Abstract

ABSTRACT Background The purpose of the study was to assess the effect of recombinant hybrid protein of tumor necrosis factor-alpha-thymosin-alpha1 (TNF-T) on B-cell component of the immune system of patients with locally advanced breast cancer (LABC). Methods Eligibility criteria included LABC of IIB-IIIB stages, ECOG ≤ 1, adequate liver, kidney and bone marrow function, no brain metastases. TNF-T 200000 IU was injected locally around the tumor on D1-5 (30 min before cytostatics injection), combined with standard FAC or PA regimens. Results 56 women were recruited between April 2012 and October 2013 (mean age 53.3 ± 1.1 years). Group A (25 pts) received TNF-T combined with PA (17) and FAC (8) up to 4 courses. Group B (31pts) received standard PA (21) and FAC (10) up to 6 courses. Immune status in both groups of patients was assessed before the treatment and after neoadjuvant chemotherapy (CT). The study showed that levels of T-lymphocytes and CD3 + CD4+ cells did not differ significantly neither in comparison of groups A and B nor in the course of treatment. Quantity of CD3 + CD8+ cells in group A (PA) was significantly higher than in group B (PA) (31.5 ± 2.8% and 21.7 ± 2.25%, respectively, p Conclusions The proposed method of the local application of recombinant hybrid protein of TNF-T has a mainly immunostimulant effect on B-cell component of the immune system. Disclosure All authors have declared no conflicts of interest.

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