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A randomized trial comparing interferon-alpha with busulfan for newly
diagnosed chronic myelogenous leukemia in chronic phase
K Ohnishi, R Ohno, M Tomonaga, N Kamada, K Onozawa, A Kuramoto, H Dohy, H Mizoguchi, S Miyawaki and K Tsubaki
Department of Medicine III, Hamamatsu University School of Medicine, Japan.
A multicenter randomized study was conducted to compare the effect of
interferon-alpha (IFN-alpha) with that of busulfan in newly diagnosed
patients with chronic myelogenous leukemia (CML) in chronic phase. From
October 1988 to October 1991, 170 patients were randomized to receive
either IFN-alpha or busulfan. Of 159 eligible patients, 31 (38.8%) of 80
patients in the IFN-alpha group and 43 (54.4%) of 79 patients in the
busulfan group achieved complete hematologic remission, and 38.8% in the
IFN-alpha group and 43.0% in the busulfan group achieved partial
hematologic remission. A complete cytogenetic response was induced in seven
(8.8%) of 80 patients treated with IFN-alpha and two (2.5%) of 79 patients
treated with busulfan, and a partial cytogenetic response was 7.5% (6/80)
and 2.5% (2/79), respectively. The difference in major (complete and
partial) cytogenetic response between the two groups was significant (P =
.046). At a median follow-up of 50 months, the predicted 5-year survival
rate was 54% in the IFN-alpha group and 32% in the busulfan group (P =
.0290), and the predicted 5-year rate of remaining in chronic phase was 41%
in the IFN-alpha group and 29% in the busulfan group (P = .1165). As
compared with the patients with no cytogenetic response, the patients with
any cytogenetic response (complete, partial or minor) after the IFN-alpha
or busulfan treatment were significantly superior in the duration of
chronic phase (IFN-alpha group; P = .0017, busulfan group; P = .0010) even
after correction for the time to response using the landmark analysis.
However, there was no significant difference in survival rate in the
IFN-alpha group (P = .1065). There was no significant difference in
survival rate (P = .3923) and the duration of chronic phase (P = .6258)
between the IFN- alpha and the busulfan group in the patients with a
cytogenetic response (complete, partial or minor). These results
demonstrate that IFN-alpha treatment produces a significantly superior
cytogenetic response and survival rate as compared with the busulfan
treatment, and unexpectedly, that busulfan can also eliminate Philadelphia
chromosome positive clone in a few patients who showed prolonged survival
rate and duration of chronic phase.
Volume 86,
Issue 3,
pp. 906-916,
08/01/1995
Copyright © 1995 by The American Society of Hematology
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