improved cancer treatment

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Benefits of annual screening mammography beginning at age 40 outweigh the harms Screening mammography reduces mortality Current mammography technology and image guided needle biopsy have reduced harm from false positives Improved understanding of cancer biology reducing harm from overdiagnosis For now mammography is our best method for detecting small curable cancers