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A double-blind controlled study of granulocyte colony-stimulating factor
started two days before induction chemotherapy in refractory acute myeloid
leukemia. Kohseisho Leukemia Study Group [see comments]
R Ohno, T Naoe, A Kanamaru, M Yoshida, A Hiraoka, T Kobayashi, T Ueda, S Minami, Y Morishima and Y Saito
Department of Medicine, Nagoya University Branch Hospital, Japan.
We conducted a prospective, double-blind controlled study to determine the
efficacy of a recombinant granulocyte colony-stimulating factor (G- CSF,
200 microgram/m2) starting daily from 2 days before an induction therapy
until neutrophils recovered to above 1,500/microL or until 35 days after
the therapy in 58 patients with relapsed or refractory acute myeloid
leukemia (AML). Twenty-eight patients in the G-CSF group showed
significantly faster recovery of neutrophils (P < .001) than 30 patients
in the placebo group. The incidence of febrile episodes and of documented
infections was almost the same in both groups. However, among 39 patients
who did not show any infectious episodes during the 2- week period after
the start of chemotherapy, the incidence of documented infections after the
third week tended to be lower in the G- CSF group, but not statistically
significantly. There was no evidence that G-CSF stimulated the growth of
AML cells in the bone marrow during the 2-day period before the
chemotherapy, nor that G-CSF accelerated the regrowth of AML cells during
the 5-week period after the therapy. Fifty percent of patients in the G-CSF
group and 37% in the placebo group had complete remission (CR). Although
the rate was higher in the G-CSF group, the difference was not
statistically significant (P = .306). There was no difference between the
two groups in event-free survival of all patients and in disease-free
survival of patients who had achieved CR.
Volume 83,
Issue 8,
pp. 2086-2092,
04/15/1994
Copyright © 1994 by The American Society of Hematology
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