The following article features coverage from the 2021 American Society of Hematology Annual Meeting. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Cardiac complications were seen in 20% of patients receiving venetoclax with hypomethylating agents (HMA) for the treatment of acute myeloid leukemia (AML) in a single-center study.

These findings were presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

For this study, researchers assessed cardiac outcomes in 170 patients treated at Mayo Clinic in Rochester, Minnesota, between November 2018 and November 2020.

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The patients received venetoclax plus HMAs (azacitidine or decitabine) to treat newly diagnosed or relapsed/refractory AML. Patients who had relapsed after allogeneic transplant were excluded.

The researchers defined a cardiac event as any cardiac complication occurring while treatment was ongoing, said Karen Thompson, MD, an internal medicine resident at Mayo Clinic who presented this study at the meeting.

“This can be a new diagnosis, such as newly diagnosed pericarditis, or a change in baseline cardiac status,” Dr Thompson explained. “Patients with known stable cardiac disease, for example, if they had known stable chronic heart failure with reduced ejection fraction who did not experience any exacerbations or drop in EF on treatment would not have been considered as a cardiac event.”

A total of 48 cardiac events were observed in 34 patients (20%). Most events occurred during treatment cycles 1 (41%) and 2 (26%).

Of the patients with cardiac events, 32% (n=11) had no pre-existing cardiac disease, and 88% (n=30) had no cardiovascular risk factors.

The cardiac events included decreased left ventricular ejection fraction (21%), atrial fibrillation with rapid ventricular response (17%), troponin elevation without electrocardiogram changes (15%), worsening heart failure with preserved ejection fraction (8%), other symptomatic arrhythmia (8%), type 1 non-ST elevation myocardial infarction (6%), symptomatic pericardial effusion or pericarditis (6%), worsening right ventricular dysfunction (6%), cardiogenic pulmonary edema (6%), cardiopulmonary arrest (4%), and worsening coronary artery disease (2%).

Cardiac events caused 27% of patients to interrupt venetoclax-HMA treatment and 21% to discontinue treatment. The events were managed by new medication (77%), admission to the hospital (62%), admission to the intensive care unit (26%), outpatient treatment (12%), or a procedure (6%).

Nine patients died during admission for a cardiac event (27%). None of these patients died as a result of AML.

There were no significant differences in baseline characteristics between the patients who did and did not have cardiac events.

The researchers also compared the current cohort with an independent cohort of 58 AML patients who received an HMA alone. The rate of cardiac events was significantly higher among patients who received venetoclax than those who received an HMA alone — 20% and 9%, respectively (P =.04).

Dr Thompson noted that these findings require validation in multicenter, prospective, real-world studies.

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

Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.


Johnson IM, Bezerra ED, Farrukh F, et al. Cardiac events in patients with acute myeloid leukemia treated with venetoclax in combination with hypomethylating agents. Presented at ASH 2021; December 11-14, 2021. Abstract 219.