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Low-dose versus high-dose methotrexate during remission induction in
childhood acute lymphoblastic leukemia (Protocol 81-01 update)
CM Niemeyer, RD Gelber, NJ Tarbell, M Donnelly, LA Clavell, SR Blattner, K Donahue, HJ Cohen and SE Sallan
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA
02115.
We evaluated event-free survival (EFS) and leukemia-free interval (LFI) of
children treated for acute lymphoblastic leukemia (ALL). Patients were
randomized to receive either a low dose or high dose of methotrexate (MTX)
as a single agent at the time of diagnosis. Five days later, multidrug
therapy was begun. We assessed the early antileukemic efficacy of the two
doses of MTX, as well as toxicity and long-term efficacy. An increase in
cell kill, as indicated by a larger decrease in the percentage of viable
cells in the bone marrow between days 0 and 5, was observed for the
high-dose MTX group when compared with the low-dose MTX group (P = .04). At
7.1 years of median follow- up, the 38 children randomized to receive
high-dose MTX had a better EFS and LFI compared with the 39 patients
randomized to receive low- dose MTX. The 7-year percentages (+/- SE) for
EFS were 82% +/- 6% for high-dose MTX and 69% +/- 7% for low-dose MTX (P =
.13). The 7-year percentages for LFI were 91% +/- 5% and 69% +/- 7%,
respectively (P = .01). We recommend that high-dose MTX be considered as an
effective addition to induction therapy in childhood ALL.
Volume 78,
Issue 10,
pp. 2514-2519,
11/15/1991
Copyright © 1991 by The American Society of Hematology
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