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Int J Hematol. 2009 Oct;90(3):353-360. doi: 10.1007/s12185-009-0400-8. Epub 2009 Aug 25.

Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality.

Author information

1
Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan. herf1@hiroshima-u.ac.jp.
2
Osaka Red Cross Hospital, Osaka, Japan.
3
Japan Red Cross Medical Center, Tokyo, Japan.
4
Shizuoka General Hospital, Shizuoka, Japan.
5
Division of Hematology, Jichi Medical University, Tochigi, Japan.
6
Takeda General Hospital, Kyoto, Japan.
7
Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan.
8
Department of Hematology, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
9
Department of Laboratory Medicine, Kawasaki Medical School, Okayama, Japan.
10
Department of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
11
Celgene K.K., Tokyo, Japan.

Abstract

Lenalidomide is an immunomodulatory agent recently reported to be effective in the treatment of transfusion-dependent anemia due to low- or intermediate-1 risk myelodysplastic syndromes (MDS) associated with a deletion 5q (del 5q) cytogenetic abnormality. We conducted a multicenter, single-arm clinical trial to evaluate the safety and efficacy of lenalidomide in Japanese patients with anemia in low- or intermediate-1 risk MDS associated with the del 5q cytogenetic abnormality. Eleven patients (5 with transfusion-dependent anemia; 6 with transfusion-independent symptomatic anemia) received once daily oral administrations of 10 mg of lenalidomide for 21 consecutive days in a 28-day treatment cycle. The efficacy was assessed by the IWG criteria. At an interim analysis after > or =24 weeks of therapy, hemoglobin increase was noted in all 11 patients, with a median increase of 6.0 g/dL (range, 0.9-10.9) from the baseline. All transfusion-dependent patients achieved transfusion independence. Histopathologic and cytogenetic improvement was also noted. Neutropenia and thrombocytopenia were the most common adverse events related to lenalidomide. The adverse events were manageable, and no patients experienced serious adverse events or adverse events requiring treatment discontinuation. The results indicate that lenalidomide can be a useful agent for treating Japanese patients with anemia associated with low- or intermediate-1 risk MDS with the del 5q cytogenetic abnormality.

PMID:
19705057
DOI:
10.1007/s12185-009-0400-8
[Indexed for MEDLINE]

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