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PubMed2000

HPV DNA testing in cervical cancer screening: results from women in a high-risk province of Costa Rica.

CONTEXT: Human papillomaviruses (HPVs) are known to cause most cervical cancer worldwide, but the utility of HPV DNA testing in cervical cancer prevention has not been determined. OBJECTIVE: To provide comprehensive data on the screening performance of HPV testing for the most common carcinogenic types, at different levels of analytic sensitivity. DESIGN: Laboratory analysis conducted during 1993-1995, using 3 cytologic techniques and cervicography, followed by colposcopic examination of women with any abnormal cervical finding, to detect all high-grade intraepithelial lesions and cancer (reference standard of clinically significant disease). The HPV testing was performed subsequently with masking regarding clinical findings. SETTING: Guanacaste Province, Costa Rica, a region with a high age-adjusted incidence of cervical cancer. PARTICIPANTS: Of 11742 randomly selected women, 8554 nonpregnant, sexually active women without hysterectomies underwent initial HPV DNA testing using the original Hybrid Capture Tube test; a stratified subsample of 1119 specimens was retested using the more analytically sensitive second generation assay, the Hybrid Capture II test. MAIN OUTCOME MEASURES: Receiver operating characteristic analysis of detection of cervical high-grade intraepithelial lesions and cancer by HPV DNA testing based on different cut points of positivity. RESULTS: An analytic sensitivity of 1.0 pg/mL using the second generation assay would have permitted detection of 88.4% of 138 high-grade lesions and cancers (all 12 cancers were HPV-positive), with colposcopic referral of 12.3% of women. Papanicolaou testing using atypical squamous cells of undetermined significance as a cut point for referral resulted in 77.7% sensitivity and 94.2% specificity, with 6.9% referred. Specificity of the second generation assay for positivity for high-grade lesions and cancer was 89.0%, with 33.8% of remaining HPV DNA-positive subjects having low-grade or equivocal microscopically evident lesions. The higher detection threshold of 10 pg/mL used with the original assay had a sensitivity of 74.8% and a specificity of 93.4%. Lower levels of detection with the second generation assay (<1 pg/mL) proved clinically nonspecific without gains in diagnostic sensitivity. CONCLUSIONS: In this study population, a cut point of 1.0 pg/mL using the second generation assay permitted sensitive detection of cervical high-grade lesions and cancer, yielding an apparently optimal trade-off between high sensitivity and reasonable specificity for this test. The test will perform best in settings in which sensitive detection of high-grade lesions and cancer is paramount. Because HPV prevalence varies by population, HPV testing positive predictive value for detection of high-grade lesions and cancer will vary accordingly, with implications for utility relative to other cervical cancer screening methods.

Adult↗
PubMed2001

Interobserver reproducibility of cervical cytologic and histologic interpretations: realistic estimates from the ASCUS-LSIL Triage Study.

CONTEXT: Despite a critical presumption of reliability, standards of interpathologist agreement have not been well defined for interpretation of cervical pathology specimens. OBJECTIVE: To determine the reproducibility of cytologic, colposcopic histologic, and loop electrosurgical excision procedure (LEEP) histologic cervical specimen interpretations among multiple well-trained observers. DESIGN AND SETTING: The Atypical Squamous Cells of Undetermined Significance-Low-grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), an ongoing US multicenter clinical trial. SUBJECTS: From women enrolled in ALTS during 1996-1998, 4948 monolayer cytologic slides, 2237 colposcopic biopsies, and 535 LEEP specimens were interpreted by 7 clinical center and 4 Pathology Quality Control Group (QC) pathologists. MAIN OUTCOME MEASURES: kappa Values calculated for comparison of the original clinical center interpretation and the first QC reviewer's masked interpretation of specimens. RESULTS: For all 3 specimen types, the clinical center pathologists rendered significantly more severe interpretations than did reviewing QC pathologists. The reproducibility of monolayer cytologic interpretations was moderate (kappa = 0.46; 95% confidence interval [CI], 0.44-0.48) and equivalent to the reproducibility of punch biopsy histopathologic interpretations (kappa = 0.46; 95% CI, 0.43-0.49) and LEEP histopathologic interpretations (kappa = 0.49; 95% CI, 0.44-0.55). The lack of reproducibility of histopathology was most evident for less severe interpretations. CONCLUSIONS: Interpretive variability is substantial for all types of cervical specimens. Histopathology of cervical biopsies is not more reproducible than monolayer cytology, and even the interpretation of LEEP results is variable. Given the degree of irreproducibility that exists among well-trained pathologists, realistic performance expectations should guide use of their interpretations.

Biopsy↗
PubMed1984

Flow cytometric DNA analysis as a diagnostic aid for cervical condyloma and cancer.

Flow cytometric DNA analysis data (FCDA) were obtained from 324 samples provided through the Gynecology-Oncology Clinic. These samples consisted of 294 combined endoectocervical and vaginal smears and 30 peritoneal washings. Using a conventional scheme for G0/G1, S + G2/M and the coefficient of variation with computer correction for the cell-cycle kinetics, it was possible to assign a diagnostic Class I, II, III or V similar to that used by the Cytology Laboratory. These data were then compared with the histopathologic and colposcopic diagnoses. The correlation between FCDA and cytologic results were essentially similar to the previous data obtained from only endocervical sampling. The most interesting finding in this study was the recognition of an FCDA pattern showing a higher DNA content in the G0/G1 and the early S regions in 70 of 94 (74.5%) of samples from patients with condyloma acuminata. All condyloma samples were diagnosed either by cytologic, histopathologic, or colposcopic examination, or a combination of two or three. All biopsy specimens were then reviewed by one pathologist to verify any discrepancies. The relationship of this pattern to the viral etiology of this disease is discussed with the three methods of diagnosis and electron microscopic observations. It is suggested that, based on this study. FCDA analysis of pap smears may also be useful in determining the presence of condyloma in a gynecology clinic. The potential value of FCDA analysis from peritoneal washings for the diagnosis of gynecologic cancer can not be ascertained in this preliminary investigation because of insufficient samples.

Cell Cycle↗
PubMed1994

Serum level of squamous cell carcinoma antigen and tumor size are useful to identify preoperatively patients at high risk of cervical cancer.

BACKGROUND: The benefit of postoperative adjuvant therapy for patients with cervical cancer is uncertain, and moreover, may increase morbidity. In this study, patient age, clinical stage of the cancer, tumor size, and levels of serum squamous cell carcinoma cell antigen and carcinoembryonic antigen were studied in patients with Stage Ib and IIa squamous cell carcinoma of the uterine cervix to determine if these parameters can be used, before the surgical intervention, to distinguish patients who require postoperative adjuvant therapy from those who do not. METHODS: Ninety-nine patients were studied. After surgery, patients were classified either as high risk or low risk according to the results of histopathologic findings. The age of the patient was noted, and FIGO stage, squamous cell carcinoma antigen, carcinoembryonic antigen, and clinical tumor size were determined. A univariate analysis and then a stepwise logistic regression procedure were performed to select significant clinical predictors from among the five variables mentioned above. Any selected predictors were further analyzed by the receiver operator characteristic curve. RESULTS: Serum squamous cell carcinoma antigen and clinical tumor size measured by colposcopic examination were significant clinical predictors of the treatment strategy postoperatively. From the receiver operator characteristic curve, a sensitivity of 84.2%, a specificity of 91.8%, a positive predictive value of 84.5% were attained. CONCLUSIONS: Serum squamous cell carcinoma antigen assays and clinical tumor size estimated by colposcopic examination are helpful in identifying patients who require postoperative adjunctive therapy.

Adult↗
PubMed2006

DNA ploidy compared with human papilloma virus testing (Hybrid Capture II) and conventional cervical cytology as a primary screening test for cervical high-grade lesions and cancer in 1555 patients with biopsy confirmation.

BACKGROUND: Because 80% of cervical cancers arise in low-resource settings, many inexpensive strategies are being tested. In that spirit, the authors are testing large-scale genomic or DNA ploidy measurements as an inexpensive and semiautomated strategy. METHODS: Patients entered either a screening or diagnostic study of several optical technologies: quantitative cytology, quantitative histopathology, and fluorescence and reflectance spectroscopy using a point probe, a multispectral digital colposcope, or a combination of the two. We calculated sensitivities, specificities, positive and negative predictive values, and their confidence interval testing conventional cytology, Hybrid Capture (HC) II testing, and DNA ploidy measured on the Feulgen-stained quantitative Pap smear. RESULTS: The current investigation reports on 1555 patients for whom colposcopically directed biopsies were read 3 times by study pathologists. The final histopathologic diagnosis was high grade (cervical intraepithelial neoplasia [CIN] 2, CIN 3, carcinoma in situ [CIS], and cancer) in 16% of patients. Using high-grade squamous intraepithelial lesions (SILs) histopathology as the threshold and gold standard, the sensitivity and specificity, respectively, were: 0.47 and 0.96 for conventional cytology, 0.91 and 0.80 for HC II, and 0.59 and 0.93 for DNA ploidy. The positive and negative predictive values (PPV, NPV) for conventional cytology were 0.70 and 0.90, 0.46 and 0.98 for HC II, and 0.63 and 0.92 for DNA ploidy. CONCLUSIONS: DNA ploidy shows comparable sensitivity, specificity, PPV, and NPV values to conventional cytology and HC II. Unlike conventional cytology, DNA ploidy is semiautomated and can be performed in less than 8 hours. Cost effectiveness studies are under way, but in the authors' laboratory DNA ploidy is inexpensive.

Adolescent↗
PubMed2005

HPV DNA testing in the triage of atypical squamous cells of undetermined significance (ASCUS): cost comparison of two methods.

Human papillomavirus (HPV) DNA testing for triage of cervical cytologies showing atypical squamous cells of undetermined significance (ASCUS) has become the standard of practice. Currently, Hybrid Capture II (HCII) is the preferred method for ASCUS triage. In situ hybridization for HPV represents an alternative to HCII and appears to have a superior specificity but is more expensive. We compare the reimbursement rates of ASCUS triage (HPV high risk) using the methods of HCII and INFORM (in situ hybridization for HPV) in a series of 431 ASCUS patients. The patients were followed for 1 yr, during which each patient had either colposcopic biopsy or follow-up cervical cytology after ASCUS HPV DNA triage. Eighty-nine patients were excluded from the analysis because of incomplete follow-up. The HPV triage percentages, colposcopic biopsy positivity rates and cervical cytology positivity percentages were calculated for each method. The reimbursement rates of the tests/procedures used in the analysis were those in effect at the University of Utah in 2003. The total triage and follow-up reimbursement costs were calculated for HCII and INFORM and compared.HCII referred 19.9% of patients to colposcopy, with a biopsy positivity rate of 25.6% for dysplasia. INFORM referred 11.8% of patients to colposcopy, of whom 34% had a biopsy diagnosis of dysplasia. HCII negative cases revealed 19% to have ASCUS or higher on the follow-up cervical cytology, while 19.9% of INFORM negative cases had a reading of ASCUS or higher at follow-up cytologic examination. The 1-yr HPV DNA triage and follow-up reimbursements for HCII were 316,942.00 US dollars per 1,000 women, and for the INFORM methodology, the reimbursements were 369,484.00 US dollars per 1,000 women. The INFORM method was associated with higher specificity and sent fewer (41%) patients to colposcopy than did HCII. Although this smaller referral rate reduced reimbursement costs associated with colposcopy, the increased reimbursement paid for follow-up cytologies and office visits of HPV DNA negative patient and the greater cost of the INFORM test results in higher overall reimbursement for INFORM. Based on these costs and diagnostic accuracies, it appears that the INFORM HPV technology represents a viable option to HCII ASCUS triage. INFORM HPV appears to be 16% more expensive than HCII but has the advantage of sending 41% fewer women to colposcopy.

Adolescent↗
PubMed1990

Cytologic diagnosis of human papillomavirus infection: spindled nuclei.

The classic cytologic criteria, koilocytotic atypia and dyskeratocytosis, fail to identify most cases with colposcopic and histologic evidence of cervical condylomata. The purpose of this study was to identify a novel cytologic diagnostic criterion, spindled nuclei, to predict the presence of human papillomavirus (HPV) infection of the cervical epithelium. Review of the hospital records of 100 consecutive cases with spindled nuclei on Papanicolaou smear identified 36 patients in whom a colposcopic examination and/or cervical biopsy had been performed between January 1, 1988, and March 31, 1989. Ninety-seven percent of these 36 cases were positive by colposcopy and 89% of the cases were positive by cervical biopsy for changes of condyloma or intraepithelial neoplasia. HPV DNA hybridization in situ was positive in 16 of 36 patients, and the probe for types 31/33/35 most often stained histologic sections showing condylomatous change without concurrent dysplasia. Electron microscopy of spindled nuclei showed evidence of HPV-type viral particles in the five cases examined.

Cell Nucleus↗
PubMed1985

Papillomavirus infection of the lower genital tract: detection of viral DNA in gynecological swabs.

A total of 311 smears from the lower genital tract were examined by the filter in situ hybridization method to identify human papillomavirus (HPV) DNA. Of these 311 smears, 229 came from clinically and cytologically negative patients and served as a control group. In this group HPV-DNA was detected in 5 cases (2.2%). Of 82 cytologically positive cases (25 confirmed by histology) 56 (68%) contained HPV-DNA. A high prevalence of HPV 6/11 and absence of HPV 16/18 was found in cases with cytological signs of permissive HPV infection. In mild and moderate dysplasia all viruses occurred at almost the same frequency. In severe dysplasia/carcinoma in situ HPV 16/18 was found 5 times more frequently than HPV 6/11. HPV 16/18 was identified in all 4 invasive cancer cases. Cervical irrigation of colposcopically suspect areas was performed in 15 cytologically and HPV-DNA positive cases using the hydrodynamic filtration method. In 12 cases only the cells obtained from the colposcopically positive areas contained HPV-DNA. The sensitivity and reproducibility of the filter in situ hybridization was shown by: comparing the results obtained by HPV-DNA hybridization using Southern blot analysis of tumor biopsies; analysing the correlation of cytologic diagnosis and presence of HPV-DNA in follow-up examinations, and diagnosing presence or absence of HPV-DNA in parallel filters from the same patients.

Animals↗
PubMed1992

Prevalence of human papillomavirus infections among heterosexual men and women with multiple sexual partners.

A prospective study of 65 men and 111 women with multiple heterosexual partners was designed to assess the prevalence and potential risk factors of genital human papillomavirus (HPV) infections. In addition, the HPV reservoir in genital, rectal, and oral mucosa was examined. The specimens for the detection of HPV DNA were taken from different sites such as the urethra and coronal sulcus (men), cervix and labia minora (women), anus, rectum, tongue, and buccal mucosa (both men and women). Women underwent speculum examination and colposcopic evaluation of the anogenital region, and a smear for routine cytological classification was also taken. In men, the anogenital region was examined clinically and colposcopically. The polymerase chain reaction (PCR) was used for the detection of HPV types 6/11, 16, 18, and 33. A high prevalence of HPV infection at one or more sites was detected, in 32% of the male and in 23% of the female participants. Seventeen percent of the male distal urethral specimens were positive for HPV DNA. From the female cervical specimens 14% were found positive. Ten proctal specimens (five men and five women) were positive for HPV DNA without any discernible lesion. The persons from whom these samples were taken denied anal insertive intercourse. No oral manifestation of HPV infection was detected. In both men and women a difference between HPV DNA-positive and -negative persons was not found in relation to known risk factors associated HPV infection.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Fluorescence spectroscopy: a diagnostic tool for cervical intraepithelial neoplasia (CIN).

A spectroscopic system incorporating a pulsed nitrogen laser, an optical fiber probe, and an optical multichannel analyzer was utilized to record fluorescence spectra of the intact cervix at colposcopy. Spectra were obtained from 66 colposcopically normal areas and 49 histologically abnormal areas (5 pathologic inflammation, 21 HPV infection, 9 CIN I, 10 CIN II, and 4 CIN III) in 28 patients. The resulting spectra could be used to differentiate histologically abnormal tissues from colposcopically normal tissues with a sensitivity, specificity, and positive predictive value of 92, 90, and 88%. Furthermore, CIN could be differentiated from nonneoplastic abnormal tissues with a sensitivity, specificity, and positive predictive value of 87, 73, and 74%. These results suggest that laser-induced fluorescence can be used in the recognition and differential diagnosis of CIN at colposcopy.

Algorithms↗
PubMed1994

The correlation between HIV seropositivity, cervical dysplasia, and HPV subtypes 6/11, 16/18, 31/33/35.

Twenty-one human immunodeficiency virus (HIV) seropositive patients were studied to determine the prevalence of cervical dysplasia, the distribution of human papilloma virus (HPV) subtypes, and the utility of cytologic diagnosis in this population. The patients ranged in age from 18 to 41 years. HIV infection was diagnosed in all patients by ELISA method and confirmed by Western blot. Patients were interviewed to document risk factors for HIV infection and cervical dysplasia. All were examined colposcopically and identifiable lesions were biopsied. In patients with normal colposcopic findings four quadrant biopsies were performed. Cervical and endocervical smears were obtained on all patients at the time of colposcopy and blood was collected for T-cell studies. Eighteen patients (86%) had abnormal cytologic findings. The Pap smear was able to identify 10 of 13 biopsy-proven epithelial abnormalities. In 14 patients there was sufficient tissue for HPV typing by in situ hybridization; the HPV subtypes identified were 6/11 (10 patients), 16/18 (9 patients), and 31/33/35 (9 patients). Dysplasia was present in 11/14 (79%) of the specimens submitted for subtyping. The absolute CD4 cell counts were 342 per mm3 for the dysplasia group and 281 per mm3 for the patients without dysplasia. Patients with dysplasia did not differ significantly from patients without dysplasia in regard to risk factors for cervical dysplasia, including history of STD, tobacco use, multiple sexual partners, age at first coitus, and parity. In addition, history of medication use and risk factors associated with HIV infection were similar in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

The evaluation of PCNA/cyclin expression in cervical intraepithelial lesions.

This study aims at evaluating the expression of PCNA/cyclin in the cells of cervical intraepithelial lesions. The material constituted 121 colposcopic biopsies from patients with cytological and/or colposcopical evidence of condyloma (HPV) or CIN. The cases were classified as follows: 20 as koilocytosis, 31 as CIN I and HPV, 30 as CIN II and HPV, 1 as CIN III and HPV, and 7 as CIN III. Immunohistochemical detection of PCNA/cyclin was performed on paraffin sections by the avidin-extravidin method using the monoclonal antibody PC10 (DAKO). According to our results a statistically significant difference was observed between all groups of our material (P < 0.01). The expression of PC10 may thus offer useful information on the proliferation capacity of a CIN lesion with regard to the histological pattern. Moreover, this method is simple and reproducible, requiring no specialized equipment or medical staff.

Antibodies, Monoclonal↗
PubMed1994

The adequacy of cytology and colposcopy in diagnosing cervical neoplasia in HIV-seropositive women.

The purpose of this study was to compare cytology and colposcopy as predictors of cervical intraepithelial neoplasia (CIN) in women infected with the human immunodeficiency virus (HIV). A cross-sectional analysis of cytology, colposcopy, and colposcopic biopsy results from 51 HIV-seropositive women attending an ambulatory HIV service was conducted. Cytology slides were reviewed by two cytopathologists blinded to patients' HIV status. There was strong agreement in the readings of two cytopathologists, with a kappa score of 0.9. Of 29 women with normal cytology, 21 (72%) had pathology on histology, including 7 (24%) with CIN. Colposcopic impression correlated well with histology results. Of 22 women with abnormal cytology, 82% had abnormal histology. The overall prevalence of CIN was high at 45%, increasing from 35% in women with CD4 counts over 400 to 56% in women with CD4 counts below 200. In conclusion, screening cytology is limited by false-negative results; routine colposcopy should be considered in this high-risk population.

Adult↗
PubMed1995

The value of cervical cytology in HIV-infected women.

The purpose of this study was to assess the ability of cytology to predict the results of colposcopically directed cervical biopsies in HIV-infected women. We performed a case-control study of 52 HIV(+), 31% of whom had AIDS, and 57 HIV(-) women referred to two tertiary care centers for colposcopy from July 1991 to November 1993. All 57 HIV(-) controls and 27 HIV (+) cases underwent colposcopy for evaluation of an abnormal Pap smear. The remaining HIV(+) cases (n = 25) had colposcopy as part of their routine assessment. In women with abnormal Pap smears, colposcopic biopsy agreed with the Pap smear results in 83% of 24 HIV(+) women and 65% of 37 controls (chi 2; P = 0.34). For patients with low-grade SIL on Pap smear, 14% of HIV(+) and 11% of HIV(-) women had moderate or severe dysplasia on biopsy (P = 0.52). The positive predictive value of an abnormal Pap smear was 96% in HIV(+) women vs 78% in noninfected patients (P = 0.05). In the overall series of 52 HIV(+) women, the Pap smear did not match the biopsy in 44% of patients and was less severe than the cervical biopsy results in 91% of these mismatches. The Pap smear had a sensitivity of 57%, a specificity of 92%, a positive predictive value of 96%, and a negative predictive value of 39%, when compared to biopsy results in HIV-seropositive patients. Pap smears missed 43% of biopsy-proven intraepithelial lesions in this series of HIV (+) women. However, when abnormal, the Pap smear was no worse in predicting the presence and degree of an intraepithelial lesion in HIV(+) women than in noninfected women. These characteristics may justify immediate treatment of HIV(+) women at the time of colposcopy after an abnormal Pap smear given its high positive predictive value.

Adult↗
PubMed1996

Microinvasive cervical carcinoma and cervical intraepithelial neoplasia: biologic significance and clinical implications of 72-kDa metalloproteinase immunostaining.

OBJECTIVE: The immunohistochemical expression of 72-kDa metalloproteinase was evaluated in cervical intraepithelial neoplasia (CIN) and microinvasive carcinoma, with the aim to define a relationship between 72-kDa metalloproteinase expression and neoplastic invasiveness, useful to identify subsets of intraepithelial lesions with higher risk of progression. MATERIALS AND METHODS: Cervical bioptic samples were obtained consecutively from 54 women who attended our Colposcopic Service from January 1993 to July 1993 because of abnormal pap smear, suspicious for cervical dysplasia and/or human papillomavirus infection. After written consent, 29 women with CIN were included in the study. All women with CIN 3 lesion underwent conization; in 21 women with mild or moderate cervical dysplasia, we did not perform any medical or physical treatment but followed them longitudinally at close interval. After 12 months, the clinical evolution was classified as spontaneous remission, persistence, or progression depending on the absence or presence of lesion and/or HPV infection in colposcopy, histology, and polymerase chain reaction findings. In the study we also included surgical specimens from 10 women with microinvasive squamous carcinoma who underwent primary radical surgery. Seventy-two kilodalton metalloproteinase positivity was immunohistochemically stained on serial sections by using the avidin-biotin complex technique (Vector Laboratories, Burlingame, CA) and expressed as percentage of cells per 10(3) counted neoplastic cells. RESULTS: Cytoplasmatic positive 72-kDa metalloproteinase immunostaining was significantly higher in microinvasive cervical carcinomas than in CIN lesion (Student's t test; P < 0.001). Considering only cervical intraepithelial neoplasias, a significant increase in 72-kDa metalloproteinase immunostaining was observed with CIN degree increasing (one-way analysis of variance; P = 0.002). No correlation was found between 72-kDa metalloproteinase immunostaining and HPV infection and lesion size defined by quadrants of the cervix involved with colposcopically evident dysplasia. By analyzing 72-kDa metalloproteinase positivity, regressive dysplasia showed low values of 72-kDa metalloproteinase immunostaining (median 1.2%, range 0.5-1.8%), while persistent (median 2.6%, range 1.9-3.6%) and progressive lesions (median 4.6%, range 2.3-6.9%) presented a significantly higher positivity (one-way analysis of variance; P < 0.001). DISCUSSION: In conclusion, the 72-kDa metalloproteinase expression is related to invasive potential with a significant increase in staining positivity in microinvasive carcinomas; 72-kDa metalloproteinase is detectable in cervical dysplasia, and it is related to the severity of cellular atypia. A clinical implication of 72-kDa metalloproteinase immunostaining seems to be indicated, by analyzing the differences in 72-kDa metalloproteinase positivity rates between regressive and persistent or progressive disease.

Adult↗
PubMed1997

Comparison of Fourier-transform infrared spectroscopic screening of exfoliated cervical cells with standard Papanicolaou screening.

To compare Fourier-transform infrared (FTIR) spectroscopy in screening cervical cytology and standard Papanicolaou (Pap) screening with colposcopic directed biopsy as a "gold standard," we prospectively gathered FTIR samples and Pap smears of all patients attending our program's colposcopy clinics, from February to October 1995. We recorded demographic data for each patient including colposcopy, cytology, treatment follow-up, and histology. Using the colposcopically directed biopsy as the gold standard, exfoliated cervical cells from 301 patients were collected to compare cytology and FTIR spectroscopy. Based on previously established criteria, we provided distinctive definitions of both negative/positive FTIR, cytology, and histology. Results of 301 cases showed 196 positive and 105 negative cytologies. The sensitivity, specificity, false-negative rate, and false-positive rate for the Pap test were 86.6, 90.5, 13.4, and 9.5%, respectively. However, FTIR results versus histology showed 215 positive and 86 negative with a sensitivity of 98.6% and specificity of 98.8%. False-negative and false-positive rates were 1.4 and 1.2%, respectively. In the 12 cervical cancers there were no false-negative FTIR results but 3 false-negative Pap smears. The positive and negative predictive values for FTIR were 99.5 and 96.5% while the Pap values were 95.9 and 72.3%. Compared to standard Pap smears, FTIR has a better false-negative rate and negative predictive value in this preliminary study. Further work, to establish the range of each of the spectral criteria for different grades of dysplasia and that among various infectious effects, needs to be conducted before applying this research tool to a population-based study.

Biopsy↗
PubMed1998

The pre- and postoperative value of endocervical curettage in the detection of cervical intraepithelial neoplasia and invasive cervical cancer.

OBJECTIVE: The study was conducted to evaluate the pre- and postoperative value of endocervical curettage (ECC) in the detection of cervical intraepithelial neoplasia and invasive cervical cancer. METHODS: Patients undergoing cervical conization were studied retrospectively to evaluate the correlation of grade of preoperative endocervical curettage and the grade of dysplasia in the conization specimen. The role of routine preoperative ECC in satisfactory and unsatisfactory colposcopy and the need for routine ECC in the detection of postoperative residual dysplasia was also evaluated. RESULTS: Results showed that 297/391 (76%) patients had ECC as part of preoperative assessment for cervical dysplasia on Papanicolaou smear. There was good association of grade of preoperative ECC and grade of conization specimen, weighted kappa-0.135 (P = 0.0003). Of 17 patients with invasive disease on conization specimen, only patients with a positive ECC had invasion at conization. None of 113 patients with a negative preoperative ECC had invasive disease on their conization specimens. The proportion of satisfactory colposcopic examinations between positive and negative ECC is not significantly different (P = 0.673). Follow-up of positive margins of resection was performed with Papanicolaou smear in only 20 patients and with Papanicolaou smear and ECC in 53 patients. In the latter group, 4% had a positive ECC with negative Papanicolaou smear (P = 0.310). CONCLUSIONS: There is good agreement between grade of dysplasia on preoperative ECC and on subsequent conization specimen. Colposcopic examination was not a good predictor of pathology in the endocervical canal. Routine ECC should be part of the preoperative assessment of an abnormal Papanicolaou smear but may be unnecessary in the evaluation for residual dysplasia.

Biopsy↗
PubMed1999

Clinical evaluation of follow-up methods and results of atypical glandular cells of undetermined significance (AGUS) detected on cervicovaginal Pap smears.

OBJECTIVES: The aim of this study was to evaluate the efficacy of the follow-up methods and results of atypical glandular cells of undetermined significance (AGUS) detected on cervicovaginal Pap smears. METHODS: From May 1991 to December 1996, we have performed 407, 451 cervicovaginal Pap smears, of which 326 patients were identified as AGUS. Of the 326 patients, 268 patients were followed by repeat Pap smears, colposcopy, cone biopsy, or endometrial curettage. RESULTS: The incidence of AGUS on Pap smears is approximately 0.08%. The mean age of the patients was 43 years (range 22-79 years). The most common complaint was abnormal vaginal bleeding. The gross findings of the cervix were normal to mild erosion. The following past histories of patients could affect the AGUS results on Pap smear: 30 had cone biopsy, 21 had Pap smears on pregnancy and within 8 weeks after delivery or evacuation, 3 were on hormonal replacement therapy, 2 had intrauterine devices for contraception, and 5 were undergoing follow-up after treatment of cervical cancer. The benign lesions detected during follow-up periods were 6 microglandular hyperplasia of the cervix, 5 atypical squamous metaplasia of the cervix, 2 cervical endometriosis, 2 tubal metaplasia, 10 cervical myoma, 11 cervical polyps, 9 endometrial polyps, 3 uterine myoma, 1 pelvic endometriosis, 1 ovarian endometriosis, and 4 uterine adenomyosis. The premalignant or malignant lesions of the cervix were 4 low-grade squamous intraepithelial lesions, 24 high-grade squamous intraepithelial lesions, 8 glandular atypia/dysplasia, 5 adenocarcinoma in situ, 3 microinvasive adenocarcinoma, and 4 invasive adenocarcinoma. The neoplastic lesions of the uterus were 6 endometrial hyperplasia, 11 endometrial adenocarcinoma, 1 malignant mixed Müllerian tumor, and 1 metastatic endometrial adenocarcinoma. Sixty-seven (25%) of 268 patients followed up were identified as having clinically significant lesions of the cervix or uterus. The detection rates of abnormal lesions were 3.1% with repeated Pap smears (3/98), 28.4% with colposcopic-directed biopsy (31/109), 63.6% with cone biopsy (35/55), and 29.7% with endometrial curettage (19/64). CONCLUSION: AGUS on Pap smears showed various benign and malignant lesions of the cervix or uterus. The clinicians must communicate with the pathologists regarding the patient's clinical information as well as the origin of the atypical glandular cells in Pap smears. We recommend that patients with AGUS on Pap smear should undergo immediate intensive diagnostic studies, including colposcopic-directed biopsy with endocervical curettage or cone biopsy, to detect cervical lesions and endometrial curettage to detect endometrial lesions.

Adult↗