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A randomized clinical trial of chlorambucil versus COP in stage B chronic
lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic
Leukemia
In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia
started a randomized clinical trial in which intermediate prognosis
patients (stage B) received either an indefinite course of chlorambucil
(0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine,
cyclophosphamide, and prednisone). We present the results of the third
interim analysis based on 291 patients (151 in the chlorambucil group and
140 in the COP group) with a mean follow-up of 53 months at the reference
date of June 1, 1987. At this date, 129 deaths were observed, 65 in the
chlorambucil group and 64 in the COP group; there was no improvement in
overall survival with the COP regimen (P = .44) even after adjusting for
both prognostic and imbalanced factors (P = .24). The 3-year and 5-year
overall survival rates were, respectively, 69% and 44% in the chlorambucil
group as compared with 73% and 43% in the COP group. The median survival
times were 58 months in the chlorambucil group and 57 months in the COP
group. Moreover, no significant difference was observed between the two
treatment groups in terms of either treatment response, 9-month status,
time to disease progression to stage C, or causes of death.
Volume 75,
Issue 7,
pp. 1422-1425,
04/01/1990
Copyright © 1990 by The American Society of Hematology
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