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Blood, Vol. 94 No. 4 (August 15), 1999:
pp. 1226-1236
Intensive Treatment of Children With Acute Lymphoblastic Leukemia
According to ALL-BFM-86 Without Cranial Radiotherapy: Results of Dutch
Childhood Leukemia Study Group Protocol ALL-7 (1988-1991)
W.A. Kamps,
J.P.M. Bökkerink,
K. Hählen,
J. Hermans,
H. Riehm,
H. Gadner,
M. Schrappe,
R. Slater,
E. van den Berg-de Ruiter,
L.A. Smets,
G.A.M. de Vaan,
R.S. Weening,
J.F. van Weerden,
E.R. van Wering, and
A. van der Does-van den Berg
From the Dutch Childhood Leukemia Study Group (DCLSG), The Hague, The
Netherlands; Beatrix Children's Hospital, University Hospital,
Groningen, The Netherlands; the Department of Pediatrics, University
Hospital, Nijmegen, The Netherlands; Sophia Children's Hospital,
University Hospital, Rotterdam, The Netherlands; the Department of
Medical Statistics, University of Leiden, Leiden, The Netherlands; Emma
Kinderziekenhuis Academic Medical Center, Amsterdam, The Netherlands;
the Department of Clinical Genetics/Department of Cell Biology and
Genetics, Erasmus University, Rotterdam, The Netherlands; the Division
of Experimental Therapy, The Netherlands Cancer Institute, Amsterdam,
The Netherlands; the Berlin-Frankfurt-Münster (BFM) Group,
Hannover, Germany; the Dutch Workgroup on Cancer Genetics and
Cytogenetics (NWKGC); the Department of Pediatric
Hematology and Oncology, Medizinische Hochschule, Hannover, Germany; St
Anna Kinderspital, Vienna, Austria; and the Department of Medical
Genetics, University of Groningen, Groningen, The Netherlands.
In The Netherlands from July 1988 to October 1991, children (0 to 16 years of age) with de novo acute lymphoblastic leukemia (ALL)
were treated according to protocol ALL-7 of the Dutch Childhood Leukemia Study Group (DCLSG). In this protocol, chemotherapy and treatment stratification were identical to the ALL-BFM-86
protocol (Reiter et al, Blood 84:3122, 1994), but
cranial irradiation was restricted to patients with initial central
nervous system (CNS) involvement. Patients were stratified
into 3 risk groups, based on leukemia cell mass and response to initial
treatment: standard-risk group (SRG), risk group (RG), and experimental
group (EG). As in ALL-BFM-86, a randomized study on late
intensification (protocol S) was performed in RG patients, and during
the study (since October 1990), early reinduction treatment (protocol
II) was introduced for SRG patients. Treatment duration for all
patients was 18 months. Two hundred eighteen children entered the
study: 74 SRG, 127 RG, and 17 EG patients. The overall complete
remission (CR) rate was 98%. The 5-year event-free survival (EFS) for
all DCLSG ALL-7 patients was 65.3% (standard error [SE]
3.2%), which was significantly different from the 73% (SE 1%) 5-year
EFS achieved in the ALL-BFM-86 study (P = .02, Z-test).
However, restricting the analysis to SRG patients receiving protocol II
with a total duration of treatment of 18 months, the 5-year EFS rates
were 64.6% (SE 4.0%) and 67% (SE 4%), respectively, and no
significant difference could be established (P = .67, Z-test). The 5-year EFS rates for SRG, RG, and EG patients were 63.5%
(SE 5.6%), 66.6% (SE 4.2%), and 63.3% (SE 12.0%), respectively.
SRG patients receiving protocol II fared better than patients not
receiving protocol II (5-year EFS 76.7% [SE 7.7] and 54.5% [SE
7.5], respectively). No difference in 5-year EFS was observed in RG
patients randomized to receive or not to receive late
intensification with protocol S. The overall CNS relapse rate at 5 years was 5.5%. The incidence rate at 5 years was 11.4% in SRG
patients not receiving protocol II, whereas no CNS relapses occurred in
SRG patients receiving protocol II. Six children died in first complete
remission and 2 children developed a second malignancy (thyroid
carcinoma and acute nonlymphoblastic leukemia). Systemic high-dose
methotrexate (MTX) and intrathecal chemotherapy is a safe
and effective method of CNS prophylaxis in the context of BFM-oriented
treatment for all children with ALL, regardless of the risk group (with
the possible exception of T-ALL patients with high white blood cell
counts). The results of the DCLSG ALL-7 study confirm those of the
ALL-BFM-86 study showing that early reinduction with protocol II is
essential in the treatment of SRG patients and that late
intensification with protocol S does not improve the prognosis for RG patients.
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