Tumor markers are laboratory tests that optimize the diagnosis, follow-up and treatment of patients with neoplastic diseases.
Oncological diseases take second place after cardiovascular diseases as a cause of mortality. In women, the most common localization of cancers are the mammary gland, colon, rectum and anus, body of the uterus, cervix, ovary.
Ovarian cancer is the fourth leading cause of death from malignant tumors in women worldwide. For Europe, the death rate from ovarian cancer is 3.6 – 9.3 per 100,000 women.
The approach to oncological diseases is complex – after a detailed anamnesis and physical examination, together with imaging methods, TM complements the diagnosis and follow-up of patients, but the interpretation of all these data should be carried out only by medical specialists.
Tumor markers (TM) are substances that are produced by tumor tissue or their synthesis is provoked during tumor growth. According to their chemical composition, TM can be enzymes, hormones, glycoproteins, products of immune synthesis, etc.
To improve the assessment of the risk of malignancy of the tissue mass in the area of the ovaries and fallopian tubes, a risk algorithm for ovarian malignancy – ROMA (risk of ovarian malignancy algorithm) has been developed, which includes the simultaneous examination of two tumor markers – HE4 (human epididymis protein , human epididymis protein) and CA 125 (carbohydrate antigen 125). The results of this combined test are interpreted together with the results of other research methods – clinical examination, ultrasound and other imaging methods. In addition, the ROMA index was also associated with menopausal status in outcome calculations that correlated with the likelihood of malignancy.
The simultaneous increase of both HE4 and CA 125 suggests the presence of gynecological malignancies.
Elevated levels of CA 125 alone with low HE4 levels are more suggestive of gynecological benign disease.
In comparative studies of patients with ovarian cancer and healthy, it is found that HE4 has the highest diagnostic sensitivity of the other proteins that prove ovarian cancer. The combination of the two markers HE4 and CA 125 was found to be more accurate at predicting cancer than either test alone. The sensitivity of the test combination was found to be 76% and the specificity was 95%.
It is important for the treatment of malignant disease to start at an early stage. The combination of clinical examination of the patient, CA 125 testing, and imaging showed the highest degree of predictability for malignancy.
The possibility of using the HE4 test to monitor the development of malignant ovarian cancer or its recurrence is being investigated. Currently, multiple monitoring of HE4 in the same patient is used in combination with other research methods (clinical, imaging and other laboratory markers).