Screening Mammography: The Controversy, Risk Assessment and Individualized Screening recommendations. Jonathan T. Sims MD, MBA

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Agenda Discuss the recent studies calling into question the benefits of mammography. What are the facts and statistics we track Screening recommendations in the general public, special populations, and the importance of breast density

RECENT STUDIES CALLING INTO QUESTION THE BENEFITS OF MAMMOGRAPHY

UK Independent Review Nordic Cochrane Institute Review US Preventive Services Task Force Review EUROSCREEN Review All of the studies attempted to answer the question how many women need to undergo breast cancer screening, in order to save 1 woman s life, from dying from breast cancer (during the observation time period)? Results varied from 80-2,000

Why the large variance? Definition of undergo breast cancer screening Nordic Cochrane Institute Review considered a women being notified and instructed to undergo mammography as being screened. 23% of women didn t show up. During the observational time period Studies ranged from 10 years to 20 years The longer the observational time period, the more efficaous screening mammography became. Which ages were included 40-74 50-74

Nordic Cochrane Institute Review 2,000 women need to get screened to save 1 life. Screening means- getting a reminder Time period- over 10 years Age- 40-74. Change the variables, changes the numbers: 600:1- Screening=mammogram, time frame is 20 years, ages included 40-74 300:1 restrict ages to 50-74

The controversy s take home points Screening mammography works- Are the benefits immediate- The benefits can be concentrated- But they shouldn't be

FACTS

FACT #1 Age is the number one risk factor

FACT #2 Must catch it early Prognosis most influenced by axillary node status No nodes- 5 year survival 82.8% 1-3 nodes- 5 year survival 73% 4-12 nodes- 5 year survival 46% >13 nodes- 5 year survival 28.4% Tumor size matters immediate and long term size correlates with axillary node status And is an independent prognostic indicator <1cm- 99% five year survival (88% 20 year recurrence free survival) 1-3 cm 89% (72% 20 year recurrence free survival) >3 cm 86% (59% 20 year recurrence-free survival

FACT #3 Screening mammography works Technological improvements have led to better detection

FACT #4 Detecting small tumors decreases mortality

Take home facts: Screening mammography is the only modality that is proven to save lives Best chances of surviving breast cancer is catching it early 1/8 women will have breast cancer sometime during their lifetime Of women that undergo screening mammography, about 6-8% will need additional evaluation, and 6-8% of those women will be diagnosised with breast cancer Of all the baseline screening exams, almost 1% will have breast cancer Non baseline screening exams, about 0.5% will have breast cancer Over the last 4 months OIC has diagnosised 13 breast cancers in asymptomatic women between 40-50 years of age. All of our mammographers see every cancer that is diagnosised at OIC

ACR target statistics

RECOMMENDATIONS: THEN, NOW, AND TOMORROW

THEN: Screening recommendations Normal Risk Yearly Mammograms- starting at 40 years of age and continuing for as long as the patient is in good health Clinical breast exams, every three years from 20-40, yearly for patients >40 Monthly self breast exams

NOW: Screening recommendations Normal Risk Moderate Risk High Risk Yearly Mammogramsstarting at 40 years of age and continuing for as long as the patient is in good health Clinical breast exams, every three years from 20-40, yearly for patients >40 Monthly self breast exams NOW: recommendations are influenced by breast density, and personal/familial risk factors.

Family history Family history risk: Strong family history First degree w/ premenopausal Male relatives Known family history of BRCA genes Intermediate family history First degree w/ postmenopausal Weak family history Second degree relatives No family history

Family history of proven genetic cancer syndromes Li-fraumeni syndrome (p53 gene mutation) Sarcoma, breast, leukemia and adrenal gland (SBLA) syndrome Bannayan-Riley-Ruvalcaba syndrome (PTEN mutation) Cowden syndrome breast carcinoma, follicular carcinoma of the thyroid, and endometrial carcinoma (hamartomas everywhere)

Personal medical history History of XRT of chest for lymphoma History of Breast Cancer (IDC or ILC) Previous breast biopsies Atypical anything LCIS (50% multi ipse, 30% bilateral) 5-20% will be diagnosised with breast cancer within the next 5 years.

Mammographic breast density Not perceived density on breast exam. Proportion of breast composed of glandular elements and stoma seen at mammography

Mammographic breast density Senate bill 420 Effective January 1, 2014 Oregon became the 11 th state to pass breast density legislation requiring providers to inform women with dense breast tissue that they have dense breasts. This increases their risk of developing breast cancer Decreases the sensitivity of screening mammography The patient may need additional screening Failed to require the additional screening be covered by insurances intended to start a conversation between patients and their providers concerning if and what they need.

Required notification

Case report Patient presents with confusion- I got a letter saying no breast cancer. But on the same letter, it says I have dense breasts so I might have cancer. And I was instructed to talk to you.

Reassure and risk stratify Risk stratify Risk model (like the Gail model) Take a detailed history

Personal breast cancer risk assessment Gail model, the Claus model, and the Tyrer- Cuzick model Give approximate estimates of breast cancer risk based on different combination of risk factors and different data sets May give different risk estimates for the same women Take home- Gail model is the best one currently- used for determining adjuvant hormonal therapy

Gail model The tool calculates a woman's risk of developing breast cancer within the next five years and within her lifetime (up to age 90). It takes into account seven key risk factors for breast cancer. Age Age at first period Age at the time of the birth of her first child (or has not given birth) Family history of breast cancer (mother, sister or daughter) Number of past breast biopsies Number of breast biopsies showing atypical hyperplasia Race/ethnicity Women with a five-year risk of 1.67 percent or higher are classified as "high-risk." This score (a five-year risk of 1.67 percent or higher) is the cut-off for the FDA guidelines for taking tamoxifen or raloxifene to reduce breast cancer risk. Limitations- based on white women, no paternal history), doesn t take into account personal history of DCIS, IDC, LCIS, or ILC

NOW: Screening recommendations Normal Risk (10-15%) Moderate Risk (15-20%) High Risk (>20%) High Risk and dense Yearly Mammogramsstarting at 40 years of age and continuing for as long as the patient is in good health Clinical breast exams, every three years from 20-40, yearly for patients >40 Monthly self breast exams NOW: recommendations are influenced by breast density, and personal/familial risk factors.

When is additional screening recommended? People at normal risk (10-15% lifetime risk)- No change CBE q3 years between ages 20-40 CBE q1 year beginning at age 40 Screening digital mammography starting at age 40 Yearly, for as long as the patient is in moderately good health.

Patients at moderate risk 15-20% lifetime risk. Would additionally screen with bilateral whole breast US Dense breasts with elastography Previous biopsy results of LCIS, atypical anything Intermediate family history and heterogeneously dense breasts

Additional Screening with Whole breast US Is elastography important- yes What screening interval? Is this covered by insurance? Is this done else where in the world?

Patients at high risk >20% lifetime risk. Strongly consider additional breast MRI Personal or family history of genetically proven cancer syndrome (BRCA/p53/PTEN) Strong family history (1 st degree w/ premenpasual disease, or male relatives) Previous mediastinal XRT (starting 10 years after cessation of mediastinal XRT) Previous breast cancer (IDC or ILC)

Additional screening with Breast MRI Best done at a facility that also does breast biopsies. Or the patient may ultimately get billed for an additional breast MRI.

Low Risk (10-15%) Intermediate Risk (15-20%) High Risk (>20%) High risk and dense Family History No family history, a few 2 nd degrees 1 st degree post Multi 2 nd degrees 1 st degree w/ pre male Carrier/possible carrier of proven cancer syn. Personal history of: Breast Bx Atypical anything LCIS Mediastinal XRT Previous Breast CA (IDC or ILC) Breast Density (if dense breasts shift column to right) Extremely Dense or Heterogenou sly dense. Yearly dig Mammo with US at least q2 yr Yearly dig mammo And occ. MRI and occ. US Yearly dig mammo AND yearly MRI

TOMORROW: Screening recommendations?????? Digital genonmics, tomosynthesis, automated US

Questions Jonathan T. Sims jts@rapc.com 541-284-4016

My patient received the letter stating she has dense breasts. Now she is wondering whether she should continue to get mammograms at all. She should continue to get screening mammograms. The breat density law does not reflect any change in the current mammography screening recommendations by professional medical societies. Mammograms have been shown to be effective in lowering breast cancer mortality for all breast densities.

My patient received the new breast density letter. She is concerned because she now thinks she is at high risk for breast cancer. Reassure the patient that breast density alone has only a small impact on breast cancer risk. She wants to know specifically how it changes her risk. Look up the mammogram report. Her density will be either heterogeneously dense (RR= 1.2), or extremely dense (RR= 2.0) So a 50 y/o female with no other risk factors fatty or scattered Risk is 1/42 50 y/o female with no risk factors and hetero, risk is 1.2/42. 50 y/o female with no risk factors and extememly dense, risk is 1/21.

My patient received the letter stating she has dense breasts. Now she wants to be screened with another modality instead of mammography. THERE IS NO MODALITY RECOMMENDED TO REPLACE MAMMOGRAPHY. Certain findings of cancer are ONLY seen on mammography. Other screening options referred to in the letter are in addition to, and not instead of, a routine screening mammogram.

My patient received the letter stating she has heterogneeously dense or extremely dense breasts. She has completed a risk assessment showing her overall risk to be high (>20% lifetime risk), or has a BRCA mutation or history of mantle radiation. Recommend annual breast MRI and annual memmogram for screening. Screening breast MRI is typically covered by insurance for high-risk women. If a woman is being screened annually with MRI and mammogram, no additional screening tests (such as ultrasound) are needed.

My patient received the letter stating she has heterogneeously dense or extremely dense breasts. She has completed a risk assessment showing her overall risk to be high (>20% lifetime risk). I recommended an annual MRI, but the patient has either claustrophobia, pacemaker, contrast allergy, limited insurance coverage plan, or other reasons why she does not want to have an MRI Recommend screening ultrasound as the second-best supplementary screening test for high risk women. Studies have shown some utility for ultrasound in high risk women if screening MRI is not performed.