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Clinical Trial
. 2012 Apr;97(4):529-33.
doi: 10.3324/haematol.2011.044347. Epub 2011 Nov 18.

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

Frédéric Baron  1 , Stefan Suciu, Sergio Amadori, Petra Muus, Heinz Zwierzina, Claudio Denzlinger, Michel Delforge, Antoine Thyss, Dominik Selleslag, Karel Indrak, Gert Ossenkoppele, Theo de Witte
Affiliations
Clinical Trial

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

Frédéric Baron et al. Haematologica. 2012 Apr.

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.

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Figures

Figure 1.
Figure 1.
Progression-free survival from randomization according to infliximab dosage arm (A) or IPSS score (B). P value given by the Wald test (Cox’s model).
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