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Background/aim: To compare the diagnostic reliability, accuracy and safety of ultrasound-guided biopsy (Tru-Cut biopsy) and ascites puncture in patients with a primarily inoperable malignant ovarian tumor., Patients and Methods: This is a retrospective analysis of the studied methods in consecutively examined patients and a prospective validation of these methods. 79 women with a suspected primarily inoperable ovarian tumor underwent Tru-Cut biopsies and were included in the ultrasound-guided biopsy group. In addition, 55 patients after ascites puncture were enrolled in the comparison group. Both procedures were performed in 48 patients for the prospective validation., Results: Significant differences in favour of ultrasound-guided biopsy were found in all studied variables (malignancy confirmation 72.9% vs. 95.8%, tumor origin 52.1% vs. 89.6%, histologic subtype 43.8% vs. 85.4% and accuracy, i.e. agreement of preoperative and definitive diagnosis 43.7% vs. 95.4%)., Conclusion: Ultrasound-guided biopsy is an accurate, reliable, safe and minimally invasive method. Owing to the high reliability and accuracy, it has the capacity to replace ascites puncture with cytologic examination or a more invasive method (laparoscopy, laparotomy) for adequate tumor sampling., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Aim: To analyze the utility of HE4 assessment in preoperative management of patients with early-stage endometrial cancer for stratification into low-risk and high-risk groups., Patients and Methods: The following data were prospectively collected from patients operated for endometrial cancer from 05/2012 till 9/2016; age, HE4, CA125, expert ultrasound examination of the pelvis, histotype, grade, FIGO stage., Results: In total, 124 patients were enrolled. A cut-off of ≥113 pmol/l HE4 demonstrated 40.3% sensitivity and 83.9% specificity for detection of high-risk patients. Correlations of HE4 with age (p<0.001), depth of myometrial invasion (p=0.001), clinical stage of the disease according to ultrasound - T1a vs. T1b (63.6 pmol/l vs. 110.6 pmol/l, p<0.001) were found. However, no correlation of HE4 with lymph node invasion (p=0.07) and tumor grade (p=0.212) was identified., Conclusion: HE4 levels correspond to clinical and FIGO stage of the disease. The sensitivity and specificity does not reach the transvaginal ultrasound results in preoperative assessment of the extent of the disease. Combination of HE4 with ultrasound does not improve the stratification of patients into low-risk and high-risk groups. Preoperative assessment of HE4 is useful providing no imaging method is available., (Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Aim: The aim of the present study was to compare the use of cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) biomarkers in patients with endometrial cancer for preoperative management and to particularly focus on relationship between CA125 and HE4 and disease stage in predicting myometrial invasion or intrauterine tumor spread., Patients and Methods: Thirty-four patients diagnosed with endometrial cancer and 32 healthy controls were enrolled into the pilot study in the period between May 2012 and March 2013. Blood from all the females was collected and examined for CA125 and HE4. Based on standardized ultrasound examination, including gynecological examination, the clinical disease stage was determined., Results: We found a significant difference (p<0.0001) for means of serum levels of HE4: females with endometrial cancer, 75.5 pmol/l, versus healthy females, 40.0 pmol/l. A non-significant statistical difference was found for mean serum CA125 levels (p=0.4442): females with endometrial cancer 19.0 IU/l, versus healthy females, 15 IU/l. A significant correlation with histopathological disease stage was found for both biomarkers (Spearman correlation). Sensitivity and specificity, and the related cut-off for HE4 suggest that HE4 would be a more appropriate biomarker for differential diagnosis between benign and malignant states., Conclusion: Based on our pilot study, we found that parallel examination of HE4 and CA125 may support endometrial ultrasound finding verification prior to biopsy. This study is ongoing and we expect that results on a larger population may enable HE4 measurement to be implemented in routine practice.

Aim: The first aim of the project was to evaluate the benefits of the determination of human epididymis protein 4 (HE4) and the risk of ovarian malignancy algorithm (ROMA) index for primary detection of ovarian cancer in a population of Czech women. The second aim was to study the advantages HE4, cancer antigen 125 (CA125) and ROMA index for distinguishing between benign and malignant tumors. Aware of the age distribution of ovarian cancer, we focused on postmenopausal patients., Patients and Methods: Our group of patients consisted of 256 females, 21 with ovarian cancer and 235 with benign ovarian tumors. All diagnoses were histologically verified. We determined the serum levels of HE4 and CA125 and calculated the ROMA2 index for postmenopausal women. Serum levels of the analytes were measured using an Architect 1000i instrument. Serum samples were collected prior to surgery or any other form of treatment and the results of the two groups of patients were compared (malignant vs. benign)., Results: There was a significant difference in the serum levels for all parameters studied between the groups of patients with malignant and those with benign diagnoses (Wilcoxon test, p<0.0001). When all parameters were evaluated at 95% specificity, the HE4 cut-off was 112 pmol/l at a sensitivity of 71.42%, a positive predictive value (PPV) of 55.56%, a negative predictive value (NPV) of 97.14% and an area under the curve (AUC) of 0.9152. The CA125 cut-off was 81 IU/l at a sensitivity of 80.95%, a PPV of 58.62%, a NPV of 98.23% and an AUC of 0.9731. ROMA2 index had a cut-off 37.70% at a sensitivity of 85.71%, a PPV of 62.06%, a NPV of 98.65% and an AUC of 0.9803. The highest diagnostic efficiency was achieved by the ROMA2 index., Conclusion: Determination of HE4 along with CA125 and ROMA2 index calculation is a suitable method for the improvement of the primary detection of ovarian cancer. This approach also improves the differential diagnostic possibilities for distinguishing between malignant and benign tumors.

Background: An ovarian cancer marker panel including leptin, prolactin, osteopontin, insulin-like growth factor II (IGFII), macrophage migration inhibitory factor and CA125 was tested for multiplex marker measurement. Multiplex was compared to single assayed tumour markers: CA125, TPS, thymidine kinase, monototal and HE4., Patients and Methods: The serum marker levels in ovarian cancer patients were compared to controls with benign ovarian disease. xMAP technology was used for multiplex panel and routine immunoanalytic methods for other markers., Results: Considering the multiplexed markers, only CA125(Luminex), osteopontin and IGF-II differed significantly between groups. Levels of all non-multiplexed tumour markers were significantly higher in the cancer group compare to the control., Conclusion: Multiplex is a powerful tool for multiparametric studies, but we are still in the era of looking for the right marker combinations for cancer diagnostics and monitoring. The panel will be tested on a larger ovarian cancer cohort and in patients with other cancer and non-cancerous diseases.