The clinical efficacy of drugs of “ERBISOL” class in the treatment of colorectal cancer patients with liver metastases

O. Nikolaenko¹, V. Zhylchuk^2,3, G. Maksim’yak², Yu. Chyshkevich², O. Sichkoriz³, N. Bezdenezhnykh⁴, Yu. Kudryavets⁴

¹Scientific-Production Center “Erbis”, Kyiv, Ukraine

²Rivne Region Oncology Hospital, Rivne, Ukraine

³Danylo Halytsky Lviv National Medical University, Lviv, Ukraine

⁴R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology NAS of Ukraine, Kyiv, Ukraine

kudryavets@mail.ru

Introduction: In recent years the incidence of colorectal cancer (CRC) is significantly increased in all countries, including Ukraine. The problem is CRC metastasis in the liver at the time of diagnosis in 25–30% of patients. Aim: To improve the efficiency of treatment of CRC patients with liver metastases using drugs of “ERBISOL” class (Kyiv, Ukraine). Patients and Methods: The study included 111 CRC patients with liver metastases at the disease stage T1–4N0–2M1. All patients underwent surgical treatment. The patients were divided into 2 groups: group 1 (control, 54 patients) who underwent treatment by Roswell-Park scheme; group 2 (57 patients), which, on chemotherapy Roswell-Park scheme held 18 cycles of treatment with Erbisol Ultrapharm.. The study protocol was approved by Ethical committee. Results: According to preliminary research, Erbisol Ultrapharm is a metabolic antimutagen, its use helped to reduce the number of multiaberrant and aneuploid cells, also Erbisol Ultrapharm exhibits properties of natural cytostatic agent that inhibits the abnormal cell growth. The analysis of the clinical course of the disease showed that in patients of group 2 general condition has been improved without local and general side events, and allergic reactions. In group 2, stabilization of the disease occurred in almost half of cases, compared with control patients where the progression of the disease was recorded in two thirds of patients. Additional biotherapy with Erbisol showed improvement in clinical response and duration of stable disease (13.5 months ± 1.0 in the main group, 7.4 ± 1.1 months in the control group, p <0.05); and the median duration of effect (13.3 ± 1.0 months in the main group, 7.0 ± 1.1 months in the control group, p < 0.05). The trend for improved clinical effect was observed in patient survival rate. Conclusion: The use of drugs of “Erbisol” class in the combined treatment of CRC patients is a new and promising approach improving treatment effectiveness. Combined therapy of CRC patients with liver metastases using 5-FU and drugs of “Erbisol” class prolongs duration of disease stabilization and increases patient survival (p < 0.05).

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