Original Article

International Journal of Hematology

, Volume 90, Issue 3, pp 353-360

First online:

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

  • Hironori HaradaAffiliated withDepartment of Hematology and Oncology, Hiroshima University Email author 
  • , Mitsumasa WatanabeAffiliated withOsaka Red Cross Hospital
  • , Kenshi SuzukiAffiliated withJapan Red Cross Medical Center
  • , Soshi YanagitaAffiliated withShizuoka General Hospital
  • , Takahiro SuzukiAffiliated withDivision of Hematology, Jichi Medical University
  • , Yataro YoshidaAffiliated withTakeda General Hospital
  • , Akiro KimuraAffiliated withDepartment of Hematology and Oncology, Hiroshima University
  • , Mitsuru TsudoAffiliated withOsaka Red Cross Hospital
  • , Akira MatsudaAffiliated withDepartment of Hematology, Saitama International Medical Center, Saitama Medical University
    • , Kaoru TohyamaAffiliated withDepartment of Laboratory Medicine, Kawasaki Medical School
    • , Masafumi TaniwakiAffiliated withDepartment of Hematology and Oncology, Kyoto Prefectural University of Medicine
    • , Kenichi TakeshitaAffiliated withCelgene K.K.
    • , Masaaki TakatokuAffiliated withCelgene K.K.
    • , Keiya OzawaAffiliated withDivision of Hematology, Jichi Medical University

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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

Lenalidomide Myelodysplastic syndromes Chromosome 5q deletion