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Objectives: To investigate the clinical effects of TP-based hyperthermic intraperitoneal chemotherapy (HIPEC) on the levels of antigen cluster protein 133 (CD133) and human epididymal secretory protein 4 (HE4) in patients with advanced epithelial ovarian cancer (EOC). Methods: A total of 104 patients with advanced EOC hospitalized in Affiliated Hospital of Hebei Engineering University from April 2015 to December 2018 were assigned to two groups using a random number table. A control group (n =52) treated by the conventional postoperative TP regimen and an observation group (n =52) receiving HIPEC in addition to the conventional postoperative TP regimen. CD133 and HE4 expression in serum, overall response rate (ORR), long-term efficacy, and incidence of drug toxicity were measured for comparative analysis. Results: The serum levels of CD133 and HE4 expression in the observation group were lower than in the control group (P < 0.005, respectively); the observation group surpassed the control group in ORR, 2-year survival, and progression-free survival (PFS) (P < 0.005, respectively); however, the two groups had no statistically significant difference in the incidence of drug toxicity (P > 0.05). Conclusions: TP-based HIPEC can effectively inhibit CD133 and HE4 expression in advanced EOC, which thereby improves the clinical efficacy and encourages longer survival. [ABSTRACT FROM AUTHOR]

Human epididymal secretory protein 4 (HE4) elevation has been studied as a crucial biomarker for malignant gynecological cancer, such us ovarian cancer (OC). However, there are conflicting reports regarding the optimal HE4 cut-off. Thus, the goal of this study was to develop an analytical approach to harmonize HE4 values obtained with different laboratory resources. To this regard, six highly qualified Italian laboratories, using different analytical platforms (Abbott Alinity I, Fujirebio Lumipulse G1200 and G600, Roche Cobas 601 and Abbott Architett), have joined this project. In the first step of our study, a common reference calibration curve (designed through progressive HE4 dilutions) was tested by all members attending the workshop. This first evaluation underlined the presence of analytical bias in different devices. Next, following bias correction, we started to analyze biomarkers values collected in a common database (1509 patients). A two-sided p-value < 0.05 was considered statistically significant. In post-menopausal women stratified between those with malignant gynecological diseases vs. non-malignant gynecological diseases and healthy women, dichotomous HE4 showed a significantly better accuracy than dichotomous Ca125 (AUC 0.81 vs. 0.74, p = 0.001 for age ≤ 60; AUC 0.78 vs. 0.72, p = 0.024 for age > 60). Still, in post-menopausal status, similar results were confirmed in patients with malignant gynecological diseases vs. patients with benign gynecological diseases, both under and over 60 years (AUC 0.79 vs. 0.73, p = 0.006; AUC 0.76 vs. 0.71, p = 0.036, respectively). Interestingly, in pre-menopausal status women over 40 years, HE4 showed a higher accuracy than Ca125 (AUC 0.73 vs. 0.66, p = 0.027), thus opening new perspective for the clinical management of fertile patients with malignant neoplasms, such as ovarian cancer. In summary, this model hinted at a new approach for identifying the optimal cut-off to align data detected with different HE4 diagnostic tools. [ABSTRACT FROM AUTHOR]

Objective: Human epididymal secretory protein 4 (HE4) is originally described as an epididymis specific protein but more recently suggested to be a putative serum tumor marker for ovarian cancer. The aim of this study was to investigate the association between tissue HE4 expression and the clinicopathological features of ovarian epithelial tumors. Materials and Methods: HE4 expression was studied in a total of 137 formalin-fixed, paraffin-embedded ovarian epithelial tumors specimens, and its association with different clinicopathologic parameters was evaluated. Results: In this series, there were 89 ovarian epithelial carcinomas, 12 borderline serous tumors, and 36 benign serous tumors. Among the malignant tumors, 34 were serous carcinomas, 17 were mucinous carcinomas, and 38 were endometrioid carcinomas. Statistically it was determined that as the tumor became more invasive, it gained HE4 expression (p = 0.037) and all epithelial over carcinomas demonstrated high rate of HE4 expressions. However there was no statistical difference between HE4 status and type of carcinoma or survival. Conclusion: The present findings demonstrated a link of HE4 expression and the aggressiveness of ovarian cancer. Therefore it may be suggested that the tissue expression of HE4 can be used to differentiate the borderline tumors from carcinomas. [ABSTRACT FROM AUTHOR]