期刊
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL
卷 97, 期 4, 页码 529-533出版社
FERRATA STORTI FOUNDATION
DOI: 10.3324/haematol.2011.044347
关键词
infliximab; tumor necrosis factor alpha; TNF-alpha; MDS; myelodysplastic syndrome; phase II; randomized
类别
资金
- National Cancer Institute (Bethesda, Maryland, USA) [5U10 CA11488-32, 2U10 CA011488-41]
- Fonds Cancer (FOCA) from Belgium
- Centocor R&D, Inc., Great Valley Parkway, Malvern, PA, US
Tumor-necrosis factor alpha activity has been correlated to ineffective erythropoiesis in lower risk myelodysplastic syndromes. Infliximab (Remicade (R)) 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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