Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality.
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.
Harada
Hironori
H
Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan. herf1@hiroshima-u.ac.jp.
Watanabe
Mitsumasa
M
Osaka Red Cross Hospital, Osaka, Japan.
Suzuki
Kenshi
K
Japan Red Cross Medical Center, Tokyo, Japan.
Yanagita
Soshi
S
Shizuoka General Hospital, Shizuoka, Japan.
Suzuki
Takahiro
T
Division of Hematology, Jichi Medical University, Tochigi, Japan.
Yoshida
Yataro
Y
Takeda General Hospital, Kyoto, Japan.
Kimura
Akiro
A
Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan.
Tsudo
Mitsuru
M
Osaka Red Cross Hospital, Osaka, Japan.
Matsuda
Akira
A
Department of Hematology, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
Tohyama
Kaoru
K
Department of Laboratory Medicine, Kawasaki Medical School, Okayama, Japan.
Taniwaki
Masafumi
M
Department of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Takeshita
Kenichi
K
Celgene K.K., Tokyo, Japan.
Takatoku
Masaaki
M
Celgene K.K., Tokyo, Japan.
Ozawa
Keiya
K
Division of Hematology, Jichi Medical University, Tochigi, Japan.
D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics*; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D044466:Asian People / Q000235:genetics / Q000706:statistics & numerical data; D002872:Chromosome Deletion; D002895:Chromosomes, Human, Pair 5; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics*; D012307:Risk Factors; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide
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