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

  • Hironori Harada
  • Mitsumasa Watanabe
  • Kenshi Suzuki
  • Soshi Yanagita
  • Takahiro Suzuki
  • Yataro Yoshida
  • Akiro Kimura
  • Mitsuru Tsudo
  • Akira Matsuda
  • Kaoru Tohyama
  • Masafumi Taniwaki
  • Kenichi Takeshita
  • Masaaki Takatoku
  • Keiya Ozawa
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

Authors and Affiliations

  • Hironori Harada
    • 1
  • Mitsumasa Watanabe
    • 2
  • Kenshi Suzuki
    • 3
  • Soshi Yanagita
    • 4
  • Takahiro Suzuki
    • 5
  • Yataro Yoshida
    • 6
  • Akiro Kimura
    • 1
  • Mitsuru Tsudo
    • 2
  • Akira Matsuda
    • 7
  • Kaoru Tohyama
    • 8
  • Masafumi Taniwaki
    • 9
  • Kenichi Takeshita
    • 10
  • Masaaki Takatoku
    • 10
  • Keiya Ozawa
    • 5
  1. 1.Department of Hematology and OncologyHiroshima UniversityHiroshimaJapan
  2. 2.Osaka Red Cross HospitalOsakaJapan
  3. 3.Japan Red Cross Medical CenterTokyoJapan
  4. 4.Shizuoka General HospitalShizuokaJapan
  5. 5.Division of HematologyJichi Medical UniversityTochigiJapan
  6. 6.Takeda General HospitalKyotoJapan
  7. 7.Department of HematologySaitama International Medical Center, Saitama Medical UniversitySaitamaJapan
  8. 8.Department of Laboratory MedicineKawasaki Medical SchoolOkayamaJapan
  9. 9.Department of Hematology and OncologyKyoto Prefectural University of MedicineKyotoJapan
  10. 10.Celgene K.K.TokyoJapan