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Screening Mammography Value vs. Jeopardy

Screening Mammography Value vs. Jeopardy . Archie Bleyer, MD ableyer@stcharleshealthcare.org Department of Radiation Medicine Knight Cancer Institute at the Oregon Health & Science University Chair, Institutional Review Board, St. Charles Health System, Central | Eastern Oregon. What if …

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Screening Mammography Value vs. Jeopardy

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  1. Screening MammographyValue vs. Jeopardy Archie Bleyer, MDableyer@stcharleshealthcare.orgDepartment of Radiation MedicineKnight Cancer Institute at the Oregon Health & Science University Chair, Institutional Review Board, St. Charles Health System, Central | Eastern Oregon

  2. What if … the widely quoted breast cancer risk of one in every 8 women is actually one in 11 ?

  3. What if … a significant proportion of the reported improvement in overall breast cancer survival is an artifact of overdiagnosis ?

  4. What if you …were completing 5 years of tamoxifenafter a partial mastectomy and breast irradiation,coping with premature menopause, and undergoing annual mammograms of the other breast, you learn that there was a one in three chance of not having had breast cancer ?

  5. Objectives Compare overdiagnosis risk with benefit of screening Review requisites of disease screening Explain personal motivation Describe the NEJM report and our replies Convey reaction of ‘professionals’ to the controversy

  6. Annual Incidence of In Situ and Localized Breast Cancer, Age 40+ - Western Washington State 1983: Screening Mammography Initiated in Washington 300 250 Incidence per 100,000 200 Doubling UW ACS Professor Clinical Oncology 1983-1990Relay for LifeGordon Klatt, MD 150 100 50 0 1970 1980 1990 2000 2010

  7. A mammogram is a safe, low-dose X-ray that can detect breast cancer before there’s a lump. In other words, it could save your life and your breast. If you are a women over 35, be sure to schedule a mammogram. Unless you’re still not convinced of its importance. In which case, you may need more than your breasts examined. Find the time. Have a mammogram Get yourself the chance of a lifetime.

  8. Prerequisite Stage Shift for a Successful Cancer Screening Program Advent of screening Early Stage Cancer Reciprocal Stage Shift Incidence LateStageCancer

  9. Annual Incidence of Colorectal Carcinoma by Extent of Disease at Diagnosis, SEER9 Age 50+ Regional Localized 80 60 40 Distant 20 Incidence per 100,000 0 Age <50 4 Unscreened Regional Localized 2 Distant 0 1970 1975 1980 1985 1990 1995 2000 2005 2010

  10. Screening Mammography Penetration, U.S. Age 40+ 80% • 10,000 % Screened (within 2 years) • Number of Mammography Units in U.S. • 8,000 60% • 6,000 40% 4,000 1976 1984 1992 2000 2008 20% 1980 1988 1996 2004 2,000 0% 0 1976 1980 1984 1988 1992 1996 2000 2004 2008 Annual Breast Cancer Incidence, Early- vs. Late-Stage Disease at Diagnosis Age <40 EarlyStage Incidence per 100,000 Late Stage 10 5 0

  11. Screening Mammography Penetration, U.S. Age 40+ 80% • 10,000 % Screened (within 2 years) • Number of Mammography Units in U.S. • 8,000 60% • 6,000 40% 4,000 1976 1984 1992 2000 2008 20% 1980 1988 1996 2004 2,000 0% 0 1976 1980 1984 1988 1992 1996 2000 2004 2008 Annual Breast Cancer Incidence, Early- vs. Late-Stage Disease at Diagnosis 250 EarlyStage 200 Hormone Replacement Therapy (HRT) Incidence per 100,000 150 Late Stage 100 50 0

  12. Age 40+ 250 Early Stage DCIS 200 Localized 150 250 Incidence per100,000 200 Late Stage 100 150 Regional Late Stage 50 100 Distant 50 0 1976 1984 1992 2000 2008 0 1980 1988 1996 2004 1976 1984 1992 2000 2008 1980 1988 1996 2004

  13. Relative Survival by Extent of Late Stage, U.S.Females, Breast Cancer, Age 40+Diagnosed during 2000-2009 100% 90% 80% Regional 70% 60% Survival 50% 40% 30% 20% Distant 10% 0% 0 1 2 3 4 5 6 7 8 9 10 Years

  14. Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9 Best Guess Very Extreme Assumption 90,000 80,000 70,000 60,000 Early-Stage Number of Women Diagnosed with Breast Cancer 50,000 Overdiagnosis Estimate 40,000 Extremeand Very Extreme Assumption 1.37 M 1.02 M Advent of screening mammography 30,000 0.5 %/Year 0.25 %/Year Best Guess 1990 1995 2000 2005 1990 1995 2000 2005 10,000 Late-Stage 1980 0 Best Guess -10,000 Very Extreme Assumption -20,000

  15. Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9 Best Guess Very Extreme Assumption 90,000 80,000 70,000 Overdiagnosis2008 60,000 Early-Stage Number of Women Diagnosed with Breast Cancer 31% 50,000 +74,000 40,000 22% +53,000 Advent of screening mammography 30,000 0.5 %/Year 0.25 %/Year 1990 1995 2000 2005 10,000 Late-Stage 1980 Best Guess 0 -10,000 Very Extreme Assumption -20,000

  16. Overdiagnosis Reported in 12 Prior StudiesNEJM Supplemental Appendix OD Rate 2004 Zahl Norway and Sweden One-third 2006 Anderson WF, et al. Connecticut, U.S. 40% 2006 Zackrisson Malmö, Sweden 24%** 2008 ZahlPH, et al. Four counties in Norway 22% 2009 JørgensenKJ, et al. Denmark 33%** 2009 JørgensenKJ, et al. Various One-third 2010 Morrell S, et al. New S. Wales, Australia 30-42% 2010 Martinez-Alonso M Catalonia, Spain 47% 2012 HellquistBN, et al. Two counties in Sweden 5% 2012 KalagerM, et al. Entire country of Norway 15-25%** 2012 ZahlPH, et al. Seven counties in Norway ~75% 2012 PulitiD, et al. Florence, Italy 10% Mean 31.5% **of screen-detected cancers (other reports are of all breast cancer)

  17. NEJM Correspondence Background Incidence Increase Assumptions Stage Migration Unwarranted Criticism Inclusion of DCIS

  18. Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9 Best Guess 90,000 80,000 Radiologist’s Wish1.0%/year increase during 1940-1980 “per” Garfinkel et al (ACS) 1994 70,000 60,000 Number of Women Diagnosed with Breast Cancer Early-Stage Cancer 50,000 +34,000 Overdiagnosis Estimate Overdiagnosis in 2008 40,000 0.88 M Advent of screening mammography 30,000 20,000 1990 1995 2000 2005 10,000 Late-Stage Cancer 1980 0 Best Guess -10,000 Radiologist’s Wish -20,000

  19. The Treatment and Cost of Breast Cancer Overdiagnosis • mastectomy or lumpectomy + radiation • anti-hormone therapy for 5-10 years • HER2/neu+: trastuzumabIV q 3 wks x 1 yr • Triple neg: chemotherapy Overtreatment antidotes • Premature menopause: supportive care • Osteopenia: biphosphonate, etc. Cost • Financial, physical, emotional, …

  20. Randomized Trials of Screening Mammography 30 to 50 Years Ago • Cochrane Analysis • One biased trial excluded 600,000 women in analyses • Three trials with adequate randomization did not show a significant reduction in breast cancer mortality at 13 years (RR=0.90, CI 0.79-1.02) • 4 trials with suboptimal randomization showed a significant reduction in BrCa mortality with an RR=0.75 (CI 0.67-0.83) • The RR for all 7 trials combined was 0.81 (CI 0.74-0.87) • Cochrane Analysis • Breast cancer mortality was an unreliable outcome biased in favor of screening, mainly because of differential misclassification of cause of death • Trials with adequate randomization did not find an effect of screening on cancer mortality: • Either breast cancer, after 10 years (RR=1.02, 95% CI 0.95-1.10), or • All-cause mortality after 13 years (RR=0.99, 95% CI 0.95 to 1.03)

  21. Comparison of Old vs. 2009 USPSTF Guidelines Current Average Lifespan of Oregon’s Females* ACS, NCCN, … 44 Mammograms 30+ mSv 13 Mammograms USPSTF, 2009 Heidi Nelson, MD, MPHOHSU 35 40 45 50 55 60 65 70 75 80 85 Age +Pop Health Metrics 2011,9:16)

  22. How Screening Mammograms ‘Cause’ Breast Cancer (and not from the radiation of mammograms) To the extent that screening mammograms result in the diagnosis of ‘cancer’ that either does not need to be diagnosed or detected when it is, it can be said that they cause breast cancer. These women undergo the same diagnostic interventions and treatment (including surgery, radiation, and hormonal therapy and in some chemotherapy) and the associated adverse physical, emotional, and financial effects of women who develop breast cancer without being screened.

  23. “One in every 8 women will develop breast cancer in her lifetime” If 31% of all breast cancer is overdiagnosed, the actual risk is one in every 11 women

  24. How much of the reported improvement in overall breast cancer survival is an artifact of overdiagnosis?

  25. mproved5-Year Relative Survival of All Breast Cancer (DCIS+ + LRD) Attributable to Overdiagnosis 95% With Overdiagnosis 90% 85% Without Overdiagnosis 80% Survival 75% 70% • 31% rate of overdiagnosis after 1989 • Graded increase of overdiagnosis during 1980s • Assume overdiagnosis to be limited to DCIS and localized disease at diagnosis 65% 60% 1975 1980 1985 1990 1995 2000 2005

  26. 36 Years Ago

  27. We are disappointed by the comments from the leadership of the mammography community. The first step in addressing any problem is to acknowledge it.

  28. The Big Squeeze A Social and Political History of the Controversial Mammogram Handel Reynolds Radiologist MD Atlanta Aug 7, 2012 Cornell Press

  29. comedsoc. org http://comedsoc.org/Breast_Cancer_Screening.htm?m=66&s=447

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