surgoncoКреативная хирургия и онкологияCreative surgery and oncology2076-30932307-0501Башкирский государственный медицинский университет10.24060/2076-3093-2022-12-2-164-171surgonco-698Research ArticleОБЗОР ЛИТЕРАТУРЫREVIEWSПротивоопухолевые лекарственные препараты «вне инструкции» в онкологииOff-Label Drug Use in Oncologyhttps://orcid.org/0000-0001-6062-5318КарабинаЕ. В.KarabinaE. V.

отделение противоопухолевой лекарственной терапии, кафедра онкологии с курсами онкологии и патологической анатомии ИДПО

 Уфа 

 Department of Anticancer Drug Therapy, Department of Oncology with  courses of Oncology and Pathological Anatomy for Advanced Professional  Education 

 Ufa 

kev-251@yandex.ruhttps://orcid.org/0000-0003-4341-6017СакаеваД. Д.SakaevaD. D.

 д.м.н., профессор, кафедра фармакологии с курсом клинической фармакологии

 Уфа 

 Dr. Sci. (Med.), Prof., Department of Pharmacology with a course of Clinical Pharmacology 

 Ufa 

https://orcid.org/0000-0002-8867-504XЛипатовО. Н.LipatovO. N.

 д.м.н., профессор, кафедра онкологии с курсами онкологии и патологической анатомии ИДПО

 Уфа 

 Dr. Sci. (Med.), Prof., Department of Oncology with courses of Oncology and Pathological Anatomy for Advanced Professional Education 

 Ufa 

Тульский областной клинический онкологический диспансер; Башкирский государственный медицинский университетРоссияTula Regional Clinical Oncology Dispensary; Bashkir State Medical UniversityRussian FederationБашкирский государственный медицинский университет; Клинический госпиталь «Мать и дитя»РоссияBashkir State Medical University; Mother and Child Clinical HospitalRussian FederationБашкирский государственный медицинский университетРоссияBashkir State Medical UniversityRussian Federation202216072022122164171Copyright © Карабина Е.В., Сакаева Д.Д., Липатов О.Н., 20222022Карабина Е.В., Сакаева Д.Д., Липатов О.Н.Karabina E.V., Sakaeva D.D., Lipatov O.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.surgonco.ru/jour/article/view/698

Использование противоопухолевых лекарственных препаратов «вне инструкции» является неотъемлемой частью рутинной клинической практики в онкологии, особенно у пациентов со злокачественными новообразованиями, не имеющих альтернативных вариантов лечения, при исчерпанности возможностей зарегистрированной терапии или с противопоказаниями к стандартным методам лечения. Наблюдающийся в последнее время переход от одиночных генных тестов к мультигенным панелям и платформам полноэкзомного и полногеномного секвенирования расширяет возможности прецизионной терапии, что повлечет за собой увеличение количества агностического использования таргетных препаратов «вне инструкции» при детекции того или иного молекулярно-генетического нарушения. Изучение проблем применения лекарственных препаратов «вне инструкции» в онкологии позволит получить информацию о целесообразности и безопасности подобных назначений у пациентов с редкими формами злокачественных новообразований при исчерпанности зарегистрированной терапии или в ситуациях с наличием противопоказаний к стандартным методам лечения. Данная статья посвящена изучению распространенности и ландшафта применения указанных препаратов не в соответствии с инструкцией по медицинскому применению у онкологических больных, а также подробному разбору термина «вне инструкции». Эта публикация демонстрирует критическое осмысление проблем использования противоопухолевых лекарственных препаратов не в соответствии с инструкцией по медицинскому применению в онкологии.

The off-label use of medicines is a routine clinical practice of oncology, especially in malignant-tumour patients with no treatment alternatives left when registered-drug options have been exhausted or standard therapies reveal contraindications. The recent shift from single-gene assays to multigene panels powered by full-exome or -genome sequencing expands the capacity of precision therapy, leading to a wider agnostic off-label use of targeted drugs for detecting a particular molecular genetic disorder. Studies of the off-label drug use in oncology will clarify the feasibility and safety of such prescriptions in patients with rare forms of malignancy when registered therapies have been exhausted or standard treatment reveals contraindications. This article examines the prevalence and landscape of off-label drug use in cancer patients and elaborates on the off-label principle. The paper presents a critical reflection on the off-label use of medicines in oncology.

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