vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2025-655vedomostiregmed-655Research ArticleДОКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ: КУРС НА ТРАНСЛЯЦИОННОСТЬPRECLINICAL TRIALS: A COURSE TOWARDS TRANSLATIONALITYМетоды доклинической оценки эффективности противоопухолевых лекарственных средств in vivo (обзор)Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines in vivo (Review)https://orcid.org/0000-0002-3295-8411ВасютинаМ. Л.VasyutinaM. L.

Васютина Марина Львовна

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Marina L. Vasyutina

2 Akkuratov St., St Petersburg 197341

vasyutina_ml@almazovcentre.ruhttps://orcid.org/0000-0002-4056-050XЛепикК. В.LepikK. V.

Лепик Кирилл Викторович, канд. мед. наук

ул. Рентгена, 12, Санкт-Петербург, 197022

Kirill V. Lepik, Cand. Sci. (Med.)

12 Roentgen St., St Petersburg 197022

lepikkv@gmail.comhttps://orcid.org/0000-0002-2497-653XИстоминаМ. С.IstominaM. S.

Истомина Мария Сергеевна

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Maria S. Istomina

2 Akkuratov St., St Petersburg 197341

ist_mary@mail.ruhttps://orcid.org/0000-0002-2883-2496ЛевчукК. А.LevchukK. A.

Левчук Ксения Александровна

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Ksenia A. Levchuk

2 Akkuratov St., St Petersburg 197341

ksenialevchuk2@gmail.comhttps://orcid.org/0000-0002-7298-5238ПетуховА. В.PetukhovA. V.

Петухов Алексей Вячеславович

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Alexey V. Petukhov

2 Akkuratov St., St Petersburg 197341

alexeysakhalin@gmail.comЩелинаЕ. В.ShchelinaE. V.

Щелина Екатерина Викторовна

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Ekaterina V. Shchelina

2 Akkuratov St., St Petersburg 197341

katfromspb@yandex.ruhttps://orcid.org/0000-0002-5791-8360ЕршоваА. Е.ErshovaA. E.

Ершова Алина Евгеньевна

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

Олимпийский просп., д. 1, Краснодарский край, федеральная территория «Сириус», 354340

Alina E. Ershova

2 Akkuratov St., St Petersburg 197341

1 Olympic Ave, Sirius Federal Territory, Krasnodar Region 354340

lina.ershova.99@gmail.comhttps://orcid.org/0000-0003-4323-7174ДемидовО. Н.DemidovO. N.

Демидов Олег Николаевич, д-р мед. наук 

Тихорецкий пр., д. 4, Санкт-Петербург, 194064

Олимпийский просп., д. 1, Краснодарский край, федеральная территория «Сириус», 354340

Oleg N. Demidov, Dr. Sci. (Med.)

4 Tikhoretsky Ave, St Petersburg 194064

1 Olympic Ave, Sirius Federal Territory, Krasnodar Region 354340

demidov.on@mail.ruhttps://orcid.org/0000-0003-1629-7868ТороповаЯ. Г.ToropovaYa. G.

Торопова Яна Геннадьевна, д-р биол. наук 

ул. Аккуратова, д. 2, Санкт-Петербург, 197341

ул. Ивана Черных, д. 31–33, Санкт-Петербург, 198095

Yana G. Toropova, Dr. Sci. (Biol.)

2 Akkuratov St., St Petersburg 197341

31–33 Ivan Chernykh St., St Petersburg 198095

yana.toropova@mail.ruФедеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр им. В.А. Алмазова» Министерства здравоохранения Российской ФедерацииРоссияV.A. Almazov National Medical Research CenterRussian FederationНИИ детской онкологии, гематологии и трансплантологии имени Р.М. Горбачевой, Федеральное государственное бюджетное образовательное учреждение высшего образования «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Министерства здравоохранения Российской ФедерацииРоссияR.M. Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Academician I.P. Pavlov First St Petersburg State Medical UniversityRussian FederationФедеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр им. В.А. Алмазова» Министерства здравоохранения Российской Федерации; Научно-технологический университет «Сириус»РоссияV.A. Almazov National Medical Research Center; Sirius University of Science and TechnologyRussian FederationФедеральное государственное бюджетное учреждение науки «Институт цитологии РАН»; Научно-технологический университет «Сириус»РоссияInstitute of Cytology of the Russian Academy of Sciences; Sirius University of Science and TechnologyRussian FederationФедеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр им. В.А. Алмазова» Министерства здравоохранения Российской Федерации; Институт аналитического приборостроения Российской академии наукРоссияV.A. Almazov National Medical Research Center; Institute for Analytical Instrumentation of the Russian Academy of SciencesRussian Federation202502072025153289300Copyright © Васютина М.Л., Лепик К.В., Истомина М.С., Левчук К.А., Петухов А.В., Щелина Е.В., Ершова А.Е., Демидов О.Н., Торопова Я.Г., 20252025Васютина М.Л., Лепик К.В., Истомина М.С., Левчук К.А., Петухов А.В., Щелина Е.В., Ершова А.Е., Демидов О.Н., Торопова Я.Г.Vasyutina M.L., Lepik K.V., Istomina M.S., Levchuk K.A., Petukhov A.V., Shchelina E.V., Ershova A.E., Demidov O.N., Toropova Y.G.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/655ВВЕДЕНИЕ

ВВЕДЕНИЕ. Основной риск низкой транслируемости результатов доклинических исследований препаратов для лечения онкологических заболеваний в клиническую практику базируется на сложности моделирования клинических условий в эксперименте. Всего около 5% из общего числа препаратов-кандидатов оказываются эффективными в клинических условиях, поэтому поиск новых подходов для доклинической оценки эффективности противоопухолевых лекарственных препаратов является одним из актуальных направлений в медицине.

ЦЕЛЬ

ЦЕЛЬ. Анализ и систематизация методов, используемых в доклинических исследованиях эффективности противоопухолевых средств в условиях in vivo, для формирования методической поддержки при планировании экспериментальной работы с моделированием опухолевого процесса.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Рассмотрены этапы создания опухолевых моделей на животных, выбора клеточных линий, их тестирования на туморогенность и жизнеспособность. Показано, что использование систем визуализации, окраски витальными красителями, флуоресцентного и люминесцентного методов позволяет производить оценку эффективности противоопухолевых препаратов на моделях как солидных, так и гематологических опухолей. Основные разновидности опухолевых моделей на мышах представлены в виде схемы. Показано, что универсальной модели для экспериментального моделирования опухолевых заболеваний in vivo не существует. Особое внимание при выборе моделей и оценке их преимуществ и недостатков следует уделять сходству механизмов заболевания в модели и у человека на тканевом и молекулярном уровнях в зависимости от поставленных задач исследования.

ВЫВОДЫ

ВЫВОДЫ. Результаты проведенного сравнительного анализа методов доклинической оценки эффективности противоопухолевых средств необходимы для планирования экспериментальных исследований и для обеспечения достоверности получаемых результатов. Правильный выбор метода исследований позволит повысить успех трансляции экспериментальных данных в клиническую практику.

INTRODUCTION

INTRODUCTION. The main risk to the clinical translatability of preclinical results for anticancer medicinal products is posed by the difficulty of simulating clinical conditions in an experimental model. With only 5% of product candidates proving clinically effective, the search for new approaches to the preclinical development of anticancer medicinal products is currently an active area of research in medicine.

AIM

AIM. This study aimed to provide methodological support for planning experiments with modelling of neoplastic processes through analysis and classification of the methods used in preclinical studies of the efficacy of anticancer medicinal products in vivo.

DISCUSSION

DISCUSSION. This article reviews the development of animal tumour models and the selection of cell lines and their testing for tumourigenicity and viability on a step-by-step basis. According to the study results, imaging systems, vital staining, and fluorescence- and luminescence-based methods can be used to assess the efficacy of anticancer medicinal products in both solid tumour models and haematological malignancy models. The article presents a schematic representation of the main types of mouse cancer models. However, no single animal species is universally suitable for in vivo cancer modelling. Researchers selecting models and considering their advantages and disadvantages should pay special attention to the similarity of disease mechanisms in animal models and humans at the tissue and molecular level, keeping in mind the aims of their research.

CONCLUSIONS

CONCLUSIONS. The results of this comparative analysis of methods for preclinical efficacy evaluation of anticancer medicinal products are essential for designing experimental studies and ensuring the reliability of the results obtained. Choosing the correct research method will increase the chances of obtaining experimental data that can be successfully translated into clinical practice.

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The authors declare that there are no conflicts of interest present.