The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Hematology Advisor‘s conference coverage.

Among unfit patients with newly diagnosed AML who are not eligible for intensive chemotherapy, survival outcomes may not significantly differ between treatment with azacitidine or decitabine, according to the results of a large retrospective comparison of clinical outcomes presented by Jorge Labrador, of Hospital Universitario de Burgos, in Spain, at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

“[T]here are a few direct comparative data of azacitadine and decitabine in the context of trials or in the real-life setting,” said Mr Labrador.

To help fill this gap, the investigators retrospectively compared clinical outcomes between azacitidine and decitabine in AML patients who were not eligible for intensive chemotherapy in the epidemiologic PETHEMA registry ( Identifier: NCT02607059). Patients included in the study were treated with azacitidine (75 mg/m2/d intravenously or supportive care on days 1-7) or decitabine (20 mg/m2/don days 1-5). The primary endpoints were the composite complete remission (CR) rates (rates of CR and CR with incomplete recovery [CRi]; International Working Group 2003 criteria) and overall survival (OS).

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Data from 638 patients were included in the study (azacitidine, n= 497, 78%; decitabine, n=141, 22%). Baseline characteristics were similar between the groups, except for bone marrow blasts count of 30% or more (59.2% in azacitidine group vs 77.1% in decitabine group, P <.001).

The CR, composite CR (CR plus CRi), and the overall response rates did not significantly differ between the 2 treatment groups (P =.23, P =.35, and P =.20, respectively).

Variables associated with a significantly higher response to azacitidine were Easter Cooperative Oncology Group (ECOG) performance status less than 2 (33.9% vs 12.4% in patients with ECOG ≥2; odds ratio [OR], 0.22; 95% CI, 0.10-0.49, P =.000), de novo AML (35.3% vs 21.9% in secondary AML; OR, 0.38; 95% CI, 0.20-0.71; P =.002), and an estimated glomerular filtrate rate (eGFR) of 45 mL/min/1.73 m2 or more (30.4% vs 9.3% in patients with eGFR ≥45 mL/min/1.73 m2; OR, 0.15; 95% CI, 0.034-0.67; P =.013). Bone marrow blast count less than 50% was the only variable associated with a significantly higher response to decitabine (43.7% vs 25% in ≥50% bone marrow blasts; P =.029).

The median follow up was 12 months, and no significant difference was observed in median OS between the overall azacitidine and decitabine groups (P =.46). For patients who achieved CR/CRi vs partial response vs no response, the median OS was 21 months (95% CI, 17.8-24.1), 16 months (95% CI, 12.6-19.3) and 6 months (95% CI, 5.0-7.0), respectively (P <.001).

Subgroup analyses according to baseline characteristics revealed median OS survival advantages with azacitidine treatment in patients 80 years or older (median OS of 8 months vs 4 months; P =.042), those with white blood cell counts 10 x109/L or more (8 months vs 5 months; P =.036), platelet count less than 20 x109/L (8 months vs 4 months, P =.021), and those with eGFR 45 mL/min/1.73 m2 or more (10 months vs 5 months; P =.033).

“There were no significant differences in overall response rate, complete response rate, or overall survival between azacitadine and decitabine,” concluded Mr Labrador. “However, patients with leukocytes greater than or equal 10,000, platelet count less than 20,000, and estimated glomerular filtrate rate greater than or equal to 45 mL/m could benefit from azacitadine in terms of overall survival.”

Disclosure: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

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Labrador J, Martínez-Cuadrón D, de la Fuente A, et al. Azacitidine vs. decitabine in unfit newly diagnosed acute myeloid leukemia patients: results from the PETHEMA registry. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstract 634.