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Six-year experience with a comprehensive approach to the treatment of
recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85). A
relapse study of the BFM group
G Henze, R Fengler, R Hartmann, B Kornhuber, G Janka-Schaub, D Niethammer and H Riehm
Department of Hematology and Oncology, University Children's Hospital,
Berlin, Germany.
Between April 1985 and March 1987 130 children and adolescents up to 18
years of age with first relapse of acute lymphoblastic leukemia (ALL) were
registered on the stratified and randomized multicentric trial ALL- REZ BFM
85 designed for patients pretreated with intensive front-line therapies.
Stratification criteria were time and site of relapse: bone marrow (BM)
relapse on or up to 6 months after stopping front-line therapy (group A),
BM relapse beyond 6 months after therapy (group B), and isolated
extramedullary relapse at any time (group C). Treatment consisted of
alternating courses of polychemotherapy including randomly administered
high- or intermediate-dose methotrexate (HDMTX:12 g/m2 as 4-hour infusion;
IDMTX: 1 g/m2 as 36-hour infusion). During maintenance therapy the patients
received daily oral thioguanine and biweekly intravenous (IV) MTX. The
overall second complete remission (CR) rate was 92% (groups A, B, and C:
88%, 92%, and 100%), and the probability of event-free survival (EFS) at 6
years is 0.31 +/- 0.04 (groups A, B, and C: 0.18 +/- 0.05, 0.30 +/- 0.07,
and 0.72 +/- 0.11). HDMTX did not prove to be superior to IDMTX, which led
to premature stopping of randomization. Risk factor analyses showed early
relapse, particularly BM relapse within 18 months, and T-cell phenotype to
be independent predictors of poor outcome. The incidence of central nervous
system (CNS) relapses following BM relapse was 19%, indicating that
reprophylaxis to the CNS with IV/intrathecal (IT) MTX was insufficient. For
17 children who received bone marrow transplantation in second CR from
HLA-compatible siblings the EFS was 0.53 +/- 0.12 at 5 years. Their outcome
was not influenced by the above-mentioned risk factors. With the proposed
treatment regimen long-lasting second remissions can be achieved in about
one third of patients even after intensive front- line treatment.
Volume 78,
Issue 5,
pp. 1166-1172,
09/01/1991
Copyright © 1991 by The American Society of Hematology
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