Azacitidine/Venetoclax Combination as First-Line Therapy in Elderly Patients with Acute Myeloid Leukemias: A First Step

MA Granatkin1,2, EA Nikitin1,2, ES Mikhailov1, VA Doronin1, SV Minenko1, MM Okuneva1,2, NV Degtyareva1, ME Pochtar1,2, SA Lugovskaya1,2, YuN Kobzev1, OYu Vinogradova1, VV Ptushkin1,2

1 SP Botkin City Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

2 Russian Medical Academy of Postgraduate Education, 2/1 Barrikadnaya ul., Moscow, Russian Federation, 125993

For correspondence: Prof. Evgenii Aleksandrovich Nikitin, MD, PhD, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284; Tel.: +7(916)572-06-44; e-mail:

For citation: Granatkin MA, Nikitin EA, Mikhailov ES, et al. Azacitidine/Venetoclax Combination as First-Line Therapy in Elderly Patients with Acute Myeloid Leukemias: A First Step. Clinical oncohematology. 2022;15(3):282–8. (In Russ).

DOI: 10.21320/2500-2139-2022-15-3-282-288


Background. The treatment of elderly patients with acute myeloid leukemias (AML) is one of the most formidable challenges in oncohematology. Hypomethylating drugs combined with venetoclax show relatively high efficacy and lower toxicity in elderly AML patients.

Aim. To retrospectively analyze the efficacy and tolerability of the combined azacitidine/venetoclax therapy in AML primary patients of older age as well as to determine a spectrum of issues related to the implementation of this regimen in real-world clinical practice.

Materials & Methods. The retrospective analysis enrolled a cohort of patients followed-up at the Botkin City Clinical Hospital (n = 35). The median age was 73 years (range 60–90 years), 57 % of patients were over 70 years of age. The median follow-up duration was 5.2 months (range 1.6–42.6 months). By the time of final analysis 15 patients were still receiving the therapy. The median of overall survival was 11.1 months (95% confidence interval [95% CI] 8.1–14.1 months). The causes of death in 20 patients were AML progression (n = 3), non-COVID-19 infectious complications (n = 3), and COVID-19 (n = 10). In 4 patients the cause of death remained unidentified.

Results. Complete remission (CR) was documented in 17 (48.5 %) patients; CR with incomplete hematologic recovery was identified in 9 (26 %) patients. The median time before achieving remission was 67 days (range 27–120 days). In 96 % of patients CR was achieved after 3 azacitidine/venetoclax cycles. The mean CR duration was 9.2 months (95% CI 5.7–12.6 months); the median time before loss of response was 19 months. Relapses were diagnosed in 5 patients. Neutropenia > grade 3 was identified in patients who achieved remission on subsequent therapy cycles in 100 % of cases (n = 26), anemia > grade 2 was reported in 9 (34 %) patients, and thrombocytopenia > grade 3 was detected in 13 (50 %) patients. Despite frequent neutropenia, patients with remission did not show any severe infectious complications.

Conclusion. The combined azacitidine/venetoclax therapy in elderly patients yields remission in more than 70 % of cases and is not marked by any severe infectious complications, despite developing neutropenia. Due to its ease of administration and low toxicity, this regimen can be performed in outpatient units.

Keywords: acute myeloid leukemias, efficacy of therapy, venetoclax, hypomethylating drugs.

Received: January 31, 2022

Accepted: May 5, 2022

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