title: Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality.
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.
authors.affiliation: Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan. herf1@hiroshima-u.ac.jp.
authors.forename: Hironori
authors.initials: H
authors.lastname: Harada
authors.affiliation: Osaka Red Cross Hospital, Osaka, Japan.
authors.forename: Mitsumasa
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Japan Red Cross Medical Center, Tokyo, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: Shizuoka General Hospital, Shizuoka, Japan.
authors.forename: Soshi
authors.initials: S
authors.lastname: Yanagita
authors.affiliation: Division of Hematology, Jichi Medical University, Tochigi, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: Takeda General Hospital, Kyoto, Japan.
authors.forename: Yataro
authors.initials: Y
authors.lastname: Yoshida
authors.affiliation: Department of Hematology and Oncology, Hiroshima University, Hiroshima, Japan.
authors.forename: Akiro
authors.initials: A
authors.lastname: Kimura
authors.affiliation: Osaka Red Cross Hospital, Osaka, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Tsudo
authors.affiliation: Department of Hematology, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Matsuda
authors.affiliation: Department of Laboratory Medicine, Kawasaki Medical School, Okayama, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Tohyama
authors.affiliation: Department of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.affiliation: Celgene K.K., Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Takeshita
authors.affiliation: Celgene K.K., Tokyo, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Takatoku
authors.affiliation: Division of Hematology, Jichi Medical University, Tochigi, Japan.
authors.forename: Keiya
authors.initials: K
authors.lastname: Ozawa
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide
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