We read with great interest the manuscript by Baron and colleagues entitled “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”.1 The reported findings showed that infliximab displayed modest efficacy in patients with low-risk myelodysplastic syndrome (MDS). However, since a combination of infliximab and chemotherapy might represent a promising therapeutic strategy for MDS and acute myeloid leukemia (AML) patients, two safety issues should be considered.
The first issue concerns the possible risk of secondary malignancies associated with infliximab treatment. We recently diagnosed chronic myeloid leukemia (CML) in chronic phase (high Sokal risk; e14a2, high BCR-ABLIS transcript 74.6%) in a 54-year old patient with rheumatoid arthritis who had been taken infliximab (5 mg/kg) for five years (from 2002 to 2007). Because of his newly diagnosed CML, he is now receiving tyrosine kinase inhibitor therapy (imatinib mesylate 400 mg daily) and has achieved a major molecular remission after 12 months. Thi is by no means an isolated case, since other accounts of lymphoproliferative or myeloproliferative disorders in patients receiving tumor necrosis alpha inhibitors have been published in the literature.2–6 Therefore, although a direct causative link between infliximab and increased risk of second hematologic disorders has not been established, a warning should be raised.
A second issue relates to the potential risk of infections in patients treated with infliximab. Baron et al. reported a high cumulative incidence of grade 3–5 infections in both arms of their study (41% of patients in the 3 mg/kg arm and 19% of patients in the 5 mg/kg arm).1 This finding might represent a second warning signal when using infliximab in patients with hematologic malignancies because of the suppressive effect that the drug might exert on normal hematopoietic progenitors.7
In conclusion, while infliximab might represent a promising agent with therapeutic activity in both MDS and AML, potential toxicities associated with this drug might warrant further assessment of its safety profile in specific subpopulations.
Footnotes
The information provided by the authors about contributions from persons listed as authors and in acknowledgments is available with the full text of this paper www.haematologica.org.
Financial and other disclosures provided by the authors using the ICMJE (www.icmje.org) Uniform Format for Disclosure of Competing Interests are also available www.haematologica.org.
References
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