Results of the first randomized multicentre trial on childhood acute lymphoblastic leukaemia in Russia.

Abstract:

:Until 1990, the survival of children with acute lymphoblastic leukaemia (ALL) in Russia was below 10%. To establish a protocol feasible under conditions there, ALL-MB 91 was designed to avoid prolonged bone marrow aplasia, thereby reducing needs for extensive supportive care, blood transfusions, long-lasting hospitalization and costs. High-dose therapies were avoided, anthracycline use was limited and CNS radiation therapy only foreseen in high-risk patients (about 30%). This was randomized against a modified BFM protocol. From 1995 to 2002, 834 patients of age up to 18 years were registered in 10 centres and 713 received after central randomization the allocated risk-stratified treatment. After a median follow-up of 7 years, the event-free survival (EFS) was 67+/-3% on ALL-MB 91 (N=358) vs 68+/-3% on ALL-BFM 90m (N=355). The overall survival (OS) was 71+/-3% vs 74+/-2%, respectively. Anaemia, thrombocytopenia, agranulocytosis >10 days and hospitalization (median 35 vs 68 days) were lower on ALL-MB 91 (P<0.01, N=197). While EFS and OS were similar with both protocols, ALL-MB 91 significantly incurred fewer toxicity and resource requirements and, therefore, has been increasingly used across Russia.

journal_name

Leukemia

journal_title

Leukemia

authors

Karachunskiy A,Herold R,von Stackelberg A,Miakova N,Timakow A,Mahortih T,Bajdun L,Maschan A,Fechina L,Shamardina A,Dudkin S,Lebedev V,Varfolomeeva S,Timofeeva V,Roumiantseva J,Chipsanova N,Rumjanzew A,Henze G

doi

10.1038/leu.2008.63

subject

Has Abstract

pub_date

2008-06-01 00:00:00

pages

1144-53

issue

6

eissn

0887-6924

issn

1476-5551

pii

leu200863

journal_volume

22

pub_type

杂志文章,多中心研究,随机对照试验

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