Journal of Clinical Oncology, Vol 12, 1939-1945, Copyright © 1994 by American Society of Clinical Oncology
Comparison of two schedules of intermediate-dose methotrexate and cytarabine consolidation therapy for childhood B-precursor cell acute lymphoblastic leukemia: a Pediatric Oncology Group study
VJ Land, JJ Shuster, WM Crist, Y Ravindranath, MB Harris, RA Krance, D Pinkel and DJ Pullen
St Louis Children's Hospital, Washington University Medical Center, MO.
PURPOSE: To compare efficacy and toxicity of two schedules of
intermediate-dose methotrexate (IDM) and cytarabine (Ara-C) in remission
consolidation of childhood acute lymphoblastic leukemia (ALL). PATIENTS AND
METHODS: In 1986, the Pediatric Oncology Group (POG) began a randomized
trial to test two schedules of consolidation chemotherapy in children with
newly diagnosed B-precursor cell ALL. MTX and Ara-C were given as
overlapping 24-hour infusions. The dose and sequence of MTX and Ara-C
administration were based on a preclinical model that had demonstrated
synergism between these two agents. Two hundred fifteen patients in
complete remission were randomized to front- loading consolidation therapy
in which six MTX/Ara-C infusions were administered at 3-week intervals from
the 7th through the 19th week of therapy. Two hundred thirteen patients in
complete remission were randomized to receive standard consolidation
therapy in which the six MTX/Ara-C infusions were given every 12 weeks from
the 7th through the 67th week of therapy. RESULTS: Both regimens produced
similar rates of adverse side effects, except for a higher incidence of CNS
toxicity in individuals randomized to the front-loading arm (32 of 215 v 12
of 213 patients, P = .002). Leukoencephalopathy occurred in three patients
on the front-loading regimen and was permanent in one. By Kaplan-Meier
analysis, the probability of continuing in complete remission for 5 years
was 79% (SE = 5%) and 85% (SE = 5%) for good-risk patients, and 66% (SE =
6%) and 61% (SE = 7%) for poor-risk patients randomized to front-loading
and standard regimens, respectively. CONCLUSION: Although differences in
complete remission durations were not statistically significant by log-rank
analysis (P = .62 for good-risk patients, .89 for poor-risk patients, and
.99 overall), the results are comparable to those in previous studies using
more toxic agents as components of remission consolidation therapy.
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