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Acute myeloid leukemia (AML) is a common blood tumor in the elderly, with approximately 40-60% of AML patients over 60 years of age achieving complete remission through standard induced chemotherapy, but most patients (80-90%) subsequently relapse, resulting in a decrease in overall survival.
researchers recently conducted a randomized, double-blind, placebo-controlled Phase III study to examine the effects of the low methylated drug aza cytosine oral agent (CC-486) on maintenance of treatment after chemotherapy remission in AML patients.
AML patients over 55 years of age participated in the study to achieve complete remission after standard induced chemotherapy, without considering the recovery of the patient's blood count and without a hematopoietic stem cell transplant program.
were randomly treated with 300 mg CC-486 or a placebo, once a day for 14 days and 1 treatment cycle every 28 days.
end of the study was total lifetime, and the secondary endpoint was non-relapse and health-related quality of life.
472 patients in the study, including 238 in the CC-486 group and 234 in the placebo group, with an average age of 68.
the CC-486 group had a higher average survival than the placebo group (24.7 months vs 14.8 months) and the recurrence period was longer than the placebo group (10.2 vs. 4.8 months).
in most subgroups, the benefits of CC-486 in terms of overall and recurrence are also significant. The most common adverse events between
groups were level 1-2 gastrointestinal reactions, and the most common level 3 or 4 adverse events were neophilic white blood cell reduction (CC-486 vs placebo: 41% vs 24%) and plate reduction (22% vs 21%).
the quality of life of patients is not affected during CC-486 treatment.
in elderly patients with acute myeloid leukemia who achieved remission after induced chemotherapy, receiving oral azatide (CC-486) maintenance therapy extended the overall survival and recurrence period.
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