A randomized controlled trial of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome (MDS) receiving decitabine
Abstract MDS patients receiving hypomethylating agents commonly develop thrombocytopenia. This double-blind study evaluated the efficacy and safety of romiplostim, a peptibody protein that increases platelets, in MDS patients receiving decitabine. Patients received romiplostim 750μg (n=15) or placebo (n=14) and decitabine. Median platelet counts at the beginning of each decitabine cycle trended lower in placebo treated than romiplostim treated patients. Bleeding events occurred in 43% of placebo and 27% of romiplostim patients; platelet transfusions were administered to 57% of placebo and 47% of romiplostim patients. Overall clinical therapeutic response was achieved by 21% of placebo and 33% of romiplostim patients. Treatment was generally well tolerated. Progression to AML occurred in one patient per group. Adding romiplostim to decitabine treatment is well tolerated and may be beneficial, as indicated by trends toward higher platelet counts at the beginning of each treatment cycle and lower platelet transfusion rates and percentages of patients with bleeding events.
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