ASCCP 2013 Guidelines for Managing

Abnormal Cervical Cancer Screening Tests

Barbara S. Apgar, MD, MS

Professor of Family Medicine
University of Michigan
Ann Arbor, Michigan
Disclosures

1. Apgar B, Brotzman G, Spitzer M. Integrated Text and Atlas

of Colposcopy. Elsevier Publishers, 2004, 2008.

2. Brotzman G, Spitzer M, Apgar B. Colposcopic Image

Library on CD. SABK, Inc 2004.

3. ASCCP Board of Directors. 2007-current.

Permission obtained from ASCCP to use algorithms

What are we
going to talk
about today?
 Principles of 2013 Management Guidelines

Preventing all cervical cancer is unrealistic.

No screening test has 100% sensitivity.

Precursor disease can recur post management/treatment.

Risk of persistent oncogenic HPV.

Women at similar risk for cancer are managed the same.

ASC-US, LSIL (lesser)

ASC-H, HSIL, AGC (greater)

Potential harms of overzealous management.

 Pain/bleeding from procedures.
 Treatment-related pregnancy complications.
 Similar Management of Similar Risks
ensures simplified, consistent management
for different test result combinations

Can be initial management or follow-up.

Is this similar
management
of similar
risks?
Cervical Intraepithelial Neoplasia
(CIN)

CIN 1 (histologic LSIL)

CIN 2 (histologic HSIL)
CIN 3 (histologic HSIL)

You will see less CIN as CIN is

converted into LSIL and HSIL
 Screening targets

CIN 3 is a true precancer, 30-50% progress
to cancer over 30 years.

Observation is unacceptable since it cannot be
predicted which CIN 3s will invade.

CIN 2 is a collection of CIN 3 and CIN 1

50% regression rate, low risk of invasion

Observation acceptable, especially in young women

CIN 1 is a transient or stable HPV infection

with minimal cancer risk: DO NOT TREAT!
 How risk is managed

High risk >>> treat

Low risk >>> observe

Intermediate risk >> manage by level of risk

Short interval rescreening.

Molecular triage (HPV, genotyping, biomarker)

Definitions of high/low/intermediate risk are

arbitrary, based on balancing risks of
intervention vs. risks of cancer
 Cervical cancer screening guidelines

Age 30-65. Testing with cytology alone every 3 years or co-testing

with cytology and testing for high-risk HPV types every 5 years.

Co-testing preferred and cytology acceptable by all but USPSTF.

 USPSTF says either acceptable

1. Saslow et al. ACS/ASCCP/ASCP. CA Cancer J Clin 2012; 62: 147-72

and AJCP 2012; 137: 516 542.
2. Moyer VA, et al. USPSTF. Ann Int Med 2012; 156: 880-91
3. ACOG Practice Bulletin #131, November 2012
4. NCCN Cervical Cancer Screening Guideline v. 2-2012. www.NCCN.org
 Proportion of Co-Test Results in
331,061 Kaiser women > 30 years
3.7% 1.4%
2.4%

Discordant
92.5%

Katki HA, et al. Lancet Oncol 2012; 12: 663

 35 year old G1P1 has a negative Pap test and positive HPV
testing. She was previously screened with Pap's only but has
had no screening in 5 years. What is the next step?

1. Cotesting in 1 year.
2. Routine screening (cotesting) in 5 yrs.
3. Immediate colposcopy.
2013 ASCCP management guidelines

Wright TC, et al. J Lower Genital Tract Disease, 2007; 11: 201-222 and 223-239
She returns in one year. Cotesting results
show Pap HPV
What is the next step?

1. Repeat cotesting in 1 year.

2. Repeat cotesting in 3 years.
3. Pap only in 3 years.
 2013 ASCCP consensus guidelines
Women > age 30, Pap -, HPV +

Wright TC, et al. J Lower Genital Tract Disease, 2007; 11: 201-222 and 223-239
She returns in 3 years and her
cotesting is Pap - HPV +
What does she do now?
1. Go back and start all over with
cotesting in 1 year.

2. Immediate colposcopy.
 2013 ASCCP mgt guidelines
Women > age 30, Pap - HPV +

NO

Wright TC, et al. J Lower Genital Tract Disease, 2007; 11: 201-222 and 223-239
 HPV Genotyping

Both DNA and mRNA tests available

Prognostic information seems similar.

5 year risk of CIN2+ if HPV 16 + = ~10%

Risk of CIN2+ is lower if HPV 18 , but there is
association for adenocarcinoma.

Bottom line: ASCCP guidelines show genotyping

acceptable without recommending for or against use

Allows for clinician discretion and patient choice
 42 year old woman is Pap HPV +
You decide to genotype her and she is
HPV 16 and 18 negative.
What is the next step?

1. Cotesting in 1 year.
2. Cotesting in 3 years.
3. Colposcopy.
HPV -
 Her cotesting in one year is
Pap HPV +. What do you do now?

1. Immediate colposcopy.
2. Repeat cotesting in 1 year.
3. Repeat cotesting in 3 years.
Pap -
HPV +
 Women > age 30, genotyping

Pap -
HPV +

Wright TC, et al. J Lower Genital Tract Disease, 2007; 11: 201-222 and 223-239
ASCCP Management
Guidelines, 2012-2013
22 year old presents for her first Pap. She has
been sexually active since age 17 (3 partners).
You decide to do cotesting because she is
sexually active. She is Pap negative but HPV +.
What do you do now?

Pap in one year. No HPV testing.

Pap in 3 years. No HPV testing.

Cotesting in one year.

Genotyping now.
 2012 Consensus Guidelines:
Screening Frequency

Age 21-29. Testing with cytology alone every 3 years.

Co-testing should NOT be performed for women under age 30.

1. Saslow et al. ACS/ASCCP/ASCP. CA Cancer J Clin 2012; 62:

147-72 and AJCP 2012; 137: 516 542.
2. Moyer VA, et al. USPSTF. Ann Int Med 2012; 156: 880-91
3. ACOG Practice Bulletin #131, November 2012
4. NCCN Cervical Cancer Screening Guideline v. 2-2012.
www.NCCN.org
 Managing Women 21-24

Kaiser data

3 cancers noted in 133,947 women ages 21-24

HPV infection incidence peaks in this age group.

Likelihood of future pregnancy is high.

Most CIN2 in this age group will regress.

Be conservative, conservative, conservative!

22 year old with ASC-US. This is her first
Pap. You requested reflex HPV testing.
She is HPV +
What is the next step?

1. Colposcopy now.
2. Pap in 1 year.
3. HPV testing in 1 year.
 Management of Women Ages 21-24 years with either Atypical Squamous Cells of
Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)

Women ages 21-24 years with ASC-US or LSIL

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

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

or LSIL HPV Negative

Repeat Cytology
@ 12 months
Routine
Screening
Negative x 2 > ASC Colposcopy
Routine
Screening

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
 23 year old G1P1 has a Pap showing HSIL. Her
previous Pap was ASC-H (PCP records) 2 years ago.
She did not return until now.
What is the next step?

1. Repeat Pap in 1 year.

2. Ask for HPV testing.
3. Ask for genotyping.
4. Immediate colposcopy.
 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
Cytology Negative Observation with
Results colposcopy & cytology* High-grade colposcopic
and @ 6 month intervals for up to 2 years lesion or HSIL
Persists for 1 year
No High-grade
Colposcopic
Abnormality
Other HSIL Biopsy
results Persists for 24 months with
no CIN2,3 identified

CIN2,3
(If no CIN2,3,
Routine Manage per Diagnostic continue observation)
Screening Excisional Manage per
Figure 9 ASCCP Guideline
Procedure+ ASCCP Guideline
for young women
*If colposcopy is adequate and with CIN2,3
endocervical sampling is negative.
Otherwise a diagnostic excisional
procedure is indicated.
+Not if patient is pregnant

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
ASC-H and HSIL in Women Ages 21-24

Precancer risk higher than after ASC-US/LSIL

5 year CIN3+ risk

16% after ASC-H

28% after HSIL

5 year cancer risk

0% after ASC-H

0% after HSIL

Bottom line: cancer unlikely during extended

observation
TREAT women with high risk
of
developing invasive disease

OBSERVE women who are not

at high risk of developing
invasive disease
and
protect them from over-treatment
 Treatment in young women

Treatment can have adverse consequences on
future pregnancy.

CIN 2 can regress up to 49%.

Risk of progression is real but usually takes
significant time.

Treat if CIN 2 present for 2 years.

Treatment recommended for CIN 3.

Risk of progression is high enough to justify
potential risks to future pregnancy.
 23 year old presents for a Pap. She had a slightly bad
Pap during pregnancy at age 18. She does not know the
result and did not follow-up. She is referred to colposcopy
for HSIL cytology. What is your colposcopic impression?

1. Normal

2. Low grade

3. High grade

4. Cancer
 Biopsies showed LSIL (CIN 1) and HSIL
(CIN 2). ECC negative. What is the next step?

1. Colposcopy and cytology at 6 and 12

months.
2. LEEP.
3. Cotesting in one year.
Management of Young Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia -
Grade 2,3 (CIN2,3) in Special Circumstances

Young Women with CIN2,3

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.

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
persists for 1 year
CIN3 or CIN2,3 persists for 24 months
Cotest in 1 year Either test
abnormal
Repeat
Both tests negative Colposcopy/Biopsy Treatment Recommended
Recommended

Cotest in 3 years

Figure 17 Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
HSIL persists for 12 months. The lesion is
larger on colposcopy. Biopsy shows CIN
3. What is the next step?

1. Repeat colposcopy and biopsy in 6

months
2. LEEP
3. Cotesting in one year.
Management of Young Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia -
Grade 2,3 (CIN2,3) in Special Circumstances

Young Women with CIN2,3

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.

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
persists for 1 year
CIN3 or CIN2,3 persists for 24 months
Cotest in 1 year Either test
abnormal
Repeat
Both tests negative Colposcopy/Biopsy Treatment Recommended
Recommended

Cotest in 3 years

Figure 17 Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Lets
discuss
adult
women
now
 Managing ASC-US in adult women

Up to 2/3 are HPV-associated

HPV+ more frequent in younger women

>60% ages <25 vs. <25% ages 45-55

More frequent among those with more
partners

HPV triage of ASC-US more cost-effective
than repeat cytology
Arbyn M et al Vaccine 2006;24:S3:78-70
Eltoum IA et al Cancer 2005;105:194-99
 Management of Women with Atypical Squamous Cells of
Undetermined Significance (ASC-US) on Cytology*

Repeat Cytology HPV Testing

@ 1 year
Acceptable
No colpo Preferred

Negative > ASC HPV Positive

(managed the same as HPV Negative
women with LSIL)

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

*Management options may vary if the Manage per

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

Figure 4

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
 What has changed in adult women
with ASC-US from prior guidelines ?

Colposcopy is not immediate option (2006).

HPV- ASC-US insufficient to exit from

screening at age 65.
- Repeat cotesting in one year.
28 year old G1P1 has had 3 normal Pap tests.
She now has LSIL. What is the next step?

1. Colposcopy.
2. Reflex HPV testing.
3. Genotyping.
4. Repeat Pap in 1 year.
 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

Preferred
Acceptable

Repeat Cotesting Colposcopy

@ 1 year

ASC
Cytology Negative or
and HPV positive
HPV Negative

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

Manage per Manage per

ASCCP Guideline ASCCP Guideline

* Management options may vary if the woman is

pregnant, postmenopausal, or ages 21-24 years
(see text)

Figure 6
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
 Managing ASC-H in adult women

> 60% are HPV+

HPV triage relatively inefficient

CIN3+ risk when HPV negative = 3.5% at 5 years

CIN3+ risk when HPV+ = 25% at 5 years

 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

pregnant or ages 21-24 years.

Figure 8

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
 HSIL in adult women

Immediate CIN3+ risk is 36%

Risk rises to 47% at 5 years
Justifies immediate excision when pregnancy
not at issue

Bottom line: 6% of women ages 30-64 with HSIL

have cancer
Management of Women with High-grade Squamous Intraepithelial Lesions (HSIL) *

Immediate Loop Colposcopy

Electrosurgical Excision + Or (with endocervical assessment)

No CIN2,3 CIN2,3

Manage per
ASCCP Guideline

* Management options may vary if the woman is

pregnant, postmenopausal, or ages 21-24
+ Not if patient is pregnant or ages 21-24

Figure 10

Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
 37 year old had a LEEP for CIN 3.
Margins clear. LEEP sample showed
CIN 3. What is the next step?

1. Colposcopy and cytology at 6 and 12 months.

2. HPV testing at 12 months.
3. Cotesting at 12 and 24 months.
4. Cotesting in 3 years.
 Management of Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia -
Grade 2 and 3 (CIN2,3) *

Adequate Colposcopy Inadequate Colposcopy or

*Management options
will vary in special
Recurrent CIN2,3 or
circumstances or if the Endocervical sampling is CIN2,3
woman is pregnant or
ages 21-24
If CIN2,3 is identified

at the margins of an
excisional procedure Either Excision or Diagnostic Excisional
or post-procedure Ablation of T-zone * Procedure
ECC, cytology and
ECC at 4-6mo is
preferred, but repeat
excision is acceptable
and hysterectomy is
acceptable if re-
excision is not feasible.
Cotesting at 12 and 24 months

2x Negative Any test abnormal

Results

Repeat cotesting
in 3 years
Colposcopy
With endocervical sampling
Routine screening

Figure 16
Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
Cumulative risk of CIN 2 +
following subsequent
negative follow-up tests
after tx for CIN 2,3 or AIS.

Katki HA et al. JLGTD

2013; 17(5):s78-84.
23 year old G1P1 has had no endocervical
cells on 2 recent negative Pap's.

What is the next step?

1. Pap in 1 year.
2. Pap in 3 years.
3. Request HPV testing now.
4. Colposcopy.
 Cytology NILM* but EC/TZ Absent/Insufficient

Ages 21-29+ Age 30 years

HPV negative HPV unknown

HPV testing Repeat cytology in 3

(Preferred) years (Acceptable)
HPV positive
or

Cytology + HPV test in 1 year Genotyping

Routine screening
Manage per
ASCCP Guideline

*Negative for intraepithelial lesion or malignancy

+HPV testing is unacceptable for screening women ages 21-29 years

Figure 2 Copyright, 2013, American Society for Colposcopy and Cervical Pathology. All rights reserved.
The
End..

Thanks!
 For More Information

Explanatory text available at J Lower Genital

Tract Dis 2013;17:S1-S27

Algorithms are available for free download at
www.asccp.org/consensus2012

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