Abstract:Objective To investigate the predictive value of serum regulatory T cell (Treg) frequency combined with carcinoembryonic antigen (CEA) and human epididymal secretory protein 4 (HE4) for the clinical outcome of ovarian cancer.Methods We retrospectively analyzed the clinical data of 98 ovarian cancer patients and 80 healthy volunteers who received physical examinations in the Second Affiliated Hospital of Chongqing Medical University and Sichuan Cancer Hospital from February 2019 to January 2021, and they were recorded as the study group and the control group, respectively. The Treg frequency, and CEA and HE levels were tested in all participants. Patients with ovarian cancer were evaluated after the last chemotherapy, and were divided into complete remission group (62 cases) and incomplete remission group (36 cases) based on the clinical outcome. The clinical characteristics of patients in the complete remission group and the incomplete remission group were compared. Multivariable Logistic regression model was applied to determine the factors affecting the clinical outcome of patients with ovarian cancer. The receiver operating characteristic (ROC) curve was used to analyze the predictive value of the combination of serum Treg frequency, CEA and HE4 for the clinical outcome of ovarian cancer.Results The Treg frequency, and CEA and HE4 levels in the study group were higher than those in the control group (P < 0.05). After the last chemotherapy, the complete remission rate in 98 ovarian cancer patients was 63.27%. The proportions of poorly differentiated tumors, lymph node metastasis, residual lesions with a diameter > 1 cm after the operation, and the non-adherence to the whole course of chemotherapy, serum Treg frequency, and CEA and HE4 levels were higher in the incomplete remission group than those in the complete remission group (P < 0.05). Multivariable Logistic regression analysis showed that non-adherence to the whole course of chemotherapy [O^R = 2.824 (95% CI: 1.052, 4.375) ], serum Treg frequency [O^R = 2.843 (95% CI: 1.368, 5.172) ], CEA level [O^R = 3.267 (95% CI: 2.046, 7.815) ] and HE4 level [O^R = 3.618 (95% CI: 2.368, 8.754) ] were risk factors affecting the clinical outcome of ovarian cancer patients (P < 0.05). The receiver operating characteristic (ROC) curve analysis exhibited that the sensitivities of serum Treg frequency, CEA level, HE4 level and the combination of these indicators for predicting the clinical outcome of ovarian cancer were 66.67%, 72.22%, 69.44% and 63.89%, with the specificities being 74.19%, 69.35%, 72.58% and 96.77%, and the areas under the ROC curve (AUCs) being 0.738, 0.751, 0.674 and 0.904, respectively.Conclusions The combination of serum Treg frequency, CEA level and HE4 level exhibits relatively high efficacy in predicting the clinical outcome of patients with ovarian cancer.