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Prepublished online as a Blood First Edition Paper on June 28, 2002; DOI 10.1182/blood-2002-02-0532.
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Blood, 1 January 2003, Vol. 101, No. 1, pp. 64-70
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Early blast clearance by remission induction therapy is a major
independent prognostic factor for both achievement of complete
remission and long-term outcome in acute myeloid leukemia: data
from the German AML Cooperative Group (AMLCG) 1992 Trial
Wolfgang Kern,
Torsten Haferlach,
Claudia Schoch,
Helmut Löffler,
Winfried Gassmann,
Achim Heinecke,
Maria Christina Sauerland,
Wolfgang Berdel,
Thomas Büchner, and
Wolfgang Hiddemann
From Ludwig-Maximilians-University, University Hospital
Grosshadern, Department of Internal Medicine III, Muenchen,
Germany; Department of Internal Medicine III, St.
Marien-Krankenhaus, Siegen, Germany; and Department of
Biostatistics and Department of Internal Medicine A, Westfälische
Wilhelms-University, Muenster, Germany.
Risk assessment in acute myeloid leukemia (AML) using
pretreatment characteristics may be improved by incorporating
parameters of early response to therapy. In the 1992 trial of the
German AML Cooperative Group (AMLCG), the amount of residual leukemic blasts in bone marrow was assessed one week after the first induction course (day 16 blasts). A total of 449 patients 16 to 76 years of age
(median, 53 years) with de novo AML entered the trial and were
evaluable. Treatment included TAD/HAM (thioguanine, cytosine arabinoside, and daunorubicin/high-dose cytosine arabinoside and mitoxantrone) double induction, TAD consolidation, and randomly either
maintenance therapy or S-HAM consolidation. Cytogenetics were
favorable, intermediate, unfavorable and not available in 10.0%,
48.3%, 13.1%, and 28.5%, respectively. Day 16 blasts ranged from 0% to 100% (median, 5%, mean ± SD, 18.6 ± 28.5%).
Complete remission (CR) rate was 72.6%, 17.6% had persistent leukemia
(PL), and 9.8% succumbed to hypoplastic death. Median overall survival (OS), event-free survival (EFS), and relapse-free survival (RFS) were
18, 9, and 15 months with 28.4%, 21.6%, and 30.1% at 5 years, respectively. As a continuous variable, day 16 blasts were related to
CR rate (P < 0.0001), PL rate
(P < 0.0001), OS (P < 0.0001), EFS
(P < 0.0001), and RFS (P = 0.0049).
Multivariate analyses identified the following parameters to be
associated with the respective end points. CR rate: day 16 blasts
(P < .0001), age (P = .0036), and LDH
(P = .0072); OS: unfavorable cytogenetics (P < .0001), day 16 blasts (P < .0001),
age (P < .0001), and LDH (P = .0040); EFS:
unfavorable cytogenetics (P < .0001), LDH
(P < .0001), day 16 blasts (P < .0001),
and age (P = .0061); RFS: unfavorable cytogenetics
(P < .0001), LDH (P < .0001), and day 16 blasts (P = .0359). The prognostic significance of day 16 blasts is independent of pretherapeutic parameters and predicts outcome even in patients achieving a CR.
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