Cardiac Risk Factors and Adverse Events Among Patients With CLL Treated in Real-World Setting

A recent study comparing cardiac risk factors and adverse events among patients with chronic lymphocytic leukemia (CLL) receiving first-line treatment found that ibrutinib monotherapy may result in higher rates of cardiovascular adverse events when compared to other treatments.

CLL is commonly treated with first-line ibrutinib monotherapy, however, it is associated with cardiovascular adverse events. Real-world data on this subject is limited.

“The aim of this study was to compare baseline cardiac risk factors and cardiovascular adverse events in patients receiving [first-line] ibrutinib monotherapy vs intensive therapy (aggressive, less tolerable, majority were bendamustine plus anti-CD20 antibody) or non-intensive therapy (less aggressive, more tolerable, majority were anti-CD20 antibody alone),” wrote Anthony Mato, MD, Memorial Sloan Kettering Cancer Center, New York, NY, and colleagues.

The team compared clinical characteristics, baseline cardiovascular risk factors, and subsequent cardiovascular adverse events among patients with CLL receiving ibrutinib monotherapy, intensive therapy, and non-intensive therapy. Patients included in this study were 18 years or older with a CLL/SLL diagnosis, had 2 or more clinic encounters, and initiated first-line treatment between January 1, 2016 and December 31, 2019. Data on 515 patients was collected and included from the Flatiron Health database.

Significance was assumed if P <.05 in descriptively comparing baseline characteristics and subsequent cardiovascular adverse events between patients receiving ibrutinib monotherapy, intensive therapy, and non-intensive therapy.

Of those included in this study, 191 were treated with ibrutinib monotherapy, 195 with intensive therapy, and 129 with non-intensive therapy.

The mean age at baseline for those in in the ibrutinib monotherapy group was 71.2 years, 66.2 years in the intensive therapy group, and 74.5 years in the non-intensive therapy group.

The ibrutinib monotherapy group had a significantly higher proportion of del(17p)compared to the intensive therapy and non-intensive therapy groups (ibrutinib monotherapy, 26.7%; intensive therapy, 3.6%; non-intensive therapy, 3.1%). In comparing the ibrutinib monotherapy group vs the intensive therapy group, researchers found significant differences in baseline ECOG (ECOG 0:  28.8% vs 43.1%, respectively), diabetes mellitus (56% vs 44.1%), and hypercholesterolemia (68.6% vs 58%). In comparing the ibrutinib monotherapy group vs the intensive therapy group, researchers found significant differences in new or worsening atrial fibrillation/atrial flutter (11.5% vs 5.1%), other arrhythmias (9.4% vs 3.1%), and hypertension (20.4% vs 8.2%).

“This is one of the first real-world studies focused specifically on [first-line] CLL to describe baseline cardiovascular risk factors and compare cardiovascular adverse events in CLL patients treated with ibrutinib monotherapy as compared to intensive therapy or non-intensive therapy,” wrote Dr Mato and colleagues, concluding, “Results show higher cardiovascular adverse event rates of atrial fibrillation/atrial flutter, other arrhythmias, and hypertension for ibrutinib monotherapy vs intensive therapy.”—Marta Rybczynski