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Blood, 1 September 2001, Vol. 98, No. 5, pp. 1302-1311
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Attempts to improve treatment outcomes in acute myeloid leukemia
(AML) in older patients: the results of the United Kingdom
Medical Research Council AML11 trial
Anthony H. Goldstone,
Alan
K. Burnett,
Keith Wheatley,
Alastair G. Smith,
R. Michael Hutchinson, and
Richard E. Clark on behalf of the Medical Research
Council Adult Leukaemia Working Party
From the Department of Haematology, University College
Hospital, London; Department of Haematology, University of Wales
College of Medicine, Cardiff; Birmingham Clinical Trials Unit,
University of Birmingham; Department of Haematology, Southampton
University NHS Trust; Department of Haematology, Leicester Royal
Infirmary; Department of Haematology, Royal Liverpool Hospital; all of
the United Kingdom.
In an attempt to improve induction chemotherapy for older patients
with acute myeloid leukemia (AML),1314 patients were randomized to 1 of
3 induction treatments for 2 courses of DAT (daunorubicin, cytarabine,
and thioguanine) 3 + 10, ADE (daunorubicin, cytarabine, and
etoposide) 10 + 3 + 5, or MAC (mitoxantrone-cytarabine). The remission rate in the DAT arm was significantly better than ADE (62%
vs 50%; P = .002) or MAC (62% vs 55%;
P = .04). This benefit was seen in patients younger and
older than 70 years. There were no differences between the induction
schedules with respect to overall survival at 5 years (12% vs 8% vs
10%). A total of 226 patients were randomized to receive granulocyte
colony-stimulating factor (G-CSF) or placebo as supportive care from
day 8 after the end of treatment course 1. The remission rate or
survival were not improved by G-CSF, although the median number of days to recover neutrophils to 1.0 × 109/L was reduced by 5 days. Patients who entered remission (n = 371) were randomized to
stop after a third course (DAT 2 + 7) or after 6 courses, ie, a
subsequent COAP (cyclophosphamide, vincristine, cytarabine, and
prednisolone), DAT 2 + 5, and COAP. The relapse risk (81% vs 73%),
disease-free survival (16% vs 23%), and overall survival at 5 years
(23% vs 22%) did not differ between the 3-course or 6-course arms. In
addition to a treatment duration randomization, 362 patients were
randomized to receive 12-month maintenance treatment with low-dose
interferon, but no benefit was seen with respect to relapse risk,
disease-free survival, or overall survival.
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