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

Baron, Frédéric; Suciu, Stefan; Amadori, Sergio; Muus, Petra; Zwierzina, Heinz; Denzlinger, Claudio; Delforge, Michel; Thyss, Antoine; Selleslag, Dominik; Indrak, Karel; Ossenkoppele, Geert; De Witte, Theo

doi:10.3324/haematol.2011.044347

Article (Scientific journals)

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

Baron, Frédéric; Suciu, Stefan; Amadori, Sergio et al.

2012 • In Haematologica, 97 (4), p. 529–533

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/112511

DOI
10.3324/haematol.2011.044347

PubMed
22102701

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Keywords :

infliximab; tumor necrosis factor alpha; MDS; myelodysplastic syndrome; phase II; randomized

Abstract :

[en] 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 heumatoid 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 versus 5 mg/kg). The primary endpoint 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.

Disciplines :

Hematology

Author, co-author :

Baron, Frédéric ; Université de Liège - ULiège > GIGA-R : Hématologie

Suciu, Stefan; EORTC Headquarters (Brussels)

Amadori, Sergio; Tor Vergata University Hospital (Rome, Italy)

Muus, Petra; Radboud University Nijmegen Medical Centre (The Netherlands)

Zwierzina, Heinz; Medizinische Universitätsklinik (Innsbruck, Austria)

Denzlinger, Claudio; Medical Clinic III (Stuttgart, Germany)

Delforge, Michel; University Hospital Gasthuisberg (Leuven, Belgium)

Thyss, Antoine; Centre Antoine-Lacassagne (Nice, France)

Selleslag, Dominik; Algemeen Academisch Ziekenhuis St Jan (Bruges-Oostende, Belgium)

Indrak, Karel; University Hospital Olomouc (Czech Republic)

Ossenkoppele, Geert; Vrije Universiteit Medical Centre (Amsterdam, The Netherlands)

De Witte, Theo; Medizinische Universitätsklinik (Innsbruck, Austria)

Language :

English

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

Publication date :

2012

Journal title :

Haematologica

ISSN :

0390-6078

eISSN :

1592-8721

Publisher :

Ferrata Storti Foundation, Pavia, Italy

Volume :

Issue :

Pages :

529–533

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 22 February 2012

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