The median age of the 152 patients was 35 years, with a mean of 34 and a range of 17 to 71 years. The median gravidity was 3 and the median parity was 2. The majority (83%) of the patients were parous. Race distribution was: 67% black, 16% white, 11% Hispanic, and 6% other or unknown.
The conization specimen had no pathology in 26 (17%) cases. It had CIN 1 in 21 (14%). CIN 2 or 3 was present in 94 (62%), and microinvasive or invasive carcinoma was identified in 11 (7%). The endocervical margin was positive in 30 (20%) of the 152 cases and the ectocervical margin was positive in 38 (25%). Twenty (13%) of the 152 ECC specimens obtained at the time of conization were positive for dysplasia or carcinoma. In 29 (19%) of the 152 ECC specimens there was not enough tissue for histopathologic diagnosis.
Thirty-three of the 152 patients underwent a hysterectomy within 12 months of the conization. Ten had a repeat conization and 17 had a cervical biopsy with or without ECC. In addition to follow-up colposcopy and cervical cytology, 4 had an ECC. The follow-up of the other 88 patients consisted of cervical cytology and colposcopy only (ie, no biopsies were obtained). Persistent/recurrent dysplasia or cancer was seen in 41 (27%) of the 152 cases (15 CIN 1, 22 CIN 2/3, 4 carcinoma). Persistent/recurrent disease was detected by hysterectomy in 18 cases (3 CIN 1, 11 CIN 2/3, 4 carcinoma), repeat conization in 7 (3 CIN 1, 4 CIN 2/3), cervical biopsy in 2 (both with CIN 1), and cervical cytology in 14 (7 CIN 1, 7 CIN 2/3).
Table 1 presents a summary of the presence or absence of persistent/recurrent disease in patients with positive, negative or "tissue insufficient for diagnosis" on ECC. Persistent/recurrent dysplasia or cancer was present in 16 of 20 patients (80%) with a positive ECC. Nineteen of 103 patients (18.5%) with a negative ECC and 6 of 29 patients (20.7%) with insufficient tissue for histopathologic diagnosis had persistent/recurrent disease.
Persistent/recurrent dysplasia or cancer was detected in 20 of 30 patients (66.7%) with positive endocervical margins in the cervical conization specimen. Twenty-one of 122 patients (17.2%) with negative endocervical margins had persistent/recurrent disease. Eighteen of 38 patients (47.4%) with positive ectocervical margins had persistent/recurrent dysplasia or cancer. Twenty-three of 114 patients (20.2%) with negative ectocervical margins had persistent/recurrent disease. Persistent/recurrent disease was present in 26 of 52 patients (50%) with positive endocervical and/or ectocervical margins. Persistent/recurrent disease was found in 15 of 100 patients with negative endocervical and ectocervical margins.
Table 2 presents a summary of the presence or absence of persistent/recurrent cervical neoplasia as it relates to the status of the ECC specimens and the endocervical margin. Thirteen of 13 patients (100%) with both a positive ECC and positive endocervical margins had persistent/recurrent disease. Persistent/recurrent disease was detected in 13 of 91 patients (14.3%) with a negative ECC and a negative endocervical margin. Three of 7 patients (42.9%) with positive ECC and negative endocervical margins had persistent/recurrent cervical neoplasia. Six of 12 patients (50%) with negative ECC and positive endocervical margin had persistent/recurrent disease. Persistent/recurrent cervical neoplasia was detected in 1 of 5 patients (20%) with insufficient tissue for diagnosis on ECC and positive endocervical margin. Five of 24 patients (20.8%) with insufficient tissue for diagnosis on endocervical curettage and negative endocervical margins had persistent/recurrent disease.
The sensitivity of the ECC at time of conization to detect persistent/recurrent disease is 0.46 (95% confidence interval [CI]: 0.29, 0.63). The specificity is 0.96 (95% CI: 0.88, 0.99). The positive predictive value is 0.80 (95% CI: 0.56, 0.93), and the negative predictive value is 0.82 (95% CI: 0.72, 0.88). The sensitivity of the endocervical and/or ectocervical margin status to predict persistent/recurrent disease is 0.63 (95% CI: 0.47, 0.77). The specificity is 0.77 (95% CI: 0.67, 0.84). The positive predictive value is 0.50 (95% CI: 0.36, 0.64), and the negative predictive value is 0.85 (95% CI: 0.36. 0.64).
In patients with normal or CIN 1 findings on the conization specimen, 7.7% and 9.5%, respectively, had persistent/recurrent disease (3 CIN 1, 1 CIN2/3). In patients with CIN 2/3 or cancer diagnosis on the conization, 33% and 54.5%, respectively, had persistent/recurrent disease. More than 90% of patients with normal or CIN 1 on the conization did not have persistent/recurrent disease. As the severity of cervical neoplasia in the conization specimen increases, there is an increase in the percentage of patients who have persistent/recurrent disease.
Using univariate logistic regression, a positive endocervical margin (odds ratio [OR], 9.618; 95% CI: 3.939, 23.488), positive ectocervical margin (OR, 3.561; 95% CI: 1.626, 7.799), positive ECC specimens (OR, 17.683; 95% CI: 5.308, 58.912), and histopathologic diagnosis (OR, 2.730 per grade; 95% CI: 1.507, 4.947) were all individually significantly associated with the presence of persistent/recurrent disease. Age of the patient at the time of cervical conization was not significantly associated with the presence of persistent/recurrent disease (OR, 1.008; 95% CI: 0.975, 1.042).
In the multivariate stepwise logistic regression analysis, the endocervical margin status and the ECC specimen findings together, ECC specimens (OR, 8.710; 95% CI: 2.302, 32.958) and endocervical margin (OR, 9.170; 95% CI: 2.887, 29.125) were significant predictors of persistent/recurrent disease having adjusted for the other variable.
Four variables (endocervical margin status, ectocervical margin status, ECC specimen findings, and histopathologic diagnosis in the conization specimen) were combined in a multivariate stepwise logistic regression to estimate the incremental risk of persistent/recurrent disease for each factor independent of (adjusted for) the other factors. Based on this analysis, endocervical margin (OR, 6.761; 95% CI: 2.657, 17.202) and histopathologic diagnosis in the conization specimen (OR, 1.930, 95% CI: 1.038, 3.59) significantly predicted the occurrence of persistent/recurrent disease. Adding the results of the ECC specimens to the histopathologic diagnosis and the endocervical margin status did not add incremental value to the ability of predicting persistent/recurrent cervical neoplasia.
Cite this: Predicting Persistent/Recurrent Disease in the Cervix After Excisional Biopsy - Medscape - May 01, 2007.