A retrospective study involving patients with acute myeloid leukemia (AML) showed no significant differences between azacitidine (AZA) and decitabine (DEC) for upfront treatment in terms of overall survival (OS) or response. The study results were reported in the journal Cancer (Basel).

In this multicenter analysis (ClinicalTrials.gov Identifier: NCT02607059) of the PETHEMA registry, based in Spain, outcomes were evaluated for patients receiving AZA or DEC as initial therapy. AZA was given at 75 mg/m2/d for 7 days, either intravenously or subcutaneously, and DEC was given at 20 mg/m2/d intravenously for 5 days. The primary study end point was OS, while treatment response and other outcomes were secondary end points. Possible predictors associated with outcomes were also analyzed.

The analysis included 626 patients with AML, 487 of whom received AZA, while 139 were treated with DEC. The median patient age for the overall population was 75.06 years (range, 29.18-89.85), and median ages were 74.89 years with AZA and 75.68 years with DEC. Median OS for the total study population was 10.0 months (95% CI, 8.9-11.2). The 1-year OS rate for the total population was 40.7%, and the 3-year OS rate was 5.3%. The median follow-up time for patients who were alive was 12.29 months (range, 0.99-88.38).

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By treatment group, the AZA group had a median OS of 10.4 months (95% CI, 9.2-11.7), compared with 8.8 months (95% CI, 6.7-11.0) for DEC (P =.455). The 1-year OS rates were 41.9% with AZA and 36.4% with DEC (P =.269), and the 3-year OS rates were 6.1% with AZA and 1.9% with DEC (P =.091).

Among evaluable patients, complete remission (CR) rates were 17.9% in the AZA group and 23.4% in the DEC group, which were not significantly different (P =.201). The rates of CR plus CR with incomplete recovery were 20.5% with AZA and 25% with DEC, which were also similar (P =.276). Overall responses rates (ORRs) were not significantly different between treatment arms, at 32% for the AZA group and 39.5% for the DEC group (P =.120).

Factors that were associated with a significantly OS benefit with AZA, compared with DEC, included a platelet count of <20×109/L, an age of ≥80 years, a leukocyte count of ≥10×109/L, and an estimated glomerular filtration rate of ≥45 mL/min/1.73 m2. Factors associated with a significantly higher ORR with DEC, compared with AZA, included a bone marrow blast count <50%, a leukocyte count of <10×109/L, and a European Cooperative Oncology Group Performance Status score of ≥2.

“In conclusion, we found no differences in the response rates and OS between first-line treatment with AZA or DEC in a large retrospective cohort of newly-diagnosed AML, patients with long-term follow-up,” the study investigators concluded in their report. However, they also indicated that the results may suggest certain subgroups react more favorably with either agent.


Labrador J, Martínez-Cuadrón D, de la Fuente A, et al; on behalf of PETHEMA Group. Azacitidine vs. decitabine in unfit newly diagnosed acute myeloid leukemia patients: results from the PETHEMA Registry. Cancers (Basel). 2022;14(9):2342. doi:10.3390/cancers14092342