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Alternating v repeated postremission treatment in adult acute myelogenous
leukemia: a randomized phase III study (AML6) of the EORTC Leukemia
Cooperative Group
R Zittoun, U Jehn, D Fiere, C Haanen, B Lowenberg, R Willemze, J Abels, J Bury, M Peetermans and M Hayat
Service d'Hematologie, Hotel-Dieu, Paris, France.
The value of a postremission treatment in acute myelogenous leukemia (AML),
with alternating combinations of non-cross-resistant drugs, has been
prospectively assessed. Of 515 evaluable patients, 347 (67.4%) entered into
complete remission (CR), following induction treatment with daunorubicin
(DNR), vincristine (VCR), and cytosine arabinoside (ara-C). After one
consolidation course, 248 patients were randomized for six courses of
intensive maintenance: either repeated treatment with DNR-VCR-ara-C, or
alternating treatment where amsacrine (AMSA) was combined with high dose
ara-C on cycle 1,3, and 5 and with 5- azacytidine on cycle 2, 4, and 6.
Ninety-nine patients were not randomized: 57 were introduced in a bone
marrow transplantation (BMT) program, and 42 went off study, mainly for
treatment toxicity or refusal. The main prognostic factors for achievement
of CR were performance status, cytogenetics, and age, and for the
disease-free survival (DFS): age and number of courses to CR. The rate of
second remission was fairly high (64%) for patients relapsing off therapy.
The DFS appeared identical (median, 53 weeks), in the two randomized arms,
the alternating treatment not showing superiority to the repeated one, in
spite of an increased toxicity. The median overall survival for patients
achieving a CR was 90 weeks. The reason for the failure of alternating
maintenance treatment to improve the DFS is probably related to an
insufficient dose intensity: five patients who relapsed during maintenance
arm B achieved a second CR with a more intensive combination of high-dose
ara-C and AMSA. In addition, 60 patients underwent a BMT (43 allogeneic and
17 autologous). The DFS of patients treated with allogeneic BMT tended to
be superior to the one obtained with the chemotherapy program. However the
overall survival, as well as the event-free survival, seemed equivalent,
including patients who relapsed before the planned BMT. Comparisons between
allogeneic BMT, autologous BMT, and intensive consolidation during first CR
deserve further prospective studies in AML.
Volume 73,
Issue 4,
pp. 896-906,
03/01/1989
Copyright © 1989 by The American Society of Hematology
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