Use of risk of malignancy index to indicate frozen section analysis in the surgical care of women with ovarian tumors.

OBJECTIVE: To evaluate the importance of the risk of malignancy index (RMI) in the decision to perform frozen section analysis among women with ovarian tumors. METHODS: A retrospective study was conducted in 11 centers in the Netherlands. Women who underwent surgical treatment of an ovarian mass with unknown histology between January 2005 and September 2009 were included. The RMI was calculated retrospectively. Frozen section analysis and RMI values were assessed for patients with benign, borderline, and malignant ovarian tumors on final histopathology. RESULTS: Overall, 670 women were included. Frozen sections were performed in 323 (48.2%) patients, of whom 206 (63.8%) were diagnosed with benign ovarian tumors, 55 (17.0%) with borderline tumors, and 62 (19.2%) with malignant tumors. Overall, 109 (16.3%) women had an RMI below 20, 106 (97.2%) of whom had benign histology results. Among 235 patients with an RMI over 100, 3 (1.3%) postmenopausal women had malignancies that were missed because frozen sections were not performed. CONCLUSION: Women with an RMI below 20 have a low risk of malignancy and therefore do not require frozen section analysis. Postmenopausal women with an RMI greater than 100 should be referred to centers where frozen sections can be performed, and proper facilities and expertise are available to perform staging procedures if necessary.

Preoperative CA-125 predicts extra-uterine disease and survival in uterine papillary serous carcinoma patients.

OBJECTIVE: We determined the clinical utility of preoperative serum CA-125 as predictor of extra-uterine disease and as prognosticator for survival in patients with uterine papillary serous carcinoma (UPSC). METHODS: Patients diagnosed with UPSC, identified between 1992 and 2009, and with preoperative CA-125 measurement were included. A receiver operator characteristic (ROC) curve was used to quantify marker performance. Overall and progression free survival were analyzed using the Kaplan-Meier method. Regression analyses were used to investigate the association of preoperative CA-125 levels and other clinicopathological variables with the presence of extra-uterine disease and the effects on survival. RESULTS: Sixty-six patients met the study criteria. Using ROC, the CA-125 concentration of 45 U/mL as cutoff level provided the best sensitivity (75%) and specificity (74%) for extra-uterine disease, with a positive predictive value of 86%. Survival was significantly longer in patients with preoperative CA-125 ≤ 45 U/mL (p<0.001). Only preoperative CA-125 >45 U/mL remained significantly associated with extra-uterine disease (OR=6.30, 95% CI 1.93-20.62). Furthermore, advanced FIGO stage (HR=4.53, 95% CI 1.50-13.62) and preoperative CA-125 >45 U/mL (HR=3.12, 95% CI 1.13-8.73) were associated with decreased survival. CONCLUSION: Preoperative elevated serum CA-125 is an independent predictor for the presence of extra-uterine disease and an independent risk factor for survival in UPSC patients.

External validation of the adapted Risk of Malignancy Index incorporating tumor size in the preoperative evaluation of adnexal masses.

OBJECTIVE: The Risk of Malignancy Index (RMI) is a simple scoring system to standardize and improve the preoperative evaluation of adnexal masses. Since 1990, three versions of the RMI have been validated in different clinical studies. Recently, a fourth version of the RMI (RMI-4) was introduced that includes tumor size as an additional parameter. The aim of this study was to validate the ability of RMI-4 to discriminate between non-invasive lesions and invasive malignant adnexal masses, and to compare its performance with RMI-3. STUDY DESIGN: Women scheduled for surgery for an adnexal mass between 2005 and 2009 in 11 hospitals were included. Ultrasonographic characteristics, menopausal status and serum CA 125 level were registered preoperatively, and combined into the RMI. The performances of RMI-3 and RMI-4 were assessed and statistically tested for differences. RESULTS: A total of 643 patients were included: 469 benign, 73 borderline and 101 malignant tumors. The RMI-3 had a sensitivity of 76%, specificity of 82%, positive and negative predictive values (PPV and NPV) of 45% and 95%, and an accuracy of 81%. The RMI-4 had a sensitivity of 74%, specificity of 79%, PPV of 40%, NPV of 94%, and an accuracy of 78%. The accuracy of RMI-3 was significantly higher than the accuracy of RMI-4 (p=.001). Both models had an area under the curve of 0.86. CONCLUSION: Both RMI-3 and RMI-4 were able to discriminate between non-invasive lesions and invasive malignant adnexal masses, with similar performances. Including tumor size in the RMI does not improve its performance.

Factors influencing the use of frozen section analysis in adnexal masses.

OBJECTIVE: To determine the factors that influence the use of frozen section analysis in adnexal masses and the factors that predict malignancy. METHODS: The study participants were women scheduled for adnexal mass surgery in 11 hospitals between 2005 and 2009. Factors that potentially influenced the use of frozen section analysis and potentially predicted malignancy were studied, such as menopausal status, CA 125 level, ultrasound characteristics, presence of adhesions, and tumor size. We used univariable and multivariable analyses to assess the factors. RESULTS: A total of 670 patients were included in the study. The frozen section analyses for 323 patients (48%) showed 206 benign, 55 borderline, and 62 malignant adnexal masses. The CA 125 level, locularity of the tumor, and presence of solid areas predicted both the use of frozen section analysis and the presence of malignancy. The presence of adhesions predicted malignancy, but not the use of frozen section analysis. Menopausal status and tumor size predicted the use of frozen section analysis, but not malignancy. CONCLUSION: Menopausal status and tumor size are associated with more use of frozen section analysis, but they have not been identified as factors associated with malignancy. Frozen section analysis is useful when the CA 125 levels are greater than 35 units/mL and when there are multilocular tumors, solid areas on ultrasonography, and adhesions revealed during surgery.

Evaluation of the Risk of Malignancy Index in daily clinical management of adnexal masses.

OBJECTIVE: To verify the effectiveness of the Risk of Malignancy Index in the discrimination between non-invasive (benign and borderline) lesions and invasive malignant adnexal masses in daily clinical practice. METHODS: This prospective observational study was conducted in a multicentre cooperation of 11 hospitals. A total of 548 women with adnexal masses were included. Ultrasound characteristics, menopausal status and serum CA 125 level were registered preoperatively, and combined into the RMI afterwards. Final diagnosis was based on routine histopathologic examination. The decision to have patients operated by or with a gynecologic oncologist was based on the clinical impression of the gynecologist in the local hospital, based on physical examination, testing of serum samples, and ultrasound examination. This was compared with the hypothetical situation in which the RMI would have been applied as method of selection. RESULTS: An RMI of 200 achieved a sensitivity of 81% and specificity of 85% in the detection of ovarian cancer. Positive and negative predictive values were 48% and 96% respectively. In current practice, 64% of ovarian cancer patients were operated by a gynecologic oncologist. This percentage would have increased to 80% if the RMI with a cutoff value of 200 would have been used as method of selection. CONCLUSIONS: In our study population, introduction of the RMI would improve the management of adnexal masses, with a higher percentage of ovarian cancer patients that are operated by a gynecologic oncologist. At the same time, referral of patients with non-invasive (benign and borderline) lesions would be reduced.