4 prof james bently management guidelines 2014

Colposcopy Management Guidelines

IFCCP Jeddah Jan 2014James Bentley

Professor Dept. Obstetrics and GynecologyDalhousie University

Halifax, Canada

ASCCP Management Guidelines 2012

• Consensus meeting Sept 2012• 47 experts, 23 societies, national and international

organisations• Used available literature and data from the Kaiser

Permanente Northern California health plan– Basis of recommendations was equal management for

equal risk– Immediate colposcopy for >5% risk of CIN 3 over 5 years– 6 to 12 month return for a CIN 3 risk of 2-5%– 3 year return for an CIN 3 risk of 0.1-2%– 5 year return interval for a risk comparable to women

without a history of abnormality or 0.1%

Massad et al. JLGTD Vol 17, 5, 2013, S1-27

SOGC SCC Colposcopy Guidelines 2012

Colposcopic Exam• The new IFCPC terminology should be used• Biopsy: take 2

– ALTS trial 2 Bx’s detected 81.8% of CIN2 or> vs. 68.3%1

• Biopsy a lesion: even if you think its just metaplastic• Random Biopsy generally not indicated• ECC:

– Calgary review 99 ECC’s needed to detect one additional case of CIN 2 or >

– Largest benefit in older women with high-grade cytological abnormalities2

• HPV testing for all cases: NO

1Gage et al Obs Gyn 2006 Aug;108(2):264-272.2Gage et al. Am J Obstet Gynecol 2010 Nov 203 (5) 481. 1-9

Abnormal cytology in the woman < 21 years old

• Should not be screened < 21 years old

• Controversial issues if screened:

– ASCUS or LSIL; repeat vs. refer for colp vs. do not repeat till after 21 years old

– Refer to provincial guidelines

• ASC-H, HSIL, AGC should be colposcoped

Wait Times

– Suggested time receipt of referral to visit:

– ASC-H or AGC: 6 weeks

– HSIL: 4 weeks

– Carcinoma: 2 weeks

– ASCUS/LSIL 12 weeks

Unsatisfactory Cytology

HPV negative(age ≥30)

HPV unknown(any age)

ColposcopyRepeat Cytology

after 2-4 months

Manage per

ASCCP Guideline

Abnormal

Negative Unsatisfactory

Routine screening(HPV-/unknown)

or

Cotesting @ 1 year (HPV+)

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

HPV positive(age ≥30)

Cytology NILM* but EC/TZ Absent/Insufficient

Ages 21-29+

HPV negative

HPV positive

HPV testing

(Preferred)

Routine screening

HPV unknown

Manage per

ASCCP Guideline

Cytology + HPV

test in 1 yearGenotyping

Repeat cytology in 3

years (Acceptable)

or

Age ≥30 years


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

Abnormal HPV test and Normal Cytology

Bentley J et al. J Obstet Gynecol Can 2012;34(12)1188-1202http://www.sogc.org/scc/guidelines/index.html www.colposcopycanada.org

http://www.sogc.org/scc/guidelines/index.html

http://www.sogc.org/scc/guidelines/index.html

http://www.colposcopycanada.org

HR#HPV#+ve#Cytology#nega1ve##

<#30#yrs#

ALGORITHMS BASED ON SOGC/SCC GUIDELINESJ Obstet Gynaecol Can 2012;34(12):1188-1202

HR#HPV#+ve#Cytology#nega1ve#>#30#yrs#

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

Cytology Negativeand

HPV Negative

≥ASC

orHPV positive

Repeat Cotesting@ 1 year

Acceptable

Repeat cotesting@ 3 years

HPV DNA Typing

HPV 16 or 18 Positive

Colposcopy

Acceptable


HPV 16 and 18 Negative


Manage per

ASCCP GuidelineManage per

ASCCP Guideline

5 year risk of CIN3+ ~10%

Management of LSIL/ ASCUS

• Referral for low grade lesion varies across the country – Repeat cytology

– Reflex HPV testing for ASCUS

• Colposcopy done to rule out CIN 2/3 (potentially pre-malignant changes)

• CIN 2+: 10% with ASCUS, 17% with LSIL1

• CIN 3+: 6% with ASCUS, 12% with LSIL1

• Biopsy any lesion and consider random Biopsy at TZ

• If negative colp/Bx/ECC with any TZ type discharge to annual cytology for 3 yrs then per provincial guidelines

1 Arbyn M JNCI 2004, GynecolOncology 2005, Vaccine 2006

1Any colposcopic lesion identified should be biopsied. If no lesion is identified biopsies of the TZ should be considered.

LSIL/ASCUS x 2 or ASCUS HPV+ve

Colposcopy1

Return to screening protocol

Manage as per SCC guidelines

No CIN CIN 1 or >


Management of Women with Atypical Squamous Cells of Undetermined Significance (ASC-US) on Cytology*

Negative > ASC

Repeat Cytology@ 1 year

Acceptable

HPV Testing

HPV Positive(managed the same as

women with LSIL)

ColposcopyEndocervical sampling preferred in women with no lesions, and those with inadequate

colposcopy; it is acceptable for others

Preferred

Repeat Cotesting@ 3 years

HPV Negative

Manage per

ASCCP Guideline


*Management options may vary if the

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

Routine

Screening+

5 year risk of CIN3+ ~0.54%

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

Negative, ASC-USor LSIL

ASC-H, AGC, HSIL

Reflex HPV TestingAcceptable for ASC-US only

Negative x 2 > ASC

Routine

Screening

Repeat Cytology@ 12 months

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

Colposcopy


PreferredHPV Positive

Routine

Screening

HPV Negative


Management of Women with Low-grade Squamous Intraepithelial Lesions (LSIL)*

Non-pregnant and no lesion identified Endocervical sampling “preferred”

Inadequate colposcopic examination Endocervical sampling “preferred"

Adequate colposcopy and lesion identified Endocervical sampling “acceptable”

Colposcopy

CIN2,3No CIN2,3Repeat Cotesting

@ 3 years

* Management options may vary if the woman is

pregnant, postmenopausal, or ages 21-24 years

(see text)

Manage per

ASCCP Guideline

LSIL with no HPV test LSIL with positive HPV testLSIL with negative HPV test


PreferredAcceptable

≥ASC

orHPV positive

Cytology Negativeand

HPV Negative


Manage per

ASCCP Guideline

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

CIN2,3

ColposcopyPreferred

Pregnant Women with LSIL

Defer Colposcopy(Until at least 6 weeks postpartum)

Acceptable

^ In women with no cytological, histological, or colposcopically suspected CIN2,3 or cancer

No CIN2,3^

Postpartum follow-up


Manage per

ASCCP Guideline

Management of ASC-H

• Bareth et al. 517 cases ASC-H CIN2 + in 70%, Carcinoma in 2.9%

• Women need colpscopy and liberal biopsy

ASC-H

Colposcopy1

No CIN


CIN1 or >

Colposcopy, cytology, at 6 months x 2 ( +/-

HR HPV testing)


CIN 1 or >No CIN

HR-HPV +ve follow in colposcopy clinic

1 Biopsies should be taken of any lesion identified at colposcopy


Colposcopy Regardless of HPV status

CIN2,3

Management of Women with Atypical Squamous Cells: Cannot Exclude High-grade SIL (ASC-H)*

Manage perASCCP Guideline

No CIN2,3



*Management options may vary if the woman is pregnant or ages 21-24 years.

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)

No CIN2,3 CIN2,3

Two Consecutive Cytology Negative

Resultsand

No High-grade ColposcopicAbnormality

High-grade colposcopic lesion or HSILPersists for 1 year

Routine

Screening

Observation with colposcopy & cytology*

@ 6 month intervals for up to 2 years

Manage per

ASCCP Guideline

for young women

with CIN2,3

Colposcopy(Immediate loop electrosurgical excision is unacceptable)

Biopsy

CIN2,3(If no CIN2,3,

continue observation)

HSILPersists for 24 months with

no CIN2,3 identified

DiagnosticExcisional

Procedure+

Otherresults


Manage per

ASCCP Guideline

*If colposcopy is adequate and endocervical sampling is negative. Otherwise a diagnostic excisional procedure is indicated.+Not if patient is pregnant

Management of HSIL

• High rates of CIN 2 + have been reported, 56-66% when biopsy is performed1

• Patients need prompt colposcopy and biopsy with an ECC if the TZ is not seen in its entirety

• Areas of concern:

– HSIL with no lesion in a young woman

– HSIL in older woman when the TZ is not seen in its entirety: Should have an appropriate excision

1 Massad LS Gynecol Oncol 2001 sep 82(3) 516-522

1 Consider HPV testing

HSIL

Colposcopy(Bx, +/- ECC)

No CIN 2, 3


CIN 2 or greater

SatisfactoryColposcopy

(Type 1 or 2 TZ)

UnsatisfactoryColposcopy(Type 3 TZ)

Observe with Colposcopy

and cytologyQ 6/12 x21


Consider Diagnostic Excision procedure

Cytology/histology review

Concern re high grade findings

Low grade CIN/Cytolog

y


Colposcopy(with endocervical assessment)

* Management options may vary if the woman ispregnant, postmenopausal, or ages 21-24

+ Not if patient is pregnant or ages 21-24

CIN2,3No CIN2,3

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

Immediate Loop Electrosurgical Excision + Or

Manage per

ASCCP Guideline


Management of AGC-NOS, AGC-N, AIS

• Canadian review 456 cases of AGC– 7% CIN 1,– 36% CIN 2/3– AIS in 20%– Ca Cx 9%– Endometrial pathology in 29 %

• Need to adequately assess the patient• Appropriate ECC, endometrial biopsy, cervical Bx• AGC-NOS vs. AGC-N

– AGC N has a much higher rate of abnormalities and requires an excisional procedure

Daniel A Int J Gynecol Obstet 2005 91(3) 238-242

AGC

Colposcopy 1

With ECC +/- endo Bx

No CIN


Invasive CancerSatisfactoryColposcopy

(Type 1 or 2 TZ)

UnsatisfactoryColposcopy(Type 3 TZ)


cytology and HR-HPV testingQ 6/12 x2 2


Diagnostic Excision procedure

AGC-NOS AGC-Neoplasia

ColposcopyWith ECC +/endo Bx

AGC-endometrial

Endometrial biopsy (all women over 35)

Manage as per Gynecologic Oncology

Guidelines

CIN AIS


1Consider HR-HPV testing, n.b. not acceptable for initial triage2 If HR-HPV testing not available repeat q 6/12 x 4

Manage endometrial

pathology

No endometrial pathology

All negative

AGC


Initial Workup of Women with Atypical Glandular Cells (AGC)

No Endometrial Pathology

All subcategories(except atypical endometrial cells)

Atypical Endometrial Cells

Colposcopy (with endocervical sampling)

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

Endometrial and

Endocervical Sampling

Colposcopy

*Includes unexplained vaginal bleeding or conditions suggesting chronic anovulation.


Subsequent Management of Women with Atypical Glandular Cells (AGC)

No CIN2+, AIS or Cancer

Initial Cytology isAGC - NOS

Manage per

ASCCP GuidelineCotest

At 12 and 24 months

Any abnormality

Colposcopy

CIN2+ but no Glandular Neoplasia

Initial Cytology isAGC (favor neoplasia) or AIS

No Invasive Disease

DiagnosticExcisional

Procedure +

+Should provide an intact specimen with

interpretable margins. Concomitant endocervical sampling is preferred

Both negative

Cotest 3 years later


Managing Histological abnormalities

Managing CIN 1

• Seldom progresses• Regression occurs in 60%-80%

with in 2-5 years1, up to 91% in younger women2

• So if you are not going to treat, where should these women be observed?– Screening Program vs.– Colopscopy Clinic

– Favor return to annual screening with re-referral if have abnormal cytology

CIN 1 on Biopsy or ECC

Satisfactory Colposcopy

(Type 1 or 2 TZ)


and cytologyQ 6/12 x2


Unsatisfactory Colposcopy(type 3 TZ)

Treatment

Colposcopy and cytology -ve

CIN persists or progresses

Observe with Cytology at12 months(preferred)

Manage according to cytology

CIN 1 after HSIL/AGC

Review cytology and histology (if available)

If discrepancy remains consider

excisional procedure


*“Lesser abnormalities” include ASC-US or LSIL Cytology, HPV 16+ or 18+, and persistent HPV

∞ Management options may vary if the woman is pregnant or ages 21-24

+Cytology if age <30 years, cotesting if age ≥30 years

† Either ablative or excisional methods. Excision preferred if colposcopy inadequate, positive ECC, or previously treated.

Management of Women with No Lesion or Biopsy-confirmed Cervical Intraepithelial Neoplasia - Grade 1 (CIN1) Preceded by “Lesser Abnormalities”*∞

Manage per

ASCCP Guideline

Follow-up without Treatment

Cotesting at 12 months > ASC or HPV (+)

HPV (-)and

Cytology Negative

Colposcopy

Age appropriate* retesting 3 years later

No CIN CIN2,3 CIN1

If persists forat least 2 years


Follow-up orTreatment †

Cytology negative+/-

HPV (-)

Routine

screening

Management of Women with No Lesion or Biopsy-confirmed Cervical Intraepithelial Neoplasia - Grade 1 (CIN1) Preceded by ASC-H or HSIL Cytology

Cotesting at 12 and 24 months*

Age-specificRetestingin 3 years+

Colposcopy

HPV(+) or Any cytology

abnormality except HSIL

*Only if colposcopy was adequate and endocervical sampling negative

^ Except in special populations (may include pregnant women and those ages 21-24)

+ Cytology if age <30; cotesting if age ≥30 years


HPV(-)and

Cytology Negativeat both visits

HSILat either visit

Diagnostic Excision

Procedure ^

OrReview of cytological,

histological, and colposcopic findings

Or


for revised diagnosis

Management of Women Ages 21-24 with No Lesion or Biopsy-confirmed Cervical Intraepithelial Neoplasia - Grade 1 (CIN1)

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


Negative > ASC

Routine

Screening

Repeat Cytology@ 12 mos

After ASC-US or LSIL After ASC-H or HSIL


Colposcopy

Manage per ASCCP Guidelinefor Women Ages 21-24 with ASC-H or HSIL

using postcolposcopy path for No CIN2,3

Managing CIN 2/3

• Clarify if it is CIN 2 vs. CIN 3

• use p16 to help

• Especially in the woman < 25

CIN 2/3 in women 25+

• CIN 3 when followed has a malignant potential of 31% over a 31 year period1

• Treatment, preferably with excision for CIN 3

Mc Credie et al. Lancet Oncol 2007 Nov 8(5):425-434

CIN 2,3 on Biopsy(>25 yrs old)


(Type 3 excision of TZ)

CIN 2,3

Treatment


(type 1 or 2 TZ)

Unsatisfactory Colposcopy(Type 3 TZ)


Management of Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia -Grade 2 and 3 (CIN2,3) *

Either Excision† or Ablation of T-zone *

Cotesting at 12 and 24 months

2x NegativeResults

Any test abnormal

Diagnostic Excisional Procedure †

Adequate Colposcopy Inadequate Colposcopy orRecurrent CIN2,3 or

Endocervical sampling is CIN2,3

ColposcopyWith endocervical sampling

*Management options will vary in special circumstances or if the woman is pregnant or ages 21-24†If CIN2,3 is identified at the margins of an excisional procedure or post-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.

Repeat cotestingin 3 years


Routine screening

CIN 2 in the woman < 25 years old

• Regression occurs in >40 %

• Study from NZ showed regression rate of 62% over 8 months1

• So:

– Clarify CIN 2 vs. 3 (even for HSIL designation)

– Observe in colposcopy clinic those with CIN 2

– Treat CIN 3

McAllum B AJOG 2011;205:478.e1-7

CIN 2,3 on Biopsy inwoman < 25 yrs1

CIN 2



CIN 3


and cytologyQ 6/12 x2 yrs

Treatment2


(Type 1 or 2 TZ)

Unsatisfactory Colposcopy(Type 3 TZ)

1 Pathologist should be asked to clarify whether the lesion is CIN 2 or 32 LEEP or excision preferred for CIN 3

Negative

CIN persists or

progresses

CIN Resolves


Management of Young Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia -Grade 2,3 (CIN2,3) in Special Circumstances

Young Women with CIN2,3

Colposcopy worsens or

High-grade Cytology or Colposcopypersists for 1 year

2x Cytology Negativeand Normal Colposcopy

Repeat Colposcopy/Biopsy

Recommended

Observation - Colposcopy & Cytology@ 6 month intervals for 12 months

Treatment using Excision or Ablation of T-zone


CIN3 or CIN2,3 persists for 24 months

Treatment Recommended

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.

Cotest in 1 year

Cotest in 3 years

Both tests negative

Either test abnormal

Excision types

• Removal/ treatment of a lesion should be adjusted to the lesion type.– Type 1 TZ requires a shallower excision or type 1

excision

– Type 3 TZ requires a full “cone” or type 3 excision

• New nomenclature suggested so that confusion is less, particularly when describing complications

Transformation zone type

Type I Type II Type III

completely ectocervical

fully visible

small or large

ectocervical component

has an endocervical

component

fully visible

may have ectocervical

component which may

be small or large

has an endocervical

component

is not fully visible

may have ectocervical

component which may

be small or large

Managing AIS

• Need to perform an adequate excision: Type 3 (20 mm long)

• Consider Hyst if child bearing is complete

• When the lesion is diagnosed after a LEEP for CIN, with negative margins• Further surgery is

unnecessary1

Bryson et al. Gynecol Oncol 2004 May;93(2) 465-468

AIS on Biopsy

Observe with Colposcopy, ECC & cytology

for 5 years 2


Diagnostic Excisional procedure1

1 ECC after DEP preferred2 consider HPV testing

Margins +ve for AIS

Hysterectomy if childbearing

complete

Repeat Excisional Procedure

Conservative Management

Preferred

No CIN 2 or >

Margins -ve for AIS

Acceptable

Consider Hysterectomy if

childbearing complete


Management of Women Diagnosed with Adenocarcinoma in-situ (AIS) during a Diagnostic Excisional Procedure

Margins Involved or

ECC Positive

Re-excisionRecommended

Hysterectomy - Preferred

Long-term

Follow-up

Conservative ManagementAcceptable if future fertility desired


Margins Negative

* Using a combination of cotesting and colposcopy with endocervical sampling

Re-evaluation*@ 6 months - acceptable

1 HPV testing for high risk HPV


Follow-up at 6 and 12 months with colposcopy

and cytology

Follow-up at 6 months with cytology and HR-HPV testing1

OR

Treat per guidelines,Excision preferred for

CIN 2,3

CIN Negative

Follow-up Post treatment for CIN


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

Manage like CIN1

Low Grade Squamous Intraepithelial Lesion

(LSIL)*


*Histopathology Results only.

Manage like CIN2,3

High Grade Squamous Intraepithelial Lesion

(HSIL)*

ASCCP algorithms available for iphone and android phones

www.ifcpc.org

www.colposcopycanada.org

www.asccp.org

www.ifcpc2014.com

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4 prof james bently management guidelines 2014

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