Newly diagnosed patients with
acute myeloid leukemia (AML) were randomized to receive either 2.5 or 5 microg/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/m(2)
daunorubicin on days 1-3, 100 mg/m(2)
cytarabine (
ARA-C) for 7 days, and 2
gm/m(2) 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 x 10(9)/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 x 10(9)/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. (Blood. 2000;95:2530-2535)