title: Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group.
abstract: Tumor-necrosis factor alpha activity has been correlated to ineffective erythropoiesis in lower risk myelodysplastic syndromes. Infliximab (Remicade(®)) is an anti-tumor necrosis factor alpha chimeric antibody that is used in the treatment of patients with rheumatoid arthritis or Crohn's disease. Forty-six patients with myelodysplastic syndromes and a relatively low risk of developing acute leukemia were included in a randomized phase II study assessing the therapeutic activity of two dosages of infliximab administration (3 mg/kg vs. 5 mg/kg). The primary end point was the response rate. Responses were observed in 3 of 22 patients (13.1%) randomized to the 3 mg/kg arm, versus 0 of 21 patients randomized in the 5 mg/kg arm. According to the statistical design of the current study, neither of the two infliximab dose schedules tested showed sufficient activity as a single agent in this cohort of unselected patients with early myelodysplastic syndrome.
authors.affiliation: University of Liège, Liège, Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Baron
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Petra
authors.initials: P
authors.lastname: Muus
authors.forename: Heinz
authors.initials: H
authors.lastname: Zwierzina
authors.forename: Claudio
authors.initials: C
authors.lastname: Denzlinger
authors.forename: Michel
authors.initials: M
authors.lastname: Delforge
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.forename: Dominik
authors.initials: D
authors.lastname: Selleslag
authors.forename: Karel
authors.initials: K
authors.lastname: Indrak
authors.forename: Gert
authors.initials: G
authors.lastname: Ossenkoppele
authors.forename: Theo
authors.initials: T
authors.lastname: de Witte
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
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