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at the National Institutes of Health
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Personal history of breast cancer
Prior radiation therapy
Dense breast tissue
Other risk factors and risk prediction models
Breast Cancer Diagnosis and Patholog y
Evaluation of Breast Symptoms
Pathologic Diagnosis of Breast Cancer
Ductal Carcinoma In Situ
Breast Cancer Screening Concepts
Bias
Assessment of Performance and Accuracy
Sensitivity
Specificity and false-positive rate
Interval cancers
Breast Cancer Screening Modalities—Mammography
Mammography Description and Background
Benefit of Mammography
Randomized controlled trials Summary of RCTs
Effectiveness of Population-Based Screening Programs
Statistical Modeling of Breast Cancer Incidence and Mortality in the Uni
Characteristics of Cancers Detected by Screening Mammography
Mammography—Variables Associated with Accuracy
Patient Characteristics
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ed States
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Section_110
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Tumor Characteristics
Physician Characteristics
Facility Characteristics
International ComparisonsPrevalent Versus Subsequent Examination and the Interval Between Ex
Digital Mammography
Mammography and Computer-Aided Detection (CAD)
Harms of Screening Mammography
False-Positives Leading to Possible Additional InterventionsOverdiagnosis
False-Negatives Leading to Possible False Sense of Security
Discomfort
Radiation Exposure
Anxiety
Breast Cancer Screening Modalities—Beyond Mammography
Clinical Breast Examination
Breast Self-examination
Ultrasonography
Magnetic Resonance Imaging
Thermography
Tissue Sampling (Fine-Needle Aspiration, Nipple Aspirate, Ductal Lava
Special Populations
Individuals With Little to Gain from Screening
Women with limited life expectancy
Elderly women
Young women
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ms
e)
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Men
Individuals at Increased Risk of Breast Cancer and Thus Possibly With
Women who have received thoracic radiation
Race
Appendix of Randomized Controlled Trials
Changes to This Summary (08/29/2014)
Questions or Comments About This Summary
About This PDQ Summary
Purpose of This Summary
Reviewers and Updates
Levels of Evidence
Permission to Use This Summary Disclaimer
Contact Us
Get More Information From NCI
Overview
Note: Separate PDQ summaries on Breast Cancer Prevention, Breast Can
Treatment, and Breast Cancer Treatment and Pregnancy are also availabl
This summary covers the topic of breast cancer screening and includes in
incidence and mortality, risk factors for breast cancer, the process of brea
and harms of various breast cancer screening modalities. This summary a
screening among special populations.
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ore to Gain From Screening
er Treatment, Male Breast Cancer
.
rmation about breast cancer
t cancer diagnosis, and the benefits
so includes information about
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Mammography is the most widely used screening modality, with solid evi
to 74 years. Clinical breast examination and breast self-exam have also be
benefit. Technologies such as ultrasound, magnetic resonance imaging, to
imaging are being evaluated, usually as adjuncts to mammography.
Screening With Mammography
Benefits
Based on solid evidence, screening mammography may lead to the followi
Decrease in breast cancer mortality
Magnitude of Effect: In the randomized controlled trials (
years, screening with mammography has been associated wit
in mortality due to breast cancer.[1] Absolute mortality bene
10 years is approximately 1% overall, ranging from 4 per 10,
age 40 years to 50 per 10,000 women who start at age 50 ye
up from the Canadian National Breast Screening Study (CNB
screening,[3] there is some uncertainty about the magnitudepresent day.
Study Design: RCTs, population-based evidence.
Internal Validity : Variable, but meta-analysis of RCTs goo
Consistency : Fair.
External Validity : Good.
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ence of benefit for women aged 40
n evaluated but are of uncertain
osynthesis, and molecular breast
g benefit:
CTs), for women aged 40 to 74
h a 15% to 20% relative reduction
it for women screened annually for
00 women who start screening at
rs.[2] Based on the 25-year follow-
SS), an RCT of breast cancer
of benefit of mammography in the
.
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g harms:
ncers: Diagnosis of cancers that
s lifetime can expose a woman to
radiation therapy, hormone
fects of therapeutic radiation (new
cy, and tumor type (ductal
detected by screening
iagnosis.[6] The best estimations
Ts of screening or the calculation of
are uncertainties with each
ted excess incidence studies in the
% of screen-detected breast
utopsy series, and series of
called from each screening
recalled will have cancer.[10]
in the United States will
sies.[11,12] Additional testing is
ison.
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False-Negatives with False Sense of Security and Potential
Magnitude of Effect: 6% to 46% of women with invasive c
mammograms, especially if they are young, have dense breas
lobular, or rapidly growing cancers.[15]
Study design: Descriptive population-based.
Radiation-Induced Breast Cancer: Radiation-induced mutatio
especially if exposure occurs before age 30 years and is at high dose
therapy for Hodgkin disease. The breast dose associated with a typiapproximately 4 mSv and extremely unlikely to cause cancer. One
mammograms. Latency is at least 8 years, and the increased risk is
Magnitude of Effect: Theoretically, annual mammograms
cause up to one breast cancer per 1,000 women.[16,17]
Study design: Descriptive population-based.
For all these potential harms of screening mammography, internal validit
are good.
Clinical Breast Examination
Benefits
Clinical breast examination (CBE) has not been tested independently; it w
mammography in one Canadian trial, and was the comparator modality v
trial. Thus, it is not possible to assess the efficacy of CBE as a screening musual care (no screening activity).
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Delay in Cancer Diagnosis.
ncer will have negative
s,[13,14] or have mucinous,
ns can cause breast cancer,
s, such as from mantle radiation
al two-view mammogram isv is equivalent to 200
ifelong.[16,17]
in women aged 40 to 80 years may
, consistency and external validity
as used in conjunction with
rsus mammography in another
dality when it is used alone versus
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Magnitude of Effect: The current evidence is insufficient to asse
of CBE. The single RCT comparing high-quality CBE to screening
benefit for both modalities. Accuracy in the community setting mig
Study Design: Single RCT, population cohort studies.
Internal Validity : Good.
Consistency and External Validity : Poor.
Harms
Screening by CBE may lead to the following harms:
False-Positives with Additional Testing and Anxiety.
Magnitude of effect: Specificity in women aged 50 to 59 y
false-positive rate of 1% to 12%.[18]
Study Design: Descriptive population-based.
Internal Validity, Consistency and External Validity :
False-Negatives with Potential False Reassurance and Del
Magnitude of Effect: Of women with cancer, 17% to 43%
higher with longer duration and higher quality of the examin
Study Design: Descriptive population-based.
Internal and External Validity : Good.
Consistency : Fair.
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s the additional benefits and harms
ammography showed equivalent
t be lower than in the RCT.
ars was 88% to 99%, yielding a
Good.
y in Cancer Diagnosis.
ave a negative CBE. Sensitivity is
tion by trained personnel.
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-
Benefits
Breast self-examination (BSE) has been compared to usual care (no scree
shown to reduce breast cancer mortality.
Magnitude of Effect: No effect.[19,20]
Study Design: Two RCTs.
Internal Validity and Consistency : Fair.
External Validity : Poor.
Harms
Based on solid evidence, formal instruction and encouragement to perfor
and diagnosis of more benign breast lesions.
Magnitude of Effects on Health Outcomes: Biopsy rate was 1.
compared with 1.0% among the control group.[19]
Study Design: Two RCTs, cohort studies.
Internal Validity : Good.
Consistency : Fair.
External Validity : Poor.
References
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference1.19http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference1.20http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference1.19
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ing activity) and has not been
BSE leads to more breast biopsies
8% among the study population
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mmography screening
7, 2009. [PUBMED Abstract]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=19589821&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=20413742&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12888370&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=19920273&dopt=Abstract
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10. Rosenberg RD, Yankaskas BC, Abraham LA, et al.: Performance be
mammography. Radiology 241 (1): 55-66, 2006. [PUBMED Abstract]
11. Elmore JG, Barton MB, Moceri VM, et al.: Ten-year risk of false po
clinical breast examinations. N Engl J Med 338 (16): 1089-96, 199
12. Hubbard RA, Kerlikowske K, Flowers CI, et al.: Cumulative probab
recommendation after 10 years of screening mammography: a coho
481-92, 2011. [PUBMED Abstract]
13. Rosenberg RD, Hunt WC, Williamson MR, et al.: Effects of age, bre
replacement therapy on screening mammographic sensitivity and c
183,134 screening mammograms in Albuquerque, New Mexico. Ra
[PUBMED Abstract]
14. Kerlikowske K, Grady D, Barclay J, et al.: Likelihood ratios for mod
of breast cancer based on age and mammographic interpretation. J
Abstract]
15. Porter PL, El-Bastawissi AY, Mandelson MT, et al.: Breast tumor cmammographic detection: comparison of interval- and screen-dete
(23): 2020-8, 1999. [PUBMED Abstract]
16. Ronckers CM, Erdmann CA, Land CE: Radiation and breast cancer:
Breast Cancer Res 7 (1): 21-32, 2005. [PUBMED Abstract]
17. Goss PE, Sierra S: Current perspectives on radiation-induced breas
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9440762&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15642178&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10580027&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8667537&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9807581&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=22007042&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16990671&dopt=Abstract
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chmarks for screening
itive screening mammograms and
[PUBMED Abstract]
lity of false-positive recall or biopsy
rt study. Ann Intern Med 155 (8):
st density, ethnicity, and estrogen
ncer stage at diagnosis: review of
iology 209 (2): 511-8, 1998.
rn screening mammography. Risk
MA 276 (1): 39-43, 1996. [PUBMED
aracteristics as predictors of ted cancers. J Natl Cancer Inst 91
a review of current evidence.
cancer. J Clin Oncol 16 (1): 338-
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8667537&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9545356&dopt=Abstract
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, .
18. Fenton JJ, Rolnick SJ, Harris EL, et al.: Specificity of clinical breas
practice. J Gen Intern Med 22 (3): 332-7, 2007. [PUBMED Abstract]
19. Thomas DB, Gao DL, Ray RM, et al.: Randomized trial of breast sel
results. J Natl Cancer Inst 94 (19): 1445-57, 2002. [PUBMED Abstract]
20. Semiglazov VF, Manikhas AG, Moiseenko VM, et al.: [Results of a p
investigation [Russia (St.Petersburg)/WHO] to evaluate the signifi
early detection of breast cancer]. Vopr Onkol 49 (4): 434-41, 2003.
Description of the Evidence
Background
Breast cancer incidence and mortality
Breast cancer is the most common noncutaneous cancer in U.S. women,
situ disease, 232,670 new cases of invasive disease, and 40,000 deaths ex
1 of 6 women diagnosed with breast cancer die of the disease. By compari
are estimated to die of lung cancer in 2014.[1] Males account for 1% of bre
deaths (refer to the Special Populations section of this summary for more
Widespread adoption of screening increases breast cancer incidence in acharacteristics of cancers detected, with increased incidence of lower-risk
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page10#Section_123http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12359854&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17356964&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9440762&dopt=Abstract
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examination in community
-examination in Shanghai: final
rospective randomized
ance of self-examination for the
[PUBMED Abstract]
ith an estimated 62,570 cases of in
ected in 2014.[1] Thus, fewer than
on, about 72,330 American women
ast cancer cases and breast cancer
nformation).
iven population and changes thecancers, premalignant lesions, and
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14569932&dopt=Abstract
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ductal carcinoma in situ (DCIS). (Refer to the Ductal Carcinoma In Situ s
Diagnosis and Pathology section of this summary for more information.)
States [2] and the United Kingdom [3] demonstrate an increase in DCIS a
since the 1970s, attributable to the widespread adoption of both postmen
screening mammography. In the last decade, women have refrained from
and breast cancer incidence has declined, but not to the levels seen prior t
mammography.[4]
One might expect that if screening identifies cancers before they cause cli
screening will be followed by a period of compensatory decline in cancer r
incidence rates or in incidence rates in older women. However, no compe
ever been seen following the adoption of screening, suggesting that scree
identification of clinically insignificant cancers (refer to the Overdiagnosis
Mammography section of this summary for more information).
Breast cancer incidence and mortality risk also vary according to geograp
socioeconomic status (refer to the Special Populations section of this sum
Risk Factors for Breast Cancer
Breast cancer risk is affected by many factors besides participation in scre
quantifying these risks is important to a woman, to her physicians, and to
Table 1. Risk of Breast Cancer Diagnosisa
Current Age (in Years) Risk in Next 10 Years
30 1 in 250
40 1 in 71
50 1 in 42
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ction in the Breast Cancer
cologic studies from the United
d invasive breast cancer incidence
pausal hormone therapy and
sing postmenopausal hormones,
the widespread use of screening
ical symptoms, then the period of
tes, either in annual population
satory drop in incidence rates has
ng leads to overdiagnosis—the
section in the Harms of Screening
y, culture, race, ethnicity, and
ary for more information).
ning activities. Understanding and
public policy makers.
Enlarge
Lifetime Risk of a Breast CancerDiagnosis
1 in 8
1 in 9
1 in 9
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a Adapted from Altekruse et al.[2]
70 1 in 27
Age
The incidence of breast cancer increases with a woman's age. As shown in
higher risk of being diagnosed with breast cancer in the next 10 years tha
The cumulative lifetime incidence decreases with advancing age because t
breast cancer diagnosis, the lower her lifetime risk compared to a younger
cancer at a younger or older age. The commonly quoted risk of one in eig
with breast cancer is based on lifetime risk of a diagnosis (not death) start
account for the woman’s current age.[2]
Breast cancer mortality increases with age. For a 40-year-old woman with
chance of dying from breast cancer within the next 10 years is extremely s
65, it is about 1%. For a woman older than 70, the risk of dying of breast c
dying of any cause is higher yet.[5]
Personal history of breast cancer
Women with a personal history of invasive breast cancer, DCIS, or lobulaincreased risk of being diagnosed with a new primary breast cancer.[6] Re
mammograms vary, but evidence for various strategies is scant.
Prior radiation therapy
Women treated with thoracic radiation before the age of 30 years have a 1
starting 8 years after the irradiation and for the rest of their lives.[7,8] An
resonance imaging (MRI) has been proposed in such women, beginning 8
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years, whichever is later.[9] In a study of screening with mammography a
among 98 asymptomatic women who received a chest radiation dose of 15
cancer. Four of those cancers would not have been detected without the u
multiple screening modalities observed a similar increase in cancer detect
These data suggest that earlier detection is possible with MRI, but do not
adjunct MRI screening.
Dense breast tissue
Women with radiologically dense breasts (heterogeneously dense or extre
the Breast Imaging Reporting and Data System [BI-RADS]) [12-15] haveof breast cancer compared with women who have fatty breasts.[16]
Other risk factors and risk prediction models
Other risk factors for breast cancer include an inherited predisposition ( B
age at menarche and late age at first birth; and previous breast biopsies s
disease.[17-19] Menopausal hormone use, obesity, lack of physical activity
with an increased risk of breast cancer. (Refer to the PDQ summaries on
Breast Cancer Prevention for more information.) Several models estimate
on these and other factors.[20-23]
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. , , , .
cancer for white females who are being examined annually. J Natl
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Breast Cancer Diagnosis and Pathology
Evaluation of Breast Symptoms
Women with breast symptoms are not candidates for screening because t
During a 10-year period, 16% of 2,400 women aged 40 to 69 years sought
symptoms at their health maintenance organization.[1] Women younger t
seek evaluation. Additional testing was performed in 66% of these women
performed in 27%. Cancer was diagnosed in 6.2%, most often stage II or I
prompting medical attention, a mass was most likely to lead to a cancer di
likely (1.8%) to do so.
Pathologic Diagnosis of Breast Cancer
Breast cancer is most often diagnosed by pathologic review of a fixed spec
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al. model for predicting individual
bstract]
k of breast cancer: a review of risk
MED Abstract]
ey require a diagnostic evaluation.
medical attention for breast
an 50 years were twice as likely to
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I. Of the breast symptoms
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tissue can be obtained from a symptomatic area or from an area identifie
lesion can be biopsied with core needle biopsy or, less often, fine-needle a
excision; image guidance improves accuracy. Nonpalpable lesions can be
using stereotactic x-ray or ultrasound guidance or can be surgically excise
In a retrospective study of 939 patients with 1,042 mammographically de
needle biopsy or surgical needle localization under x-ray guidance, sensiti
than 95% and the specificity was greater than 90%. Compared with surgic
guidance, core needle biopsy resulted in fewer surgical procedures for def
likelihood of clear surgical margins at the initial excision.[2]
Ductal Carcinoma In Situ
Ductal carcinoma in situ (DCIS) is a noninvasive condition that can evolv
frequency and time course.[3] Some authors include DCIS with invasive b
argue that the term be replaced by ductal intraepithelial neoplasia, simila
cervical and prostate precursor lesions, and that breast cancer statistics e
DCIS is most often diagnosed by mammography. In the United States, on
with DCIS in 1983, compared with approximately 64,000 women who are
when mammographic screening has been widely adopted.[3-5] The Cana
Study-2 of women aged 50 to 59 years found a fourfold increase in DCIS c
breast examination (CBE) plus mammography compared with those scree
difference in breast cancer mortality.[6] (Refer to the PDQ summary on Binformation.)
The natural history of DCIS is poorly understood because nearly all DCIS
retrospective review of 11,760 breast biopsies performed between 1952 an
[7,8] which were detected by physical examination, biopsied without rese
years. Nine women developed invasive breast cancer and four women dieinteresting but probably not relevant to women with screen-detected DCI
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.7http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessionalhttp://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.6http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.5http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.3http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.3http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.2
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by an imaging test. A palpable
piration biopsy or surgical
ampled by core needle biopsy
after image-guided localization.
ected lesions who underwent core
ity for malignancy was greater
l needle localization under x-ray
nitive treatment, with a higher
to invasive cancer, with variable
east cancer statistics, but others
to the terminology used for
clude these DCIS cases.
y 4,900 women were diagnosed
expected to be diagnosed in 2013,
ian National Breast Screening
ses in women screened by clinical
ned by CBE alone, with no
east Cancer Treatment for more
ases are treated. A single
1968 identified 28 cases of DCIS,
tion, and then followed for 30
of the disease. These findings arein an era of improved cancer care.
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Development of breast cancer after treatment of DCIS depends on the cha
the delivered treatment. One large randomized trial found that 13.4% of w
developed ipsilateral invasive breast cancer within 90 months, compared
lumpectomy and radiation.[9] The best evidence indicates that most DCI
cancer and that those that do can still usually be managed successfully, ev
detection and treatment of nonpalpable DCIS often represents overdiagn
Among women diagnosed with (and treated for) DCIS between 1984 and
cancer within 10 years,[10] which was a lower mortality rate than for the
This favorable outcome may reflect the benign nature of the condition, th
volunteer effect (women undergoing breast cancer screening are generally
Attempts to define low-risk DCIS cases that can be managed with fewer t
effort analyzed a series of 706 DCIS patients who were monitored to devel
California/Van Nuys Prognostic Scoring Index, which defines the risk of r
among women with DCIS based on age, margin width, tumor size, and gr
comprising a third of the cases, experienced only 1% DCIS recurrences an
of the use of postoperative radiation therapy. The moderate- and high-ris
rates, and they benefited from postlumpectomy radiation. Overall, only a
cancer. In a separate study, adjuvant tamoxifen therapy was shown to red
cancer.[12]
References
1. Barton MB, Elmore JG, Fletcher SW: Breast symptoms among wo
maintenance organization: frequency, evaluation, and outcome. An
[PUBMED Abstract]
2. White RR, Halperin TJ, Olson JA Jr, et al.: Impact of core-needle b
management of mammographic abnormalities. Ann Surg 233 (6): 7
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racteristics of the lesion but also on
omen treated by lumpectomy alone
ith 3.9% of those treated by
lesions will not evolve to invasive
n after that transition. Thus, the
sis and overtreatment.
989, only 1.9% died of breast
ge-matched population at large.
benefits of treatment, or the
healthier than those who do not).
erapies is important. One such
op the University of Southern
current DCIS and invasive cancer
de.[11] The low-risk group,
no invasive cancers, independent
groups had higher recurrence
proximately 1% died of breast
ce the incidence of invasive breast
en enrolled in a health
Intern Med 130 (8): 651-7, 1999.
east biopsy on the surgical
69-77, 2001. [PUBMED Abstract]
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3. Allegra CJ, Aberle DR, Ganschow P, et al.: National Institutes of He
Conference statement: Diagnosis and Management of Ductal Carci
2009. J Natl Cancer Inst 102 (3): 161-9, 2010. [PUBMED Abstract]
4. American Cancer Society: Cancer Facts and Figures 2013. Atlanta,
Available online. Last accessed January 10, 2014.
5. Virnig BA, Tuttle TM, Shamliyan T, et al.: Ductal carcinoma in situ
incidence, treatment, and outcomes. J Natl Cancer Inst 102 (3): 17
6. Miller AB, To T, Baines CJ, et al.: Canadian National Breast Screeni
randomized trial in women aged 50-59 years. J Natl Cancer Inst 92
7. Page DL, Dupont WD, Rogers LW, et al.: Intraductal carcinoma of
only. Cancer 49 (4): 751-8, 1982. [PUBMED Abstract]
8. Page DL, Dupont WD, Rogers LW, et al.: Continued local recurrenc
diagnosis of low grade ductal carcinoma in situ of the breast treate
1197-200, 1995. [PUBMED Abstract]
9. Fisher B, Dignam J, Wolmark N, et al.: Lumpectomy and radiationintraductal breast cancer: findings from National Surgical Adjuvan
Clin Oncol 16 (2): 441-52, 1998. [PUBMED Abstract]
10. Ernster VL, Barclay J, Kerlikowske K, et al.: Mortality among wom
the breast in the population-based surveillance, epidemiology and
Med 160 (7): 953-8, 2000. [PUBMED Abstract]
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alth State-of-the-Science
oma In Situ September 22-24,
a: American Cancer Society, 2013.
f the breast: a systematic review of
-8, 2010. [PUBMED Abstract]
ng Study-2: 13-year results of a
(18): 1490-9, 2000. [PUBMED Abstract]
he breast: follow-up after biopsy
of carcinoma 15-25 years after a
only by biopsy. Cancer 76 (7):
herapy for the treatment of Breast and Bowel Project B-17. J
n with ductal carcinoma in situ of
nd results program. Arch Intern
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11. Silverstein MJ: The University of Southern California/Van Nuys pr
in situ of the breast. Am J Surg 186 (4): 337-43, 2003. [PUBMED Abstr
12. Fisher B, Dignam J, Wolmark N, et al.: Tamoxifen in treatment of i
Surgical Adjuvant Breast and Bowel Project B-24 randomised contr
1993-2000, 1999. [PUBMED Abstract]
Breast Cancer Screening Concepts
Bias
Numerous uncontrolled trials and retrospective series have documented t
diagnose small, early-stage breast cancers, which have a favorable clinical
also show better cancer-related survival in screened versus nonscreened biases may explain that finding:
1. Lead-time bias: Survival time for a cancer found mammographicall
detection and the time when the cancer would have been detected
this time is not included in the survival time of cancers found beca
2. Length bias: Mammography detects a cancer while it is preclinical,Cancers with longer preclinical durations are, by definition, presen
discovery and therefore are more likely to be detected by screening;
growing and to have better prognoses, irrespective of screening.
3. Overdiagnosis bias: An extreme form of length bias; screening may
growing and would never have become manifest clinically in the wo
4. Healthy volunteer bias: The screened population may be the healthconscious women in the general population.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10376613&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14553846&dopt=Abstract
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gnostic index for ductal carcinoma
ct]
traductal breast cancer: National
olled trial. Lancet 353 (9169):
e ability of mammography to
course.[1] Although several trials
omen, a number of important
includes the time between
ecause of clinical symptoms, but
se of symptoms.
nd preclinical durations vary.during more opportunities for
these cancers tend to be slow
find cancers that are very slow
man’s lifetime.
est and/or the most health-
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14553846&dopt=Abstract
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Because the extent of these biases is never clear in any particular study, m
controlled trials to assess the benefits of screening. (Refer to the Cancer S
more information.)
Assessment of Performance and Accuracy
Performance benchmarks for screening mammography in the United Stat
Cancer Surveillance Consortium (BCSC) Web site.
Sensitivity
The sensitivity of mammography is the percentage of breast cancers detec
breast cancer is present. Sensitivity depends on tumor size, conspicuity, a
breast tissue density, patient age, timing within the menstrual cycle, over
skill of the radiologist. Overall sensitivity is approximately 79% but is low
with dense breast tissue (see the BCSC Web site).[2-4] Delay in diagnosis
common cause of medical malpractice litigation and half of the cases resu
involve false-negative mammograms.[5]
Specificity and false-positive rate
The specificity of mammography is the likelihood of the test being normal
false-positive rate is the likelihood of the test being abnormal when cance
many false-positive examinations result in unnecessary follow-up examinsubsection on Harms in the Screening With Mammography section of the
for more information.)
Interval cancers
Interval cancers are cancers that are diagnosed in the interval after a nor
before the subsequent screen. Some of these cancers were present at the t
negatives), and others grew rapidly in the interval between mammograph
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page1#Section_7http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page1#Section_13http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.5http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.4http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.2http://breastscreening.cancer.gov/http://breastscreening.cancer.gov/data/benchmarks/screening/2009/table7.htmlhttp://www.cancer.gov/cancertopics/pdq/screening/overview/HealthProfessional
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st groups rely on randomized
reening Summary Overview for
s are described on the Breast
ed in a given population, when
d hormone sensitivity as well as
ll image quality, and interpretive
r in younger women and in those
f breast cancer is the most
ting in payment to the claimant
when cancer is absent, whereas the
is absent. If specificity is low,
tions and procedures. (Refer to theOverview section of this summary
al screening examination and
me of mammography (false-
and detection. As a general rule,
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interval cancers have characteristics of rapid growth [6,7] and are frequen
discovery/diagnosis.[8]
One study of 576 women with interval cancers reported that interval canc
aged 40 to 49 years. Interval cancers appearing within 12 months of a neg
appear to be related to decreased mammographic sensitivity, attributable
cases. Those appearing within a 24-month interval appear to be related b
sensitivity due to greater breast density in 37.6% and to rapid tumor grow
Another study that compared the characteristics of 279 screen-detected c
cancers found that interval cancers were much more likely to occur in wo be of mucinous or lobular histology; or to have high histologic grade, high
benign features mammographically and/or to lack calcifications. Screen-d
have tubular histology; to be smaller, low stage, and hormone sensitive; a
ductal carcinoma in situ.[6]
References
1. Moody-Ayers SY, Wells CK, Feinstein AR: "Benign" tumors and "ea
screened patients of a natural cohort with breast cancer. Arch Inter
[PUBMED Abstract]
2. Carney PA, Miglioretti DL, Yankaskas BC, et al.: Individual and co
and hormone replacement therapy use on the accuracy of screenin
138 (3): 168-75, 2003. [PUBMED Abstract]
3. Rosenberg RD, Hunt WC, Williamson MR, et al.: Effects of age, bre
replacement therapy on screening mammographic sensitivity and c
183,134 screening mammograms in Albuquerque, New Mexico. Ra[PUBMED Abstract]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9807581&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12558355&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10789603&dopt=Abstracthttp://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.6http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.7http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.6
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ly of advanced stage at the time of
rs are more prevalent in women
tive screening mammogram
o greater breast density in 68% of
th to decreased mammographic
h in 30.6%.[9]
ncers with those of 150 interval
en younger than 50 years and toproliferative activity, relatively
etected cancers were more likely to
d to have a major component of
ly detection" in mammography-
Med 160 (8): 1109-15, 2000.
bined effects of age, breast density,
mammography. Ann Intern Med
st density, ethnicity, and estrogen
ncer stage at diagnosis: review of
iology 209 (2): 511-8, 1998.
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4. Kerlikowske K, Grady D, Barclay J, et al.: Likelihood ratios for mod
of breast cancer based on age and mammographic interpretation. J
Abstract]
5. Physician Insurers Association of America: Breast Cancer Study. W
Association of America, 1995.
6. Porter PL, El-Bastawissi AY, Mandelson MT, et al.: Breast tumor c
mammographic detection: comparison of interval- and screen-dete(23): 2020-8, 1999. [PUBMED Abstract]
7. Hakama M, Holli K, Isola J, et al.: Aggressiveness of screen-detecte
(8944): 221-4, 1995. [PUBMED Abstract]
8. Tabár L, Faberberg G, Day NE, et al.: What is the optimum intervalexaminations? An analysis based on the latest results of the Swedis
screening trial. Br J Cancer 55 (5): 547-51, 1987. [PUBMED Abstract]
9. Buist DS, Porter PL, Lehman C, et al.: Factors contributing to mam
40-49 years. J Natl Cancer Inst 96 (19): 1432-40, 2004. [PUBMED Abs
Breast Cancer Screening Modalities—Mammography
Mammography Description and Background
Mammography utilizes ionizing radiation to image breast tissue. The exa
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15467032&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3606947&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7741862&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10580027&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8667537&dopt=Abstract
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rn screening mammography. Risk
MA 276 (1): 39-43, 1996. [PUBMED
shington, DC: Physician Insurers
aracteristics as predictors of
ted cancers. J Natl Cancer Inst 91
breast cancers. Lancet 345
between mammographic screening two-county breast cancer
ography failure in women aged
ract]
ination is performed by
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compressing t e reast irm y etween two p ates. Suc compression spre
reduces the amount of radiation needed to image the breast. For routine s
examinations are taken in both mediolateral oblique and craniocaudal pr
breast tissue from the nipple to the pectoral muscle. Radiation exposure i
screening examination. Two-view examinations are associated with a low
examinations because they eliminate concern about abnormalities due to
structures.[1]
Under the Mammography Quality Standards Act (MQSA) enacted by Con
perform mammography must be certified by the U.S. Food and Drug Adm
of standardized training for personnel and a standardized mammographydose.[2] (Refer to the FDA's Web page on Mammography Facility Surveys
Evaluations, and Medical Physicist Qualification Requirement under MQ
Reauthorization Act requires that patients receive a written lay-language
The following Breast Imaging Reporting and Data System (BI-RADS) cate
mammographic results:[3]
0: Incomplete—needs additional image evaluation and/or prior ma
1: Negative.
2: Benign.
3: Probably benign.
4: Suspicious.
5: Highly suggestive of malignancy.
6: Known biopsy—proven malignancy.
About 10% of women screened will be recalled for additional evaluation;
receive a final disposition of normal or benign after a full diagnostic work
mammographic views, ultrasound or both. About 15% of women recalled biopsy. The chance that biopsy will indicate malignant disease differs by
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.3http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094405.htmhttp://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.2http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.1
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s out over apping tissues an
reening in the United States,
jections. Both views should include
4 to 24 mSv per standard two-view
r recall rate than are single-view
uperimposition of normal breast
ress in 1992, all U.S. facilities that
inistration (FDA) to ensure the use
technique utilizing a low radiationMammography Equipment
A.) The 1998 MQSA
ummary of mammography results.
gories are used for reporting
mograms for comparison.
ore than 80% of women will
p, which may include additional
ill receive a recommendation forI-RADS classification. Results from
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, -
indicated the following chance of malignancy (invasive or ductal carcino
2, 0%; category 3, 2%; category 4, 30%; or category 5, 97%.[4]
Benefit of Mammography
Randomized controlled trials
Randomized controlled trials (RCTs), with participation by nearly half a
examined the breast cancer mortality rates of women who were offered re
Canadian National Breast Screening Study (NBSS)-2, compared mammo
examination (CBE) with CBE alone; the other eight trials compared scree
CBE to a control consisting of usual care.
The trials differed in design, recruitment of participants, interventions (b
management of the control group, compliance with assignment to screeniof outcomes. Some trials used individual randomization, while others use
cohorts were identified and then offered screening; one trial used nonran
in any given month. Cluster randomization sometimes led to imbalances
control groups. Age differences have been identified in several trials, altho
too small to have a major effect on the trial outcome.[5] In the Edinburgh
correlates with the risk of breast cancer mortality, differed markedly betw groups, so it is difficult, if not impossible, to interpret the results.
Breast cancer mortality is the major outcome parameter for each of these
determine cause of death are critically important. Efforts to reduce bias in
have been made, including the use of a blinded monitoring committee (N
independent data sources, such as national mortality registries (Swedish tattempts could not ensure a lack of knowledge of women’s assignments to
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a in situ): category 0, 13%; category
illion women from four countries,
ular screening. One trial, the
ram plus clinical breast
ing mammogram with or without
th screening and treatment),
g and control groups, and analysis cluster randomization in which
omized allocation by day of birth
etween the intervention and
ugh the differences were probably
Trial, socioeconomic status, which
en the intervention and control
rials, so the methods used to
the attribution of mortality cause
w York) and a linkage to
ials). Unfortunately, thesescreening or control arms.
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Evidence of possible misclassification of breast cancer deaths in the Two-
favor of screening has been analyzed.[6]
There were also differences in the methodology used to analyze the result
Swedish trials were designed to include a single screening mammogram i
correspond with the end of the series of screening mammograms in the st
these trials used an "evaluation" analysis, tallying only the breast cancer d
whose cancer was discovered at or before the last study mammogram. In
in the performance of the end-of-study mammogram, resulting in more ti
group to develop or be diagnosed with breast cancer. Other trials used a "
all deaths attributed to breast cancer, regardless of the time of diagnosis.
meta-analysis of four of the five Swedish trials in response to concerns ab
The accessibility of the data for international audits and verification also
been undertaken only in the Canadian trials. Other trials have been audit
less rigor.[7]
All of these studies are designed to study breast cancer mortality rather th
the infrequency of breast cancer deaths relative to the total number of dea
these trials was examined retrospectively, only the Edinburgh Trial showe
could be attributed to socioeconomic differences. The meta-analysis (follo
trials also showed a small but significant improvement of all-cause mortal
The trials are described in detail in the Appendix of Randomized Controll
Summary of RCTs
Screening for breast cancer does not affect overall mortality, and the abso
mortality is small.
A way to view the potential benefit of breast cancer screening is to estimat
because of early breast cancer detection.[8,9] One author estimated the o
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.9http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page11#Section_377http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.7http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference5.6
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ounty Trial with possible bias in
of these trials. Four of the five
the control group, timed to
dy group. The initial analysis of
aths that occurred in women
ome of the trials a delay occurred
e for members of the control
ollow-up" analysis, which counts
his type of analysis was used in a
ut the evaluation analyses.[6]
aries, with formal audit having
d to varying degrees, usually with
n all-cause mortality because of
hs. When all-cause mortality in
a significant difference, which
-up methods) of the four Swedish
ty.
d Trials section of this summary.
ute benefit for breast cancer
e the number of lives extended
tcomes of 10,000 women aged 50
http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page11#Section_377http://www.cancer.gov/can