Pediatric Hematology/Oncology and ImmunopathologyPediatric Hematology/Oncology and ImmunopathologyВопросы гематологии/онкологии и иммунопатологии в педиатрии1726-17082414-9314Fund Doctors, Innovations, Science for Children58610.24287/1726-1708-2022-21-1-20-35ORIGINAL ARTICLESОРИГИНАЛЬНЫЕ СТАТЬИThe outcomes of children with acute myeloid leukemia treated in accordance with the AML–MM-2006 protocolРезультаты терапии детей с острым миелоидным лейкозом, получивших терапию по протоколу ОМЛ-ММ-2006https://orcid.org/0000-0002-0813-5626KalininaI. I.КалининаИ. И.
Russian Federation

Irina I. Kalinina, Cand. Med. Sci., a hematologist at the Department of Pediatric Hematology/Oncology

1 Samory Mashela St., Moscow 117997 

Калинина Ирина Игоревна, канд. мед. наук, врач-гематолог отделения детской гематологии/онкологии

117997, Москва, ул. Саморы Машела, 1

burbir@mail.ruhttps://orcid.org/0000-0002-0183-1530VenyovD. A.ВенёвД. А.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-2352-7716OlshanskayaYu. V.ОльшанскаяЮ. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-7918-680XSadovskayaM. N.СадовскаяМ. Н.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-8571-5395GoronkovaO. V.ГоронковаО. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-2958-1705SalimovaT. Yu.СалимоваТ. Ю.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-1258-8281PetrovaU. N.ПетроваУ. Н.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-7130-8596BaidildinaD. D.БайдильдинаД. Д.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-8404-1800SuntsovaE. V.СунцоваЕ. В.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-8610-0624EvseevD. A.ЕвсеевД. А.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-8709-5238MatveevV. E.МатвеевВ. Е.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-6001-2746AntonovaK. S.АнтоноваК. С.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-8264-2258KhaminI. G.ХаминИ. Г.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-8228-4876DubrovinaM. Е.ДубровинаМ. Э.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-9634-5828ZerkalenkovaE. A.ЗеркаленковаЕ. А.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0002-3277-9018GaskovaM. V.ГаськоваМ. В.
Russian Federation

Moscow

Москва

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

Moscow

Москва

https://orcid.org/0000-0002-5220-7412KashporS. A.КашпорС. А.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0003-4039-430XMandzhievaA. I.МанджиеваА. И.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0001-6271-7435KonyukhovaT. V.КонюховаТ. 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/0000-0003-2689-0569BalashovD. N.БалашовД. Н.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0003-0520-5630ShelikhovaL. N.ШелиховаЛ. Н.
Russian Federation

Moscow

Москва

https://orcid.org/0000-0003-1735-0093MaschanM. A.МасчанМ. А.
Russian Federation

Moscow

Москва

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

Moscow

Москва

https://orcid.org/0000-0002-0016-6698MaschanA. A.МасчанА. А.
Russian Federation

Moscow

Москва

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 России3003202221120352703202227032022Copyright ©; 2022, «D. Rogachev NMRCPHOI»Copyright ©; 2022, ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава России2022«D. Rogachev NMRCPHOI»ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава Россииhttps://creativecommons.org/licenses/by/4.0https://hemoncim.com/jour/article/view/586

Over the past years, the outcomes of patients with acute myeloid leukemia (AML) have significantly improved due to the use of intensive chemotherapy, more effective supportive therapy, and the availability of allogeneic hematopoietic stem cell transplantation. This article presents the outcomes of children with AML treated in accordance with the AML-MM-2006 protocol. Our study was approved by the Independent Ethics Committee of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. The study included 233 patients with a median age of 6.5 years (7 days – 18 years) who were stratified into the following risk groups: standard risk, intermediate risk, and high risk. The 5-year event-free survival (EFS) was 0.64 ± 0,14, 0.49 ± 0.05, and 0.43 ± 0.05 for standard-risk (n = 12), intermediate-risk (n = 106), and high-risk (n = 115) patients, respectively (p = 0.14), while the 5-year overall survival (OS) was 1.0 year, 0.7 ± 0.05 and 0.55 ± 0.05, respectively (p = 0.001). The OS in the entire cohort was 0.68 ± 0.032. Factors associated with poor prognosis included hyperleukocytosis, the presence of extramedullary lesions, and age < 1 year. The overall survival rates in these patient groups were 0.55 ± 0.08, 0.39 ± 0.09 and 0.49 ± 0.08, respectively. The worst prognosis was for patients with monosomy 7 and t(7;12) whose OS rates were 0.25 ± 0.2 and 0.4 ± 0.2, respectively. For non-responders and patients with relapsed AML, the OS was 0.33 ± 0.08 and 0.54 ± 0.06, respectively. Early death (before remission could be achieved) occurred in 4% of patients, and 3.8% of patients died in first remission. Sixtytwo percent of deceased patients died of disease progression. In the entire cohort of patients, the five-year EFS was 0.53 ± 0.047, the cumulative risk of relapse after 3 years of remission was 40%, the confidence interval was 23–89%.

Результаты лечения острого миелоидного лейкоза (ОМЛ) значительно улучшились за последние годы благодаря интенсивности проводимой полихимиотерапии, совершенствованию сопроводительной терапии и доступности аллогенной трансплантации гемопоэтических стволовых клеток. В данной статье приведены результаты терапии детей с ОМЛ в соответствии с протоколом ОМЛММ-2006. Данное исследование одобрено независимым этическим комитетом и утверждено решением ученого совета НМИЦ ДГОИ им. Дмитрия Рогачева. В исследование включены 233 пациента с медианой возраста 6,5 года (7 дней – 18 лет). Согласно стратификации на группы риска, 12 пациентов были отнесены к группе стандартного риска, 106 – к группе промежуточного риска и 115 – к группе высокого риска, для которых 5-летняя бессобытийная выживаемость составила 0,64 ± 0,14, 0,49 ± 0,05 и 0,43 ± 0,05 соответственно (p = 0,14) и 5-летняя общая выживаемость (ОВ) – 1,0, 0,7 ± 0,05 и 0,55 ± 0,05 соответственно (р = 0,001). Во всей группе пациентов ОВ была 0,68 ± 0,032. Факторами, ухудшающими прогноз заболевания, были гиперлейкоцитоз, наличие экстрамедуллярного поражения и возраст до 1 года, ОВ составила 0,55 ± 0,08, 0,39 ± 0,09 и 0,49 ± 0,08 соответственно. Наихудший прогноз был у пациентов с моносомией 7 и t(7;12), ОВ составила 0,25 ± 0,2 и 0,4 ± 0,2 соответственно. ОВ в группе рефрактерных больных была 0,33 ± 0,08 и у пациентов с рецидивом ОМЛ – 0,54 ± 0,06. Ранняя смерть до ремиссии составила 4%, смерть в первой ремиссии – 3,8% и смерть от прогрессии – 62% среди умерших пациентов. Пятилетняя безрецидивная выживаемость для всей когорты пациентов составила 0,53 ± 0,047, кумулятивный риск развития рецидива через 3 года от достижения ремиссии во всей группе – 40%, доверительный интервал 23–89%.

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