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Re: client abstinence before PapsFrom: Efrain Ramirez (eramirez@icepr.com)Tue Dec 5 21:05:59 2000
This time -the word intercourse not found -- FYIO Number 183--August 1993 (Replaces #81, October 1984) Cervical Cytology: Evaluation and Management of Abnormalities Despite the significant decrease in the incidence of and mortality from invasive cervical carcinoma in the United States, there is evidence that the rate of decline is leveling off, and the rate may even be rising slightly in young women (1). Since cervical cytology screening continues to be the mainstay in the early detection of this neoplasm, this Technical Bulletin will review the current status of cervical cytology in the light of current recommendations for the frequency of screening, improvements in the methodology of specimen collection, and recent changes in the diagnostic terminology used to report cervical and vaginal cytologic diagnoses. In view of the persuasive evidence that has been advanced implicating human papillomavirus (HPV) in the etiology of preinvasive and invasive cervical neoplasms, the role of HPV detection is discussed (2). Finally, the diagnostic evaluation and guidelines for management and therapy of cervical cytologic abnormalities will be summarized. Frequency of Cytologic Screening In 1988, a consensus recommendation was developed by the American College of Obstetricians and Gynecologists, the American Cancer Society, the National Cancer Institute, the American Medical Association, the American Nurses' Association, the American Academy of Family Physicians, and the American Medical Women's Association. The recommendation suggested that all women who are or who have been sexually active or who have reached age 18 years of age should have an annual cervical smear and pelvic examination (3). It was further recommended that after a woman had three or more consecutive, satisfactory, normal annual examinations, the cervical smear could be performed less frequently at the discretion of her physician. The U.S. Preventive Services Task Force recommended in 1989 that the time interval between smears should be 1-3 years, depending on the presence of risk factors for cervical cancer (4). The risk of an abnormality occurring within 3-5 years after three consecutive negative annual smears is minimal in low-risk patients. Women who are at increased risk for preinvasive lesions of the cervix include those who are infected with HPV (5, 6) or human immunodeficiency virus (HIV) (7) and those who smoke cigarettes (8). Because having multiple sexual partners increases the likelihood of exposure to human papillomavirus and HIV, it could also be considered a risk factor. Women with any of these risk factors should have cervical smears performed annually. The cost-effectiveness of cytologic screening for vaginal neoplasia after removal of the cervix for benign disease has not been demonstrated. In consideration of the low risk of preinvasive vaginal lesions or invasive cancer, however, periodic cytologic evaluation of the vagina, based on the patient's risk factors, is suggested. Following treatment of preinvasive lesions of the cervix or vagina, patients should undergo cytologic evaluation at frequent intervals, every 3-4 months if feasible, for approximately 1 year and then annually thereafter (9). For invasive lesions, evaluation should occur every 3-4 months for approximately 2 years and then every 6 months (10). Close follow-up of these women is necessary because those treated for squamous cell carcinoma of the cervix are at increased risk of developing preinvasive or invasive squamous neoplasms elsewhere in the lower genital tract. Technique of Cytologic Screening One of the major factors that accounts for false-negative smears is sampling error. A cellular sample from the endocervical canal obtained with an endocervical brush and a scraping of the portio, to include the entire transformation zone, provides a reliable sample. In the past, endocervical samples have been obtained either by aspiration of cervical mucus with a bulb syringe or with a cotton-tipped applicator. Recent studies have shown that the use of an endocervical brush can increase the yield of endocervical cells by sevenfold (11). Preliminary findings suggest that the brush can be used during pregnancy (12). If the brush is used in pregnancy, it is important that the patient be informed that slight spotting may occur immediately after the procedure but that this is not thought to jeopardize the pregnancy. Providers should use the technique that is most reliable for them in terms of identifying CIN, providing adequate cytologic specimens, and limiting false-negatives and false-positives. A single slide combining both the endocervical and ectocervical samples or two separate slides from the ectocervix and endocervix can be used. The most important consideration is rapid fixation; it should be appreciated that cellular samples, particularly those from the endocervical canal, can become air dried in a matter of seconds, underscoring the need for prompt fixation. Important steps in obtaining an adequate sample include the following: Cells should be collected prior to the bimanual examination. Care should be taken to avoid contaminating the sample with lubricant. If testing for sexually transmitted diseases is indicated, the Pap smear should be taken first, followed by tests for gonococcus and chlamydia. Ideally, the entire portio should be visible when the smear is obtained. Vaginal discharge, when present in large amounts, should be carefully removed before obtaining the smear so as not to disturb the epithelium. Small amounts of blood will not interfere with cytologic evaluation, but large amounts, as occurring during menses, preclude cytologic sampling. If the patient has no signs or symptoms of a cervical disorder, consideration may be given to treating the vaginitis first. The portio sample should be obtained first and then the endocervical sample because of the frequency of bleeding from the endocervix when the brush is used and the drying factor. The endocervical canal is best sampled by gently rotating a brush. Excessive manipulation should be avoided to prevent bleeding. The collected material should be applied uniformly to the slide, without clumping, and should be rapidly fixed to avoid air drying. If spray fixatives are used, the spray should be held at least 10 inches away from the slide to prevent dispersal and destruction of the cells by the propellant. For diethylstilbestrol-exposed patients, some providers take smears circumferentially from the upper two thirds of the vagina in addition to evaluating the cervix Reporting of Cytologic Diagnosis Since December 1988, multidisciplinary workshops have been convened by the National Cancer Institute to address the "diagnostic chaos" that existed in cervical cytology reporting. The classification that was developed was designated the Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses (13). The Bethesda system (TBS) eliminates the numerical Papanicolaou class designations, requires an evaluation of specimen adequacy as an integral part of the diagnostic report, and uses new terms that can be correlated with the histologic diagnosis (see box). Since TBS represents a significant departure from the previously used classification, the following discussion elaborates on the rationale of TBS terminology with respect to 1) atypical squamous cells of undetermined significance (ASCUS); 2) the inclusion of changes associated with HPV (ie, koilocytosis) along with cervical intraepithelial neoplasia (CIN) 1 within the category of low-grade squamous intraepithelial lesion (LSIL); and 3) the use of only two terms, LSIL and high-grade squamous intraepithelial lesion (HSIL), to encompass the spectrum of squamous cell carcinoma precursors, in lieu of four degrees of dysplasia/carcinoma in situ (CIS) (mild, moderate, severe, CIS) or the three grades of CIN (CIN 1, 2, 3). The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses Format of the Report: 1.A statement on Adequacy of the Specimen for Evaluation 2.A General Categorization which may be used to assist with clerical triage (optional) 3.The Descriptive Diagnosis Adequacy of the Specimen Satisfactory for evaluation Satisfactory for evaluation but limited by . . . (specify reason) Unsatisfactory for evaluation . . . (specify reason) General Categorization (Optional) Within normal limits Benign cellular changes: See descriptive diagnoses Epithelial cell abnormality: See descriptive diagnoses Descriptive Diagnoses Benign cellular changes Infection Trichomonas vaginalis Fungal organisms morphologically consistent with Candida spp Predominance of coccobacilli consistent with shift in vaginal flora Bacteria morphologically consistent with Actinomyces spp Cellular changes associated with herpes simplex virus Other Reactive changes Reactive cellular changes associated with: Inflammation (includes typical repair) Atrophy with inflammation ("atrophic vaginitis") Radiation Intrauterine contraceptive device (IUD) Other Epithelial Cell Abnormalities Squamous Cell Atypical squamous cells of undetermined significance: Qualify* Low-grade squamous intraepithelial lesion encompassing: HPV Mild dysplasia/CIN 1 High-grade squamous intraepithelial lesion encompassing: Moderate and severe dysplasia CIS/CIN 2 and CIN 3 Squamous cell carcinoma Glandular Cell Endometrial cells, cytologically benign, in a postmenopausal woman Atypical glandular cells of undetermined significance: Qualify* Endocervical adenocarcinoma Endometrial adenocarcinoma Extrauterine adenocarcinoma Adenocarcinoma, not otherwise specified (NOS) Other malignant neoplasms: Specify Hormonal evaluation (applied to vaginal smears only) Hormonal pattern compatible with age and history Hormonal pattern incompatible with age and history: Specify Hormonal evaluation not possible due to: Specify *Atypical squamous or glandular cells of undetermined significance should be further qualified as to whether a reactive or a premalignant/malignant process is favored. **Cellular changes of human papillomavirus (HPV)-previously termed koilocytosis atypia, or condylomatous atypia-are included in the category of low-grade squamous intraepithelial lesion. Atypical Squamous Cells of Undetermined Significance In the past, the terms inflammatory atypia and atypia were overused to refer to anything from benign reactive changes to preinvasive cellular changes. With such diagnoses, gynecologists have been uncertain as to the appropriate follow-up. The Bethesda system directs the cytopathologist to be more specific in the use of the term atypia. Cellular changes thought to be purely reactive in nature are described as such and are not included under the category of ASCUS. In TBS, atypia is limited to those cases in which the cytologic findings are of uncertain significance. Relatively few cytology specimens should be reported as ASCUS, as laboratories will be encouraged to avoid this designation when a more precise diagnosis is appropriate. Any questions about the significance of specimens reported as ASCUS should be resolved through communication with the laboratory. Cellular Changes Associated with Human Papillomavirus and Low-Grade Squamous Intraepithelial Lesion Koilocytosis is a term that has been used in various and imprecise ways. Koilocytosis is a descriptive, not a diagnostic, term that should be applied to squamous cells showing both cytoplasmic vacuolization and nuclear abnormalities characterized by enlargement, hyperchromasia, and wrinkling (14). Cytoplasmic vacuolization in the absence of these nuclear alterations does not qualify as koilocytosis. This latter change can be found in normally glycogenated squamous epithelium or in association with various types of inflammation, notably that due to Trichomonas. The Bethesda system incorporates cellular changes associated with HPV (ie, koilocytosis and CIN 1) within the category of LSIL because the natural history, distribution of various HPV types, and morphologic features of both of these lesions--and thus their treatment--are similar. First, long-term follow-up studies have shown that lesions classified as "koilocytosis" and mild dysplasia progress to high-grade intraepithelial neoplasia at similar rates (15-17). Second, a recent pathologic and molecular virologic analysis has demonstrated a similar heterogeneous distribution of low- and high-risk HPV types in both koilocytosis and CIN 1 (18-20). Third, studies evaluating the dysplasia/CIS or CIN terminology have repeatedly demonstrated a lack of interobserver and intraobserver reproducibility (21). The greatest lack of reproducibility is between koilocytosis and CIN 1 (22). Thus, the distinction between koilocytosis and CIN 1 is blurred on the basis of clinical behavior, molecular virologic findings, and morphologic features. The forthcoming World Health Organization (WHO) Histologic Classification of Cervical Neoplasms also combines koilocytosis and CIN 1 into one category. High-Grade Squamous Intraepithelial Lesion The Bethesda system combines moderate dysplasia with severe dysplasia and CIS into a single category (HSIL) for several reasons. First, separating moderate dysplasia from severe dysplasia and severe dysplasia from CIS has been shown to be irreproducible (21, 22). Second, from a clinical standpoint, no useful purpose is served by this separation; moderate dysplasia is not usually managed differently from severe dysplasia and CIS. Third, combining moderate dysplasia with severe dysplasia and CIS will reduce discordance between the cytology and the biopsy reports by reducing the possible categories from three to one. Since the management of cervical lesions is based on correlation of the cytologic and histologic findings, greater concordance will reduce the morbidity, anxiety, and cost to the patient of repeated examinations. Human Papillomavirus Detection in Diagnosis and Management With highly sensitive molecular techniques, HPV DNA can be detected in over 90% of preinvasive and invasive squamous neoplasms of the cervix (23). Although 70% of invasive squamous carcinomas contain HPV types 16 or 18, these HPV types can also be detected in many patients with LSIL. Prevalence rates vary for women with normal cytology according to the population studied and the HPV detection method used but generally range from 10-50%, with a mean of 25-30% when sensitive techniques are used (24). It has been estimated that 10-20 million women between the ages of 18-50 years in the United States have detectable HPV DNA in the cervix when sensitive assays are used, and each year there are approximately 16,000 incident cases of cervical cancer. It is therefore clear that HPV testing lacks the specificity necessary to be a useful screening test for cervical cancer or its precursors, since the vast majority of women with HPV DNA detected from cervical lavages would be cytologically normal. Finally, the natural history of HPV infection, especially in cytologically normal women, is not currently known. Preliminary results from a large cohort study suggest that HPV testing with identification of specific HPV types may be of value in the triage of certain subsets of patients, such as those with LSIL or ASCUS and older women. The utility of HPV testing in conjunction with cytology, however, must be evaluated prospectively in a clinical trial before it can be recommended for routine clinical use. Diagnostic Procedures The evaluation of the cervix following an abnormal cytology report includes visual inspection of the cervix and vagina, repeat cytology, colposcopic examination with directed biopsies, endocervical curettage (ECC), and bimanual pelvic examination. This approach minimizes the need for diagnostic and therapeutic cervical conization and permits individualized treatment. Occasionally, cervical conization and dilation and fractional curettage are necessary. The first objective is to rule out the presence of invasive carcinoma. Once this has been accomplished, the objectives are to determine the grade and distribution of the intraepithelial lesion. Colposcopically Directed Biopsies Following the liberal application of a solution of 3-5% acetic acid, the cervix is inspected to detect abnormal areas (white epithelium, punctation, mosaic cells, atypical vessels). Punch biopsies of the abnormal areas are obtained under direct vision with the colposcope. If necessary, hemostatic agents such as Monsel solution (ferric subsulfate) or silver nitrate may be applied to the biopsy site. The accuracy of directed biopsies has been reported to vary from 85-95%. If the physician is not experienced in grading lesions colposcopically, it is important to obtain samples of all the areas involved and mark the location of the specimen. Endocervical Curettage Most colposcopists advocate routine ECC except during pregnancy. The ECC should be performed under direct colposcopic visualization; otherwise, a positive ECC may not necessarily indicate a lesion in the endocervical canal but may represent inadvertent detection of a lesion on the ectocervix near the external os. Conization of the Cervix A cone specimen suitable for histologic evaluation can be obtained by surgery (cold knife cone), laser, or loop electrode excision procedure. With the latter two methods, a certain degree of "cautery effect," which may interfere with histologic evaluation of the surgical margins, is unavoidable, but with proper technique, this should be minimal. An ECC performed immediately after the conization provides additional tissue for microscopic assessment. Diagnostic conization is indicated in the following instances: An intraepithelial lesion or microinvasive carcinoma is present in the endocervical curettings. Cytologic assessment indicates an abnormality that is not consistent with the tissue diagnosis. The entire transformation zone is not visible. Microinvasive carcinoma is diagnosed by directed biopsy. Cytologic or biopsy evidence of premalignant or malignant glandular epithelium is detected. Recent data indicate that the use of colposcopy has reduced the incidence of conization to approximately 5-20% of patients with atypical cytology. Conization is not generally indicated as an initial diagnostic procedure. Endometrial Sampling of Atypical Glandular Cells Women with atypical glandular cells of endocervical origin should undergo biopsy and ECC directed by colposcopy. If preinvasive or invasive adenocarcinoma is suspected from these studies, diagnostic conization is indicated. Abnormal endometrial cells on cytology should be investigated by endometrial biopsy, fractional dilation and curettage, or hysteroscopy to exclude the possibility of endometrial adenocarcinoma. If no abnormalities are detected with diagnostic dilation and curettage, the possibility of extrauterine sites of malignancy should be considered (ie, ovary, fallopian tube, gastrointestinal tract, breast). Guidelines for Management Unfortunately, TBS terminology was not "pretested" before introduction. Thus, the implications of some reports are not known. A long-term research project is needed to develop guidelines for the management of patients with abnormal cytology reports and is under consideration by the National Cancer Institute. Until this research is completed, interim guidelines for patient management have been proposed by the National Cancer Institute which are similar to those outlined below. Atypical Squamous Cells of Undetermined Significance
In TBS, the term atypia is reserved for abnormalities that do not
qualify as squamous intraepithelial lesions
or reactive changes. These cellular changes are therefore truly of
undetermined significance. The prognosis
of patients with an ASCUS report can vary dAt Tue, 5 Dec 2000, Marilyn
Ringst wrote:
>
-- "Do not take life too seriously. You will never get out of it alive."
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