CLINICAL EFFECTIVENESS OF ERBISOL® ULTRAPHARM IN COMPLEX TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
DOI:
https://doi.org/10.32471/oncology.2663-7928.t-23-4-2021-g.10048Keywords:
chemotherapy, Erbisol® Ultrapharm, nonsmall cell lung cancer, therapeutic effectAbstract
Aim: to study the effectiveness of the ERBISOL® ULTRApharm in the complex treatment of patients with disseminated non-small cell lung cancer (NSCLC). Object and methods: 84 patients with stage T2–4N1–3M1 NSCLC. All the patients received 6 palliative courses (at intervals 21 days) of chemotherapy (CT): gemcitabine (1000 mg/m2 on days 1 and 8); cisplatin (85 mg/m2 on 1 day). Patients in the experimental group received ERBISOL® ULTRApharm according to the appropriate scheme (course duration 19 days) in addition to each course of CT. Two months after completion of 6 courses of CT in combination with ERBISOL® ULTRApharm, patients of the main group with partial regression or stabilization of the tumor process received two immunotherapy courses with ERBISOL® ULTRApharm. Patients in control and experimental groups with cancer disease progression received 4 courses of the second-line CT (each 3 weeks — paclitaxel 225 mg/m2 on day 1; carboplatin AUC 6, on day 1) after 2–3 months of the end of primary CT. In addition to the second-line CT, patients in the experimental group received ERBISOL® ULTRApharm according to the scheme similar to primary CT. Standard clinical, laboratory and instrumental methods of patient examination were used. The effectiveness of the drug was assessed by the level of the objective tumor response, the duration of the stabilization period, patient survival, characteristics of patients’ quality of life and the toxicity of CT. Results: the application of ERBISOL® ULTRApharm allowed to achieve a significant improvement in clinical symptoms and the indexes of clinical and biochemical examination and led to a decrease in the frequency of CT adverse reactions, an improvement of life quality (Karnowski index 66.3% vs 51.9% in the control group). Disease stabilization was registered in 57.1% patients in the experimental group and in 40.5% in the control group; partial regression was seen in 11.9% and 2.4% patients in the experimental and control groups respectively. Conclusions: the application of ERBISOL® ULTRApharm allowed to achieve a positive therapeutic effect in patients with NSCLC, namely, to reduce CT side effects, to improve life quality, to prolong disease stabilization, and to increase overall and 12-month survival. ERBISOL® ULTRApharm can enrich the arsenal of tools for nowadays immunotherapy of patients with malignant neoplasms.
References
Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021; 71 (3): 209–49.
Thun MJ, Henley SJ, Travis WD. Lung cancer. In: Thun M, Linet MS, Cerhan JR, Haiman CA, Schottenfeld D, eds. Cancer Epidemiology and Prevention. 4th ed. Oxford University Press; 2018: 519–78.
Jemal A, Miller KD, Ma J, et al. Higher lung cancer incidence in young women than young men in the united states. N Engl J Med 2018; 378 (21): 1999–2009.
Fidler-Benaoudia MM, Torre LA, Bray F, et al. Lung cancer incidence in young women vs. young men: A systematic analysis in 40 countries. Int J Cancer 2020; 147 (3): 811–9.
World Health Organization. WHO Report on the Global Tobacco Epidemic, 2008: the MPOWER package [Internet]. Geneva: World Health Organization; 2008 p. 329 p. Available from: https://apps.who.int/iris/handle/10665/43818
World Health Organization. WHO report on the global tobacco epidemic, 2019: offer help to quit tobacco use [Internet]. Geneva: World Health Organization; 2019 p. 209 p. Available from: https://apps.who.int/iris/handle/10665/326043
Wang JB, Huang X, Li FR. Impaired dendritic cell functions in lung cancer: a review of recent advances and future perspectives. Cancer Commun (Lond) 2019; 39 (1): 43.
Lung cancer incidence and mortality with extended follow-up in the national lung screening trial. J Thorac Oncol 2019; 14 (10): 1732–42.
Pastorino U, Silva M, Sestini S, et al. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol 2019; 30 (7): 1162–9.
de Koning HJ, van der Aalst CM, de Jong PA, et al. Reduced lung-cancer mortality with volume ct screening in a randomized trial. N Engl J Med 2020; 382 (6): 503–13.
Domagala-Kulawik J, Raniszewska A. How to evaluate the immune status of lung cancer patients before immunotherapy. Breathe (Sheff) 2017; 13 (4): 291–6.
Domagala-Kulawik J, Osinska I, Hoser G. Mechanisms of immune response regulation in lung cancer. Transl Lung Cancer Res 2014; 3 (1): 15–22.
Aerts JG, Hegmans JP. Tumor-specific cytotoxic T cells are crucial for efficacy of immunomodulatory antibodies in patients with lung cancer. Cancer Res 2013; 73 (8): 2381–8.
Burkholder B, Huang RY, Burgess R, et al. Tumor-induced perturbations of cytokines and immune cell networks. Biochim Biophys Acta 2014; 1845 (2): 182–201.
Galluzzi L, Senovilla L, Zitvogel L, et al. The secret ally: immunostimulation by anticancer drugs. Nat Rev Drug Discov 2012; 11 (3): 215–33.
Lyamina S, Malyshev I. Polarization of macrophages in the modern concept of the formation of the immune response. Fundamental research 2014; (10): 930–5. (in Russian)
Sarbaeva N, Ponomareva YU, Milyakova M. Macrophages: variety of phenotypes and functions, interaction with foreign materials. Genes & Cells 2016; 11 (1): 9–17. (in Russian)
Nikolayenko A. Conceptual approaches in the development of highly effective new generation drugs of the «ERBISOL®» class. News of pharmacy1998; (6): 68–74.
Nikolayenko A. Analysis of antigens of the plasma membranes of hepatocytes of the regenerating rat liver. Ukr Biochem J 1992; 64 (1): 29–35.
Nikolayenko A. The main directions in the creation and implementation of a new drug Erbisol. New Ukrainian medical product Erbisol 1994; 4–9.
Bazyka D, Gladkij A, Kornilina E, Nikolayenko A. Features of the influence of the ERBISOL® class drug on the expression of surface markers of blood cells of healthy donors and patients with immunosuppression of cellular immunity in vitro and in the dynamics of treatment. News of pharmacy 2009; (1): 39–47. (in Russian)
Nikolayenko A. Pharmacological features of highly effective new generation drugs of the «ERBISOL®» class. Praktikuyuchiy likar 2018; 7 (2): 5–15. (in Russian)
Nikolayenko A, Bazyka D, Drannik G, et al. The influence of drugs of the «ERBISOL®» class on the production of cytokines and the expression of surface markers of blood cells in healthy donors and cancer patients. Eurasian J Oncol 2016; 4 (1): 79–89. (in Russian)
Chubenko A, Babich P, Lapach S, et al. Principles of application of statistical methods in conducting clinical trials of medicinal products. Methodical Recommendations. Kyiv: АVК Izdatel’skiy dom «Аvitsenna», 2003. 60 p. (in Russian)