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NCCN Clinical Practice Guidelines in Oncology™
Cervical Cancer
Screening
V.1.2010
www.nccn.org
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
NCCN Cervical Cancer Screening Panel Members
Edward E. Partridge, MD/Chair
University of Alabama at Birmingham
Comprehensive Cancer Center
Nadeem Abu-Rustum, MD
Memorial Sloan-Kettering Cancer Center
Susan M. Campos, MD, MPH, MS
Dana-Farber/Brigham and Women’s
Cancer Center
Patrick J. Fahey, MD
The Ohio State University Comprehensive
Cancer Center - James Cancer Hospital
and Solove Research Institute
Benjamin E. Greer, MD
Fred Hutchinson Cancer Research
Center/Seattle Cancer Care Alliance
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Þ
Anna Giuliano, PhD &
H. Lee Moffitt Cancer Center & Research
Institute
Diljeet K. Singh, MD, DrPH
Robert H. Lurie Comprehensive Cancer
Center of Northwestern University
Karen Smith-McCune, MD, PhD
UCSF Helen Diller Family Comprehensive
Cancer Center
Nelson Teng, MD, PhD
Stanford Comprehensive Cancer Center
Cornelia Liu Trimble, MD
The Sidney Kimmel Comprehensive Cancer
Center at Johns Hopkins
Fidel Valea, MD
Duke Comprehensive Cancer Center
Sharon Wilczynski, MD, PhD
City of Hope Comprehensive Cancer Center
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* Writing Committee member
Gynecology oncology
† Medical oncology
Þ Internal medicine, including Family
practice, Preventive management
Pathology
& Epidemiology
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*
NCCN Guidelines Panel Disclosures
Howard W. Jones, III, MD
Vanderbilt-Ingram Cancer Center
Subodh M. Lele, MD
UNMC Eppley Cancer Center at The
Nebraska Medical Medical Center
Richard W. Lieberman, MD
University of Michigan Comprehensive
Cancer Center
Mark Morgan, MD
Fox Chase Cancer Center
Maria Enriqueta R. Nava, MD
Roswell Park Cancer Institute
R. Kevin Reynolds, MD
University of Michigan Comprehensive
Cancer Center
Helen E. Rhodes, MD
The University of Texas M. D. Anderson
Cancer Center
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Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
Table of Contents
NCCN Cervical Cancer Screening Panel Members
Summary of Guidelines Updates
21 y
Follow-up of Screening Exam-Adult > 21 y (CERVS-6
Atypical Glandular Cells,
Atypical Glandular Cells, Follow-up of Adenocarcinoma in Situ (CERVS-15
Atypical Glandular Cells, Follow-up of Endometrial Biopsy Findings (CERVS-16
Screening Guidelines for Early Detection of Cervical Cancer (CERVS-1
Initial Findings of Screening Exam (CERVS-3
Follow-up for HPV High Risk DNA Testing 30 y (CERVS-4
Follow-up of Screening Exam-Adolescents or Young Women (CERVS-5
Findings on Initial Screening/Pap Test, Colposcopy Findings, Cervical Biopsy
Findings, Follow-up, Treatment (CERVS-7
Findings at Treatment, Follow-Up Post-Treatment for CIN (CERVS-11
Follow-up and Management (CERVS-12
Bethesda System 2001 (CERVS-A
Colposcopy During Pregnancy (CERVS-B
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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
Guidelines Index
Print the Cervical Cancer
Screening Guidelines
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
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
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.
UPDATES
SUMMARY OF GUIDELINES UPDATES
CERVS-1
CERVS-2
CERVS-3
CERVS-4
CERVS-6
CERVS-11
CERVS-B
CERVS-10
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When to discontinue screening, second sub bullet was
modified, “Women who have a history of cervical cancer
...”
Screening interval, first bullet was modified, “unless they have
a history ...”
Screening interval, third bullet was modified from, “Until more
data are available, women who test positive for HPV DNA
should continue screening at the discretion of their health care
provider” to “Women whose cytology is negative but test
positive for HPV High Risk DNA should have screening as
shown on CERVS-4.”
Footnote b, “HPV HR DNA tests detect whether any of the 14
high-risk types of HPV are present, although the tests do not
indicate which types are present” is new to the page.
Visible/suspicious lesion on cervix, after biopsy, “If invasive
cancer, see NCCN Cervical Cancer Guidelines” and “If no
cancer, consider CKC” were added.
Cervical cytology/Pap test positive for invasive cancer, after
biopsy visible lesion; diagnostic excision if no visible lesion, “If
cancer, see NCCN Cervical Cancer Guidelines” and “If CIN I- III,
see CERVS-11” were added.
Follow-up for “Cervical cytology/Pap test negative and HPV
High Risk DNA positive 30 y” algorithm was added to the
guidelines.
Footnote j, “In women with ACS-US who are HPV HR positive,
the NCCN and ASCCP do not recommend using the HPV 16/18
specific DNA test (ie, HPV genotyping) to screen for who should
proceed to colposcopy” is new to the page.
Footnote k, “For colposcopy for ASC-US or LSIL, see CERVS-7
and for ASC-H or HSIL, see CERVS-9. If appropriate, see
Colposcopy During Pregnancy (CERVS-B)” is new to the page.
Unsatisfactory colposcopy was separated into HSIL and ASC-H.
After ASC-H, “perform ECC” and follow-up findings and
management were added.
CIN II, III with positive margins, reexcision, “especially if
invasion is suspected” replaced “not recommended unless both
endocervical and ectocervical margins are positive” and follow-
up of reexcision results “If CIN, see Follow-up Therapy for CIN”
and “If invasive cancer, see NCCN Cervical Cancer Guidelines”
were added for clarification.
Third bullet was clarified as, “Colposcopically directed cervical
biopsy during pregnancy should be limited to patients where
high-grade neoplasia
or invasive cancer is suspected.”
or
diagnosis of CIN III
of CIN III
based on cytology (ie, ASC-H, HSIL, AGC)
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Summary of changes in the 1.2010 version of the Cervical Cancer Screening Guidelines from the 1.2009 version include:
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
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 GUIDELINES FOR EARLY DETECTION OF CERVICAL CANCER
When to start screening
When to discontinue screening
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Cervical cancer screening should begin approximately 3 years after the onset of vaginal intercourse.
Screening should begin no later than 21 years of age.
It is critical that adolescents who may not need a cervical cytology test obtain appropriate preventive health care, including
assessment of health risks, contraception and prevention counseling, screening and treatment of sexually transmitted diseases.
The need for cervical cancer screening should not be the basis for the onset of gynecologic care.
Women at age 70 and older with an intact cervix who have had three or more documented, consecutive, technically satisfactory
negative cervical cytology tests, and no abnormal/positive cytology test, within the 10 year period prior to age 70 may elect to cease
cervical cancer screening.
Screening is recommended for women who have not been previously screened, women for whom information about previous
screening is unavailable, and when past screening is unlikely.
Women who have a history of cervical cancer or diagnosis of CIN III, in utero exposure to diethylstilbestrol (DES), and/or who are
immunocompromised (including HIV+) should continue cervical cancer screening for as long as they are in reasonably good health
and do not have a life-limiting chronic condition.
Women over the age of 70 should discuss their need for cervical cancer screening with their health care provider based on their
individual circumstances, including the potential benefits, harms, and limitations of screening, and make informed decisions about
whether to continue screening.
Women with comorbid or life-threatening illnesses may forego cervical cancer screening.
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CERVS-1
Screening Guidelines continued (See CERVS-2)
From Saslow D, Runowicz C, Solomon D, et al., American cancer society guideline for the early detection of cervical neoplasia and cancer. CA: A
Cancer Journal for Clinicians 52(6):342-362. Adapted from Lippincott, Williams & Wilkins.2002;
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
Hysterectomy
Screening interval
OR
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Screening with vaginal cytology tests after total hysterectomy (with removal of the cervix) for benign gynecologic disease is not
indicated.
Efforts should be made to confirm and/or document via physical exam and review of the pathology report (when available) that the cervix
was completely removed.
Women who have had a subtotal hysterectomy should continue cervical cancer screening as per current guidelines.
Patients with a history of cervical intraepithelial neoplasia (CIN) II-III, or for whom it is not possible to document the absence of CIN II-III
prior to or as the indication for the hysterectomy, should be screened until three documented, consecutive, technically satisfactory
negative vaginal cytology tests, and no abnormal/positive cytology tests, within a 10 year period are achieved.
Women with a history of in utero exposure and/or with a history of cervical carcinoma should continue screening
after hysterectomy for as long as they are in reasonably good health and do not have a life-limiting chronic condition.
After initiation of screening, cervical screening should be performed annually with conventional cervical cytology smears every 2
years using liquid-based cytology; at or after age 30, women who have had 3 consecutive, technically satisfactory negative cytology
results may be screened every 2-3 years (unless they have a history of CIN III, in utero DES exposure, are HIV+, or are
immunocompromised).
Human papillomavirus (HPV) high risk DNA testing for primary cervical cancer screening has recently been approved by the FDA for
women 30 y of age. It is reasonable to consider that for women age 30 and over, as an alternative to annual cervical cytology testing
alone, cervical screening may be performed every 3 years using conventional or liquid-based cytology combined with a test for DNA for
high-risk HPV types.
Frequency of combined cytology and HPV High Risk DNA testing should NOT be more often than every 3 years, if both tests are negative.
Counseling and education related to HPV infection is a critical need.
Women who received HPV vaccination should continue cervical cancer screening according to the guidelines.
diethylstilbestrol (DES)
Women whose cytology is negative but test positive for HPV High Risk DNA should have screening as shown on .a,b CERVS-4
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 GUIDELINES FOR EARLY DETECTION OF CERVICAL CANCER
From Saslow D, Runowicz C, Solomon D, et al., American cancer society guideline for the early detection of cervical neoplasia and cancer. CA: A
Cancer Journal for Clinicians 52(6):342-362. Adapted from Lippincott, Williams & Wilkins.2002;
CERVS-2
See Initial Findings of Screening Exam (CERVS-3)
aFDA approved HPV DNA testing for high-risk virus types. It is not useful to test for low-risk virus types.
HPV HR DNA tests detect whether any of the 14 high-risk types of HPV are present, although the tests do not indicate which types are present.b
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
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.
c
d
e
Referral to specialist with oncological expertise for complex clinical situations should be strongly considered. Examples of complex clinical situations include:
Atypical glandular cells
Adenocarcinoma in-situ
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Cervical cytology/Pap test results should be reported using the Bethesda System. .
Conventional Pap test or thin-layer technology is an acceptable method for primary screening.
See The Bethesda System 2001 (CERVS-A)
CERVS-3
INITIAL FINDINGS OF SCREENING EXAMc
�Visible/suspicious lesion on cervix
�Cervical cytology/Pap test negative for
intraepithelial lesion or malignancy
d,e
�Cervical cytology/Pap test unsatisfactoryd,e
� High-grade squamous intraepithelial lesions (HSIL)
� Atypical glandular cells (AGC)c
See Screening Findings
Adolescents or Young
Women 21 y (CERVS-5)�
See AGC Follow-Up and
Management (CERVS-12)
Suspicion of high-grade dysplasia (ASC-H)
� Atypical squamous cells (ASC)
Undetermined significance (ASC-US)
� Low-grade squamous intraepithelial lesions (LSIL)
�Cervical cytology/Pap test positive for invasive cancerd,e c
See Screening Findings
Adult > 21 y (CERVS-6)
�Cervical cytology/Pap test positive ford,e epithelial abnormalities:
�Cervical cytology/Pap test negative and
HPV High Risk DNA positive 30 y
d,e
�
See Follow-up for HPV High Risk DNA testing (CERVS-4)� 30 y
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Pregnancy
Persistent/recurrent dysplasia with desire for fertility preservation
FOLLOW-UP
Biopsy
Screening frequency based on screening guidelines
See Screening for Early Detection of Cervical Cancer (CERVS-1)
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Repeat cervical cytology/Pap test should be done within 6-12 weeks.
Treat infection if present and indicated
Biopsy visible lesion; diagnostic
excision if no visible lesion
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If cancer,
If CIN I- III,
see NCCN
Cervical Cancer Guidelines
see CERVS-11
�
�
If invasive cancer,
If no cancer, consider CKC
see NCCN Cervical Cancer Guidelines
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
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.
HPV DNA specific test
for 16/18 genotypeh
Colposcopyg
CERVS-4
HPV High Risk (HR)
DNA positive
and
Cytology/Pap test
negative
b
Positive HPV
16/18 specific
DNA test
Negative HPV
16/18 specific
DNA test
Resume routine
screening per
guidelines in 3 y
( )See CERVS-2
Repeat both tests
at 12 mo
Cytology/Pap
test
HPV HR DNA test
�
�
and
Both tests
negative
Colposcopyg
HPV HR test
positive
and
Cytology/Pap
test negative
HPV HR test
positive or
negative
and
Cytology/Pap
test positive
See CERVS-3
b
h
HPV HR DNA tests detect whether any of the 14 high-risk types of HPV are present, although the tests do not indicate which types are present.
The HPV 16/18 DNA diagnostic test is a separate test that detects whether HPV 16 or HPV 18 are present.
f
g
Because HPV genotyping (ie specific HPV DNA 16/18) does not detect other high risk HPV types, (eg, HPV 31 and 45), proceeding directly to
colposcopy is an option.
Follow appropriate colposcopy findings pathway (i.e. satisfactory or unsatisfactory). If appropriate,
only
see Colposcopy During Pregnancy (CERVS-B)
MANAGEMENTFOLLOW-UP FOR
HPV HIGH RISK (HR)
DNA TESTINGf
Colposcopyf,g
or
FOLLOW-UP FOR HPV HIGH RISK DNA TESTING � 30 y
SCREENING
FINDINGS
(Cytology
negative)
Guidelines Index
Cervical Cancer Screening TOC
Discussion, References
Practice Guidelines
in Oncology – v.1.2010
Version 1.2010, 10/20/09 © 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.
Cervical Cancer ScreeningNCCN
®
gFollow appropriate colposcopy findings pathway (i.e. satisfactory or unsatisfactory).
If appropriate, .
HPV DNA testing is not recommended in adolescent or young women 21 y.i �
see Colposcopy During Pregnancy (CERVS-B)
CIN= Cervical intraepithelial neoplasia
ECC= Endocervical curettage
LEEP= Loop electrosurgical excision procedure
CKC= Cold-knife conization
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
FINDINGS
SCREENING
FOLLOW-UP
FOLLOW-UP FINDINGS
ASC-US
or
LSIL
i
i
Repeat cervical
cytology/Pap test