Disclosure I am human and I have biases. I am a breast cancer survivor. I make my living in breast imaging and diagnosis. I have met and come to know a few of the experts embroiled in the CNBSS controversy in my former university capacity in Texas. I am a radiologist. I am not an epidemiologist, an oncologist, or a surgeon.

The practice of medicine is a human endeavor that uses science as a tool.

SCIENCE………….DOCTOR……………PATIENT

Breast cancer mortality is DOWN ~ 30% Mammography is not perfect, but it is the BEST tool we have for screening to detect early clinically occult breast cancer. YET----BREAST CANCER SCREENING IS ABOUT TO BE CUT BACK Why all the fuss?

Major influences include: USPSTF is about to finalize their new guidelines for breast cancer screening (2014: Now “finalized” and incorporated into ObamaCare) Major influences include: Canadian National Breast Screening Study 25 years later Economic factors

A Sampling of Controversy… Reduction in breast cancer mortality Screening Mammography? Better Treatment? (Evolving Knowledge….?) Overdiagnosis? Overtreatment? Stage Shift? Does mammography help in women <50yrs? Does screening mammography cause harm?

Costs of Breast Cancer Diagnosis Median Cost of Screening a Woman for Breast Cancer: $94 Median Cost Per Breast Cancer Detected: $10,566 Ekwueme DU, Gardner JG, et al: Cost analysis of the National Breast and Cervical Cancer Early Detection Project: selected states, 2003 – 2004. Cancer 2008 Feb 1,112(3):626-35.

A Sampling of the Economic Factors Screening Costs Workup Costs Approx 10 in 100 Followup Costs Approx 5 in 100 Biopsy Costs Approx 2 in 100 Breast Cancer - approx 4/1000

Costs of Breast Cancer Diagnosis Median Cost of Screening a Woman for Breast Cancer: $94 Median Cost Per Breast Cancer Detected: $10,566 Ekwueme DU, Gardner JG, et al: Cost analysis of the National Breast and Cervical Cancer Early Detection Project: selected states, 2003 – 2004. Cancer 2008 Feb 1,112(3):626-35.

Breast Cancer Screening (until now) Annual Clinical Breast Exam (CBE) by physician or provider Monthly Breast Self Exam (BSE) by patient beginning at age 20 Annual Screening Mammography beginning at age 40 on

USPSTF New Guidelines Biennial screening mammography for women 50-74 years Screening mammography under age 50 individual decision, considering patient context and patient values regarding specific benefits and harms Inconclusive evidence concerning benefits and harms of screening mammography in women age 75+

USPSTF New Guidelines, cont’d Recommend against teaching BSE Insufficient evidence to assess benefits or harms of CBE beyond screening mammography in women over age 40 Insufficient evidence to assess benefits or harms of screening with either digital mammography or MRI

Clinical Breast Exam Consider Skin changes Nipple changes Lymph nodes Puckering/retraction Focal redness…mastitis?....early inflammatory BC? Nipple changes Nipple erosion Nipple adenoma Nipple retraction Lymph nodes

Breast Self Exam At least 5% of breast cancers are ECCENTRIC in location; ie, NOT visible within the tissue seen on the standard mammogram images!

Accessory Breast Tissue

Breast Self Exam At least 5% of breast cancers are ECCENTRIC in location; ie, NOT visible within the tissue seen on the standard mammogram images! Aggressive cancers (30% of all cancers in young women and 10% of all cancers in older women) often arise BETWEEN SCREENING EXAMS and will be detected on BSE!

Esserman L, Shieh Y, Thompson I: Rethinking Screening for Breast Cancer and Prostate Cancer. JAMA 2009;302(15):1685-1692.

Breast Cancer Subtypes

Appendix Table 3. USPSTF Ave # Screening Exams & % Reduction in BC Mortality by Screening Strategy   Strategy Ave Screens Reduction in Breast Cancer Mortality Per1000 Wom Efficient Strategies D E G M S W Biennial 60-69 4263 11 13 11 10 9 12 Biennial 55-69 6890 15 18 15 14 13 19 Biennial 50-69 8947 16 23 17 16 15 23 Biennial 50-74 11066 22 27 21 21 20 28 Biennial 50-79 12366 25 29 24 24 25 30 Biennial 50-84 13837 29 31 25 27 26 33 Biennial 40-84 18708 31 37 28 29 27 39 Annual 50-84 36550 38 49 32 29 35 54 Borderline Strategies Biennial 40-79 17241 27 35 26 26 25 36 Annual 50-79 24419 32 39 27 26 30 42 Annual 50-84 29905 35 41 28 28 33 45 Annual 40-79 34078 34 46 30 27 33 51

Appendix Table 3. USPSTF Ave # Screening Exams & % Reduction in BC Mortality by Screening Strategy   Strategy Ave Screens Reduction in Breast Cancer Mortality Per1000 Wom Efficient Strategies D E G M S W Biennial 50-74 11066 22 27 21 21 20 28 Biennial 40-84 18708 31 37 28 29 27 39 Annual 40-84 36550 38 49 32 29 35 54 Borderline strategies Biennial 40-79 17241 27 35 26 26 25 36

USPSTF Says Screening mammography under age 50: individual decision, considering patient context and patient values regarding specific benefits and harms PROBLEMS: Breast cancer is a DEADLIER DISEASE in a younger woman Breast cancer deaths affecting women ages 40-49 will have a GREATER IMPACT on families, communities, and society Approximately 70% of breast cancers occur in patients with NO known risk factors

Percent of Deaths by Age Group: Breast Cancer SEER.cancer.gov/statfacts

USPSTF Says Inconclusive evidence concerning benefits and harms of screening mammography in women age 75+ PROBLEMS: The whole point of breast cancer screening, in older women (age 75+) is to MAINTAIN QUALITY OF LIFE, not necessarily to “cure” her cancer Neglected breast cancer causes significant PAIN

Concept of Overdiagnosis Based on expectation that increased diagnosis and treatment of early stage breast cancers should lead to fewer advanced breast cancers in later years. This has NOT been observed. Remember--- Breast cancer is a biological process Biological processes EVOLVE --”Stage Shift” occurs due to technological advance in detection of early mets in lymph nodes apparent increase in “advanced” cancers

Overdiagnosis/Overtreatment? DCIS Controversy Low Nuclear Grade 1 Intermediate Nuclear Grade 2 Mixed cell types and grades Slow evolution----faster-----islands of INVASION 25% DCIS is High Nuclear Grade 3 ALWAYS goes on to invasive ductal carcinoma

CNBSS: Overdiagnosis/Overtreatment Miller AB, Wall c, Baines CJ, et al: Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomized screening trial. BMJ 2014;348:g366.

Final Words on USPSTF Clearly oriented toward decreasing consumption of resources now used in breast cancer screening Embraced (troubled) Mammography Results from CNBSS IGNORED Breast Self Exam (BSE) and Clinical Breast Exam (CBE) from same CNBSS study (!) Too involved in “Safe” Science; too little consideration of the needs of the population they serve

Our meta-analysis of mammography screening trials indicates breast cancer mortality benefit for all age groups from 39–69 years, with insufficient data for older women. False-positive results are common in all age groups and lead to additional imaging and biopsies. Women age 40–49 years experience the highest rate of additional imaging whereas their biopsy rate is lower than older women. Mammography screening at any age is a tradeoff of a continuum of benefits and harms. The ages at which this tradeoff becomes acceptable to individuals and to society are not clearly resolved by available evidence. US Preventative Services Task Force: Screening for Breast Cancer: Systematic Evidence Review Update for the US Preventive Services Task Force [Internet]. Nelson HD, Tyne K, et al. Nov, 2009.

The practice of medicine is a human endeavor that uses science as a tool.

Canadian National Breast Screening Study (CNBSS) GOLDEN OPPORTUNITY LOST

CNBSS: All Cause Mortality Miller AB, Wall c, Baines CJ, et al: Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomized screening trial. BMJ 2014;348:g366.

CNBSS--Problems NOT PREPARED for demands of screening Images – technologists – radiologists – surgeons Randomization – Clinical breast exam BEFORE randomization 4x locally advanced cancers in 40-49 screening group compared to controls Only 2 mm difference between mean tumor size in control vs screening groups

Diagnostic “Chain” of Breast Cancer Image quality - Machine – Anode – Filter – Grid – Developer – Positioning - - - Interpretation – Detection – Workup – Diagnosis – Biopsy Guidance ? Surgical Assessment – Accuracy of Excision of Nonpalpable Tumors?