Effectiveness of Breast Cancer Recurrences Prophylaxis by means of Exogenous Peptides: Results of 24 Months Supervision

O Lytvynenko, VF Konovalenko, OFTatskyi, SV Konovalenko and VI Apostolov

Introduction: The article deals with the current state of the problem of occurrence of relapses and early metastasis of breast cancer (BC) and provides the main molecular and cellular mechanisms for avoiding systemic immune surveillance by tumor cells. The work focuses on circulating tumor cells as the main factor of the unfavorable prognosis of the disease, as well as the results of integrating the Camelyn Bio (exogenous peptides) into the BC management scheme. Objective: To study the effects of exogenous peptides on the clinical progression of breast cancer, using as a criterion disease-free survival within 24 months. Materials and Methods: The study included 76 women who had undergone subcutaneous radical mastectomy with the preservation of the skin and the nasal-arreolar complex at the stage of IIA (T1N1M0, T2N0M0). According to the recommendations of the ethics committee, the patients self-agreed to conduct the study. The statistical analysis was based on the use of descriptive statistics and comparative analysis. To compare the qualitative parameters of the studied groups, the chi-square (Pearson) criterion was used. For quantitative parameters, a preliminary assessment of the normality of distribution, which was the basis for the choice of parametric (t-test) or non-parametric criteria (Wilconson rank-sum (Mann-Whitney test), was performed. For the analysis of non-recurrent survival, Kaplan-Meier method was used. The analysis was performed using the STATA 12 statistical analysis package. Results: In the group of patients receiving exogenous peptides, there was a harmonization of immune homeostasis, manifested by increased immune surveillance over the tumor process involving activated T-lymphocytes, as well as increased expression of TNF-α and IL-12. The analysis of survival curves showed that the 24-month non-recurring survival rate of the patients in the main group was 0.918 (95% CI: 0.847-0.989), and in the comparison group -0.763 (0.628-0.898). That is, in the group of patients receiving Camelyn Bio, during the 24 months of observation there was a significant increase in non-recurring survival and a reduction in the risk of recurrence of tumors and metastases for the indicated period by 71.8%-Hazard ratio (95% CI) = 0.292 (0.094-0.907 ), p=0.046. Conclusion: The results of this work allow us to assume that the use of Camelyn Bio in patients with breast cancer leads to a significant improvement in the rate of disease-free survival in the 24-month period after surgical intervention.