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NCCN Clinical Practice Guidelines in Oncology™
Breast Cancer
Screening and Diagnosis
V.1.2010
www.nccn.org
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
NCCN Breast Cancer Screening and Diagnosis Panel Members
Benjamin O. Anderson, MD
Fred Hutchinson Cancer Research
Center/Seattle Cancer Care Alliance
Ermelinda Bonaccio, MD
Roswell Park Cancer Institute
Saundra Buys, MD
Huntsman Cancer Institute at the
University of Utah
Therese B. Bevers, MD/Chair
The University of Texas M. D. Anderson
Cancer Center
Mary B. Daly, MD, PhD
Fox Chase Cancer Center
Peter J. Dempsey, MD
The University of Texas M. D. Anderson
Cancer Center
William B. Farrar, MD
Arthur G. James Cancer Hospital &
Richard J. Solove Research Institute at
The Ohio State University
Irving Fleming, MD
St. Jude Children's Research
Hospital/University of Tennessee Health
Sciences Center
Judy E. Garber, MD, MPH
Dana-Farber/Brigham and Women's
Cancer Center | Massachusetts General
Hospital Cancer Center
Þ
Þ
¶
§
‡
§
¶
¶
†
†
†
Sara Shaw, MD
City of Hope
Mary Lou Smith, JD, MBA
Patient Consultant
Theodore N. Tsangaris, MD
The Sidney Kimmel Comprehensive Cancer
Center at Johns Hopkins
Cheryl Williams, MD
UNMC Eppley Cancer Center at The
Nebraska Medical Center
Thomas Yan eelov, PhD §
Vanderbilt-Ingram Cancer Center
Gary Lyman, MD, MPH
Duke Comprehensive Cancer Center
Elizabeth Rafferty, MD §
Dana-Farber/Brigham and Women's Cancer
Center | Massachusetts General Hospital
Cancer Center
k
† ‡
¥
§
¶
§
Randall E. Harris, MD, PhD
Arthur G. James Cancer Hospital &
Richard J. Solove Research Institute
at The Ohio State University
Alexandra S. Heerdt, MD, FACS
Memorial Sloan-Kettering Cancer
Center
Mark Helvie, MD
University of Michigan
Comprehensive Cancer Center
Þ
¶
Þ
§
�
�
§
¶
John G. Huff, MD
Vanderbilt-Ingram Cancer Center
Nazanin Khakpour, MD
H. Lee Moffitt Cancer Center &
Research Institute
Seema A. Khan, MD
Robert H. Lurie Comprehensive
Cancer Center of Northwestern
University
Helen Krontiras, MD
University of Alabama at
Birmingham Comprehensive Cancer
Center
¶
*
§ Radiologist/Radiotherapy/Radiation Oncology
¶ Surgery/Surgical Oncology
† Medical Oncology
‡ Hematology/Hematology Oncology
Þ Internist/Internal Medicine, including Family
Practice, Preventive Management
Pathology
¥ Patient Advocacy
* Writing Committee Member
�
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NCCN Guidelines Panel Disclosure
*
*
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Table of Contents
NCCN Breast Cancer Screening and Diagnosis Panel Members
S
History and Physical Examination (BSCR-1)
Normal Risk, Screening / Follow Up (BSCR-1)
Increased Risk, Screening / Follow Up (BSCR-2)
Symptomatic, Positive Physical Findings (BSCR-4)
Nipple Discharge, No Palpable Mass (BSCR-11)
Asymmetric Thickening/Nodularity (BSCR-12)
Skin Changes (BSCR-13)
Mammographic Evaluation (BSCR-14)
Breast Screening Considerations (BSCR-A)
Risk Factors Used in the Modified Gail Model (BSCR-B)
Assessment Category Definitions (BSCR-C)
Guidelines Index
Print the Breast Cancer Screening and Diagnosis Guideline
ummary of Guidelines Updates
�
�
�
�
�
Dominant Mass, Age 30 Years (BSCR-5)
Dominant Mass, Age < 30 Years (BSCR-9)
�
These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment.
Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical
circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties
of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These
guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not
be reproduced in any form without the express written permission of NCCN. ©2009.
For help using these
documents, please click here
Discussion
References
Clinical Trials:
Categories of Evidence and Consensus:NCCN
The
believes that the best management for any cancer
patient is in a clinical trial. Participation in clinical
trials is especially encouraged.
To find clinical trials online at NCCN member
institutions,
All recommendations are Category 2A unless
otherwise specified.
See
NCCN
click here:
nccn.org/clinical_trials/physician.html
NCCN Categories of Evidence and Consensus
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Summary of the Guidelines updates
UPDATES
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Summary of changes in the 1.2010 version of the Breast Cancer Screening and Diagnosis Guidelines from the 2.2009 version include:
General
Added BI-RADS assessment categories with footnote “j” linking to
BSCR-C where appropriate throughout the guideline.
Added patient history to physical examination.
Separated screening category of women 35 y or older with 5 y risk of
invasive breast cancer greater than or equal to 1.7% from women
who have a lifetime risk of greater than 20% based on models that
are largely dependent on family history to clarify that consideration
of annual MRI is only for women with a lifetime risk of greater than
20%.
Added recommendation to consider referral to genetic counselor to
the screening follow up for women with increased risk.
Changed terminology from lump/mass to dominant mass.
Footnote “n” is new to the page: “
®
�
�
�
A complex cyst has both cystic
and solid components.”
Footnote “o” is new to the page: “Concordance is needed between
clinical exam and ultrasound results. Consider therapeutic
aspiration for persistent clinical symptoms.”
BSCR-1
BSCR-2
BSCR-3
BSCR-5
BSCR-8
BSCR-12
BSCR-13
BSCR-15
BSCR-C
Added a new pathway under aspirate findings for mass resolves and
bloody fluid.
Recommendation for women > 30 years with asymmetric thickening or
nodularity was changed from “Mammogram +/- ultrasound” to
“Mammogram + ultrasound.”
Footnote “w” is new to the page: “A benign skin punch biopsy in a
patient with a clinical suspicion of inflammatory breast cancer does
not rule out malignancy. Further evaluation is recommended.”
Changed the title of the page to “Assessment Category Definitions.”
Included BI-RADS - Ultrasound assessment category definitions.
Diagnostic mammogram follow-up: Recommendation changed from
“Mammogram in 6-12 mo” to “Mammogram in 6-12 mo for 1-2 y.”
�
�
®
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
SCREENING OR SYMPTOM CATEGORY
History and
physical
examinationa
Asymptomatic
and
Negative
physical exam
Symptomatic
or
Positive physical exam
See Findings BSCR-4( )
Increased risk:
Strong family history or genetic predisposition
LCIS/Atypical hyperplasia
Prior history of breast cancer
b
c
d
d e,f
�
�
�
�
�
�
Prior thoracic RT (eg, mantle)
5-year risk of invasive breast cancer 1.7% in women
35 y
Women who have a lifetime risk > 20% as defined by
models that are largely dependent on family history
� �
See Increased Risk
Screening Follow-up
BSCR-2 BSCR-3)( ,
Normal
risk
a
b
c
d
e
f
Refer to the for a detailed qualitative and quantitative assessment.
For a definition of strong family history, see
As currently defined in the American Society of Clinical Oncology Policy Statement Update: Genetic testing for cancer susceptibility. J Clin Oncol 2003, 21:2397-2406.
gWomen should be familiar with their breasts and promptly report changes to their healthcare provider. Periodic, consistent BSE may facilitate breast self awareness.
Premenopausal women may find BSE most informative when performed at the end of menses.
See Breast Screening Considerations BSCR-A
NCCN Breast Cancer Risk Reduction Guidelines
See Risk Factors Used in the Modified Gail Model BSCR-B
NCCN Genetic/Familial High Risk Assessment Guidelines.
See NCCN Genetic/Familial High Risk Assessment Guidelines.
( ).
( ).
BSCR-1
Age 20
but < 40 y
�
Age 40 y�
�
�
Clinical breast exam every 1-3 y
Breast awarenessg
�
�
�
Annual clinical breast exam
Annual mammogram
Breast awarenessg
SCREENING FOLLOW-UPa
See Mammographic Evaluation
(BSCR-14)
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Women 35 y with 5-year risk of
invasive breast cancer 1.7%c
�
�
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
SCREENING OR SYMPTOM CATEGORY SCREENING FOLLOW-UP
Prior thoracic RT
Age < 25 y
Age 25 y�
�
�
Annual clinical breast exam
Breast awarenessg
�
�
�
Annual mammogram + clinical breast exam every 6-12 mo
Begin 8-10 y after RT or age 25, whichever occurs last
Consider annual breast MRI as an adjunct to mammogram and clinical breast exam
Breast awareness
�
g
Women who have a lifetime risk >
20% as defined by models that are
largely dependent on family historyd
�
�
�
�
Annual mammogram + clinical breast exam every 6-12 mo
Breast awareness
Consider risk reduction strategies ( )
Consider annual breast MRI
g
See NCCN Breast Cancer Risk Reduction Guidelines
BSCR-2
c
dFor a definition of strong family history, see
See Risk Factors Used in the Modified Gail Model BSCR-B
NCCN Genetic/Familial High Risk
Assessment Guidelines.
( ).
Increased Risk:
See Physical Exam (BSCR-1)
See Mammographic Evaluation (BSCR-14)
gWomen should be familiar with their breasts and promptly report changes to their
healthcare provider. Periodic, consistent BSE may facilitate breast self awareness.
Premenopausal women may find BSE most informative when performed at the
end of menses.
�
�
�
Annual mammogram + clinical breast exam every 6-12 mo
Breast awareness
Consider risk reduction strategies ( )
g
See NCCN Breast Cancer Risk Reduction Guidelines
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Prior history of breast cancer See NCCN Breast Cancer Guidelines - Surveillance Section
Strong family
history or
genetic
predisposition
d
e,f
Age < 25 yh
Age 25 y� h
�
�
�
�
�
Annual mammogram + clinical breast exam every 6-12 mo
Starting at age 25 y for Hereditary Breast and Ovarian Cancer (HBOC) patients
5-10 y prior to youngest breast cancer case for strong family history or other genetic
predispositions
Breast awareness
Annual breast MRI as an adjunct to mammogram and clinical breast exam
Consider risk reduction strategies ( )
Consider referral to genetic counselor
�
�
f
g
See NCCN Breast Cancer Risk Reduction Guidelines
LCIS/Atypical
hyperplasia
�
�
�
�
Annual mammogram + clinical breast exam every 6-12 mo
Consider annual breast MRI for LCIS as an adjunct to mammogram and clinical breast
exam
Consider risk reduction strategies ( )
Breast awarenessg
See NCCN Breast Cancer Risk Reduction Guidelines
�
�
�
Annual clinical breast exam
Breast awareness
Consider referral to genetic counselor
g
SCREENING OR SYMPTOM CATEGORY SCREENING FOLLOW-UP
Increased Risk:
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
d
e
f
For a definition of strong family history, see
As currently defined in the American Society of Clinical Oncology Policy Statement
Update: Genetic testing for cancer susceptibility. J Clin Oncol 2003, 21:2397-2406.
NCCN Genetic/Familial High Risk
Assessment Guidelines.
See NCCN Genetic/Familial High Risk Assessment Guidelines.
gWomen should be familiar with their breasts and promptly report changes to their
healthcare provider. Periodic, consistent BSE may facilitate breast self awareness.
Premenopausal women may find BSE most informative when performed at the
end of menses.
Earlier screening may be appropriate in some patients.h
BSCR-3
See Physical Exam (BSCR-1)
See Mammographic Evaluation (BSCR-14)
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Physical
examination
Symptomatic or
positive findings
on physical exam
PRESENTING SIGNS/SYMPTOMS
Dominant
mass
Nipple discharge,
no palpable mass
Asymmetric
thickening/nodularity
Skin changes:
Erythema
Nipple excoriation
Scaling, eczema
�
�
�
Peau d’orange
�
Age < 30 y
Age 30 y�
See Follow-up
Evaluation (BSCR-9)
See Follow-up
Evaluation (BSCR-5)
See Diagnostic
Follow-up (BSCR-11)
See Diagnostic
Follow-up (BSCR-12)
See Diagnostic
Follow-up (BSCR-13)
BSCR-4
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Increase
in size
Stable
See Aspirate Findings BSCR-8( )
INITIAL EVALUATION FOLLOW-UP EVALUATION
Ultrasound
Solid
No
ultrasonographic
abnormality
BI-RADS
category 1
®
j
Tissue biopsy
or
Observe every 3-6 mo
± imaging for 1-2 y to
assess stability
Dominant
mass
Age 30 y�
Mammogrami
BI-RADS®
Category 1-3j,k
BI-RADS
Category 4-5
®
j,k,l See Diagnostic Mammogram Follow-Up (BSCR-15)
Probably benign finding
BI-RADS category 3® j
Suspicious or highly suggestive finding
BI-RADS category 4-5® j
See Ultrasound Findings (BSCR-7)
Image guided biopsy
or
Surgical excision
There are a few clinical circumstances in which ultrasound would be preferred (eg, suspected simple cyst).
Mammography results are mandated to be reported using Final Assessment categories (Mammography Quality Standards Act, Final Rule. Federal Register
62(208):55988,1997).
Assess geographic correlation between clinical and imaging findings. If there is a lack of correlation return to Category 1-3 for further work-up of palpable lesion. If
imaging findings correlate with the palpable finding, workup of the imaging problem will answer the palpable problem.
A complex cyst has both cystic and solid components.
i
j
k
l
n
m
o
Round, circumscribed mass containing low level echoes without vascular flow, fulfilling most but not all criteria for simple cyst.
Concordance is needed between clinical exam and ultrasound results. Consider therapeutic aspiration for persistent clinical symptoms.
See Assessment Category Definitions BSCR-C( ).
PRESENTING
SIGNS/SYMPTOMS
AGE 30 yDOMINANT MASS / �
Non-simple
cyst
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
BSCR-5
Progression or
enlargement on
clinical exam
Stable
See
Routine
Screening
(BSCR-1)
See Tissue
Biopsy
BSCR-6
Complicatedm
Complexn
Short term
follow-up
Aspiration
See Tissue Biopsy
BSCR-6
Physical exam
and ultrasound
mammogram
every 6-12 mo
for 1-2 y to
assess stability
±
Simple cysto
BI-RADS category 2® j
See
Routine
Screening
(BSCR-1)
See Tissue
Biopsy
(BSCR-6)
See Routine Screening (BSCR-1)
BI-RADS category 4® j
BI-RADS
category 3
®
j
Guidelines Index
Breast Screening TOC
Discussion, References
Version 1.2010, 11/03/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Breast Cancer Screening and Diagnosis
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Solid:
Suspicious or
highly
suggestive
finding
BI-RADS
category 4-5
®
j
Tissue
biopsy
ULTRASOUND FINDINGS
DOMINANT MASS / AGE 30 y�
See NCCN Breast Cancer Guidelines
Excision (if
core needle
biopsy not
possible)
or
FOLLOW-UP EVALUATION
Benign and image
concordant
�
�
�
�
�
Indeterminate
or
Atypical
hyperplasia
or
LCIS
Other
Benign and
image
discordant
q
q
r
or
Surgical
excision
Malignant
See Routine Screening (BSCR-1)Benign
Malignant
Atypical
hyperplasia
LCIS
Physical exam ±
ultrasound/mammogram
every 6-12 mo for 1-2 y
to assess stability
See Routine Screening (BSCR-1)
NCCN Breast Cancer Risk
Reduction Guidelines
and
Malignant See NCCN Breast Cancer Guidelines
See Routine Screening (BSCR-1)Benign
LCIS
Atypical hyperplasia
See Routine Screening (BSCR-1)
NCCN Breast Cancer Risk Reduction Guidelines
and
Return to Lump/mass,
Age 30 y, Initial Evaluation BSCR-5� ( )
j
q
p
r
FNA and core (needle or vacuum-assisted) biopsy are both valuable. FNA requir