The beta-hCG subunit, CA 125 and CA 19-9 antigen in the women with non-trophoblastic malignancy of genital tract. Endometrial cancer

OBJECTIVES: There are few conflicting reports in regards of markers appearing in the patients with endometrial cancer. The aim of this study was to evaluate the serum levels: CA 125 antigen, CA 19-9 antigen and beta-hCG subunit in this group of patients and comparing obtained results with normal controls. MATERIALS AND METHODS: In both groups--with endometrial cancer (n = 43)- and controls-(n = 214)--CA125 antigen, CA 19-9 antigen and beta-hCG subunit the serum level were determined two = site of immunometric method. The differences of the means, correlations, specificity, sensitivity, positive predictive value, negative predictive value and efficiency were calculated. RESULTS: The women with endometrial cancer exhibited the significantly higher level of all antigens. The positive correlation between CA 125 serum level and staging and grading and between beta-hCG subunit and endometrial cancer staging was found. The positive test had: specificity--62%, sensitivity--93%, positive predictive value--66%, negative predictive value--92% and efficiency--92.5%. CONCLUSIONS: In the women with endometrial cancer appears non-specific antigens characteristic for the müllerian duct derivatives tissue, exhibiting Lewis blood group antigen and involving in membrane cell structures in normal and cancer cells. The level of these antigens correlates with grading and staging of the neoplasms.     

Diagnostic value of transvaginal ultrasound in the detection of ovarian endometriosis

The aim of the study was to estimate of efficiency of endovaginal ultrasonography in diagnosis of ovarian endometriosis. The study was performed in 59 women with ovarian tumors. Ultrasound examinations were performed with Aloka 2000 using 5.0 MHz transducers. The endovaginal ultrasonography is very useful in diagnosis of ovarian endometriosis, showing sensitivity--90%, specificity--68%, positive predictive value--75%, negative predictive value--86%. Ultrasound examination is an important tool in noninvasive diagnostic procedure of adnexal pathology.     

The beta-hCG subunit, CA 125 and CA 19-9 antigen in the women with non-trophoblastic malignancy of genital tract

OBJECTIVES: The aim of this study was preoperative estimation of serum level glicoprotein--CA 125, CA 19-9 and beta-hCG in ovarian tumors and comparison obtained values in groups divided according to postoperative pathologic examination. MATERIALS AND METHODS: In every patients with ovarian tumors before surgery the level above mentioned antigens was evaluated and compared in following groups: malignant, non-malignant and controls. In control group cut-off values was estimated. RESULTS: The levels of all investigated glycoproteins were significantly higher in malignant group comparing to benign and controls. The test differentiating non-malignant from malignant tumors was accepted as positive if at least one from markers level was elevated. Specificity of the test was 70%, sensitivity--94%, positive prognostic value--74%, negative prognostic value--94%. In the selected subgroups from non-malignant tumors the serum level of all glycoproteins was surprisingly high. CONCLUSIONS: Preoperative estimation of CA 125, CA 19-9 and beta-hCG subunit in ovarian tumors permits--at negative result--with probability 93% to qualify tumor as non-malignant and sensitivity of test is 94%.     

Preoperative evaluation of serum CA 125 levels in premenopausal and postmenopausal patients with pelvic masses: discrimination of benign from malignant disease

CA 125 levels were measured in 158 patients with palpable pelvic masses who were about to undergo diagnostic laparotomy. When the 68 patients found to have cancer were compared with the 90 patients with benign disease, those with malignancies were significantly older, were more frequently postmenopausal, and had significantly higher values of serum CA 125. Patients with benign pelvic masses had CA 125 levels greater than 65 U/ml in 8% of cases, whereas those with malignancies had CA 125 levels greater than 65 U/ml in 75% of cases. If only those patients who had frankly malignant, primary, nonmucinous epithelial ovarian carcinomas were considered, CA 125 levels greater than 65 U/ml predicted malignancy with a sensitivity of 91% for all patients. Greater sensitivity and specificity were observed in the postmenopausal subgroup than in the premenopausal subgroup. In the postmenopausal group with a 63% prevalence of ovarian cancer the predictive positive value was 98% and the predictive value negative was 72%. In a premenopausal population with a 15% prevalence of ovarian cancer the predictive value for a positive test was 49%, while the predictive value for a negative test was 93%.     

Comparison of two malignancy risk indices based on serum CA125, ultrasound score and menopausal status in the diagnosis of ovarian masses.

OBJECTIVE: To evaluate the ability of two malignancy risk indices (RMI 1 and RMI 2) incorporating menopausal status, serum CA125 level and ultrasound findings, to discriminate a benign from a malignant pelvic mass. DESIGN: A retrospective study. SETTING: Department of Obstetrics and Gynaecology, University of Siena, Italy. POPULATION: One hundred and twenty-four women over 30 years of age admitted consecutively between January 1995 and December 1997 for surgical excision of ovarian masses. MAIN OUTCOME MEASURES: The sensitivity, specificity, and positive predictive value of serum CA125, ultrasound findings and menopausal status, separately and combined into the RMI 1 and RMI 2, to diagnose ovarian cancer. RESULTS: The RMI 1 and RMI 2 were more accurate than menopausal status, ultrasound findings, and CA 125 separately in diagnosing cancer. For all cut off values between 80 and 250, RMI 2 performed better than RMI 1. The RMI 2 at a cut off level of 125 gave a sensitivity of 81%, specificity of 90%, and positive predictive value of 74%. CONCLUSIONS: We found that RMI 2 was more reliable in discriminating benign and malignant ovarian disease than RMI 1. RMI is a simple method which can be used in gynaecology clinics and less specialised centres.     

The risk of malignancy index in discrimination of adnexal masses.

OBJECTIVE: To assess the ability of the risk of malignancy index (RMI) based on a serum CA125 level, ultrasound findings and menopausal status, to discriminate benign from malignant adnexal masses. METHOD: Between September 2002 and November 2004, 296 women with adnexal masses were enrolled. The sensitivity, specificity, positive (PPV) and negative predictive values (NPV) of the CA125 serum level, ultrasound findings and menopausal status in prediction of ovarian cancer were calculated and compared individually or combined into the RMI. RESULTS: The RMI identified malignant cases more accurately than any individual criterion in diagnosing ovarian cancer. Using a cut-off level of 153 to indicate malignancy, the RMI showed a sensitivity of 76.4%, a specificity of 77.9%, a PPV of 65.9%, a NPV of 85.5% with 79.4% correct diagnosis rate. CONCLUSION: The RMI is an appropriate method in diagnosing adnexal masses with high risk of malignancy and forwarding to gynecological oncology centers for suitable surgical operations.     

Risk of malignancy index in the preoperative evaluation of pelvic masses.

OBJECTIVES: To assess the ability of a risk malignancy index (RMI) based on serum levels of CA 125, ultrasound findings, and menopausal status to discriminate between benign and malignant pelvic masses in a particular population. METHODS: A retrospective study was conducted of 100 women with pelvic masses admitted for laparotomy. The sensitivity and specificity of serum levels of CA 125, ultrasound findings, and menopausal status were calculated both separately and combined into a RMI to diagnose malignancy. RESULTS: The RMI was more accurate than any single criterion in diagnosing malignancy. Using a cut-off level of 200 to indicate malignancy, the RMI gave a sensitivity of 90%, specificity of 89%, positive predictive value of 96%, and negative predictive value of 78%. CONCLUSION: The RMI is able to correctly discriminate between malignant and benign pelvic masses. It is a simple scoring system that can be introduced easily into clinical practice to facilitate the selection of patients who would benefit from primary surgery.     

Comparison of risk of malignancy index (RMI), CA125, CA 19-9, ultrasound score,and menopausal status in borderline ovarian tumor

Objective: The aim of this study was to assess the prognostic values of risk of malignancy index (RMI IV), ultrasound score, menopausal status, and serum CA125 and CA19-9 level in patients with borderline ovarian tumor (BOT). Methods: Fifty women having borderline ovarian tumor (BOT) and 5O individuals with benign adnexal mass were enrolled in this retrospective study. The sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of preoperative serum levels of the CA125 and CA19-9, ultrasound findings and menopausal status, and RMI IV were calculated for prediction of discrimination between BOTs and benign adnexal masses and the results were compared. Results: The RMI IV was the best method for discrimination between BOTs and benign adnexal masses and was more accurate than the other parameters. When Receiver Operator Characteristic area under the curves for menopausal status was analyzed, serum CA 125 and CA19-9 level, ultrasound score, RMI IV(CA125), and RMI IV(CA19-9) were, 0.580, 0.625, 0.548, 0.694, 0.734 and 0.711, respectively. The best RMI IV cut-off was found to be 200 for discrimination of benign and BOT lesions. In the RMI formulation, replacing CA125 with CA19-9 didn’t affect RMI IV sensitivity and specificity for discrimination. Conclusion: Compared to ultrasound, menopausal status, CA-125, CA19-9, the RMI IV was found to be the best predictive method for differentiation of BOTs from benign adnexal masses. RMI IV cut–off value of 200 is suitable for differentiation of benign and BOT’s.     

Comparison of two malignancy risk indices based on serum CA125, ultrasound score and menopausal status in the diagnosis of ovarian masses

Objective To evaluate the ability of two malignancy risk indices (RMI 1 and Rh4I 2) incorporating menopausal status, serum CA125 level and ultrasound findings, to discriminate a benign from a malignant pelvic mass.
Design A retrospective study.
Setting Department of Obstetrics and Gynaecology, University of Siena, Italy.
Population One hundred and twenty-four women over 30 years of age admitted consecutively between January 1995 and December 1997 for surgical excision of ovarian masses.
Main outcome measures The sensitivity, specificity, and positive predictive value of serum CA125, ultrasound findings and menopausal status, separately and combined into the RMI 1 and RMI 2, to diagnose ovarian cancer.
Results The RMI 1 and RMI 2 were more accurate than menopausal status, ultrasound findings, and CA125 separately in diagnosing cancer. For all cut off values between 80 and 250, RMI 2 performed better than RMI 1. The RMI 2 at a cut off level of 125 gave a sensitivity of 81%, specificity of 90%, and positive predictive value of 74%.
Conclusions We found that RMI 2 was more reliable in discriminating benign and malignant ovarian disease than RMI 1. RMI is a simple method which can be used in gynaecology clinics and less specialised centres.     

Comparison of serum CA 125, clinical impression, and ultrasound in the preoperative evaluation of ovarian masses

The ability to differentiate a malignant from a benign ovarian mass was assessed for four diagnostic procedures: serum CA 125, clinical examination, original ultrasound, and reviewer ultrasound interpretation. When these tests were used individually, the sensitivity and specificity of CA 125 levels were equal to those of a review ultrasound. Overall, the sensitivity of clinical impression and original ultrasound was poor. Sensitivity and specificity were highest for CA 125 assays in postmenopausal patients, especially when these were used as the second diagnostic test. Positive and negative predictive values significantly increased among postmenopausal patients when CA 125 was added to any of the other diagnostic tests examined. In conjunction with such tests, measurement of serum CA 125 significantly increased diagnostic accuracy and may thus have an important role in the preoperative evaluation of women with ovarian masses.     

Evaluation of a risk of malignancy index based on serum CA125, ultrasound findings and menopausal status in the pre-operative diagnosis of pelvic masses

Objective To evaluate the ability of a risk of malignancy index (RMI), based on a serum CA125 level, ultrasound findings and menopausal status, to discriminate a benign from a malignant pelvic mass and to discriminate early stage (Figo Stage I) from Stages II, III and IV of ovarian cancer.
Design A prospective study.
Setting Department of Gynaecology, Trondheim University Hospital, Trondheim, Norway.
Participants One hundred and seventy-three women, 30 years or older, consecutively admitted between February 1992 and February 1994 for primary laparotomy of a pelvic mass.
Main outcome measures The sensitivity, specificity and positive predictive value of serum CA125 level, ultrasound findings and menopausal status, separately and combined into the RMI, to diagnose ovarian cancer.
Results The RMI was more accurate than any individual criterion in diagnosing cancer. Using a RMI cut-off level of 200 to indicate malignancy, the RMI derived from this dataset gave a sensitivity of 80%, specificity of 92% and positive predictive value of 83%. Applying RMI criteria developed by others, the following test performance was found: sensitivity 71%, specificity 96% and positive predictive value 89%. For the Stages II, III and IV of ovarian cancer the sensitivity increased to approximately 90% without any substantial loss in specificity.
Conclusions The risk of malignancy index is able to correctly discriminate between malignant and benign pelvic masses. It is a scoring system which can be introduced easily into clinical practice to facilitate the selection of patients for primary surgery at an oncological unit.     

恶性危险指数在盆腔肿块术前诊断中的应用

目的:评价恶性危险指数(RMI)在区分良恶性肿瘤中的作用。方法:应用RMI评价我院2 0 0 2年7月到2 0 0 3年8月间15 0例盆腔肿块患者,取RMI的阈值为2 0 0 ,计算RMI及CA12 5的敏感性、特异性、阳性预测值(PPV)及阴性预测值(NPV)。结果:RMI诊断卵巢恶性肿瘤的敏感性、特异性、PPV及NPV分别为6 3% ,87% ,85 % ,6 8% ;RMI诊断浸润性卵巢肿瘤(不包括交界性肿瘤)的敏感性、特异性、PPV及NPV分别为70 % ,87% ,83% ,77%。RMI较癌抗原12 5 (CA12 5)单独应用特异性增高。结论:RMI是一种简单易行,较为准确的鉴别良恶性卵巢肿瘤的手段,但该方法在诊断Ⅰ期及交界性卵巢肿瘤方面仍有一定局限性。     

Comparison of three risk of malignancy indices in evaluation of pelvic masses

OBJECTIVES: The aims of this study were to validate the risk of malignancy index (RMI) incorporating menopausal status, serum CA 125 levels, and ultrasound features for discriminating benign from malignant pelvic masses and to evaluate the performance of the three different risk of malignancy indices (RMI 1, RMI 2, and RMI 3). METHODS: This is a retrospective study of 152 women admitted at Kasturba Hospital, Manipal, between January 1997 and August 1999 for surgical exploration of pelvic masses. The sensitivity, specificity, and positive predictive value of serum CA 125 levels, ultrasound findings, and menopausal status were taken separately and combined into the RMI 1, RMI 2, and RMI 3 to diagnose ovarian cancer. The risk of malignancy index is the product of menopausal score, ultrasound score, and serum CA 125 levels. RESULTS: The study confirms that the malignancy risk index is more accurate than the menopausal status, serum CA 125 levels, and ultrasound features separately in diagnosing malignancy. There was no statistically significant difference in the performance of these three different malignancy risk indices in identifying malignancy. CONCLUSIONS: The risk of malignancy index is able to identify malignant and benign pelvic masses efficiently to optimize therapy. The risk of malignancy index is a simple scoring system which can be used in less specialized gynecology centers. We recommend the use of any of these risk of malignancy indices to facilitate the selection of cases for referral to an oncological unit for adequate staging and optimal debulking.     

Doppler ultrasound assessment and serum cancer antigen 125 in the diagnosis of ovarian tumors.

OBJECTIVE: To differentiate benign from malignant ovarian tumors based on sonographic detection of a solid component. METHOD: Sixty-three women with ovarian masses were evaluated preoperatively by gray scale and power/color Doppler ultrasonographic examination, with specific predefined criteria for the solid component. Sensitivity, specificity, and positive and negative predictive values were calculated and assessed against the histopathologic outcome. The contribution of cancer antigen (CA) 125 levels to the diagnostic accuracy was also assessed. RESULT: Sensitivity, specificity, and positive and negative predictive values were 100%, 95.2%, 91.3% and 100%, respectively, with two false-positive results. Had an elevated CA 125 level (>35 U/mL) been included in the malignancy criteria, the false-positive results would have been eliminated, giving an accuracy of 100%. CONCLUSION: Sonographic evaluation with predefined specific criteria for the detection of a solid tumor component is an accurate method of preoperative discrimination between benign and malignant ovarian tumors. A serum CA 125 assay may assist in eliminating false-positive results.     

以血清CA125、绝经状态和超声检查评分预测卵巢肿瘤患者术前恶性危险指数

目的：评价以血清CA125、绝经状态和超声评分对卵巢肿瘤患者术前恶性危险指数的预测。方法：分别计算血清CA125、绝经状态、超声评分和3者结合的恶性危险指数（RMI）RMI-1和RMI-2,用以诊断卵巢癌的敏感性、特异性和阳性预测值等。结果：随机测定卵巢良性肿瘤76例和恶性肿瘤37例。若以100为RMI的界值,RMI-1的敏感性、特异性分别为81.1%和93.4%。RMI-2分别为81.0%和89.5%。若以125为RMI界值,RMI-1的敏感性、特异性为78.3%和96.0%,RMI-2分别为81.0%和90.8%。RMI-1的诊断性能明显高于RMI-2。RMI的诊断准确性明显比CA125、绝经状态、超声评分单项者高,且可与其它评分方法相媲美。结论：RMI是术前比较简单、可靠、实用的鉴别诊断卵巢肿瘤性质的方法。     

The differential diagnostic potential of a panel of tumor markers (CA 125, CA 15-3, and CA 72-4 antigens) in patients with a pelvic mass

OBJECTIVE: The purpose of this study was to assess the differential diagnostic potential of a combination of CA 125, CA 15-3, and CA 72-4 antigens in the definition of malignant disease, especially ovarian carcinoma in patients with a pelvic mass. STUDY DESIGN: A total of 412 patients were evaluated in a multicenter, retrospective study. RESULTS: Two hundred twenty-six malignant, 171 benign pelvic tumors (of which 129 were benign ovarian tumors), and 15 borderline tumors were evaluated. One hundred thirty-three patients had ovarian carcinoma. In 76 cases (55%), the International Federation of Gynecology and Obstetrics stage was III or IV. Borderline tumors (n = 15) were excluded from the statistical calculations. CA 125 antigen was the most sensitive marker for ovarian carcinoma (81%). The highest specificity and positive predictive value was obtained with CA 15-3 antigen (95% and 92%, respectively). Considering a concomitant elevation of all 3 markers as positive, a positive predictive value of 97% was found. However, only 28% of the patients in the total group and 41% of the patients with ovarian carcinoma had a concomitant elevation of all 3 markers. The combination of all 3 markers with levels below the cut-off resulted in a (false-positive) positive predictive value for malignancy between 12% and 36%. With the use of logistic regression analysis, we found a correct prediction in 73% of the cases. CA 15-3 antigen makes the most significant (P <.0001) contribution to the logistic model in the prediction of malignancy in the total group, with all pelvic masses with an odds ratio of 3.86. CONCLUSION: The combination of a simultaneous elevated level of CA 125, CA 15-3, and CA 72-4 antigens was predictive for malignant disease in almost all cases. However, such concomitant elevation was found in few of the malignant masses. Logistic regression analysis revealed that CA 15-3 antigen makes the most significant contribution to a model for the prediction of malignancy in the total group. The logistic model gave a correct prediction in 73% to 83%. The present tumor marker panel seems inferior to combinations with other test modalities, which include ultrasonography and/or physical examination and/or menopausal status or age.     

Comparison of four malignancy risk indices in the preoperative evaluation of patients with pelvic masses

Objective

The aim of this study was to evaluate the ability of four malignancy risk indices (RMI 1, RMI 2, RMI 3, and RMI 4), incorporating menopausal status, serum CA125 levels, and ultrasound findings, to discriminate a benign from a malignant pelvic mass.

Study design

This is a retrospective study of 253 women admitted to the Department of Obstetrics and Gynecology of Kochi Medical School, between January 2002 and April 2005 for surgical exploration of pelvic masses. To diagnose ovarian cancer, the sensitivity, specificity, and positive predictive value of serum CA125, ultrasound findings and menopausal status were taken separately and combined into RMI 1, RMI 2, RMI 3, and RMI 4.

Results

This study confirms that, for the diagnosis of malignancy, four malignancy risk indices were more accurate than menopausal status, serum CA125 levels, and ultrasound findings separately. The accuracy of the RMI 4 was better than RMI 1 (P = 0.0013), RMI 2 (P = 0.0009) and RMI 3 (P = 0.0013). The RMI 4 at a cutoff level of 450 yielded a sensitivity of 86.8%, a specificity of 91.0%, a positive predictive value of 63.5%, a negative predictive value of 97.5%, and an accuracy of 90.4%.

Conclusion

We found that, in the discrimination between benign and malignant pelvic disease, the RMI 4 method was more reliable than RMI 1, RMI 2 and RMI 3. The RMI 4 method is a simple technique that can be used in gynecology clinics as well as less-specialized centers.