title: Recombinant human granulocyte-macrophage colony-stimulating factor after chemotherapy in patients with acute myeloid leukemia at higher age or after relapse.
abstract: To reduce critical neutropenia after chemotherapy (CT) for acute myeloid leukemia (AML) we administered recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) to patients over the age of 65 years with newly diagnosed AML and to patients with early or second relapse. CT was 9-day 6-thioguanine, ara-C, and daunorubicin (TAD9) in newly diagnosed AML and sequential high-dose ara-C and mitoxantrone (S-HAM) for relapse. In patients whose bone marrow was free from blasts a continuous intravenous infusion of GM-CSF 250 micrograms/m2/d started on day 4 after CT. Thirty-six patients entered the study and 30 of them did receive GM-CSF. For comparison, a historical control group of 56 patients was used. Complete remission rate was 50% (18 of 36) versus 32% in controls (P = .09), and early death rate was 14% versus 39% (P = .009). Treatment with GM-CSF was not associated with major adverse events. Two patients showed a marked leukemic regrowth that was completely reversible in one patient and appeared to be GM-CSF independent in the other patient. Remission duration does not seem to be reduced after GM-CSF. Under GM-CSF the blood neutrophils recovered 6 and 9 days earlier in the TAD9 (P = .009) and S-HAM (P = .043) groups associated with a rapid clearance of infections in most patients. We conclude that GM-CSF was of therapeutic benefit to our patients and this provides a basis for larger controlled trials.
authors.affiliation: Department of Hematology/Oncology, University of Münster, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Büchner
authors.forename: W
authors.initials: W
authors.lastname: Hiddemann
authors.forename: M
authors.initials: M
authors.lastname: Koenigsmann
authors.forename: M
authors.initials: M
authors.lastname: Zühlsdorf
authors.forename: B
authors.initials: B
authors.lastname: Wörmann
authors.forename: A
authors.initials: A
authors.lastname: Boeckmann
authors.forename: E A
authors.initials: EA
authors.lastname: Freire
authors.forename: G
authors.initials: G
authors.lastname: Innig
authors.forename: G
authors.initials: G
authors.lastname: Maschmeyer
authors.forename: W D
authors.initials: WD
authors.lastname: Ludwig
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007951:Leukemia, Myeloid / Q000097:blood* / Q000188:drug therapy / Q000401:mortality; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009503:Neutropenia / Q000139:chemically induced / Q000628:therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction; D013866:Thioguanine / Q000008:administration & dosage
chemical_list: D011994:Recombinant Proteins; D003561:Cytarabine; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D008942:Mitoxantrone; D013866:Thioguanine; D003630:Daunorubicin