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RAEBt-5 CMMoL-3 IPSS-low-4 Inl-1-4 Int-2-9 High-7

IWG, international working group; IPSS, International Prognostic Scoring System; WHO, World Health Organization; CR, complete remission; PR, partial remission; ITT, intent to treat; POD, progression of disease; RA, refractory anemia; RARS, refractory anemia with ringed sideroblasts; RAEB, refractory anemia with excess blasts.

weeks (median not reached). In addition, lenalido-mide induced major cytogenetic responses, including reversion to a normal karyotype in 10 patients. Response rates were highest in the RA subtype (82%), the IPSS Low/Int-1 risk groups (71%), in patients who never received rHuEPO (100%), and in patients with the 5q- cytogenetic abnormality (91% or 10/11 patients). Lenalidomide was well tolerated, with dose-dependent myelosuppression (neutropenia, thrombo-cytopenia) being the most common adverse event. Results from two recently completed, mutlicenter phase II trials, evaluating lenalidomide for 5q--patients and for non-5q- MDS patients, will likely be reported in 2005. The apparent sensitivity of patients with the 5q- cytogenetic anomaly to lenalidomide is unexplained, as is the mechanism of action of lenalidomide or thalidomide.

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