Azacitidine prolongs survival in elderly patients with acute myeloid leukemia

NEW YORK (Reuters Health) - Azacitidine prolongs overall survival and reduces morbidity in older patients with low marrow blast count acute myeloid leukemia (AML), according to a report in the December 21st Journal of Clinical Oncology.

These patients "clearly benefited from azacitidine treatment...with half of patients in the azacitidine group still alive at 2 years compared with only 16% in the conventional care regimen group," the researchers say.

Led by Dr. Pierre Fenaux from Universite Paris XIII, Bobigny, France, the investigators compared the relative efficacy and safety of azacitidine versus conventional care in 113 elderly patients (median age, 70 years) with AML with low bone marrow blast counts (20% to 30%), diagnosed according to current World Health Organization (WHO) criteria.

These patients were a subset of a larger cohort of participants in a phase III randomized trial of azacitidine versus conventional care for intermediate-2- and high-risk myelodysplastic syndromes.

The conventional care regimens included best supportive care only, low-dose cytarabine, or intensive chemotherapy. Fifty-five of the elderly AML patients had been randomized to the azacitidine arm; the other 58 were each assigned to one of the conventional care regimens.

After a median follow-up time of 20.1 months, the median overall survival was significantly longer in the azacitidine group (24.5 months) than in the conventional care regimens group (16.0 months; p = 0.005), the authors report.

Two-year overall survival was 50% in the azacitidine group and 16% in the conventional care regimens group (p = 0.001.)

Overall survival was longer for azacitidine than for best supportive care, but not significantly different in a comparison of azacitidine with low-dose cytarabine. The azacitidine group required fewer IV antibiotics and fewer hospital days than the low-dose cytarabine group, however.

For patients deemed unfit for intensive chemotherapy, azacitidine provided the best overall survival duration and rate (p < 0.0003). In these individuals, median overall survival and 2-year overall survival, respectively, were 24.5 months and 51% with azacitidine versus 16.4 months and 13% with conventional care regimens.

More patients in the azacitidine group than in the conventional care regimens group achieved red blood cell (but not platelet) transfusion independence.

"Azacitidine prolongs survival and is well tolerated when compared with conventional and low-dose induction chemotherapy in older adult patients with WHO-defined AML with low bone marrow blast counts," the authors conclude.

"The activity of azacitidine in AML with greater degrees of bone marrow infiltration (> 30% bone marrow blasts) is currently under investigation," they add.

Dr. Fenaux told Reuters Health that results from that investigation are not expected for another 2 or 3 years.

Funding for the study was provided by Celgene, which markets azacitidine as Vidaza.

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