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Romiplostim-Treated Patients: No Increased AML Risk
Lancet Haematol; ePub 2018 Jan 25; Kantarjian, et al
Use of romiplostim is not linked with increased risk of acute myeloid leukemia (AML) or death, according to a 5-year follow-up of a phase 2, multicenter, double-blind trial involving 222 individuals. Participants were between the ages of 18 and 90 years and had lower-risk myelodysplastic syndromes. They had platelet counts of either 1) ≤20 × 109/L with or without a history of bleeding or 2) ≤50 × 109 platelets/L with a history of bleeding. Patients were randomized to receive either 750 μg romiplostim (n=139) or placebo (n=83) subcutaneously weekly for 58 weeks. Investigators looked at survival and progression to AML. Among the results:
- 12% of romiplostim-treated patients progressed to AML, compared with 11% of those treated with placebo (a difference that was not statistically significant).
- Death occurred in 56% and 54%, respectively (also not a statistically significant difference).
Kantarjian H, Fenaux P, Sekeres M, et al. Long-term follow-up for up to 5 years on the risk of leukaemic progression in thrombocytopenic patients with lower-risk myelodysplastic syndromes treated with romiplostim or placebo in a randomised double-blind trial. [Published online ahead of print January 25, 2018]. Lancet Haematol. doi:10.1016/S2352-3026(18)30016-4.