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High-dose cytosine arabinoside and mitoxantrone: a highly effective regimen
in refractory acute myeloid leukemia
W Hiddemann, H Kreutzmann, K Straif, WD Ludwig, R Mertelsmann, R Donhuijsen- Ant, E Lengfelder, Z Arlin and T Buchner
In a clinical phase I/II study, high-dose cytosine arabinoside and
mitoxantrone (HAM) were given in combination to 40 patients with refractory
acute myeloid leukemia. All patients had received a 9-day combination of
thioguanine, Ara-C, and daunorubicin (TAD-9) as standardized first-line
treatment. Refractoriness was defined as (a) nonresponse against two TAD-9
induction cycles, (b) early relapse within the first 6 months on monthly
maintenance or after TAD-9 consolidation, (c) relapse after 6 months with
nonresponse against one additional TAD-9 cycle, and (d) second and
subsequent relapses after successful TAD-9 therapy at the preceding
relapse. Therapy consisted of HD-Ara-C 3 g/m2 every 12 hours on days 1
through 4; mitoxantrone was started at 12 mg/m2/day on days 3, 4, and 5 and
was escalated to 4 and 5 doses of 10 mg/m2/day on days 2 through 5 and 2
through 6. Of the 40 patients, 21 achieved a complete remission (53%), 1
patient had a partial remission, and 5 patients were nonresponders.
Thirteen patients died in aplasia due to infections (n = 11), pericardiac
effusion, or acute cardiomyopathy. Nonhematologic side effects consisted
predominantly of nausea and vomiting, mucositis, and diarrhea. Central
nervous system (CNS) symptoms were observed during six treatment courses.
Recovery of blood counts occurred at a median of 27 days from the onset of
treatment; the median time to complete remission was 36 days. Two of the 21
responders underwent successful bone marrow transplantations. The median
remission duration for the remaining 19 patients is 4.5 months, and the
median survival time is 9 months. These data emphasize that HAM has high
antileukemic activity in refractory AML and strongly suggest starting the
combination at earlier stages in AML therapy.
Volume 69,
Issue 3,
pp. 744-749,
03/01/1987
Copyright © 1987 by The American Society of Hematology
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