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Blood, 15 June 2002, Vol. 99, No. 12, pp. 4343-4349
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Gemtuzumab ozogamicin with or without interleukin 11 in patients
65 years of age or older with untreated acute myeloid leukemia and
high-risk myelodysplastic syndrome: comparison with idarubicin plus
continuous-infusion, high-dose cytosine arabinoside
Elihu H. Estey,
Peter F. Thall,
Francis J. Giles,
Xue-Mei Wang,
Jorge E. Cortes,
Miloslav Beran,
Sherry A. Pierce,
Deborah
A. Thomas, and
Hagop M. Kantarjian
From the Departments of Leukemia and Biostatistics, The
University of Texas MD Anderson Cancer Center, Houston, TX.
We investigated treatment with gemtuzumab ozogamicin (GO) in 51 patients aged 65 years or older with newly diagnosed acute myeloid
leukemia (AML), refectory anemia (RA) with excess of blasts in
transformation, or RA with excess blasts. GO was given in doses of 9 mg/m2 of body-surface area on days 1 and 8 or,
therapeutically equivalently, on days 1 and 15, with or without
interleukin 11 (IL-11; 15 µg/kg per day on days 3 to 28), with
assignment to IL-11 treatment made randomly. Complete remission (CR)
rates were 2 of 26 (8%) for GO without IL-11 and 9 of 25 (36%) for GO
with IL-11. Regression analyses indicated that IL-11 was independently
predictive of CR but not survival. We compared GO with or without IL-11
with idarubicin plus cytosine arabinoside (IA), as previously
administered, in similar patients. The CR rate with IA was 15 of 31 (48%), and survival was superior with IA compared with GO with or
without IL-11 (P = .03). Besides accounting for possible
covariate effects on outcome, we also accounted for possible trial
effects (TEs) arising because IA and GO with or without IL-11 were not
arms of a randomized trial. Bayesian posterior probabilities that GO with or without IL-11 produced longer survival than IA, after accounting for covariates and TEs, were less than 0.01 in patients with
abnormal cytogenetic findings (AC) and less than 0.15 in patients with
normal cytogenetic findings (NC). Regarding CR, the analogous
probabilities were less than 0.02 for GO without IL-11 (all cytogenetic
groups), and for GO with IL-11, less than 0.25 for AC groups and about
0.50 for NC groups. TEs 2 to 5 times the magnitude of those previously
observed would be needed to conclude that survival with GO with or
without IL-11 is likely longer than with IA. Thus, there is little
evidence to suggest that GO with or without IL-11 should be used
instead of IA in older patients with newly diagnosed AML or
myelodysplastic syndrome.
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