In the period from June 2010 to December 2011 was in the Immunoanalytical laboratory, University Hospital Pilsen serum of 553 patients from department of Gynecology and Obstetrics examined. Patients were divided into groups by diagnosis (benign, malignant) and then into the other two groups according to menopausal status.
Total of four groups were evaluated. For all patients HE4 and CA125 were determined using the chemiluminescent Architect i1000 instrument (Abbott, USA).
In addition, ROMA indexes were calculated. In the next step ROMA values were compared with the serum HE4 and CA125 values.
Results: ROMA indexes, HE4 and CA125 were significantly increased in the group of premenopausal and postmenopausal patients with histologically confirmed ovarian cancer compared with groups of benign ovarian tumors. For differential diagnosis of benign and malignant ovarian tumors can be used ROMA indexes, HE4 and CA125 (both p-value <0.0001).
According to the AUC, we compiled a ranking usefulness of the various parameters in pre-menopausal and postmenopausal period. The highest contribution had in our group of women the calculation of ROMA2 index that is calculated in postmenopusal period (AUC = 0.9777), followed by the CA125 postmenopausal (AUC = 0.9715) and CA125 premenopausal (AUC = 0.9534).
The lowest yield was HE4 premenopausal (AUC = 0.8702). Conclusion: Values of ROMA1 index, ROMA2 index, HE4 and CA125 were significantly increased in groups of ovarian cancer compared with benign ovarian tumors groups.
All the parameters can be used for differential diagnosis of ovarian cancer. If we were talking about a possible use in primary detection of ovarian cancer ROMA2 index was the best one.
ROMA1 index did not reach such efficiency. According AUC can be observed that HE4 didn't achieve such good results as CA125.
Their combination, and especially ROMA2 index calculation shows the permissibility of HE4 inclusion into routine clinical practice.