International Journal of Hematology

, Volume 90, Issue 3, pp 353–360

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

Authors

    • Department of Hematology and OncologyHiroshima University
  • Mitsumasa Watanabe
    • Osaka Red Cross Hospital
  • Kenshi Suzuki
    • Japan Red Cross Medical Center
  • Soshi Yanagita
    • Shizuoka General Hospital
  • Takahiro Suzuki
    • Division of HematologyJichi Medical University
  • Yataro Yoshida
    • Takeda General Hospital
  • Akiro Kimura
    • Department of Hematology and OncologyHiroshima University
  • Mitsuru Tsudo
    • Osaka Red Cross Hospital
  • Akira Matsuda
    • Department of HematologySaitama International Medical Center, Saitama Medical University
  • Kaoru Tohyama
    • Department of Laboratory MedicineKawasaki Medical School
  • Masafumi Taniwaki
    • Department of Hematology and OncologyKyoto Prefectural University of Medicine
  • Kenichi Takeshita
    • Celgene K.K.
  • Masaaki Takatoku
    • Celgene K.K.
  • Keiya Ozawa
    • Division of HematologyJichi Medical University
Original Article

DOI: 10.1007/s12185-009-0400-8

Cite this article as:
Harada, H., Watanabe, M., Suzuki, K. et al. Int J Hematol (2009) 90: 353. doi:10.1007/s12185-009-0400-8

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 ≥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.

Keywords

LenalidomideMyelodysplastic syndromesChromosome 5q deletion

Copyright information

© The Japanese Society of Hematology 2009