Background: Most prior studies investigating the risk of ovarian malignancy algorithm (ROMA) with cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) have involved Caucasian population or other populations. To date, there have been no unique calculations of predicted probability (PP) risk specifically for Chinese populations to help physicians in primary care settings.
Methods: A group of 534 women with ovarian tumor diagnoses were enrolled and serum HE4 and CA125 were measured in each individual. Modified cut-off values were obtained by maximizing area under the curve (AUC) values and adjusted by using logistic regression with corresponding sensitivity (SN), specificity (SP), Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV).
Results: By utilizing the ideal PPV, NPV, and AUC values, in premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively. The same test values for postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively. The SN for HE4 with the modified cut-off value was significantly lower than that for CA125 (P=0.040) in premenopausal women and lower than that for ROMA (P=0.001) and PP (P=0.044) in postmenopausal women. The AUC values for CA125, ROMA, and PP were all significantly higher than that for HE4 (P=0.006, 0.007, and 0.002, respectively) in postmenopausal women.
Conclusions: The modified cut-off values for HE4, CA125, ROMA, and PP with ideal SN, SP, YI, NPV, PPV were useful of ruling out ovarian malignancy among both pre- and post-menopausal women. In premenopausal women modified HE4, CA125, ROMA, and PP cut-off values were 73.87 pmol/L, 61.60 U/mL, 18.47%, and 0.168, respectively and in postmenopausal women were 120.90 pmol/L, 76.21 U/mL, 26.48%, and 0.485, respectively.
Keywords: Ovarian tumor (OC); cut-off values; predicted probability model.
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