•

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?

• 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 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.

Tub 4% Muc 2% Med 2% ILC 12% DCIS 16% IDC HG 50+ 6% Other 2% Pap/ Apoc 2% IDC,NOS 36% IDC HG <50 18%

Breast Cancer Subtypes

Appendix Table 3. USPSTF Ave # Screening Exams & % Reduction in BC Mortality by Screening Strategy Strategy Ave Screens Per1000 Wom Reduction in Breast Cancer Mortality Efficient Strategies Biennial 60-69 Biennial 55-69 Biennial 50-69

Biennial 50-74

Biennial 50-79 Biennial 50-84 Biennial 40-84 Annual 50 -84 4263 6890 8947

11066

12366 13837 18708 36550 D 11 15 16

22

25 29 31 38 E 13 18 23

27

29 31 37 49 G 11 15 17

21

24 25 28 32 M 10 14 16

21

24 27 29 29 S 9 13 15

20

25 26 27 35 Borderline Strategies Biennial 40-79 Annual 50-79 Annual 50-84 Annual 40-79 17241 24419 29905 34078 27 32 35 34 35 39 41 46 26 27 28 30 26 26 28 27 25 30 33 33 W 12 19 23

28

30 33 39 54 36 42 45 51

Appendix Table 3. USPSTF Ave # Screening Exams & % Reduction in BC Mortality by Screening Strategy Strategy Efficient Strategies

Biennial 50-74

Biennial 40-84 Ave Screens Per1000 Wom

11066

18708 Annual 40-84 36550 Borderline strategies Biennial 40-79 17241 Reduction in Breast Cancer Mortality D

22

31 E

27

37 G

21

28 M

21

29 38 49 32 29 27 35 26 26 S

20

27 35 25 W

28

39 54 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 – group compared to controls randomization 4x locally advanced cancers in 40-49 screening 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?