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Effects of chlorambucil and therapeutic decision in initial forms of
chronic lymphocytic leukemia (stage A): results of a randomized clinical
trial on 612 patients. 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 612 good prognosis patients
(stage A) received either no treatment (309 patients) or an indefinite
course of chlorambucil at the daily dose of 0.1 mg/kg (303 patients).
Overall survival appeared to be better in the untreated group (50 deceased
patients compared with 62 in the chlorambucil group), but the difference
was not significant (P = .21) even after adjusting for both prognostic and
imbalanced factors (P = .09). The crude 5-year survival rates were 82% in
the untreated group and 75% in the chlorambucil group. The action of
chlorambucil appeared to be a complex phenomenon associating beneficial
effects consisting in slowing down disease progression to stage B or C (P
less than .01), and favoring disease remission with harmful effects given
by a short survival after disease progression to stage B or C in the
chlorambucil group and an increased incidence of epithelial cancers (33 v
19), as well as an excess of epithelial cancer deaths (13 v 3), in the
chlorambucil group. As these results suggested an overall harmful effect of
chlorambucil, we tried to define, within stage A patients, a group of
patients with a low probability of disease progression. We showed that
stage A patients with hemoglobin greater than or equal to 120 g/L and
lymphocyte count less than 30 x 10(9)/L had a survival that was not
significantly different (P = .46) from that of the age- and sex- matched
French population. These patients, accounting for about 50% of all chronic
lymphocytic leukemia patients, should not be treated unless disease
progression is observed.
Volume 75,
Issue 7,
pp. 1414-1421,
04/01/1990
Copyright © 1990 by The American Society of Hematology
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