• There is no evidence of microinvasive or invasive cancer on cytology, colposcopy, endocervical sampling, or biopsy;

• The lesion is located on the ectocervix and can be seen entirely; and

• There is no involvement of the endocervix as determined by colposcopy and endocervical sampling.

Cryosurgery should be used only for small, low-grade lesions that can be easily covered by the cryoprobe. Several large series indicate a 93-96% cure rate for CIN I and II, but a 77-92% cure rate for CIN III.
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Laser vaporization may be chosen for patients who have either large lesions on the exocervix that extend onto the vagina or an irregular “fishmouth” cervix with deep clefts. The major advantage of laser vaporization therapy is the ability to control the depth and width of destruction by direct vision through the colposcope. Destruction of the cervical tissue to a depth of 3.8 mm will ablate all of the involved glands in 99.7% of cases. The standard procedure for laser vaporization is to destroy the tissue to a depth of 7 mm, where 100% of the endocervical glands will have been destroyed. The success rates for laser vaporization range from 83% to 97% for CIN I and II and from 77% to 96% for CIN III. More recent series indicate a greater than 90% cure rate in patients with CIN III. Excisional therapy by conization, laser excision, or loop electrosurgical excision is indicated when the operator determines there is a need for a tissue specimen to rule out invasion, when there is an abnormal finding on endocervical curettage, or when colposcopy is unsatisfactory.

Intraepithelial Lesion
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Analysis of the screening programs in British Columbia indicate that low-grade lesions in women younger than 34 years of age will regress spontaneously 84% of the time. For women older than 34 years, 40% of lesions will regress. Despite the fact that most low-grade lesions will regress spontaneously, some physicians are unwilling to manage these lesions expectantly. However, it is acceptable to repeat the Pap test in 4-6 months; if the result is abnormal, colposcopy may be performed at that time. When a woman has a colposcopically abnormal transformation zone and a low-grade squamous intraepithelial lesion is documented by biopsy, destruction of that abnormal transformation zone is acceptable. However, no treatment and monitoring by cytologic and colposcopic examination every 4-6 months are reasonable options. If a lesion persists for more than 1 year, treatment should be recommended at that time because of the diminished likelihood of spontaneous regression.

High-Grade Squamous

Intraepithelial Lesion
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Any woman with a cytologic specimen suggesting the presence of a high-grade lesion should undergo colposcopy and directed biopsy. No other management approach is currently acceptable. After confirmation of a high-grade lesion, therapy aimed at destruction or removal of the entire transformation zone should be performed. The modality of treatment is based on the location and size of the lesion, the skill of the operator, and the need for further diagnostic materials.

If a high-grade squamous lesion is reported during pregnancy, the patient should undergo colposcopy and repeat cytology. If the lesion is completely seen and there is no suggestion of invasive carcinoma on the colposcopic or cytologic evaluation, treatment can be delayed until after delivery of the fetus. Vaginal delivery can be anticipated. If the patient presents for colposcopy in the first or second trimester and a lesion is visible, a directed cervical biopsy to confirm the absence of invasion is indicated. Biopsy may be delayed until after delivery in patients in the third trimester with no evidence of invasion on colposcopy or cytology.
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Atypical Squamous Cells of Undetermined Significance

There are several management options for patients whose tests are classified as ASCUS. Some reports have indicated that there is a 10-40% rate of CIN found in patients with this report. Invasive cancer is very rare.

The 1991 Bethesda Conference recommended classifying ASCUS as “favor reactive” or “favor neoplasia.” The validity of this subclassification in predicting CIN by biopsy was subsequently confirmed. For those patients whose ASCUS test results favor a reactive process, the appropriate management is to repeat the Pap test in 4-6 months. If subsequent test results are abnormal, the patient should be scheduled for colposcopy. If there are three consecutive negative results within 2 years, the patient can be returned to routine screening.

A report of ASCUS in postmenopausal women not taking hormone replacement therapy may be due to atrophy, and a course of topical estrogen therapy may result in a normal report. If the Pap test is still equivocal after estrogen therapy, colposcopy should be considered. Colposcopy should be considered as initial evaluation for patients with ASCUS test results who previously have been treated for CIN, have a history of poor compliance to follow-up, or whose ASCUS Pap test result is qualified by a statement indicating that a neoplastic process is favored.
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Ideally the patient with an ASCUS test result would have an intermediate triage test that is less expensive than colposcopy and more reliable than repeat cytology to direct her further care. Human papillomavirus testing has been evaluated in several studies and shows a sensitivity for the detection of high-grade lesions between 74% and 93 %.
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Endometrial Cells. The presence of endometrial cells, cytologically benign, in a postmenopausal woman not receiving exogenous hormones should be investigated even when the cells are normal in appearance. Such cells may be associated with inadvertent sampling of the lower uterine segment, endometrial polyps, endometrial hyperplasia, or carcinoma. If the patient is taking hormone therapy, endometrial cells can be normal. (Endometrial cells on a Pap test from a pre-menopausal woman are considered a normal finding regardless of the phase of the menstrual cycle.)

Atypical Glandular Cells of Undetermined Significance. The term “atypical glandular cells of undetermined significance” is used to report changes beyond those encountered in the benign reactive processes but insufficient for a diagnosis of adenocarcinoma. The report should indicate whether the cells are thought to be of endocervical or endometrial origin, when possible.

Adenocarcinoma. A report of adenocarcinoma indicates a probable invasive tumor. The report should specify whether an endometrial, endocervical, or extrauterine site is suspected.

Other Neoplasias. Other malignant neoplasms may be suspected on the basis of certain cytologic findings. These include small cell carcinoma, melanoma, lymphoma, and sarcoma. When originally published, the Bethesda System included a directive for the cytopathologist to make a recommendation for further patient evaluation when appropriate. This recommendation was deleted in the second Bethesda workshop. The cytology report should not attempt to direct therapeutic management of the patient, but may include suggestions for additional cytologic or tissue evaluation if the cytopathologist believes that additional material will assist in clarifying the diagnosis. When atypical squamous cells are associated with atrophy, the cytopathologist may suggest estrogen therapy to help resolve the diagnostic uncertainty.
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Low-Grade Squamous Intraepithelial Lesion. The category of low-grade squamous intraepithelial lesion encompasses human papillomavirus (HPV) and mild dysplasia/cervical intraepithelial neoplasia (CIN) I. The inclusion of the cellular changes supportive of HPV infection (previously termed koilocytosis, koilocytotic atypia, or condylomatous atypia) in the category of low-grade squamous intraepithelial lesion requires that the diagnosis be based on specific cellular criteria to avoid overinterpretation of non-specific artifactual changes mimicking koilocytosis. A cytoplasmic halo without the typical “raisinoid” eccentric nucleus should not be interpreted as koilocytosis.
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Cellular changes associated with HPV are included in the category of low-grade squamous intraepithelial lesion because the natural history and cytologic features of both HPV and CIN I (mild dysplasia) lesions are similar. Long-term follow-up studies have shown that 14% of lesions previously classified as koilocytosis progress to high-grade intraepithelial neoplasia, and lesions classified as mild dysplasia progress to high-grade lesions in 16% of cases. There is a lack of interobserver and intraobserver reproducibility in differentiating between koilocytosis and CIN I. Thus, from the epidemiologic, virologic, and morphologic standpoints, HPV and CIN I should be grouped together as low-grade squamous intraepithelial lesion.
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High-Grade Intraepithelial Lesion. The category of high-grade intraepithelial lesion encompasses moderate and severe dysplasia, carcinoma in situ/CIN II, and CIN III. The rationale for combining CIN II and CIN 11I into the category of high-grade intraepithelial lesion is also based on biologic and virologic studies. The HPV mix of the two lesions is similar, and the separation of the two lesions has been irreproducible in inter- and intraobserver studies. In addition, the management of CIN II and III is similar, so the separation serves no useful clinical purpose. Although the Bethesda System advocates the two-tier system for squamous intraepithelial lesions, it does not preclude the addition of further subclassification of the lesion for those cytopathologists who wish to retain the degrees of dysplasia or grades of CIN.

Squamous Cell Carcinoma. A report of squamous cell carcinoma indicates the probable presence of an invasive tumor. The qualifier “microinvasive squamous cell carcinoma” may be used by those laboratories that are confident with such a diagnosis.

The “unsatisfactory for evaluation” designation indicates that the specimen is unreliable for the detection of cervical abnormalities and a repeat specimen should be obtained. If abnormal cells are detected in a specimen, the specimen is never categorized as unsatisfactory.

General Categorization

This category allows a clinician to evaluate a Pap test quickly. Three choices are provided: “within normal limits,” “benign cellular changes,” and “epithelial cell abnormality.” A descriptive diagnosis is used to further categorize changes that are other than normal. If infectious or reactive changes (benign cellular changes) are identified along with an epithelial cell abnormality, the specimen is categorized according to the most clinically significant lesion.

Descriptive Diagnoses

Benign Cellular Changes
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In this category, the Bethesda System provides for those samples that show changes consistent with infection or repair. Several infections may be identified cytologically with high specificity: trichomoniasis, yeast, and changes consistent with bacterial vaginosis. Changes associated with chlamydial infections should not be reported due to the low specificity of these changes. The term “reactive changes” is used to report cellular findings that are consistent with a reactive or reparative process, such as inflammation resulting from radiation or an intrauterine device.

The Bethesda System report includes three general categories:

1. Adequacy of the specimen

2. General categorization

3. Descriptive diagnoses

Adequacy of the Specimen

Satisfactory for Evaluation

A statement that the specimen is “satisfactory” indicates that it includes all of the following: appropriate labeling and identification, relevant clinical information, adequate numbers of interpretable squamous epithelial cells, and an adequate endocervical or transformation zone component. Well-preserved and well-visualized squamous cells should be spread over more than 10% of the slide surface.

Satisfactory for Evaluation but Limited by
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The clarification “satisfactory for evaluation but limited by” indicates that any of the following apply: lack of pertinent clinical information accompanying the slide or inability to interpret more than 50% of the epithelial cells due to obscuring blood, inflammation, poor fixation, air drying, or contaminant. There should be at least two clusters of well-preserved endocervical or squamous metaplas-tic cells, with each cluster composed of at least five cells. The report indicates that the specimen can be interpreted; however, the interpretation is compromised. Determination of specimen adequacy is ultimately the responsibility of the clinician who correlates the findings of the cytology report with the clinical status of the patient. The absence of an endocervical or transformation zone component does not necessarily require a repeat Pap test. Data from the literature are thus far inconclusive with regard to the endocervical component as a measure of adequacy. Short-term longitudinal studies have demonstrated no increase in the frequency of subsequent squamous lesions among women whose initial specimens lacked endocervical cells.