ASCCP Management Guidelines - August 2014 PDF

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The society for lower genital

tract disorders since 1964.

Updated Consensus Guidelines for


Managing Abnormal Cervical Cancer
Screening Tests and Cancer Precursors

American Society for Colposcopy and Cervical Pathology Reprinted August 2014
Introduction conference held at the National Institutes of Health in
September 2012. This report provides updated recommenda-
cervical precancer. Since then, considerable new informa-
tion has emerged about management of young women, and
tions for managing women with cytological abnormalities. the impact of treatment for precursor disease on pregnancy
Cytology A more comprehensive discussion of these recommendations outcomes. Progress has also been made in our understanding
Since the publication of the 2006 consensus guidelines, new
and their supporting evidence was published in the Journal of the management of women with adenocarcinoma in-situ,
cervical cancer screening guidelines have been published
of Lower Genital Tract Disease and Obstetrics and Gynecology also a human papillomavirus (HPV)associated precursor
and new information has become available which includes
and is made available on the ASCCP website at www.asccp.org. lesion to invasive cervical adenocarcinoma. Therefore, in
key cervical cancer screening and follow up, and cervical
2012 the ASCCP, together with its partner organizations,
precancer management data over a nine year period among
more than 1 million women cared for at Kaiser Permanente
Histopathology reconvened the consensus process of revising the guide-
Appropriate management of women with histo-pathologically lines. This culminated in the September 2012 Consensus
Northern California. Moreover, women under age 21 are no
diagnosed cervical precancer is an important component of Conference held at the National Institutes of Health. This re-
longer receiving cervical cancer screening and cotesting
cervical cancer prevention programs. Although the precise port provides the recommendations developed for managing
with high-risk HPV type assays, and cervical cytology is being
number of women diagnosed with cervical precancer each women with cervical precancer. A summary of the guidelines
used to screen women 30 years of age and older.
year in the U.S. is not known, it appears to be a relatively themselvesincluding the recommendations for manag-
Therefore, in 2012 the American Society for Colposcopy and common occurence. In 2001 and 2006, the American Society ing women with cervical cytological abnormalities are
Cervical Pathology (ASCCP), together with its 24 partner for Colposcopy and Cervical Pathology and 28 partner published in JLGTD and Obstetrics & Gynecology.
professional societies, Federal agencies, and international professional societies, federal agencies, and international
organizations, began the process of revising the 2006 organizations, convened processes to develop and update
management guidelines. This culminated in the consensus consensus guidelines for the management of women with

Copyright, 2002, 2006, 2013 American Society for Colposcopy and Cervical Pathology. All rights reserved
General Comments
Although the guidelines are based on evidence whenever The 2001 Bethesda System terminology is used for cytological is not equivalent to histopathological CIN2,3. The current
possible, for certain clinical situations limited high-quality classification. This terminology utilizes the terms low-grade guidelines expand clinical indications for HPV testing based
evidence exists. In these situations the guidelines are squamous intraepithelial lesion (LSIL) and high-grade on studies using FDA-approved, validated HPV assays.
based on consensus expert opinion. Guidelines should never squamous intraepithelial lesion (HSIL) to refer to low-grade Management decisions based on results using HPV tests
be a substitute for clinical judgment. Clinical judgment should lesions and high-grade cervical cancer precursors respec- not similarly validated may not result in outcomes intended
always be used when applying a guideline to an individual tively. For managing cervical precancer, the histopathological by these guidelines. HPV testing should be restricted to
patient since guidelines may not apply to all patient-related classification is two-tiered applying the terms cervical high-risk (oncogenic) HPV types. Testing for low-risk (non-
situations. Finally, both clinicians and patients need to intraepithelial neoplasia grade 1 (CIN1) to low-grade lesions oncogenic) HPV types has no role in evaluating women with
recognize that while most cases of cervical cancer can be and CIN2,3 to high-grade lesions. If using the 2012 Lower abnormal cervical cytological results. Therefore, whenever
prevented through a program of screening and management Anogenital Squamous Terminology (LAST), CIN1 is equivalent HPV testing is mentioned in the guidelines, it refers to
of cervical precancer, no screening or treatment modality is to histopathological LSIL and CIN2,3 is equivalent to histo- testing for high-risk (oncogenic) HPV types only.
100% effective and invasive cervical cancer can develop in pathological HSIL. Please note that cytological LSIL is not
women participating in such programs. equivalent to histopathological CIN1 and cytological HSIL

Copyright, 2002, 2006, 2013 American Society for Colposcopy and Cervical Pathology. All rights reserved

Comments
Unsatisfactory Cytology

Unsatisfactory Cytology
HPV unknown HPV negative HPV positive
(any age) (age 30) (age 30)

Repeat Cytology
after 2-4 months
Colposcopy

Abnormal Negative Unsatisfactory

Routine screening (HPV-/unknown)


Manage per ASCCP or
Guideline Cotesting @ 1 year (HPV+)
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Cytology NILM* but EC/TZ Absent/Insufficient

Ages 21-29 Age 30

HPV Unknown
HPV Negative

HPV Testing Repeat Cytology


Preferred @ 3 years
Acceptable
HPV Positive
or
Cytology & HPV Test Genotyping
@1 year

Routine Screening Manage per


ASCCP Guideline
* Negative for intraepithelial lesion or malignancy
HPV testing is unacceptable for screening women ages 21-29 years

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

NILM but EC/TZ Absent


Normal Cytology/HPV Positive

Management of Women Age 30, who are Cytology Negative, but HPV Positive

Repeat Cotesting
@ 1 year HPV DNA Typing
Acceptable Acceptable

Cytology Negative ASC HPV 16 or 18 Positive HPV 16 and 18 Negative


and or
HPV Negative HPV Positive

Repeat Cotesting
Colposcopy @ 1 year
Repeat Cotesting
@ 3 years

Manage per Manage per


ASCCP Guideline ASCCP Guideline

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with Atypical Squamous Cells of Undetermined Significance (ASC-US) on Cytology*
Repeat Cytology HPV Testing
@ 1 year
Preferred
Acceptable

Negative > ASC HPV Positive HPV Negative


(managed the same as
women with LSIL)

Routine Colposcopy
Screening Endocervical sampling preferred in women
Repeat Cotesting
with no lesions, and those with inadequate @ 3 years
colposcopy; it is acceptable for others

* Management options may vary if the


woman is pregnant or ages 21-24 Manage per
Cytology at 3 year intervals ASCCP Guideline

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

ASC-US
ASC-US or LSIL: Age 21-24

Management of Women Ages 21-24 years with either Atypical Squamous Cells of
Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)

Repeat Cytology
@ 12 months HPV Positive Reflex HPV Testing
Acceptable for ASC-US only
Preferred

Negative, ASC-US ASC-H, AGC, HSIL


or LSIL HPV Negative

Repeat Cytology Routine


@ 12 months Screening

Negative x 2 > ASC Colposcopy


Routine
Screening

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with Low-grade Squamous Intraepithelial Lesions (LSIL)*
LSIL with negative HPV test LSIL with no HPV test LSIL with positive HPV test
among women > 30 with cotesting

Preferred
Acceptable
Repeat Cotesting
@ 1 year
Colposcopy
ASC Non-pregnant and no lesion identified Endocervical sampling preferred
Cytology Negative or Inadequate colposcopic examination Endocervical sampling preferred"
and HPV positive Adequate colposcopy and lesion identified Endocervical sampling acceptable
HPV Negative

No CIN2,3 CIN2,3
Repeat Cotesting
@ 3 years

* Management options may vary if the woman


is pregnant or ages 21-24 years Manage per Manage per
Management women ages 25-29 as having LSIL ASCCP Guideline ASCCP Guideline
with no HPV test
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

LSIL
LSIL Pregnant Woman

Management of Pregnant Women with Low-grade Squamous Intraepithelial Lesion (LSIL)

Colposcopy Defer Colposcopy


(Until at least 6 weeks postpartum)
Preferred
Acceptable

No CIN2,3* CIN2,3

Manage per * In women with no cytological, histological, or


Postpartum Follow-up ASCCP Guideline colposcopically suspected CIN2,3 or cancer

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with Atypical Squamous Cells:
Cannot Exclude High-grade SIL (ASC-H)*

Colposcopy
Regardless of HPV status

No CIN2,3 CIN2,3

Manage per Manage per


ASCCP Guideline ASCCP Guideline

* Management options may vary if the woman


is ages 21-24

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

ASC-H
ASC-H and HSIL: Age 2124

Management of Women Ages 21-24 yrs with Atypical Squamous Cells, Cannot Rule Out
High Grade SIL (ASC-H) and High-grade Squamous Intraepithelial Lesion (HSIL)
Colposcopy
Immediate loop electrosurgical excision is unacceptable

No CIN2,3 CIN2,3
Two Consecutive
Observation with
Cytology Negative
Colposcopy & Cytology* High-grade colposcopic
Results
and
@ 6 month intervals for up to 2 years lesion or HSIL
Persists for 1 year
No High-grade
Colposcopic HSIL
Other
Abnormality Persists for 24 months with
Results Biopsy
no CIN2,3 identified

Routine Manage per


Screening Diagnostic CIN2,3 ASCCP Guideline
Manage per Excisional for Young Women
* If colposcopy is adequate and endocervical (If no CIN2,3,
ASCCP Guideline Procedure with CIN2,3
sampling is negative. Otherwise a diagnostic continue observation)
excisional procedure is indicated.
Not if patient is pregnant Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with High-grade Squamous Intraepithelial Lesions (HSIL)*

Immediate Loop Colposcopy


Electrosurgical Excision Or with endocervical assessment

No CIN2,3 CIN2,3

* Management options may vary if the woman


Manage per
is pregnant, postmenopausal, or ages 21-24 ASCCP Guideline
Not if patient is pregnant or ages 21-24

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

HSIL
AGC

Initial Workup of Women with Atypical Glandular Cells (AGC)

All subcategories
Atypical Endometrial Cells
(except atypical endometrial cells)

Colposcopy with endocervical sampling Endometrial and


and Endometrial sampling (if > 35 yrs or at risk for endometrial neoplasia*) Endocervical Sampling

No Endometrial Pathology

* Includes unexplained vaginal bleeding or conditions suggesting chronic anovulation Colposcopy

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Subsequent Management of Women with Atypical Glandular Cells (AGC)

Initial Cytology is Initial Cytology is


AGC - NOS AGC (favor neoplasia) or AIS

CIN2+ but no
No CIN2+, AIS or Cancer No Invasive Disease
Glandular Neoplasia

Cotest Manage per Diagnostic


@ 12 & 24 months ASCCP Guideline Excisional
Procedure*
Both Negative Any Abnormality

* Should provide an intact specimen with interpretable margins.


Cotest
Colposcopy Concomitant endocervical sampling is preferred
3 years later

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

AGC Subsequent Management


CIN1 Preceded by Lesser Abnormalities

Management of Women with No Lesion or Biopsy-confirmed Cervical


Intraepithelial Neoplasia Grade 1 (CIN1) Preceded by Lesser Abnormalities *
Follow-up without Treatment * Lesser abnormalities include ASC-US
or LSIL Cytology, HPV 16+ or 18+, and
persistent HPV
Cotesting @ 12 months > ASC or HPV Positive Management options may vary if the
woman is pregnant or ages 21-24.
Cytology if age <30 years, cotesting
HPV Negative Colposcopy
and if age 30 years
Cytology Negative Either ablative or excisional methods.
Excision preferred if colposcopy
inadequate, positive ECC, or
Age appropriate retesting No CIN CIN2,3 CIN1 previously treated.
3 years later

Cytology Negative
+/-
If persists for Follow-up or
HPV Negative Manage per
at least 2 years Treatment
ASCCP Guideline

Routine Screening
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with No Lesion or Biopsy-confirmed Cervical Intraepithelial
Neoplasia Grade 1 (CIN1) Preceded by ASC-H or HSIL Cytology

Diagnostic Review of cytological,


Cotesting
Or Excision Or histological, and
@ 12 & 24 months*
Procedure colposcopic findings

HPV Negative HPV Positive HSIL


and or Any cytology at either visit
Manage per
Cytology Negative abnormality ASCCP Guideline
at both visits except HSIL for revised diagnosis

* Only if colposcopy was adequate and endocervical sampling is negative


Age-specific Except in special populations (may include pregnant women and those ages 21-24)
Colposcopy Cytology if age < 30, cotesting if age 30 years
Retesting
@ 3 years

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

CIN1 Preceded by ASC-H or HSIL


CIN1: Age 21-24

Management of Women Ages 21-24 with No Lesion or Biopsy-confirmed Cervical


Intraepithelial Neoplasia Grade 1 (CIN1)
After ASC-US or LSIL After ASC-H or HSIL

Repeat Cytology
@ 12 months

< ASC-H or HSIL > ASC-H or HSIL


Manage per ASCCP Guideline
for Women Ages 21-24 with ASC-H or HSIL
Repeat Cytology using postcolposcopy pathway for
@ 12 mos No CIN2,3

Negative > ASC Colposcopy

Routine
Screening
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia Grade 2 and 3 (CIN2,3)*
Inadequate Colposcopy or
* Management options will Adequate Colposcopy Recurrent CIN2,3 or
vary in special circumstances Endocervical sampling is CIN2,3
or if the woman is pregnant
or ages 21-24

If CIN2,3 is identified at the Either Excision or Diagnostic Excisional


margins of an excisional Ablation of T-zone* Procedure
procedure or post-procedure
ECC, cytology and ECC at
4-6mo is preferred, but repeat
excision is acceptable and
Cotesting
@ 12 & 24 months
hysterectomy is acceptable
if re-excision is not feasible.
2x Negative Results Any Test Abnormal

Repeat cotesting
@ 3 years
Colposcopy
With endocervical sampling

Routine Screening
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

CIN2,3 Management
CIN2,3 in Young Women

Management of Young Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia


Grade 2,3 (CIN2,3) in Special Circumstances*

Observation Colposcopy & Cytology* Treatment using Excision


@ 6 month intervals for 12 months or Ablation of T-zone*

2x Cytology Negative Colposcopy Worsens or


and Normal Colposcopy
High-grade Cytology or Colposcopy CIN3 or CIN2,3 persists for 24 months
Persists for 12 Months
Cotest Either Test
@ 1 year Abnormal
Repeat Colposcopy/Biopsy Treatment Recommended
Recommended
Both Tests Negative

Cotest @ 3 years * Either treatment or observation is acceptable, provided colposcopy is adequate. When CIN2 is specified,
observation is preferred. When CIN3 is specified, or colposcopy is inadequate, treatment is preferred.

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Management of Women Diagnosed with Adenocarcinoma in-situ (AIS) during a Diagnostic Excisional Procedure

Hysterectomy Conservative Management


Preferred Acceptable if future fertility desired

Margins Involved or Margins Negative


ECC Positive

Re-excision Re-evaluation* Long-term


Recommended @ 6 months Follow-up
Acceptable

* Using a combination of cotesting and


colposcopy with endocervical sampling

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.

AIS Management
LAST Terminology

Interim Guidance for Managing Reports using the Lower Anogenital Squamous
Terminology (LAST) Histopathology Diagnoses

Low Grade Squamous High Grade Squamous


Intraepithelial Lesion Intraepithelial Lesion
(LSIL)* (HSIL)*

Manage like Manage like


CIN1 CIN2,3

* Histopathology results only


Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Definitions Terms Utilized in the Consensus Guidelines Acknowledgments
These guidelines were developed with funding from the
American Society for Colposcopy and Cervical Pathology
(ASCCP). The contents are solely the responsibility of the
n Colposcopy is the examination of the cervix, vagina, n Diagnostic excisional procedure is the process of authors and the ASCCP.
and, in some instances the vulva, with the colposcope obtaining a specimen from the transformation zone L. Stewart Massad, M.D., Washington University School
after the application of a 3-5% acetic acid solution and endocervical canal for histopathological evaluation of Medicine, St. Louis, MO; Mark H. Einstein, M.D., Albert
coupled with obtaining colposcopically-directed biop- and includes laser conization, cold-knife conization, Einstein College of Medicine, Bronx, NY; Warner K. Huh, M.D.,
sies of all lesions suspected of representing neoplasia. loop electrosurgical excision procedure (LEEP), and University of Alabama School of Medicine, Birmingham, AL;
loop electrosurgical conization. Hormuzd A. Katki, Ph.D., Division of Cancer Epidemiology and
n Endocervical sampling includes obtaining a specimen
Genetics, National Cancer Institute, Bethesda, MD; Walter K.
for either histopathological evaluation using an n Adequate colposcopy indicates that the entire
Kinney, M.D., The Permanente Medical Group, Sacramento,
endocervical curette or a cytobrush or for cytological squamocolumnar junction and the margin of any
CA; Mark Schiffman, M.D., Diane Solomon, M.D., Division of
evaluation using a cytobrush. visible lesion can be visualized with the colposcope.
Cancer Prevention, National Cancer Institute, Bethesda, MD;
n Endocervical assessment is the process of evaluating n Endometrial sampling includes obtaining a specimen Nicolas Wentzensen, M.D., Division of Cancer Epidemiology
the endocervical canal for the presence of neoplasia for histopathological evaluation using an endometrial and Genetics, National Cancer Institute, Bethesda, MD;
using either a colposcope or endocervical sampling. aspiration or biopsy device, a dilatation and curettage Herschel W. Lawson, M.D., Emory University School of
or hysteroscopy. Medicine, Atlanta, GA, on behalf of the 2012 ASCCP Consensus
Guidelines Conference
All copyright permission requests should be sent to the
ASCCP National Office, 1530 Tilco Dr., Ste. C,
Copyright, 2002, 2006, 2013 American Society for Colposcopy and Cervical Pathology. All rights reserved Frederick, MD 21704
ASCCP
1530 Tilco Drive, Suite C
Frederick, MD 21704
(301) 733-3640 (telephone)
(800) 787-7227 (toll free)
(240) 575-9880 (fax)

For more information, or to order


additional copies, please email:
[email protected]

The society for lower genital


tract disorders since 1964.

www.asccp.org/Guidelines

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