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Treatment of newly diagnosed acute myelogenous leukemia with
granulocyte-macrophage colony-stimulating factor (GM-CSF) before and during
continuous-infusion high-dose ara-C + daunorubicin: comparison to patients
treated without GM-CSF
E Estey, PF Thall, H Kantarjian, S O'Brien, CA Koller, M Beran, J Gutterman, A Deisseroth and M Keating
Department of Hematology, University of Texas M.D. Anderson Cancer Center,
Houston 77030.
We gave 56 patients with newly diagnosed acute myelogenous leukemia (AML)
granulocyte-macrophage colony-stimulating factor (GM-CSF) 20 or 125
micrograms/m2 once daily subcutaneously before (for up to 8 days or until
GM-CSF-related complications developed) and during, or only during
(patients presenting with blast counts greater than 50,000 or other
leukemia-related complications) ara-C (1.5 g/m2 daily x 4 by continuous
infusion) and daunorubicin (45 mg/m2 daily x 3) chemotherapy. Because
results seemed independent of GM-CSF schedule, we compared results in these
56 patients with results in 176 patients with newly diagnosed AML given the
same dose and schedule of ara-C without GM-CSF (110 patients ara-C alone,
66 patients ara-C + amsacrine or mitoxantrone). Comparison involved fitting
a logistic regression model predicting probability of complete remission
(CR) and a Cox regression model to predict survival (most patients in all
three studies were dead) with treatment included as a covariate in both
analyses. After adjusting for other prognostically significant covariates
[presence of an antecedent hematologic disorder, an Inv (16), t(8;21), or
abnormalities of chromosomes 5 and/or 7, performance status, age,
bilirubin], treatment with ara-C + daunorubicin + GM-CSF was predictive of
both a lower CR rate and a lower survival probability. There were no
treatment-covariate interactions, suggesting that the negative effect of
this GM-CSF treatment regime was not an artifact of some imbalance in
patient characteristics. The unadjusted Kaplan-Meier hazard rate of the
ara-C + daunorubicin + GM-CSF group was not uniquely high during the
initial 4 weeks after start of therapy, but was highest among the three
treatment groups throughout weeks 5 to 16, suggesting that the negative
effect of this treatment was not caused by acute toxicity. Patients who did
not enter CR with this treatment tended to have persistent leukemia rather
than prolonged marrow aplasia, suggesting that this treatment and, in
particular, GM-CSF may increase resistance of myeloid leukemia cells to
chemotherapy. To date, relapse rates are similar in all three groups (P =
.43) (as are survival rates once patients are in CR) but much of the
remission duration data is heavily censored, unlike the survival data. Our
results suggest caution in the use of GM-CSF to sensitize myeloid leukemia
cells to daunorubicin + ara- C chemotherapy.
Volume 79,
Issue 9,
pp. 2246-2255,
05/01/1992
Copyright © 1992 by The American Society of Hematology
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