Prolonged Administration of Azacitidine With or Without Entinostat for Myelodysplastic Syndrome and Acute Myeloid Leukemia With Myelodysplasia-Related Changes: Results of the US Leukemia Intergroup Trial E1905
作者： Thomas Prebet , Zhuoxin Sun , Maria E. Figueroa , Rhett Ketterling , Ari Melnick
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摘要: Purpose Although azacitidine (AZA) improves survival in patients with high-risk myelodysplastic syndrome, the overall response remains approximately 50%. Entinostat is a histone deacetylase inhibitor that has been combined AZA significant clinical activity previous phase I dose finding study. Design Open label II randomized trial comparing 50 mg/m2/d given for 10 days ± entinostat 4 day 3 and 10. All subtypes of myelodysplasia, chronic myelomonocytic leukemia, acute myeloid leukemia myelodysplasia-related changes were eligible The primary objective was rate hematologic normalization (HN; complete remission + partial trilineage hematological improvement). Results One hundred forty-nine analyzed, including 97 syndrome 52 leukemia. In group, 32% (95% CI, 22% to 44%) experienced HN 27% 17% 39%) group. Both ar...
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