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Blood, Vol. 95 No. 8 (April 15), 2000:
pp. 2530-2535
A double-blind, placebo-controlled trial of pegylated recombinant
human megakaryocyte growth and development factor as an adjunct to
induction and consolidation therapy for patients with acute myeloid
leukemia
Charles A. Schiffer,
Kenneth Miller,
Richard A. Larson,
Philip C. Amrein,
Joseph H. Antin,
Valter J. Zani, and
Richard M. Stone
From the Barbara Ann Karmanos Cancer Institute, Wayne
State University School of Medicine, Detroit, MI; the Greenebaum Cancer
Center at the University of Maryland, Baltimore, MD; the New England
Medical Center, Tufts University School of Medicine, Boston, MA; the
University of Chicago, Chicago, IL; Massachusetts General Hospital,
Brigham and Women's Hospital (Dana Farber Cancer Institute) at Harvard
Medical School, Cambridge, MA; and Amgen Inc, Thousand Oaks, CA.
Newly diagnosed patients with acute myeloid leukemia
(AML) were randomized to receive either 2.5 or 5 µg/kg/day of
pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or a placebo administered subcutaneously after completion of chemotherapy. The study evaluated the toxicity of PEG-rHuMGDF and
any effect on the duration of thrombocytopenia. Each of 35 patients
under 60 years of age received the following therapy: 45 mg/m2 daunorubicin on days 1-3, 100 mg/m2
cytarabine (ARA-C) for 7 days, and 2 gm/m2 high-dose ARA-C
(HIDAC) for 6 doses on days 8-10. The 22 patients 60 years or older
received standard daunorubicin and ARA-C without HIDAC. PEG-rHuMGDF was
well tolerated, and no specific toxicities could be attributed to its
use. There was no difference in the time to achieve a platelet count of
at least 20 × 109/L among the 3 groups (median 28-30 days
for patients less than 60 years old and 21-23 days for patients 60 years or older). Patients receiving PEG-rHuMGDF achieved higher
platelet counts after remission. However there was no significant
difference in the number of days on which platelet transfusions were
administered among the 3 groups. The complete remission rate was 71%
for patients less than 60 years and 64% for those 60 years or older,
with no significant difference among the 3 groups. Postremission
consolidation chemotherapy with either placebo or PEG-rHuMGDF was given
to 28 patients beginning the day after completion of chemotherapy.
There was no apparent difference in the time that was necessary to
reach a platelet count of at least 20 or 50 × 109/L or more platelets or in the number of platelet
transfusions received. In summary, PEG-rHuMGDF was well tolerated by
patients receiving induction and consolidation therapy for AML;
however, there was no effect on the duration of severe thrombocytopenia or the platelet transfusion requirement.
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