A Prospective Study Of ROMA Analyzing Chinese Women With Pelvic Masses For The Differential Diagnosis Of Ovarian Cancer And Benign Gynecological Diseases

ObjectiveOvarian cancer has the highest mortality of gynecologic malignant tumors. If the pelvic malignant tumor was not treated immediately as the main pathological type of ovarian cancer, the patients will suffer serious threat to life. Clinical examinations attach great importance to pelvic mass. But if it has early diagnosis with standard treatment, the5years survival rate can be higher than70%. In the other way around, the5years survival rate in advanced patients is less than20%. Many enclosed masses are very difficult to determine the benign or malignancy before surgery, or more specifically, before obtaining pathologic diagnosis.The early diagnosis of pelvic mass is beneficial to patients with malignant tumor getting standard treatment of specialist so as to improve curative effect. Therefore, after founding pelvic mass, further differentiate the benign or malignancy is a focus in research of diagnosis and treatment of gynecological malignant tumor.CA125is the earliest tumor marker for ovarian cancer detection. For decades, it has been recognized by the clinicians in China and abroad. HE4is the tumor marker that attracts the most attention in recent years. Both of them in the diagnosis of ovarian cancer show good sensitivity and specificity.ROMA (the risk of ovarian malignancy algorithm) is a diagnostic index which combines the two tumor markers, aiming at improving the tumor markers’ performance in the diagnosis of ovarian cancer. This prospective study investigates whether there is any advantage of ROMA in the differential diagnosis of ovarian cancer and benign gynecological diseases in Chinese women.MethodsCollect patients referred to the Women’s hospital, school of Medical, Zhejiang University from April,2012to January2013. The study enrolled women=18years of age whose imaging examination (ultrasound or CT scan) presenting with a pelvic mass. The serum CA125value must be=50U/mL for premenopausal and=35U/mL for postmenopausal. The laparotomy or laparoscopy was operated and every sample had a pathological report. Patients with a history of ovarian cancer or peritoneal cancer, any known active malignancy, bilateral ovaries removed, and pregnant women were excluded. The serum levels of CA125, HE4and FSH (follicle-stimulating hormone) were determined by use of chemiluminescent microparticle immunoassays(CMIA) on an Architect(?)(Abbott Laboratories). FSH reflects the function of ovarian. The menopausal status is based on FSH. The threshold of FSH is20mIU/mL. Calculate the ROMA values. Analyze the performance of CA125, HE4(human epididymis protein) and ROMA. The values between2and more than2subgroups were compared by use of the Mann-Whitney and Kruskall-Wallis tests, respectively. The Abbott and Roche CA125assays were compared by the use of Deming regression and we analyzed residuals with the Bland-Altman plot. Receiver operating characteristic (ROC) curves were used to evaluate the diagnostic performance of CA125, HE4and ROMA. Results1. The age of patients was from19to80years old. The average age was36years old.277cases were premenopausal and41cases were postmenopausal. Pathological diagnosis including39(12%) cases of malignant ovarian tumors (29EOC,5metastatic cancer, etc.),264(83%) cases of benign ovarian diseases, and15(5%) cases of borderline rumors.2. Significantly higher CA125, HE4and ROMA were found in patients with ovarian cancers and borderline tumors than in endometriosis and other benign diseases.3. Both values of HE4and ROMA were significantly higher in stages III-IV than stages I-II.4. By ROC curve analysis, the AUC value of ROMA, HE4and CA125was0.927,0.907and0.785, respectively. When the threshold of CA125was171.45U/mL, the sensitivity was76.9%and the specificity was81.4%. When the threshold of HE4was59.2pmol/L, the sensitivity was76.9%and the specificity was92.8%. When the threshold of ROMA was21.16, the sensitivity was82.1%and the specificity was93.6%. For the discrimination of benign gynecological diseases from ovarian cancer, the sensitivity was87.2%for ROMA and specificity was97.3%for HE4.5. The levels of CA125detected by Abbott laboratories and Roche were positively correlated, the correlation coefficient was0.983.ConclusionsAs a new tumor marker, HE4shows a high specificity in Chinese population, while ROMA algorithm that is combination of HE4and CA125shows high sensitivity. ROMA has a good value in the differential diagnosis of ovarian cancer and benign gynecological diseases in women with pelvic mass.