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Abstract
The little is known about the influence of recombinant hybrid protein of tumor necrosis factor-alpha-thymosin-alpha1 (TNF-T) on angiogenesis in breast cancer (ВС). The aim of the study was to investigate markers of angiogenesis and vascular proliferation in the tumor and to evaluate the efficacy of TNF-T in the neoadjuvant treatment of locally advanced breast cancer (LABC). Eligibility criteria included LABC of IIB-IIIB stages, ECOG ≤ 1, adequate kidney, liver and bone marrow function, no brain metastases. TNF-T 200000 IU was used peritumorally (injected around the tumor) on D1-5 (30 min before cytostatics injection), combined with standard FAC or PA regimens. The factors of angiogenesis CD31 and CD34 were studied in trephine-biopsy specimens before treatment and in postsurgical biopsies of the tumor after TNF-T courses. 82 women were recruited between April 2012 – October 2013 (mean age 53.3 ± 1.1 years). Group A (30 pts) received TNF-T combined to PA (17) and FAC (13) up to 6 courses. Group B (52pts) received standard PA (31) and FAC (21). Tumor response (TR) in Group A was 80% and in Group B 71.9% (p < 0.05), including CR 15% and 6.25%, correspondingly (p < 0.05). The number of vessels of the microcirculation in sight was for CD31: 5,9 ± 0,34 before treatment and 2,24 ± 0,35 after treatment (p < 0.05); CD34: 6.88 ± 1.07 and 2,75 ± 0,72, respectively (p < 0.05). The VEGF level in the main group decreased from 0,62 ± 0,11 to 0,11 ± 0,07(p < 0.05). The level of EGFR in the main group decreased from 0,87 ± 0,13 to 0,18 ± 0,05 (p < 0.05). All patients in Group A were operated successfully, no postoperative complications connected with TNF-T use were observed. By the time of abstract submission OS in Group A was 35.6 ± 1.2mos, in Group B was 34.1 ± 1.1mos; EFS in Group A was 33.5 ± 1.1mos, in Group B was 28.7 ± 1.2mos (p < 0.05). Three-year EFS in group A is 20% higher than in group B (83% and 63% respectively, log-rank test p = 0,04778). TNF-T injected peritumorally allows to increase the antitumor activity of cytostatics (CR) which is of great importance for survival in LABC. The data acquired in the biopsies show that the recombinant protein of TNF-T has the suppressive effect on angiogenesis.
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