[The results of a multicenter trial of acute lymphoblastic leukemia treatment on ALL-MB 91/ALL-BFM 90m in children: analysis of efficacy and toxicity].
OBJECTIVE
A comparative analysis of efficacy and toxicity of two chemotherapy regimens: standard German protocol ALL-BFM 90m and less intensive original test protocol ALL-MB 91 in a multicenter trial of acute lymphoblastic leukemia (ALL) in children.


METHODS
In 1995-2002 a total of 834 patients with newly diagnosed ALL aged 0-18 years were admitted to 10 clinics of Russia. Of them, 713 were randomized in two groups: treatment program ALL-BFM 90m (n = 355) and ALL-MB 91 program (n = 358).


RESULTS
In 7-year follow-up median, 10-year event-free survival (EFS) and overall survival (OS) did not differ significantly between the groups and was 67 +/- 3 and 68 +/- 3% (ALL-MB 91) and 74 +/- 2, 71 +/- 3% (ALL-BFM 90m), respectively. Though the rate of isolated recurrences in CNS in patients on the protocol ALL-MB 91 was 2.8%, they developed only in 0.8% patients of the standard risk group. Anemia, thrombocytopenia and agranulocytosis developed less frequently, hospital stay was significantly shorter on the test protocol vs the control one (p < 0.01).


CONCLUSIONS
EFS and OS on the test (ALL-MB 91) and control (ALL-BFM 90m) protocols were equivalent in lower toxicity and cost of therapy.
Karachunskiĭ
A I
AI
Miakova
N V
NV
Rumiantseva
Iu V
IuV
Timakov
A M
AM
Makhortykh
T Zh
TZh
Fechina
L G
LG
Shamardina
A V
AV
Dudkin
S A
SA
Lebedev
V V
VV
Varfolomeeva
S R
SR
Timofeeva
V N
VN
Herold
R
R
Stakelberg
A
A
Henze
G
G
Rumiantsev
A G
AG
D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D001215:Asparaginase / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003520:Cyclophosphamide / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D003561:Cytarabine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D003630:Daunorubicin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D015122:Mercaptopurine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D008727:Methotrexate / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome; D014750:Vincristine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use