Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality
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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.
KeywordsLenalidomide Myelodysplastic syndromes Chromosome 5q deletion
- 2.Greenberg PL. Myelodysplastic syndrome. In: Hoffman R, Benz Jr EJ, Shatil SJ, Furie B, Silberstein LE, McGlave P, editors. Hematology: basic principles and practice. 3rd ed. New York: Churchill Livingstone; 2000. p. 1106–29.Google Scholar
- 6.Takatoku M, Uchiyama T, Okamoto S, Kanakura Y, Sawada K, Tomonaga M, et al. Retrospective nationwide survey of Japanese patients with transfusion-dependent MDS and aplastic anemia highlights the negative impact of iron overload on morbidity/mortality. Eur J Haematol. 2007;78:487–94.CrossRefPubMedGoogle Scholar
- 10.National Comprehensive Cancer Network® (NCCN) (2009). Clinical practice guideline in oncology™. Myelodysplastic syndromes. Version 1. Available at http://www.nccn.org/professionals/physician_gls/PDF/mds.pdf.
- 14.An international system for human cytogenetic nomenclature. Shaffer LG, Tommerup N, editors. Basel: S Karger; 2005.Google Scholar
- 15.Alessandrino EP, Amadori S, Barosi G, Cazzola M, Grossi A, Liberato LN, et al. Italian Society of Hematology: evidence- and consensus-based practice guidelines for the therapy of primary myelodysplastic syndromes, a statement from the Italian Society of Hematology. Haematologica. 2002;87:1286–306.PubMedGoogle Scholar
- 17.List AF, Giagounidis A, Brandenburg N, Wride K, Glasmacher A, Germing U. Risk factors for AML transformation and mortality in transfusion-dependent deletion 5q MDS. Haematologica. 2008;93(s1):287. Abstract.Google Scholar
- 19.Celgene Corporation REVLIMID® (lenalidomide) packaging insert. Available at http://www.celgene.com/products/revlimid-thamolid-home.aspx.