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Older Patients With Untreated AML: Azacitidine Versus Triplet Regimen

By: Jenna Carter, PhD
Posted: Tuesday, May 18, 2021

An article published in Cancer reported findings from a phase III trial examining the effects of a semi-intensive chemotherapy regimen on elderly patients newly diagnosed with acute myeloid leukemia (AML). Pau Montesinos, MD, of the Hospital Universitari i Politècnic La Fe Valencia, Spain, and colleagues assessed compared outcomes with the triplet regimen fludarabine, cytarabine, and filgrastim (FLUGA) and azacitidine. Their findings revealed that although FLUGA achieved more remissions after three treatment cycles, the 1-year overall survival rate was better with azacitidine.

“[U]sing conventional chemotherapy, a sizable proportion of older patients (≥ 65 years) could achieve a first complete remission, which is clearly associated with improved survival,” stated Dr. Montesinos and colleagues. “This study supports the use of an azacitidine backbone for future combinations in elderly patients with AML.”

A total of 283 patients who were 65 years or older and diagnosed with AML were included in this trial. Patients were randomly assigned 1:1 to receive FLUGA (n = 141) or azacitidine (n = 142) and evaluated after treatment cycles 1, 3, 6, and 9. Efficacy and safety assessments included comparing overall survival rates between the two groups at 1, 2, and 3 years following treatment. Secondary endpoints included analyses of event-free, disease-free, and relapse-free survival. Additionally, hematologic and nonhematologic toxicities were assessed for both arms of treatment.  

Their findings revealed the complete remission rate after three cycles were higher in the FLUGA arm versus the azacitidine arm (18% vs. 9%; P = .04). However, the 1-year overall survival rate and the median overall survival were better with azacitidine: 47% versus 27% and 9.8 months (95% confidence interval [CI] = 5.6–14 months) versus 4.1 months (95% CI = 2.7–5.5 months; P = .005), respectively. Toxicity analyses revealed more frequent hematologic toxicities with FLUGA, especially during induction.

Disclosure: For full disclosures of the study authors, visit

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