Key clinical point: The administration of decitabine in alternating cycles with sapacitabine vs. decitabine monotherapy did not significantly improve outcomes in older patients with newly diagnosed acute myeloid leukemia (AML) who were unfit or chose not to receive intensive induction chemotherapy.
Major finding: The median overall survival (5.9 months vs. 5.7 months; P = .8902) and rates of complete remission (16.6% vs. 10.8%; P = .1468) were not significantly different in patients receiving decitabine plus sapacitabine vs. decitabine monotherapy.
Study details: Findings are from the phase 3 SEAMLESS trial including 482 elderly patients (age, 70 years or older) with newly diagnosed AML unsuitable or unwilling for intensive induction chemotherapy. Patients were randomly assigned to receive either decitabine in alternating cycles with sapacitabine or decitabine monotherapy.
Disclosures: This study was sponsored by Cyclacel Limited (Dundee, Scotland, United Kingdom). The lead author reported research grants and honoraria from various sources. Other authors reported ties with various pharmaceutical companies including Cyclacel.
Source: Kantarjian HM et al. Cancer. 2021 Aug 23. doi: 10.1002/cncr.33828 .