Abnormal Pap Smear Management Guidelines

Alaska Native Medical Center

Update 1/2003

(Brief update for providers who do not do Colposcopy)

Our system for the prevention of cervical cancer in Alaska Native women
requires three elements working together.

-   Regular Pap screening of women at risk for the disease.

-   Medical evaluation and management of abnormal Pap results.

-   Tracking of Pap results and treatments with patient notification.

This document updates the management of the second element.

The Bethesda System for reporting cervical cytology has changed as of
2001. There are ten basic diagnosis (see table below) and one of them is
new (ASC-H). Medical personnel providing Pap screening services will
need to recognize and appropriately manage these results. While most
abnormal results will require referral for colposcopy some can safely be
managed with repeat pap testing.

New to this revision of the guidelines is the idea of alternate
management plans for *special circumstances*. This includes Adolescents
and postmenopausal women who are at risk for atrophic vaginitis. These
two groups of patients can frequently have abnormal Pap results that do
not reliably indicate a risk of cervical dysplasia of cancer.

These guidelines do not address the management of vaginal infections
found with Pap testing.

######## Background

-   Cervical cancer is now an uncommon disease, diagnosed in about
    13,000 women in the U.S. and leading to 4500 deaths each year

-   Alaska Native women at one time had higher rates of cervix cancer
    than the general population. More recent evaluations show the cervix
    cancer occurring no more frequently in Native women. This change in
    cancer incidence most likely reflects historic lack of access to our
    utilization of preventive services (pap smears) and not a biologic
    difference.

-   Cervical cancer screening has been very successful because there is
    a long pre-cancerous phase of disease (dysplasia) that can be
    detected and treated before actual invasive cancer develops. We
    believe this phase typically lasts at least 5 years but as with any
    biological system there is wide variation.

-   Invasive cervical cancer is most commonly found in women who have
    not had pap screening for [many]{.underline} years. Since our goal
    is to reduce the incidence of cervical cancer, the efforts that will
    have the greatest impact are those that target this group of women.

-   Historically cervical cancer was a disease of women in their 30's or
    40's but the current average age at diagnosis is 56. This does not
    represent and actual increase in the incidence of disease in older
    women. It does show that the prevention of cervical cancer has been
    more successful in younger women who are more likely to get regular
    pap screening. After completing childbearing many women do not have
    regular contact with a medical provider even though they can be in
    the age range where screening is recommended.

-   The risk of invasive cervical cancer increases with persistent
    high-grade lesions. This requires that we consider any history of
    dysplasia along with the current pap result in making triage and
    treatment choices.

-   Most of the abnormal Pap results we deal with will be Low-grade
    lesions found in young women (\<30). This most likely represents
    recently acquired HPV infection. The great majority will regress
    without treatment.

-   Low-grade lesions are less common in older women while high-grade
    lesions, glandular abnormalities and invasive cancer are all more
    common in this group. This means that an abnormal Pap test is more
    likely to lead to a diagnosis of significant disease in an older
    patient.

-   While we recommend pap testing it remains a woman' choice whether
    she wants a Pap smear or any other medical procedure. Other health
    services such as birth control should not be withheld because of a
    lack of Pap screening.

-   Women who have had a hysterectomy for reasons not related to
    cervical dysplasia or cancer are very unlikely to develop a cancer
    that can be detected by Pap smear. While vulvar and vaginal cancers
    are possible after a hysterectomy their incidence does not warrant
    regular screening without specific history.

-   Gynecologic malignancies other than cancer of the cervix are
    sometimes discovered in evaluating a patient for an abnormal Pap
    smear. These include endometrial cancer, fallopian tube cancer and
    ovarian cancer. The pap smear is [not]{.underline} a good test for
    these malignancies and should not be used to evaluate for them. A
    normal pap in no way excludes these conditions. Surveillance for
    these malignancies will not be addressed in this guideline.

##### A Few Words About HPV Testing

It has become clear that HPV (Human Papilloma Virus) infection has a
central role in the development of cervical dysplasia and cervical
cancer. It is also clear that HPV infection is very very common and
usually harmless. In the future we may have understanding or treatment
options that let us address HPV infection with real benefit to our
patients but we currently do not. These Guidelines currently do not
recommend using testing for high risk HPV types to make treatment
decisions. This is an evolving topic and will be reexamined regularly.

###### Who Should Be Referred for Colposcopy

###### Triage based on Pap result.

> Bethesda (2001) Classification

# Low-Risk Group

> **ASC-US** Atypical Squamous Cells of Undetermined
>
> Significance
>
> **LSIL** Low Grade Squamous Intraepithelial Lesion

# High-Risk Group

> **ASC-H** Atypical Squamous cells cannot exclude HSIL
>
> **HSIL** High Grade Squamous Intraepithelial Lesion
>
> **Squamous Cell** Squamous Cell Carcinoma
>
> **Carcinoma**

####### 

####### **AGC** Atypical Glandular Cells 

> (specify cervical, endometrial, other)
>
> **AGC favor** Atypical Glandular Cells favor neoplastic
>
> **Neoplastic**
>
> **AIS** Endocervical Adenocarcinoma In situ
>
> **Adenocarcinoma** Adenocarcinoma
>
> **Other Malignant** All other Malignant Cells (i.e. ovary)

######### Neoplasms

The 2001 Bethesda revision has fewer categories. Hopefully this will
lessen confusion once we all adjust. These ten categories easily break
into a low-risk and a high-risk group.

-   The Low-Risk Group (ASC-US and LSIL) may require colposcopy or
    repeat Pap testing. Management recommendations are sections A, F
    and G. When Colposcopy is indicated is can be schedules for a
    provider with basic colposcopy privileges.

-   Management of LSIL is usually colposcopy as the first step but for
    patients who are at lower risk for true cervical pathology (special
    circumstances) repeat Pap testing may be a safe and appropriate
    option.

-   The remaining eight categories on the list, the High-Risk Group,
    should be referred to the Gynecologist or another provider with full
    Colposcopy privileges.

-   The category *ASC-H* is new and is part of the high --risk group and
    should not be confused with *ASC-US* in the low-risk group.

**Section A: ASC-US Atypical Squamous Cells of undetermined
significance**

### ASC-US

### Low risk Pap History History of dysplasia in last 5yrs or 

> No history of regular pap screening

### Pap in 6mo Colposcopy 

If [\>]{.underline}ASC

If negative

> Pap in 6mo again

CIN found

No CIN found (positive colposcopy)

If negative return to (Negative Colposcopy)

Annual screening Standard RX Repeat pap for CIN grade 12 months

#### ASC-US

-   This is the largest category of abnormal pap results.

-   The Bethesda 2001 update removes the category "ASCUS favor
    neoplasia".

-   The category ASC-H is new and its evaluation is described separately
    (section C).

-   We recommend evaluating these patients with 2 additional pap tests
    at 6month intervals. If either of those tests is not normal the
    patient should go on to have colposcopy.

-   We expect that about one half of these patients will need
    colposcopy.

-   Patients with a more concerning pap history should be considered for
    colposcopy as the first step. This would include;

1.  Any dysplasia in the last 5 years: LSIL, HSIL, ASC-H, AGC, CIN (any
    grade) etc.

2.  A history of not getting regular pap screening, at least two normal
    paps in the last five years.

-   We are not recommending HPV testing as explained above.

-   ASC-US is a common finding in the setting of atrophic vaginitis
    without actual dysplasia. This is addressed in section G.

**Section F; Management of LSIL with special circumstance; Adolescents**

### LSIL

### Low risk Pap History History of dysplasia in last 5yrs or 

> No history of regular pap screening
>
> Repeat Cytology
>
> (pap) in 6mo
>
> Negative [\>]{.underline}ASC-US Colposcopy and management
>
> As per section B
>
> Repeat Cytology
>
> (pap) in 6mo
>
> Negative
>
> Routine Screening

-   *Adolescents are at virtually no risk for having cervical cancer and
    have a very high incidence of transient HPV infection that presents
    as LSIL cytology.*

-   Aggressive management with colposcopy and possible therapy is
    unlikely to have any benefit and can cause significant fear and
    anxiety.

-   For patient who can comply with follow up, management based on
    repeat cytology (pap q 6mo X2) is a safe approach for this age
    group.

-   If either of the follow up paps is abnormal the patient should be
    scheduled for colposcopy.

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-   Patients with a more concerning pap history should be considered for
    colposcopy as the first step. This would include;

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-   Any dysplasia in the last 5 years: LSIL, HSIL, ASC-H, AGC, CIN any
    grade etc.

-   A history of not getting regular pap screening, (at least two normal
    paps in the last five years).

Section G: Management of LSIL and ASC-US with special circumstance;
Post-menopausal Women not on Estrogen (ERT/HRT).

### ASC-US or LSIL

### Low risk Pap History History of dysplasia in last 5yrs or 

> No history of regular pap screening
>
> Intravaginal Estrogen Therapy
>
> X3 weeks then Pap test in 1 week Colposcopy
>
> Negative (normal) [\>]{.underline}ASC-US
>
> Management as outlined
>
> Repeat pap in 6mo in sections A and B
>
> If negative return to
>
> Routine screening

-   ASC-US or LSIL in a postmenopausal woman is often due to the effect
    of estrogen loss on the epithelium rather than HPV infection.

-   A short course of vaginal estrogen to treat vaginal atrophy followed
    by a repeat pap test is a practical option for patients who have no
    contraindication to estrogen therapy.

-   If the pap doesn't normalize with treatment then colposcopy should
    be scheduled

-   Rx: Conjugated estrogen cream (Premarin) 1gm vaginally qHS X 3wks
    then repeat cytology (pap) in 1wk.

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-   Patients with a more concerning pap history should be considered for
    colposcopy as the first step. This would include;

3.  Any dysplasia in the last 5 years: LSIL, HSIL, ASC-H, AGC, CIN (any
    grade) etc.

4.  A history of not getting regular pap screening, (at least two normal
    paps in the last five years).