Ai. Karachunsky et al., TREATMENT OF ACUTE LYMPHOBLASTIC-LEUKEMIA IN CHILDREN - 6-YEAR RESULTS OF NONRANDOMIZED MONOCENTER TRIAL WITH FOLLOW-UP OVER 2 YEARS, Gematologia i transfuziologia, 42(5), 1997, pp. 14-17
The paper provides a comparative assessment of efficacy of ALL childre
n treatment according to modified protocol ALL-BFM-90m versus new prot
ocol ALL-MB-91. The trial was non-randomized monocenter and included p
atients who finished the whole program. The study included all the pri
mary patients with acute lymphoblastic leukemia admitted to the hospit
al (June 1991-April 1995) and to its outpatient department (November 1
993-April 1995). Of 139 children, 73 entered protocol ALL-MB-91 and 66
-protocol ALL-BFM-90m. The remission was achieved in 96 and 92%, a com
plete remission continues in 73 and 68% of patients on protocols ALL-M
B-91 and ALL-BFM-90m, respectively. Uneventful 6-year survival was abo
ut 70% for boths protocols. The analysis by risk groups defined in eac
h protocol reports survival for the standard risk group (by ALL-BFM-90
criteria) 80% and 62%, for moderate risk group 65 and 79% for protoco
ls ALL-BFM-90m and ALL-MB-91, respectively, According to the criteria
of the program ALL-MB-91, uneventful survival of the standard risk gro
up reached 80 and 70%, of risk groups 47 and 77% for protocols ALL-BFM
-90m and ALL-MB-91, respectively. Probability of survival for risk gro
up patients on protocol ALL-BFM-90m was significantly lower than for s
tandard risk group (p<0.01). To make final conclusions on the treatmen
ts results, multicenter study is needed which is now under way.