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Blood, Vol. 93 No. 12 (June 15), 1999:
pp. 4116-4124
Double Induction Strategy for Acute Myeloid Leukemia: The Effect of
High-Dose Cytarabine With Mitoxantrone Instead of Standard-Dose
Cytarabine With Daunorubicin and 6-Thioguanine: A Randomized Trial
by the German AML Cooperative Group
Thomas Büchner,
Wolfgang Hiddemann,
Bernhard Wörmann,
Helmut Löffler,
Winfried Gassmann,
Torsten Haferlach,
Christa Fonatsch,
Detlef Haase,
Claudia Schoch,
Dieter Hossfeld,
Eva Lengfelder,
Carlo Aul,
Axel Heyll,
Georg Maschmeyer,
Wolf-Dieter Ludwig,
Maria-Cristina Sauerland, and
Achim Heinecke
From the Departments of Hematology/Oncology and of Biostatistics,
University of Münster, Münster, Germany; the Department of
Hematology/Oncology, University of Göttingen, Göttingen,
Germany; the Department of Hematology/Oncology, University of Kiel,
Kiel, Germany; the Department of Hematology/Oncology, University of
Hamburg, Hamburg, Germany; the Department of Hematology/Oncology,
University of Düsseldorf, Düsseldorf, Germany; the
Department of Cell Biology, University of Vienna, Vienna, Austria; the
Department of Hematology/Oncology Mannheim, University of Heidelberg,
Heidelberg, Germany; and the Department of Hematology/Oncology,
Robert-Rössle Medical Center, Humboldt University, Berlin,
Germany.
Early intensification of chemotherapy with high-dose cytarabine
either in the postremission or remission induction phase has recently
been shown to improve long-term relapse-free survival (RFS) in patients
with acute myeloid leukemia (AML). Comparable results have been
produced with the double induction strategy. The present trial
evaluated the contribution of high-dose versus standard-dose cytarabine
to this strategy. Between March 1985 and November 1992, 725 eligible
patients 16 to 60 years of age with newly diagnosed primary AML entered
the trial. Before treatment started, patients were randomized between
two versions of double induction: 2 courses of standard-dose cytarabine
(ara-C) with daunorubicin and 6-thioguanine (TAD) were compared with 1 course of TAD followed by high-dose cytarabine (3 g/m2
every 12 hours for 6 times) with mitoxantrone (HAM). Second courses started on day 21 before remission criteria were reached, regardless of
the presence or absence of blast cells in the bone marrow. Patients in
remission received consolidation by TAD and monthly maintenance with
reduced TAD courses for 3 years. The complete remission (CR) rate in
the TAD-TAD compared with the TAD-HAM arm was 65% versus 71% (not
significant [NS]), and the early and hypoplastic death rate was 18%
versus 14% (NS). The corresponding RFS after 5 years was 29% versus
35% (NS). An explorative analysis identified a subgroup of 286 patients with a poor prognosis representing 39% of the entire
population; they included patients with more than 40% residual blasts
in the day-16 bone marrow, patients with unfavorable karyotype, and
those with high levels of serum lactate dehydrogenase. Their CR rate
was 65% versus 49% (p = .004) in favor of TAD-HAM and was
associated with a superior event-free survival (median, 7 v 3 months; 5 years, 17% v 12%; P = .012) and overall
survival (median, 13 v 8 months; 5 years, 24% v 18%; P = .009). This suggests that the incorporation of high-dose
cytarabine with mitoxantrone may contribute a specific benefit to
poor-risk patients that, however, requires further substantiation.
Double induction, followed by consolidation and maintenance, proved a safe and effective strategy and a new way of delivering early intensification treatment for AML.
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