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Blood, 1 March 2002, Vol. 99, No. 5, pp. 1527-1535
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
A randomized study of interferon- versus interferon- and
low-dose arabinosyl cytosine in chronic myeloid leukemia
Michele Baccarani,
Gianantonio Rosti,
Antonio de Vivo,
Francesca Bonifazi,
Domenico Russo,
Giovanni Martinelli,
Nicoletta Testoni,
Marilina Amabile,
Mauro Fiacchini,
Enrico Montefusco,
Giuseppe Saglio, and
Sante Tura for the Italian Cooperative Study Group on Chronic
Myeloid Leukemia
From the L. and A. Seràgnoli Institute of
Hematology and Medical Oncology, S. Orsola Hospital, University of
Bologna, Italy; Division of Hematology, Udine University Hospital,
Italy; Division of Hematology, La Sapienza, Rome University, Italy; and
Division of Internal Medicine, University of Turin at Orbassano, Italy.
Interferon- (IFN-) has significantly prolonged survival in
chronic myeloid leukemia (CML), but some patients do not respond and
many responses are not durable. To improve the results, IFN- has
been combined with other treatments, but so far only the association with low-dose arabinosyl cytosine (LDAC) has been shown to increase the
response rate and to prolong survival. Here are
reported the results of a study of 538 Philadelphia
chromosome-positive CML patients who were assigned at random
to treatment with IFN-2a alone or in combination with LDAC.
The scheduled dose of IFN-2a was 56
IU/m2/d. The scheduled dose of AC was 40 mg/d for the first 10 days of each month of treatment. The
efficacy endpoints were a complete hematologic response rate at 6 months (62% in the IFN--plus-LDAC arm versus 55% in the IFN-
arm; P = .11), major cytogenetic response (MCgR) rate at
24 months (28% versus 18%; P = .003), and overall survival (5-year survival, 68% versus 65%; P = .77).
Treatment did not affect overall survival within different prognostic
risk groups: low, intermediate, or high. Also the duration of MCgR was
identical. The results of this study confirm the results of a similar
French study only for the response rate, not for survival, suggesting
that the relationship between cytogenetic response and survival may be
extremely variable and that a meta-analysis of these and other studies
of IFN- versus IFN- plus LDAC is required to settle the issue of
the role of LDAC in the treatment of CML.
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