Decitabine. Acute myeloid leukaemia: no progress.

Acute myeloid leukaemia is a life-threatening disease. Its incidence increases with age. There is no consensus on treatment for patients over 60 years of age who cannot receive first-line high-dose chemotherapy. Options include low-dose cytarabine, other non-intensive chemotherapy regimens, or tailored supportive care. Decitabine, a cytotoxic drug related to cytarabine, has been authorised for patients aged 65 years or older who are not eligible for intensive chemotherapy. Clinical evaluation of decitabine in this setting is mainly based on an unblinded randomised controlled trial including 485 patients, who received either decitabine, or low-dose cytarabine or symptomatic treatment alone. There was no statistically significant difference in overall survival between the two active treatment groups (median about 6 months). Serious adverse events occurred in 80% of patients in the decitabine group, compared to 73% of those in the cytarabine group. They consisted mainly of haematological disorders (neutropenia, thrombocytopenia, anaemia), infections (pneumonia) and gastrointestinal disorders. In practice, for patients at least 65 years of age with acute myeloid leukaemia who are not candidates for intensive chemotherapy, decitabine has no advantages over existing treatments in terms of survival time or adverse effects. Low-dose cytarabine or tailored supportive care are better-assessed options.