title: A multicenter randomized, double-blind, placebo-controlled late-phase II/III study of recombinant human interleukin 11 in acute myelogenous leukemia.
abstract: To investigate the efficacy of using recombinant human interleukin 11 (rhIL-11) to reduce the need for platelet transfusions, we performed a randomized, double-blind phase II/III study with 110 acute myelogenous leukemia (AML) patients in the first complete remission. Following chemotherapy patients were subcutaneously administered either placebo (n=37) or rhIL-11 at a dose of 25 microg/kg (n=37) or 50 microg/kg (n=36). rhIL-11 administration was well tolerated. There was no difference between the rhIL-11 and placebo groups in the frequency and volume of platelet transfusions. In a perprotocol analysis set (101 patients), the platelet transfusion frequency in the 50-microg/kg group (3.0 +/- 1.76 times) was significantly lower than in the placebo group (3.9 +/-2.35 times; multiplicity-adjusted P= .049). We analyzed infection-related events retrospectively. The frequency of fever was significantly decreased in the 50-microg/kg, 25-microg/kg, and placebo groups (66.7%, 70.3%, and 89.2%, respectively; P= .018, Cochran-Armitage test). Stomatitis was less frequent in the 50-microg/kg and 25-microg/kg groups (2.8% and 0%, respectively) than in the placebo group (21.6%, P= .0012). These results show that rhIL-11 does not reduce the platelet transfusion requirement in AML patients, but the retrospective analysis confirms the previous finding that rhIL-11 reduces infection in patients undergoing chemotherapy.
authors.affiliation: Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan. usuki@kmc.mhc.east.ntt.co.jp
authors.forename: Kensuke
authors.initials: K
authors.lastname: Usuki
authors.forename: Akio
authors.initials: A
authors.lastname: Urabe
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mizoguchi
authors.forename: Fumimaro
authors.initials: F
authors.lastname: Takaku
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007239:Infections / Q000188:drug therapy / Q000209:etiology; D017370:Interleukin-11 / Q000008:administration & dosage* / Q000494:pharmacology; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017713:Platelet Transfusion; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D013280:Stomatitis / Q000188:drug therapy / Q000209:etiology
chemical_list: D017370:Interleukin-11; D010919:Placebos; D011994:Recombinant Proteins