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41 In this study, 214 patients received lenalidomide at a dose of 10 mg daily or 10 mg on days 1�C21 of a 28 day cycle. Twenty-six percent of patients achieved transfusion independence. Cyclopamine nmr Grade 3 or 4 neutropenia was observed in 30% of patients, and grade 3 or 4 thrombocytopenia was seen in 25% of patients. In a retrospective study that utilized data gathered from two Phase II trials described above,38,41 Sekeres et al investigated the relationship of treatment-related cytopenias and response to lenalidomide in patients with lower-risk MDS.42 In these studies, MDS patients with the 5q deletion developed treatment-related thrombocytopenia at higher rates than patients without the 5q abnormality. Among patients with the 5q deletion, 70% percent of patients whose platelet count decreased by 50% or more experienced transfusion independence, compared to transfusion independence in only 42% in patients whose platelet counts decreased by less than 50%. Moreover, among patients with the 5q deletion who did not have baseline neutropenia, 82% of those whose absolute neutrophil count decreased by 75% or more achieved transfusion independence, compared Selleck Sotrastaurin with 51% of those whose absolute neutrophil count remained stable. The authors conclude that their results corroborate a direct cytotoxic effect specific to the clone possessing the 5q deletion. Lenalidomide is not currently approved for IPSS intermediate-2- or high-risk MDS but has been used in this setting. In a Phase II trial, 47 patients with higher-risk MDS harboring the 5q deletion received lenalidomide at a dose of 10 mg daily. Twenty-seven percent of patients achieved a hematologic response, including seven patients who achieved morphologic complete remission (CR). Interestingly, 35% of patients with initial platelet counts greater than 100,000/mm3 achieved CR, compared to none of the patients with platelet counts lower than 100,000/mm3. AML Lenalidomide is not approved for use in AML but has been used increasingly in the setting of relapsed/refractory AML and in older patients with AML. One report describes Mdm2 sustained morphologic and cytogenetic CR in two AML patients, ages 71 and 68 years, treated with high-dose single-agent lenalidomide.43 Each patient had trisomy 13 as their sole cytogenetic abnormality. Moreover, high-dose lenalidomide has been examined in a Phase II study of patients 60 years of age or older.44 Patients received up to two 28-day cycles of lenalidomide at a dose of 50 mg daily followed by low-dose maintenance (10 mg daily). Thirty percent of patients achieved CR or CR with incomplete recovery of blood counts (CRi). CR/CRi was seen only in patients who had white blood cell counts
