Pediatric Hematology/Oncology and ImmunopathologyPediatric Hematology/Oncology and ImmunopathologyВопросы гематологии/онкологии и иммунопатологии в педиатрии1726-17082414-9314Fund Doctors, Innovations, Science for Children97210.24287/1726-1708-2025-24-1-116-125ORIGINAL ARTICLESОРИГИНАЛЬНЫЕ СТАТЬИPegylated asparaginase during induction therapy in children with intermediate-risk acute lymphoblastic leukemia: results of a randomized studyПегилированная аспарагиназа в индукции у детей с острым лимфобластным лейкозом промежуточного риска: результаты рандомизированного исследованияhttps://orcid.org/0000-0002-9300-198XKarachunskiyA. I.КарачунскийА. И.
Russian Federation

Alexander I. Karachunskiy - Dr. Med. Sci., Professor, Director of the Institute of Oncology, Radiology and Nuclear Medicine.

1 Samory Mashela St., 117997, Moscow

Карачунский Александр Исаакович, д-р мед. наук, профессор, директор Института онкологии, радиологии и ядерной медицины.

117997, Москва, ул. Саморы Машела, 1

aikarat@mail.ruhttps://orcid.org/0000-0002-3793-104XLagoykoS. N.ЛагойкоС. Н.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-9670-3728RumyantsevaYu. V.РумянцеваЮ. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-1105-8676ZharikovaL. I.ЖариковаЛ. И.
Russian Federation

Moscow

Москва

BydanovO. I.БыдановО. И.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-4779-1896MyakovaN. V.МяковаН. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-7265-0414KhachatryanL. A.ХачатрянЛ. А.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-7461-0050LitvinovD. V.ЛитвиновД. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-0889-6986PopovA. M.ПоповА. М.
Russian Federation

Moscow

Москва

PshonkinA. V.ПшонкинА. В.
Russian Federation

Moscow

Москва

KondratchikK. L.КондратчикК. Л.
Russian Federation

Moscow

Москва

FechinaL. G.ФечинаЛ. Г.
Russian Federation

Yekaterinburg

Екатеринбург

PlaksinaO. I.ПлаксинаО. И.
Russian Federation

Nizhny Novgorod

Нижний Новгород

PonomaryovaN. I.ПономареваН. И.
Russian Federation

Moscow

Москва

LebedevV. V.ЛебедевВ. В.
Russian Federation

Krasnodar

Краснодар

BoychenkoE. G.БойченкоЭ. Г.
Russian Federation

Saint Petersburg

Санкт-Петербург

https://orcid.org/0000-0003-0143-1921AleinikovaO. V.АлейниковаО. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-2322-5734NovichkovaG. A.НовичковаГ. А.
Russian Federation

Moscow

Москва

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of the Russian FederationФГБУ «Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева» Минздрава РоссииThe N.I. Pirogov Russian National Research Medical University of Ministry of Healthcare of the Russian FederationФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава РоссииRegional Children's Clinical HospitalГАУЗ СО «Областная детская клиническая больница»Nizhny Novgorod Regional Children's Clinical HospitalГБУЗ НО «Нижегородская областная детская клиническая больница»Russian Children's Clinical Hospital of the N.I. Pirogov Russian National Research Medical University of Ministry of Healthcare of the Russian FederationРоссийская детская клиническая больница – филиал ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава РоссииRegional Children's Clinical Hospital of Ministry of Healthcare of the Krasnodar KraiГБУЗ «Детская краевая клиническая больница» Минздрава Краснодарского краяChildren's City Multi-Specialty Clinical Center of High Medical TechnologiesСПб ГБУЗ «Детский городской многопрофильный клинический специализированный центр высоких медицинских технологий»080420252411161252703202527032025Copyright ©; 2025, «D. Rogachev NMRCPHOI»Copyright ©; 2025, ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава России2025«D. Rogachev NMRCPHOI»ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава Россииhttps://creativecommons.org/licenses/by/4.0https://hemoncim.com/jour/article/view/972

This study investigated the efficacy and safety of the use of pegaspargase on day 3 of remission induction in children with intermediate-risk acute lymphoblastic leukemia (ALL). The study was approved by the Independent Ethics Committee and the Scientific Council of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of the Russian Federation. The study included 1470 children with intermediate-risk ALL. The patients were randomized into two groups to receive pegaspargase (1000 IU/m²) on day 3 of induction or not to receive pegaspargase. There was no significant difference in event-free survival between the pegaspargase and non-pegaspargase groups. In the pegaspargase group, the cumulative incidence of relapse was significantly lower (8.3% vs. 13.1%; p = 0.02). A particularly notable reduction in relapse incidence was seen in the patients with B-lineage ALL, especially in those over 10 years of age. There were no significant differences in early mortality, overall survival, and incidence of hypersensitivity reactions between the two groups. The administration of pegaspargase on day 3 of induction in the patients with intermediate-risk ALL significantly reduced relapse rates without increasing toxicity. This finding led to the inclusion of pegaspargase in the updated ALL MB 2015 protocol, which is now routinely used in the treatment of children and adolescents with ALL in Russia.

В данном исследовании оценивались эффективность и безопасность применения пэгаспаргазы на 3-й день индукции ремиссии у детей с острым лимфобластным лейкозом (ОЛЛ) промежуточного риска. Исследование одобрено независимым этическим комитетом и утверждено решением ученого совета ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава России. В исследование были включены 1470 детей с ОЛЛ промежуточного риска. Пациенты были рандомизированы на 2 группы: с введением пэгаспаргазы (1000 Е/м2) на 3-й день индукции и без применения данного препарата. В обеих группах не было обнаружено значимой разницы в бессобытийной выживаемости. В группе пациентов с введением пэгаспаргазы наблюдалась значимо более низкая кумулятивная частота рецидива: 8,3% против 13,1%, (p = 0,02). Снижение частоты рецидива было более выраженным у пациентов с B-линейным ОЛЛ, особенно у детей старше 10 лет. Между группами не было отмечено значимой разницы в ранней смертности, общей выживаемости и частоте реакций гиперчувствительности. Введение пэгаспаргазы на 3-й день индукции у пациентов с ОЛЛ промежуточного риска значимо снизило частоту рецидива без увеличения токсичности. Это привело к внедрению введения пэгаспаргазы на 3-й день индукции в протокол «Москва–Берлин 2015» (ALL-MB 2015), который в настоящий момент рутинно применяется в России у детей и подростков с ОЛЛ.

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