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Concomitant granulocyte colony-stimulating factor and induction
chemoradiotherapy in adult acute lymphoblastic leukemia: a randomized phase
III trial
OG Ottmann, D Hoelzer, E Gracien, A Ganser, K Kelly, R Reutzel, T Lipp, FW Busch, M Schwonzen and G Heil
Department of Internal Medicine, University of Frankfurt, Munich, Germany.
This prospective multicenter study examined whether simultaneous
administration of granulocyte colony-stimulating factor (G-CSF; Filgrastim)
and induction chemotherapy for adult acute lymphoblastic leukemia (ALL)
could prevent treatment-related neutropenia, infections, and resulting
treatment delays. Seventy-six patients were randomly assigned to receive
either G-CSF (n = 37) or no growth factor (n = 39) in conjunction with a
uniform chemotherapy consisting of cyclophosphamide, cytarabine,
mercaptopurine, intrathecal methotrexate, and cranial irradiation. The
median duration of neutropenia (absolute neutrophil count < 1 x 10(9)/L)
during chemotherapy was 8 days in patients receiving C-CSF, compared with
12.5 days in the control group (P < .002). A similar reduction from 11.5
to 7 days was observed in patients with T-ALL receiving additional
mediastinal irradiation (P = .13). Infections occurred in 43% and 56% of
patients in the G-CSF and control arm, respectively (P = .25); the
incidence of nonviral infections was reduced by 50%, from 32 episodes in
the control arm to 16 episodes in the G-CSF arm. Prolonged interruptions of
chemotherapy administration were less frequent, with delays of 2 weeks or
more occurring in only 24% of patients receiving G-CSF as opposed to 46% in
the control arm (P = .01). Accordingly, chemotherapy was completed
significantly earlier with the use of G-CSF (39 v 44 days, P = .008). With
a median follow-up of 20 months, the probability of disease-free survival
was 0.45 in the G-CSF group and 0.43 in the control group (P = .34). In
conclusion, adult ALL patients appear to benefit by the simultaneous
administration of G-CSF with induction chemotherapy because of a
significant reduction in the duration of neutropenia, a trend to fewer
infections, and a more rapid completion of chemotherapy.
Volume 86,
Issue 2,
pp. 444-450,
07/15/1995
Copyright © 1995 by The American Society of Hematology
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