Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: Phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial
The Lancet Haematology May 08, 2019
Garcia-Manero G, et al. - In hypomethylating agent treatment-naive or relapsed or refractory patients with intermediate-risk or high-risk myelodysplastic syndromes, researchers compared two doses of guadecitabine (a next-generation hypomethylating agent) with respect to activity and safety. Having Eastern Cooperative Oncology Group performance status of 0–2 was required to be eligible. Either subcutaneous guadecitabine 60 or 90 mg/m2 was randomly (1:1) administered on days 1–5 of a 28-day treatment cycle. Findings revealed clinical activity as well as acceptable tolerability of guadecitabine in patients with intermediate-risk and high-risk myelodysplastic syndromes. Based on the responses and overall survival observed in the relapsed or refractory cohort, it could be potentially therapeutic in patients with unsuccessful outcomes with currently available hypomethylating agents. For these patients, guadecitabine at a dose of 60 mg/m 2 on a 5-day schedule was recommended.
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