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The treatment for elderly patients with high-risk myelodysplastic syndrome and low blast count acute myeloid leukemia (AML) involves the hypomethylating agents (HMA) azacitidine and decitabine.1 Azacitidine treatment failure results in poor survival for patients with high-risk relapsed/refractory (R/R) AML.2 The novel second-generation HMA guadecitabine (SGI-110) allows for extended decitabine exposure due to the dinucleotide structure and degradation resistance.3 This provides the opportunity for guadecitabine to be used as salvage therapy for patients ineligible for stem cell transplantation or intensive chemotherapy.
Marie Sébert from Hématologie Clinique, Hôpital Saint-Louis, Paris, France, and colleagues conducted a multicenter phase II (NCT02197676) study to evaluate the efficacy and safety of guadecitabine in patients with high-risk myelodysplastic syndrome and low blast count R/R AML (n = 56; median age = 75 years; range, 69–76), who have failed azacitidine therapy.1 Patients received (n = 55) subcutaneous guadecitabine (60 mg/m2/d, days 1–5 of 28-day cycle) therapy until progression, no response, toxicity, or death. The primary endpoint of this study was to assess hematological response.
In conclusion, the study authors suggested that guadecitabine therapy may be beneficial to some patients following azacitidine therapy failure. Additionally, the results indicate that patients with primary azacitidine failure may be better candidates for guadecitabine therapy than patients with secondary azacitidine failure.
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