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Randomized comparison of DAT versus ADE as induction chemotherapy in
children and younger adults with acute myeloid leukemia. Results of the
Medical Research Council's 10th AML trial (MRC AML10). Adult and Childhood
Leukaemia Working Parties of the Medical Research Council
IM Hann, RF Stevens, AH Goldstone, JK Rees, K Wheatley, RG Gray and AK Burnett
Medical Research Council, London, UK.
The relative efficacy and toxicity of the chemotherapeutic agents
thioguanine (6TG) and etoposide (VP16) were assessed by a randomized
comparison of the DAT (daunorubicin, cytarabine, thioguanine) versus ADE
(daunorubicin, cytarabine, etoposide) regimens in the Medical Research
Council's 10th acute myeloid leukaemia trial (MRC AML 10), which was open
to patient entry from May 1988 to April 1995. In this, the largest reported
trial of AML therapy to date, 1,857 eligible patients, mostly less than 56
years old, were randomized: 929 (including 143 children under 15 years old)
were allocated to DAT and 928 (143 children) to ADE. The two groups were
well matched for presentation features. The complete remission (CR) rate
was 81% with DAT and 83% with ADE (P = .3). The percentages of remitters
achieving remission after 1, 2, or more than 2 courses were 70%, 22%, and
8% for DAT and 74%, 21%, and 5% for ADE. The percentages failing to achieve
a CR due to resistant disease were 11% with DAT versus 9% with ADE (P =
.07). There was a slightly higher death rate in CR during consolidation
chemotherapy with ADE (9%) than with DAT (6%) (P = .06). Patients receiving
DAT took slightly but significantly longer to recover from neutropenia and
thrombocytopenia but the median number of days in hospital were similar in
each group. ADE patients experienced slightly more severe nonhematologic
toxicity. There was also no significant difference between the groups in
the longer-term measures of efficacy: disease-free survival at 6 years from
CR was 42% (+/-4) for DAT and 43% (+/-4) for ADE (P = .8); relapse rate at
6 years was 50% (+/-4) for DAT and 49% (+/-5) for ADE (P = .6); survival at
6 years was 40% (+/-4) for both DAT and ADE (P = .9). Subgroup analysis
failed to show any benefit for etoposide in patients with monocytic or
myelomonocytic disease, or in any other diagnostic subgroup. In conclusion,
DAT and ADE both achieve high remission rates and good long-term survival,
and are equally effective chemotherapy regimens for the treatment of AML
patients aged up to 55 years.
Volume 89,
Issue 7,
pp. 2311-2318,
04/01/1997
Copyright © 1997 by The American Society of Hematology
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