The results of an open comparative study in parallel groups of the efficacy and safety of the Refnot^® (tumor necrosis factor – thymosin – 1 alpha recombinant) drug in the treatment of disseminated triple negative breast cancer

Ilyushin A. L.
¹

Krasnaya Y. L.
¹

Shabalkin P. I.
²

1 - «Clinic of immuno-oncology and cytokine therapy», Moscow
2 - «Clinic of Dr. Fomin», Moscow

Shabalkin Pavel Igorevich, e-mail: p.shabalkin@gmail.com

The study was sponsored by NPP Farmaklon LLC.

Authors declare no conflict of interest.

The main objective of the study was to evaluate the efficacy and tolerability of the tumor necrosis factor thymosin 1 alpha recombinant (Refnot) drug in the complex treatment of HER2/neu and ER/PR negative (triple negative) metastatic breast cancer that had not previously received antitumor treatment. A total of 276 patients (women 30–70 years old, ECOG 0–2) were included in the study and distributed by simple randomization into one of the observed comparison groups. The study group (N = 136) with the inclusion of Refnot received an AC + Refnot drug therapy regimen (doxorubicin 60 mg / m² iv on day 1 + cyclophosphamide 600 mg/m² iv on day 1. Refnot 14-21-th day – at a dose of 200 thousand units (1 ml) once a day, s/c every 21 days for 6 cycles). The control group (N = 140) received an AС regimen (doxorubicin 60 mg/m² iv on day 1 + cyclophosphamide 600 mg/m² iv on day 1 every 6 days for 6 cycles). The primary endpoint was progression-free survival, secondary endpoints: overall response (CR + PR), overall survival. Additionally, the safety profile of therapy was evaluated. Results: median progression-free survival was significantly higher in the Refnot group and was 8>4 months versus 5?8 months in the control group (p = 0.001). The overall response was also significantly higher in the group with the inclusion of Refnot (72% versus 55% in the control group, p = 0.05). Both treatment regimens had a similar safety profile. Manifestations of non-hematologic toxicity were comparable in both groups. Conclusions: AC + Refnot therapy regimen is safe and significantly improves treatment outcomes for triple-negative metastatic breast cancer.

triple-negative breast cancer, immunotherapy, tumor necrosis factor alpha, tumor necrosis factor – thymosin 1 alpha recombinant

10.29234/2308-9113-2019-7-3-138-149

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