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Screening Mammography Value vs. Jeopardy . Archie Bleyer, MD [email protected] 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 … - PowerPoint PPT Presentation
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Screening MammographyValue vs. Jeopardy
Archie Bleyer, [email protected]
Department of Radiation MedicineKnight Cancer Institute at the Oregon Health & Science University
Chair, Institutional Review Board, St. Charles Health System, Central | Eastern Oregon
What if …
the widely quoted breast cancer risk of one in every 8 women
is actually one in 11
?
What if …
a significant proportion of the reported improvement
in overall breast cancer survival is an artifact of overdiagnosis
?
What if you …
were completing 5 years of tamoxifen after 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?
Objectives
Convey reaction of ‘professionals’ to the controversy
Explain personal motivation
Review requisites of disease screening
Describe the NEJM report and our replies
Compare overdiagnosis risk with benefit of screening
Annual Incidence of In Situ and Localized Breast Cancer, Age 40+ - Western Washington State
0
50
100
150
200
250
300
1970 1980 1990 2000 2010
Incidence per
100,000 Doubling
UW ACS
Professor Clinical
Oncology1983-1990
Relay for LifeGordon Klatt, MD
1983: Screening Mammography Initiated in Washington
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.
Prerequisite Stage Shift for a Successful Cancer Screening Program
EarlyStage
Cancer
LateStage
Cancer
Incidence Reciprocal Stage Shift
Advent of screening
Incidence per
100,000
Annual Incidence of Colorectal Carcinoma by Extent of Disease at Diagnosis, SEER9
0
20
40
60
80
Age 50+
LocalizedRegional
Distant
LocalizedRegional
Distant0
2
4
1970 1975 1980 1985 1990 1995 2000 2005 2010
Age <50Unscreened
0
5
10Age <40
19761980
19841988
19921996
20002004
2008
Incidence per
100,000
Early Stage
Annual Breast Cancer Incidence, Early- vs. Late-Stage Disease at Diagnosis
Late Stage
Screening Mammography Penetration, U.S.
0%
20%
40%
60%
80%
1976 1980 1984 1988 1992 1996 2000 2004 2008
% Screened (within 2 years)
Age 40+
Number of Mammography
Units in U.S.
2,000
0
6,000
4,000
8,000
10,000
Screening Mammography Penetration, U.S.
0%
20%
40%
60%
80%
1976 1980 1984 1988 1992 1996 2000 2004 2008
19761980
19841988
19921996
20002004
20080
50
100
150
200
250
Incidence per
100,000
Early Stage
Late Stage
Annual Breast Cancer Incidence, Early- vs. Late-Stage Disease at Diagnosis
Number of Mammography
Units in U.S.
2,000
0
6,000
4,000
8,000
10,000
% Screened (within 2 years)
Hormone Replacement Therapy (HRT)
Age 40+
0
50
100
150
200
250Early Stage
Late Stage
19761980
19841988
19921996
20002004
2008
Incidence per
100,000
DCIS
Localized
0
50
100
150
200
250
Late Stage
19761980
19841988
19921996
20002004
2008
Regional
Distant
Age 40+
Survival
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 1 2 3 4 5 6 7 8 9 10
Regional
Distant
Relative Survival by Extent of Late Stage, U.S.Females, Breast Cancer, Age 40+
Diagnosed during 2000-2009
Years
1980
1995 2000 20051990
90,000
80,000
70,000
60,000
50,000
40,000
30,000
0
-10,000
-20,000
10,000
Best Guess
Best Guess
Number of Women
Diagnosed with
Breast Cancer
Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9
1.37 MAdvent of screening
mammography
1995 2000 20051990
Very Extreme Assumption
Very Extreme Assumption
1.02 MOverdiagnosis
Estimate
0.25 %/Year Best Guess
0.5 %/Year
Extreme and Very Extreme Assumption
Early-Stage
Late-Stage
22%
Very Extreme Assumption
+53,000
Very Extreme Assumption
0.5 %/Year
1980
1995 2000 20051990
90,000
80,000
70,000
60,000
50,000
40,000
30,000
0
-10,000
-20,000
10,000
Best Guess
Best Guess
Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9
Early-Stage+74,000
Advent of screening
mammography
Number of Women
Diagnosed with
Breast Cancer
Overdiagnosis2008
31%
0.25 %/Year
Late-Stage
2004 Zahl2006 Anderson WF, et al.2006 Zackrisson2008 Zahl PH, et al.2009 Jørgensen KJ, et al.2009 Jørgensen KJ, et al.2010 Morrell S, et al.2010 Martinez-Alonso M2012 Hellquist BN, et al.2012 Kalager M, et al.2012 Zahl PH, et al.2012 Puliti D, et al.
Norway and SwedenConnecticut, U.S.Malmö, SwedenFour counties in NorwayDenmarkVariousNew S. Wales, AustraliaCatalonia, SpainTwo counties in SwedenEntire country of NorwaySeven counties in NorwayFlorence, Italy
Overdiagnosis Reported in 12 Prior StudiesNEJM Supplemental Appendix
One-third40%24%**22%33%**
One-third30-42%
47%5%
15-25%**~75%10%
OD Rate
**of screen-detected cancers (other reports are of all breast cancer)
Mean 31.5%
NEJM Correspondence
Stage Migration
Inclusion of DCISUnwarranted Criticism
Background Incidence Increase Assumptions
Overdiagnosis
Estimate
1980
1995 2000 20051990
90,000
80,000
70,000
60,000
50,000
40,000
30,000
20,000
0
-10,000
-20,000
10,000
Best Guess
Best Guess
Number of Women
Diagnosed with
Breast Cancer
Cumulative Number of Females Diagnosed with Early- and Late-Stage Breast Cancer since 1979, Age 40+, SEER9
Late-Stage Cancer
Early-Stage Cancer
Advent of screening
mammography
Radiologist’s Wish1.0%/year increase during 1940-1980 “per” Garfinkel et al (ACS) 1994
Radiologist’s Wish
0.88 M+34,000
Overdiagnosis in 2008
The Treatment and Cost of Breast Cancer Overdiagnosis
• mastectomy or lumpectomy + radiation• anti-hormone therapy for 5-10 years• HER2/neu+: trastuzumab IV q 3 wks x 1 yr• Triple neg: chemotherapyOvertreatment antidotes• Premature menopause: supportive care• Osteopenia: biphosphonate, etc.Cost• Financial, physical, emotional, …
Randomized Trials of Screening Mammography 30 to 50 Years Ago
Trial Country Mortality Benefit Problem(s)
Health Insurance Plan of New York, 1963 U.S. Screening arm included MD Exam
Benefit only in 50-59 y/o’s
Malmo Study Sweden
Two-County Trial Sweden
Gothenburg Breast Screening Trial Sweden
Stockholm Trial Sweden
Edinburgh Trial Scotland
Canadian Natl. Breast Screening Trial 1 Canada None
Actually worse in screened subjects
Canadian Natl. Breast Screening Trial 2 Canada None
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)
Comparison of Old vs. 2009 USPSTF GuidelinesCurrent Average
Lifespan of Oregon’s Females*
44 Mammograms
+Pop Health Metrics 2011,9:16)
35 40 45 50 55 60 65 70 75 80 85Age
13 MammogramsUSPSTF, 2009Heidi Nelson, MD, MPHOHSU
ACS, NCCN, …30+ mSv
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.
How Screening Mammograms ‘Cause’ Breast Cancer(and not from the radiation of mammograms)
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.
“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
How much of the reported improvement in overall breast cancer survival is
an artifact of overdiagnosis?
mproved 5-Year Relative Survival of All Breast Cancer (DCIS+ + LRD) Attributable to Overdiagnosis
Survival
Without Overdiagnosis
With Overdiagnosis
• 31% rate of overdiagnosis after 1989• Graded increase of overdiagnosis during 1980s• Assume overdiagnosis to be limited to DCIS
and localized disease at diagnosis 60%
65%
70%
75%
80%
85%
90%
95%
1975 1980 1985 1990 1995 2000 2005
36 Years Ago
We are disappointed by the comments from the leadership of the mammography community.
The first step in addressing any problem is to acknowledge it.
The Big Squeeze A Social and Political History
of the Controversial Mammogram
Handel Reynolds Radiologist MD Atlanta
Aug 7, 2012 Cornell Press
comedsoc.org
http://comedsoc.org/Breast_Cancer_Screening.htm?m=66&s=447