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A randomized placebo-controlled phase III study of granulocyte- macrophage
colony-stimulating factor in adult patients (> 55 to 70 years of age)
with acute myelogenous leukemia: a study of the Eastern Cooperative
Oncology Group (E1490)
JM Rowe, JW Andersen, JJ Mazza, JM Bennett, E Paietta, FA Hayes, D Oette, PA Cassileth, EA Stadtmauer and PH Wiernik
Hematology Unit, University of Rochester Medical Center, NY 14642, USA.
The treatment of adult patients greater than 55 to 70 years of age with
acute myelogenous leukemia (AML) is associated with a treatment-related
mortality of approximately 25%. This prospective, double-blind randomized
study was designed to see if the use of granulocyte- macrophage colony
stimulating factor (GM-CSF; yeast-derived) could shorten the period of
neutropenia and to determine any effect this would have on therapy-related
morbidity and mortality. A total of 124 patients entered this study.
Induction consisted of standard daunorubicin and cytarabine. A day-10 bone
marrow was examined; if this was aplastic without leukemia, patients
received blinded placebo or GM- CSF from day 11 until neutrophil recovery.
Patients who entered complete remission received the identical study
medication (blinded GM- CSF or placebo) in consolidation that they had
received during induction. The overall complete remission rate was 52%; 60%
for the GM- CSF arm and 44% for the placebo arm (P = .08). Median times to
neutrophil recovery were significantly shortened on the GM-CSF arm. The
overall treatment-related toxicity from start of GM-CSF/placebo was reduced
on the GM-CSF arm (P = .049). Similarly, the infectious toxicity was
significantly reduced on the GM-CSF arm (P = .015). The median survival for
all patients was 10.6 months in the GM-CSF group and 4.8 months in the
placebo arm (P = .048). It appears that GM-CSF is safe and efficacious for
adult patients greater than 55 to 70 years of age with AML; its major
impact is in reducing the duration of neutropenia and therapy-related
mortality and morbidity. This may result in a better response rate.
Volume 86,
Issue 2,
pp. 457-462,
07/15/1995
Copyright © 1995 by The American Society of Hematology
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