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Сравнительный анализ эффективности дексаметазона и метилпреднизолона в индукции ремиссии острого лимфобластного лейкоза у детей: результаты мультицентрового исследования ALL-MB 2002
Вопросы гематологии, онкологии и иммунопатологии в педиатрии. 2015. Т. 14. № 1. С. 16-25.
Юдина Н. Б., Карачунский А. И., Румянцева Ю. В., Лагойко С. Н., Tallen G., Алейникова О. В., Быданов О. И., Korepanova N., Мансурова Е. Г., Байдун Л. В., Наседкина Т. В., Von Stackelberg A., Новичкова Г. А., Масчан А. А., Литвинов Д. В., Мякова Н. В., Пономарева Н. И., Кондратчик К. Л., Фечина Л. Г., Стренева О. В., Шарапова Г. Р., Шамардина А. В., Гербек И. Э., Шапочник А. П., Румянцев А. Г., Henze G.
This paper presents the results of randomized study of the efficacy of two glucocorticosteroids (GCS) in induction therapy of
children and adolescents with acute lymphoblastic leukemia (ALL). A total of 1064 primary patients with ALL, aged
1–18 years, were registered from 18.04.2002 to 15.11.2006 in Russia and Belarus Republic. Randomization was carried out
before induction therapy. The patients received the dexamethasone (Dexa; 6 mg/m2) “sleeve” of ALL-MB 2002 protocol
(n = 539) or the methylprednisolone (MePred; 60 mg/m2) “sleeve” of the protocol (n = 525). The survival rates virtually did
not differ: 10-year event-free survival (EFS) was 73 ± 2% in the Dexa group vs. 70 ± 2% in MePred group, p = 0.260; 10-year
overall survival (OS) was 79 ± 2 and 77 ± 2%, respectively; p = 0.232; the incidence of relapses after ALL induction therapy
by different GCS virtually did not differ. The incidence of isolated central nervous system relapses (1.7% in patients receiving
Dexa and 3% in patients treated by MePred; p = 0.138) and of combined relapses with central nervous system involvement
differed just negligibly (3.2% in Dexa group and 3.4% in MePred group; p = 0.937). The induction mortality was also similar
(3.2% in Dexa group and 3.8% in MePred group; p = 0.677). Retrospective comparison in different age groups showed
predominant efficacy of Dexa in children under 14 years of age. This fact deserves further research in prospective randomized
multicenter studies.