Journal of Clinical Oncology, Vol 6, 213-217, Copyright © 1988 by American Society of Clinical Oncology
Combination of mitoxantrone and etoposide in refractory acute myelogenous leukemia--an active and well-tolerated regimen
AD Ho, T Lipp, G Ehninger, HJ Illiger, P Meyer, M Freund and W Hunstein
University of Heidelberg, Tubingen, West Germany.
Both mitoxantrone and etoposide have been shown to be active in monotherapy
trials of relapsed and refractory acute myelogenous leukemia (AML). This
phase II study was undertaken to assess the antitumor activity and toxicity
of the combination in refractory and poor-risk AML. The regimen consisted
of mitoxantrone, 10 mg/m2/d intravenously (IV), and etoposide, 100 mg/m2/d
as short infusion, both on days 1 to 5. Sixty-one patients are evaluable
for response and toxicity. Twenty-one were primarily refractory to
conventional courses of cytarabine, daunorubicin, and thioguanine; 20
patients had poor-risk first relapse (relapse within 6 months of first
complete remission [CR] or relapse under continuous maintenance therapy);
11 had second or subsequent relapses; and nine developed secondary AML
after myelodysplastic phase or myelofibrosis. Twenty-six patients (42.6%)
attained a CR and seven (11.5%) a partial remission (PR). The median
duration of continuous CR was 4.7 months, with a range of 21 days to 14
months, excluding four patients who underwent autologous bone marrow
transplantation. Severe myelosuppression was observed in all patients, with
a median time to CR of 49 days. Nonhematologic toxicity included stomatitis
(mainly grade 1 and 2) in 41 patients, nausea (mainly grade 1 and 2) in 44,
infections (mainly grade 3) in 33, and fever of unidentified origin in 11.
Other than transient, mild cardiac failure in nine patients, in some of
them combined with grade 1 to 2 tachyarrhythmia, no other drug-related
cardiac events were observed. Two cases of early death within the first 6
weeks of treatment were registered. Thus, the combination of mitoxantrone
and etoposide is a highly active and well-tolerated regimen for refractory
and poor-risk AML.
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