Efficacy and Effectiveness of Azacitidine In Elderly Patients with Acute Myeloid Leukemia and Blasts Counts below 30%: Experience of the Spanish Registry

The incidence of acute myeloid leukemia (AML) increases exponentially with age. Elderly patients normally have a previous hematologic condition like myelodysplastic syndrom (MDS), cytogenetic abnormalities that correlate with resistance to conventional chemotherapy schemes and a shorter duration of response. Not only responses are worse, also the hospitalization duration is longer, and the mortality associated to the treatment is higher (30%). Therefore, treating these patients with standard chemotherapy schemes is associated, in many cases, to a low probability of obtaining satisfactory results. Introducing less toxic and/or more efficient agents can change the course of the illness for this sub-group of patients. Azacitidine (AZA) is a hypomethylating drug recently approved in Europe for the treatment of AML with 20 – 30% blasts.

We present clinical data analysis of a longitudinal, multicenter and retrospective Spanish patients’ registry of patients with de novo and relapse AML. Data on the course of the disease and managment of patients with de novo and relapse AML with low blasts count (20-30%) treated with AZA under compasionate use were analized.

Twentyfive patients (male/female 13/12) with a median age of 67 years with AML were included in the registry. Ten patients (40%) had refractory/relapsed AML and had received previous treatment with intensive chemotherapy. Cytogenetic alterations were reported in 10 patients (4 monosomy-7). An average of 7 cycles of AZA were administered to the patients (range 1–25). The most frequently used dose was 75 mg (82%), of which 28% received a scheme of 5 days, 24% received a scheme of 5+2 and 48% of 7 days. The global responses were of 56% with 20% of complete responses. The most frequent toxicity described was hematologic.

Our data corroborates, with a similar rate of responses, what Journal of Clinial Oncology published about the sub analysis of the AZA-001. 5-Azacitidine is an efficient and safe drug in patients with AML. Good response rates and a toxicity and mortality related to the acceptable treatment in this sub-group of patients.

García:Celgene: Research Funding. Bargay:Celgene: Research Funding.