Incidence of tumor lysis syndrome (TLS) was increased during the first days of venetoclax (Ven) with azacitidine or decitabine (ie, hypomethylating agents [HMAs]) therapy, according to results of a retrospective study published in Leukemia Research.

Venetoclax is associated with risk for TLS, and the United States Food and Drug Administration (FDA) recommends a ramp-up dosing schedule to mitigate the risk. Despite this recommendation, little is understood about the real-world trends in TLS and infection risk among patients receiving HMA/Ven.

For this study, data from 106 patients with acute myeloid leukemia (AML) treated with HMA/Ven at the University of Alabama at Birmingham between 2017 and 2021 were reviewed for trends in TLS and infection.

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Patients were median age 70 years (range, 21 to 88), 58.4% were men, 76.4% were White, 68% had de novo AML, and 8.4% had undergone stem cell transplantation prior to HMA/Ven. Compared with patients who received HMA/Ven as a second line or beyond therapy, patients who received HMA/Ven as a first-line therapy (61 vs 45) were significantly older (72 vs 64; P <.00001) and had not undergone stem cell transplantation (0% vs 20%; P =.0003).

Laboratory TLS was observed in 18%, and 5% met the criteria for clinical TLS. The median time to TLS was 2 days. Most patients (14) received no intervention, 6 received rasburicase, and 1 received increased intravenous fluid.

An infection was diagnosed during the first HMA/Ven cycle in 24.5% of patients and 27.3% had febrile neutropenia.

Overall survival was lower among patients who developed an infection or febrile neutropenia during the first cycle compared with patients who did not develop either (median, 4.9 vs 11.6 months).

However, data were sourced from a single center, and these trends should be confirmed with an independent cohort.

Real-world evidence from this study suggested that risk for TLS and infection were increased in the initial days of HMA/Ven treatment in patients with AML, patients should be monitored closely during this period, and infection and febrile neutropenia during the first cycle associated with reduced overall survival.

Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Arora S, Zainaldin C, Bathini S, et al. Tumor lysis syndrome and infectious complications during treatment with venetoclax combined with azacitidine or decitabine in patients with acute myeloid leukemia. Leuk Res. 2022;117:106844. doi:10.1016/j.leukres.2022.106844